Pharmaceutical Jurisprudence: January 2012

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Pharmaceutical Jurisprudence
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About this book
Provides a set of learning objectives at the beginning of

each experiment.
Explains theory and principle involved in the experiment
in details.
Reviews mathematical tools required for calculations of
various pharmacokinetic parameters.
Includes applications of the experiment alongwith study
problems and practice exercise to understand the
experiment in great details.
Design of the experiments helps the students record the
observations directly.
About this book

Development of Pharmacy Profession in India | 05
Chapter 2
PHARMACEUTICAL LEGISLATION IN INDIA
Learning objectives
When you have finished this chapter you should be able to:
1. define pharmaceutical legislation.
2. explain the historical background of pharmaceutical legislation.
3. identify the objectives and scope of pharmaceutical legislation.
Introduction
Law can be defined as a rule of action established by authority, nation or a State. It
regulates and controls the various aspects of social life leading to social, economical and political
legislations. In ancient time, there were no written laws for the society and the Indian society was
governed by traditions and social customs. Even in the area of drugs and pharmaceuticals, the
effective law did not exist then in India. The drugs of vegetable, animal and mineral sources were
empirically prepared and no any scientific system of development, standardization, storage and
usage of drugs was present. In the absence of any law, the practice of manufacturing of
substandard, spurious, adulterated and even impotent drugs was prevalent in India. Thus, the
need of pharmaceutical legislation was felt.
Pharmaceutical legislation is a legislation which covers various laws enacted from time
to time by the Government for the regulation of education, practice and pharmaceutical industry
for promoting health care system and safeguarding public health. Thus, it is concerned with the
social, economical and health aspects of the society.
Objectives
The main objective of the pharmaceutical legislation is to ensure that the patient receives
the required quality of drug which is previously tested and evaluated for its safety and efficacy. In
addition to this, other objectives of the pharmaceutical legislation are:
1. to promote the health care system by regulating the manufacture and supply of good
quality drugs
2. to regulate the profession and business of pharmacy
3. to safeguard the public from such advertisements of drugs that makes false claim for the
drug or gives the misleading information about the drug
4. to promote the indigenous research technology and
5. to control the prices of drugs.
Historical Background
Indian system of medicine along with Unani system started to decline with the advent of
Allopathic system, which came in India with East India Company in 19th century. In India, the
| 13
14 | Textbook of Pharmaceutical Jurisprudence
first Chemists shop was started by Mr. Bathgate who came along with the East India Company in
1811. This unit started the manufacturing tinctures and spirits in 1910. Acharya Prafulla Chandra
Ray founded Bengal Chemicals and Pharmaceutical Works Ltd in 1901. A small factory was
started by Prof. T. K. Gajjar at Parel in 1903.
However, these pharmaceutical units were not sufficient to fulfill the need of Indian
public. Therefore, drugs were imported from abroad i.e. U.K., France and Germany. With the
advancing years, profits rather than service became the main motive of the traders. Cheaper,
adulterated drugs manufactured in the various parts of the world were imported from India due to
which Indian market got flooded with the inferior and substandard drugs. During 1927-29, The
Indian Medical Gazette reported that there was absolutely no control over manufacture, imports,
sale or distribution of drugs in India. Several deaths had been reported due to spurious drugs and
adulteration like chalk powder tablets were very common.
This situation in India was in contrast with other countries of the world. The pharmacy
profession was fully controlled in England by the Pharmaceutical Society of Great Britain while
United States of America by state laws which required only well qualified and licensed
pharmacists to dispense, compound or sell drugs, medicines or poisons that too in registered
pharmacies. Even though the Opium Act, 1878, the Poisons Act, 1919 and Dangerous Drugs Act,
1930 were in existence but they were not much effective. Indian public noticed this situation and
asked Government to make an effective legislation to control the import, manufacture,
distribution and sale of drugs.
Due to the adverse reports and protests done by the people within and outside the
country regarding this, British Government was forced to initiate action for drug legislation.
Finally, Government appointed Drugs Enquiry Committee (DEC) in 1931 under the
chairmanship of Lt. Col. R. N. Chopra and asked the Committee to look into this matter and make
an effective legislation to control the import, manufacture, distribution and sale of drugs. DEC
studied all the matters and made the following recommendations-
1. DEC recommended the legislations to control drugs and other remedies whether
belonging to British Pharmacopoeia (B.P.) or not.
2. DEC recommended the formation of Pharmacy Council of India and provisional State
Pharmacy Councils which would look after the education and training to all
pharmacists. It also, recommended that those Councils would maintain the register
which contains names and addresses of persons whose name is for time being entered in
the register of pharmacist for a State.
3. It also recommended the creation of drugs control machinery at different centers with
branches in all States.
4. It also recommended the establishment of Central Drugs Laboratory for test or analysis
of samples of drugs with a competent and expert staff for smooth and speedy work of
laboratory. It also recommended the establishment of small scale laboratories which
Pharmaceutical Legislation in India | 15
would work under the guidance of Central Drugs Laboratory.

Initially, the Government was reluctant to implement these recommendations submitted
by the committee in 1931 but these findings brought uprising in the country and spurred activity
in teaching institutions, industry and the profession. Later, the Import of Drugs Bill was passed
by Government in 1937. It was concerned with the import of drugs only and was not associated
with the manufacture, distribution and sale of drugs. Therefore, this bill was criticized from all
the quarters and was ultimately withdrawn. Finally, The Drugs Bill was introduced by the
Government in 1940 and was adopted after in depth deliberations as The Drugs Act, 1940 which
was later amended as the Drugs and CosmeticsAct, 1940.
Scope of Pharmaceutical Legislations
Drugs and CosmeticsAct, 1940
As per the recommendations of DEC, to control the import, manufacture, distribution
and sale of drugs and cosmetics, Drugs and CosmeticsAct, 1940 came into existence.
The PharmacyAct, 1948
The need of the qualified and trained pharmacists and their registration to respective
Councils was re-emphasized by the Health and Development Committee, 1945 constituted
under the Chairmanship of Justice Bhore. The foundations were laid for The Pharmacy Act based
on the recommendations of Drugs Enquiry Committee and Health Survey and Development
Committee. The Pharmacy Act, 1948, came into existence with the objective to regulate the
profession and business of pharmacy.
Drugs and Magic Remedy (ObjectionableAdvertisements)Act, 1954
The uncontrolled and unrestricted advertisements related to drugs and medicines were
freely published making obscene, false and exaggerated claims for their medicines. Hence,
Drugs and Magic Remedy (Objectionable Advertisements) Act, 1954 came into existence with
the objective to control and prohibit such advertisements of drugs which makes false claim for
the drug or which gives the misleading information about the drug.
Medicinal and Toilet PreparationsAct, 1955
Alcohol is the important solvent in pharmaceutical industry. Each State had different
sets of excise rules and different rates of duties on alcohol. To provide for the levy and uniform
collection of duties of excise on the medicinal and toilet preparations, Medicinal and Toilet
PreparationsAct, 1955 came into existence.
Drugs and Price Control Order, 1970
Drugs and Price Control Order, 1970 came into existence to fix the maximum sale price
of bulk drugs and to fix the retail sale price of the formulations in order to avoid the huge
profiteering in drug manufacturing and distribution. The prices of life saving drugs were brought
under direct control of Government.
The Indian PatentsAct, 1970

The process patent given by The Indian Patent Act, 1970, gave impetus to the
pharmaceutical industry in India. India became self sufficient and the cheapest producer of the
drugs in the ensuing period taking full advantage of process patenting.
Narcotic Drugs and Psychotropic SubstancesAct, 1985
To protect society from the dangers of addictive drugs, the Parliament enacted Narcotic
Drugs and Psychotropic Substances Act, 1985. This Act came into existence to control the
various operations relating to the narcotic drugs and psychotropic substances.
Summary
Pharmaceutical legislation is a legislation which covers various laws enacted from time
to time by the Government for the regulation of education, practice and pharmaceutical industry
for promoting health care system and safeguarding public health. Thus, it is concerned with the
social, economical and health aspects of the society. The rationale of the pharmaceutical
legislation is to give right medication to the right patient at right time by the right person that is
registered pharmacist. The various legislations enacted are as given below:
Sr No Pharmaceutical Legislations Rules to the Act Subsequent Amendments

1 Drugs and Cosmetics Act, 1954, 1960, 1969, 1975, 1955, 1960, 1962, 1964,
1940 1988, 1992, 1994, 2003 1972, 1982,1986, 1986,
1995
2 The PharmacyAct, 1948 - 1959, 1976
3 Drugs and Magic Remedy 1955 1963
Act, 1954
4 M e d i c i n a l a n d To i l e t 1976 -
PreparationsAct, 1955
5 Drugs and Price Control - 1987, 1995
Order, 1995
6 The Indian PatentAct, 1970 2006 1999, 2002, 2005
7 Narcotic Drugs and
Psychotropic Substances 1985 1988, 2001
Act, 1985
Multiple Choice Questions

1. Pharmaceutical legislation covers various laws enacted from time to time by the Government
to regulate education, practice and pharmaceutical industry for promoting_______.
a. healthcare system c. economic system
Pharmaceutical Legislation in India | 17
b. political system d. none

2. The main objective of the pharmaceutical legislation is to ensure that the patient receives the
required quality of drug that is previously tested and evaluated for its _________.
a. satisfaction and efficacy c. safety and economy
b. safety and efficacy d. satisfaction and efficacy
3._________started Bengal Chemicals and Pharmaceuticals Ltd in 1901.
a. Prof. T. K. Gajjar c. Acharya Prafulla Chandra Ray
b. Prof. M. L. Schroff d. Lt. Col. R. N. Chopra
4. Drugs Enquiry Committee was appointed under the Chairmanship of ________ in 1931.
a. Dr. B. Mukharjee c. Lt. Col. R. N. Chopra
b. Mr. Bathgate d. Acharya Prafulla Chandra Ray
5. Before independence drugs were imported from following countries except ________.
a. United Kingdom c. France
b. Germany d. America
6. In 1937, the Government of India introduced ________.
a. the Pharmacy Act c. Drugs and Cosmetic Act
b. Drugs & Magic Remedy d. Import of Drugs Bill
7. ________came into existence to control and prohibit advertisements of drugs which makes
false claim for the drug or which gives the misleading information about the drug.
a. Drugs and Magic Remedy (Objectionable advertisements) Act, 1954
b. Medicinal and Toilet Preparations Act, 1955
c. The Pharmacy Act, 1948
d. Drugs and Cosmetics Act, 1940
Important questions
1. Define law. What are the objectives of pharmaceutical legislation?
2. Describe in brief history of pharmaceutical legislation.
3. What do you mean by DEC? Give its recommendations?
4. Discuss the scope of pharmaceutical legislation.
5. Which Acts were in existence before the appointment of DEC?
Answers to multiple choice questions

1. a 2. b 3. c 4. c 5. d 6. d 7.a
Chapter 3
CODE OF PHARMACEUTICAL ETHICS
Learning objectives
1. define ethics and differentiate it with law.
2. know the relationship of pharmacist in respect to his job and trade.
3. know the relationship of pharmacist with physician and with professional colleagues.
Introduction
Ethics is a science which deals with the study of moral duties and is concerned with
human conduct and character. It is a right or wrong human behaviour. A code of ethics is a
carefully formulated set of principles for the guidance of the particular group or members of the
profession.
Ethics is different from law in many respects. It can be differentiated from the law as
given below:
Law Ethics
It is an authorative instrument that rules It is a way of conducting life laid down by
over the society. the society to help the individuals to decide
what is right and wrong.
Law can prevent the illegal practice of It can prevent unethical practices of
pharmacy. pharmacy that can cause grave risk or danger
to the life of individual or patient.
Law can prevent the sale of substandard The sale of substandard quality drugs and at
quality drugs but cannot prevent selling of cheaper rate is restricted by the code of
drug at cheaper rate. ethics.
Pharmaceutical Code of Ethics

Code of pharmaceutical ethics is framed by Pharmacy Council of India for the
pharmacists in India. It guides to the pharmacist regarding how to behave in the society i.e. with
patient, public and his colleagues.
The pharmacist is a vital link between the doctor and the patient. He is responsible to
provide professional services of high order to the community at large by ensuring production of
quality medicines and its sale, distribution to the consumers thereby safeguarding the health of
the public. Acode of pharmaceutical ethics is divided into the following parts:
1. Pharmacist in relation to his job
18 |
Code of Pharmaceutical Ethics | 19
2. Pharmacist in relation to his trade

3. Pharmacist in relation to medical profession
4. Pharmacist in relation to his profession

a) Scope of Pharmaceutical Services
Pharmacist who is engaged in hospital pharmacy should supply the medicines correctly
and properly. He should supply the medicine efficiently without delay. More care should be taken
during emergency supplies.
b) Conduct of Pharmacy
In a pharmacy section of hospital pharmacy, pharmacist prepares the medicine
according to the prescription of physician. During compounding he should not make any errors
as the medicines if dispensed wrongly may not give the necessary relief to the patient from
disease. On the contrary, there may be some undesirable side effects.
c) Handling of prescription
As the prescriptions given by physicians are presented to pharmacists for dispensing,
pharmacist is supposed to maintain its secrecy and should not make any comment on it. He
should read it carefully and then decide what type of medication is required to prepare. No any
addition, omission, or substitution of ingredients should be made without the consent of the
prescriber. If there are some errors in doses he should not correct it himself, he should consult to
physician.
d) Handling of drugs
In hospital pharmacy, the varieties of drugs are available and the chief pharmacist is
responsible for handling of drugs. During compounding and dispensing, he should use standard
quality drugs and weigh it accurately. He should take more care during handling of poisonous
substances.
e)Apprentice pharmacist
Every pharmacist has to undergo the practical training after completion of the academic
training. Chief pharmacist should provide uniform practical training to all the new pharmacists.

a) Pricing of drugs
Pricing of drugs and pharmaceuticals should be fair. The overcharging of the products
should be avoided. A suitable price structure should be adopted for pricing of drugs. He should
calculate the retail price of his formulation according to the formula prescribed under Drugs and
Price Control Order. While calculating the price he should consider the material cost, packaging
charges, cost of packaging material, etc.
b) Fair trade practice

Pharmacist should not make any attempt to capture the business of fellow pharmacist by
cutthroat competitions that is by offering gifts or reducing prices to the patient, etc. Trade marks,
signs and symbols of other pharmacist should not be copied.
c) Purchase of drugs
Pharmacist should purchase drugs of standard quality only. He should not purchase
substandard quality, adulterated drugs or misbranded drugs. He should purchase drugs under
cash or credit memo from a duly licensed manufacturers and dealers.
d) Hawking of drugs
Hawking of drugs should be prohibited under the code of pharmaceutical ethics to
prevent self medication and mismedication.
e)Advertising and display
Advertisement and display of drug should also be prohibited under the code of
pharmaceutical ethics to prevent self medication and mismedication. Advertisements of drugs
making a false claim or which gives misleading information about the drug should be prohibited.

a) Limitation of professional activity
Pharmacist should not interfere with the duties of physician. He should carry out only his
own duties that is compounding and dispensing. Under no circumstances, he should diagnose the
patient and prescribe the remedies even though requested by the patient. In emergency, he should
provide first aid services to victim.
b) Clandestine arrangement
Pharmacist should not enter into any secret agreement or contract with physician that is
by offering commission for recommending his medical store.
c) Liaison with public
Pharmacist is a link between doctor and patient. He should have up-to-date knowledge
about the developments in pharmacy profession. For this purpose, he should be always in
constant touch with the periodicals, journals, magazines related to the pharmacy profession
which are published from time to time. He should offer advice to physician on the
pharmaceuticals. Also, he should educate the patient regarding certain techniques of
administration of drugs.

a) Law abiding citizens
Pharmacist should have the knowledge of laws related to drugs, pharmaceuticals,
chemicals, foods and cosmetics. He should obey the laws of nation and State to maintain the
Code of Pharmaceutical Ethics | 21
standard of the profession.

b) Professional vigilance
Pharmacist should consider all other pharmacists as colleagues in pharmacy profession
and partner in health care system. All pharmacists should meet frequently on the occasion of
some conference. This is required for the welfare and cooperation to other pharmacist.
c)Association with various professional organizations
Pharmacist should associate himself with the various professional organizations, the
aims and objectives of which are compatible with code of pharmaceutical ethics.
d) Decorum and propriety
Pharmacist should not carry out such acts that will bring discredit to him as well as to the
pharmacy profession.
Summary
Every country has its own national and state laws. Every person including pharmacist
should be aware of it and he should obey the laws. Pharmacist being a part of healthcare system
should have the knowledge of laws related to drugs. He should maintain the relationship with
patients, his colleagues and other members of healthcare system. He should do his duties
honestly without any error. He should try to improve the status of pharmacy profession with his
social activities.
Acode of pharmaceutical ethics is divided into the following parts:

1. Ethics is the study of ________.
a. fundamental legal principles b. rule of action
c. moral duties d. None
2. ______ can prevent the sale of substandard quality drugs but cannot prevent selling of drug at
cheaper rate
a. Law b. Ethics
c. Both d. None
3. The pharmacist is a vital link between _____ in health care system.
a. doctor and senior pharmacist b. doctor and manufacturer
c. doctor and patient d. all
4. If there is any error in the prescription which one of the following statement will be correct?
a. Pharmacist should correct it himself
b. Pharmacist should ask to trainee pharmacist
c. Pharmacist should take a help of patient
d. Pharmacist should ask to doctor
5. If pharmacist is making an attempt to capture the business of fellow pharmacist it is_____.
a. cut throat competition b. professional vigillance
c. interstate agreement d. none
6. Pharmacist should not interfere the duties of physician, he should carry out his own duties that
is _______.
a. diagnosis b. prescribing remedies
c. compounding and dispensing of drugs d. None
7. If pharmacist has made secret contract with doctor it is called as ________.
a. cut throat competition b. clandestine arrangement
c. interpersonal agreement d. none
Important questions
1. Define ethics. How does it differ from laws?
2. Name the various parts of code of pharmaceutical ethics.
3. How should be the relationship of pharmacist with physician?
4. Write a note on – Pharmacist in relation to his trade.
5. How the pharmacist should supply the medicine in a hospital?
6. How pharmacist should handle the prescription?
7. What is the meaning of clandestine arrangement?
8. Write a note on – Pharmacist in relation to his profession.
9. Describe in brief Pharmacist in relation to his job.

1. c 2. a 3. c 4. d 5. a 6. c 7.b
Chapter 4
DRUGS AND COSMETICS ACT, 1940 AND RULES, 1945
Learning objectives
1. identify the objectives of Drugs and CosmeticsAct, 1940 .
2. define various terms under thisAct.
3. know various Schedules under thisAct
4. know about various administrative bodies.
5. explain various provisions relating to import, manufacture, sale and distribution of drugs and
cosmetics
6. explain various provisions relating to manufacture of Ayurvedic, Siddha and Unani Drugs.
7. explain various provisions relating to manufacture of Homeopathic medicines.
8. know various offences and penalties under thisAct.
Introduction
Drugs Enquiry Committee appointed by Government in 1931 made various
recommendations to have a control on the import, manufacture and sale of drugs. But
Government was reluctant to implement these recommendations. Following the uprising in the
country, Government passed Import of Drugs Bill in 1937 but that was not concerned with the
manufacture, distribution and sale of drugs. Finally, to control the import, manufacture,
distribution and sale of drugs and cosmetics, Drugs and Cosmetics Act was passed on10th April
1940 by the Indian Legislature. This Act was amended in1955 by the Indian Parliament and
subsequently amended in 1960,1962, 1964, 1972, 1982, 1986, 1995 and 2008.
In thisAct, provision of license is made for the import, manufacture and sale of drugs and
cosmetics. Central Government controls import of drugs and cosmetics while State Government
appoints licensing authority to control manufacture, distribution and sale of drugs and cosmetics.
TheAct consists of five chapters
Chapter I- Introductory
Chapter II - Administrative bodies
Chapter III- Import of drugs and cosmetics
Chapter IV- Manufacture, sale and distribution of drugs and cosmetics
Chapter IV-A Provisions relating toAyurvedic, Siddha and Unani drugs
Chapter V - Miscellaneous
| 23
Objective
This is an Act to regulate the import, manufacture, distribution and sale of drugs and
cosmetics.
Chapter I Introductory
Schedules to theAct
1. First Schedule
It prescribes the list of books specified in Ayurvedic, Siddha or Unani systems of
medicine.
2. Second Schedule
It prescribes the standards to be complied with by imported drugs and by the drugs
manufactured for sale, sold stocked or exhibited for sale or distributed.
Schedules to the Rules

ScheduleA
It prescribes different forms required under Drugs and Cosmetic Act, for making the
application to grant or issue of licences, sending memorandum, etc.
Schedule B
It prescribes the fees to be charged for test or analysis of samples of drugs by Central
Drugs Laboratory and GovernmentAnalyst.
Schedule C& C (i)
It prescribes the list of the biological and other special products.
Schedule D
It prescribes classes of drugs which are exempted from the certain provisions applicable
to the import of drugs.
Schedule E
It prescribes list of poisonous substances - omitted (22/6/1982).
Schedule E (i)
It prescribes list ofAyurvedic, Siddha and Unani poisonous substances.
Schedule F
It prescribes provisions applicable to the blood bank requirements and licensing to
process the blood components.
Schedule F (i)
It prescribes provisions applicable to the production of bacterial as well as viral
vaccines, sera and diagnostic antigens.
Drugs & Cosmetics Act, 1940 & Rules, 1945 | 25
Schedule F (ii)
It prescribes the standards for surgical dressings.
Schedule F (iii)
It prescribes the standards for the umbilical tapes.
Schedule FF
It prescribes the standards for ophthalmic preparations.
Schedule G
It prescribes list of drugs which are required to be taken only under the supervision of a
Registered Medical Practitioner.
It is labeled with direction: ‘Schedule G Drug’
Caution “It is dangerous to take this preparation except under the supervision of
Registered Medical Practitioner”.
Schedule H
It prescribes list of drugs which are to be sold by retail only on the prescription of
Schedule H drugs are labeled with direction-
Warning - “To be sold by retail only on the prescription of Registered Medical
Practitioner.”
Schedule I
It prescribes calculation of proportion of poisons in certain cases -omitted (22/6/1982).
Schedule J
It prescribes the list of ailments or diseases for which drugs may not claim to prevent or
cure.
Schedule K
It prescribes classes of drugs which are exempted from certain provisions applicable to
manufacture of drug.
Schedule L
It prescribes list of drugs to be sold on prescription only - omitted (22/6/1982).
Schedule M
It prescribes the good manufacturing practices (GMP) and the requirements of factory
premises, plant, equipments, etc for manufacture of drugs.
Schedule M (i)
It prescribes requirements of factory premises, plant, equipments, etc for manufacture of
Homoeopathic drugs.
Schedule M (ii)
It prescribes requirements of factory premises, plant, equipments, etc for manufacture of
cosmetics.
Schedule M (iii)
It prescribes requirements of factory premises, plant, equipments etc for manufacture of
Medical devices.
Schedule N
It prescribes minimum equipments to be possessed by pharmacy.
Schedule O
It prescribes provisions applicable to the black disinfectant fluids.
Schedule P
It prescribes life period of drugs.
Schedule P(i)
It prescribes the pack sizes of drugs.
Schedule Q
It prescribes the list of permitted coal tar colours for use in cosmetics and list of
permitted colours for use in soaps.
Schedule R
It prescribes the standards for condoms made of rubber latex intended for single use.
Schedule R (i)
It prescribes standards for medical devices.
Schedule S
It prescribes standards for cosmetics
Schedule T
It prescribes the requirements of factory premises, plant, equipments and hygienic
conditions for manufacture ofAyurvedic, Siddha, and Unani Drugs.
Schedule U
It prescribes the particulars to be shown in the manufacturing records of drugs.
Schedule U (i)
It prescribes the particulars to be shown in the manufacturing records of cosmetics.
Schedule V
It prescribes standards for patent and proprietary medicines.
Schedule W
It prescribes the list of drugs which are marketed under generic name only.
Schedule X
It prescribes list of habit forming narcotic drugs and psychotropic substances for the
import, manufacture, distribution and sale of which requires a licence.
Schedule Y
It prescribes requirements and guideline on clinical trials for the import and
manufacture of new drugs.
Definitions
1.Ayurvedic, Siddha or Unani Drug [sec. 3(a)]
It includes all medicines intended for internal or external use for or in diagnosis,
treatment, prevention, mitigation or cure of diseases in human beings or animals and
manufactured exclusively in accordance with the formulae described in the
authoritative books of Ayurvedic, Siddha and Unani systems of medicines specified in
First Schedule.
2. Cosmetic [sec. 3(aaa)]
It means any article intended to be rubbed, sprayed, poured, sprinkled on or introduced
into or otherwise applied to the human body thereof, for cleansing, beautifying or
promoting the attractiveness or altering the appearance and also includes any article
intended to be used as a component of cosmetic but does not include soap.
3. GovernmentAnalyst [sec. 3(c)]
It means-
1. In relation to any drug or cosmetic, Government Analyst appointed by Central
Government or State Government under section 20; or
2. In relation to Ayurvedic, Siddha or Unani system of Medicine, Government Analyst
appointed by Central Government or State Government under section 33 F.
4. Drug Inspector [sec. 3(e)]
1. In relation to any drug or cosmetic, Drug Inspector appointed by Central Government
or State Government under section 21; or
2. In relation to Ayurvedic, Siddha or Unani systems of Medicine, Drug Inspector
appointed by Central Government or State Government under section 33G.
5. Manufacture [sec. 3(f)]
Manufacture in relation to any drug or cosmetic includes any process or part of process
for making, altering, ornamenting, finishing, packing, labeling, treating or adopting any
drug or cosmetic with a view to its sale or distribution but does not include
compounding or dispensing of drugs in the ordinary course or the course of retail
business.
6. Drug [sec. 3(b)]
It means-
1. All medicines for internal or external use of human beings or animals and all substances
intended to be used for or in diagnosis, treatment, prevention, mitigation or cure of
diseases in human beings or animals including preparations applied on human body for
the purpose of repelling insects like mosquitoes; or
2. Such substances other than food intended to affect or alter the structure or any organic
functions of the body of human beings or animals or intended to be used for destruction
of vermins (like fleas, lice) which may cause diseases in human beings or animals; or
3. Any article intended to be used as a component of drug including empty gelatin
capsules; or
4. Such devices intended to be used for or in diagnosis, treatment, mitigation, prevention
or cure of diseases in human beings or animals.
7. Patent and Proprietary Medicine [sec. 3(h)]
It means-
1. In relation to, Ayurvedic, Siddha or Unani systems of medicine, all the formulations
containing only such ingredients mentioned in the formulae described in authoritative
books of Ayurvedic, Siddha or Unani systems as specified in First Schedule but does
not include medicine which is administered by parenteral route and also formulation
which is included in authoritative books as specified in First schedule.
2. In relation to drug, drug which is a remedy or prescription prepared for internal or
external use of human beings or animals and which is not included in any edition of
Indian Pharmacopoeia or any other Pharmacopoeia authorised by Central Government
in this behalf after consultation with Drugs TechnicalAdvisory Board.
8. Standards of Quality
It means-
a) In relation to drug that drug complies with the standards as specified in the Second
Schedule.
b) In relation to cosmetic that cosmetic complies with the standards as may be prescribed.
9. Qualified Person
It means a person-
a) who holds degree or diploma in Pharmacy or Pharmaceutical Chemistry; or
b) who is registered pharmacist; or
c) who has minimum four years experience in dispensing and compounding of drugs and
has been approved as “Qualified Person” on or before 31st December 1969.
10. Drug Store [Rule 65 (15(a)]
It is a licensed premise for the sale of drug which do not require the services of Qualified
Person and where drugs are not compounded against prescription.
11. Chemists and Druggists [Rule65 (15(b)]
It is a licensed premise for the sale of drug which requires services of Qualified Person
but where drugs are not compounded against prescription.
12. Pharmacy [Rule 65 (15(c)]

It is a licensed premise for the sale of drug which requires the services of “Qualified
Person” and where drugs are compounded against prescription.
13. Sale by the way of wholesale dealing [Rule 2 (g)]
` It means sale to a person for the purpose of selling again and also includes sale to
medical, hospital, dispensary, educational or research institutions.
14. Retail Sale [Rule 2 (f)]
It means sale other than sale by the way of wholesale dealing.
15. Repacking of Drug [Rule 69 (5)]
It is the process of breaking up any drug from the bulk container into small packages and
labeling of each package with a view to its sale and distribution but does not include
compounding and dispensing of drug in the ordinary course or the course of retail
business .
16. Loan Licence [Rule 69A]
It means a licence granted to a person who do not have his own arrangements of
manufacture but who intends to avail himself of the manufacturing facilities owned by
another manufacturer.
17.Adulterated Drug [sec. 17-A]
Adrug shall be deemed to be adulterated if-
a) it contains in whole or in parts of filthy, putrid or decomposed substances; or
b) it is prepared, packed or stored under unsanitary conditions whereby it may have been
contaminated with filth or which may render the contents injurious to the health, or
c) its container is composed in whole or in parts of poisonous or deleterious substance
which may render the contents injurious to the health; or
d) it contains or bears for the purpose of coloring only, a color other than those
prescribed ; or
e) it contains harmful or toxic substances which may render it injurious to health; or
f) any substance has been mixed therewith so as to reduce its quality or strength.
18. Misbranded Drugs [sec. 17-B]
Adrug shall be deemed to be misbranded if –
a) it is so colored, coated, powdered or polished that the damage is concealed or if it is
made to appear of better or greater therapeutic value than it really is; or
b) it is not labeled in the prescribed manner; or
c) its label or container or anything accompanying drug bears any statement, design or
devices which makes any false claim for drug or which is false or misleading in any
particular.
19. Spurious Drug [sec. 3(h)]

Adrug shall be deemed to be spurious
a) if it is imported under a name which belongs to another drug ;or
b) if it is an imitation of or is a substitute for another drug or resembles to another drug in a
manner likely to deceive or bear upon its label or container the name of another drug
unless it is plainly or conspicuously marked so as to reveal its true character and its lack
of identity with such other drugs; or
c) if its label or container bears the name of an individual or company purporting to be
product of manufacturer which individual or company is fictitious or does not exists ; or
d) if it has been substituted wholly or in parts by another drug or substance; or
e) if it purports to be product of a manufacture of whom it is not truly a product.
20. Misbranded Cosmetic [sec. 17-C]
Acosmetic shall be deemed to be misbranded
a) if it contains color other than those prescribed ; or
b) if it is not labeled in the prescribed manner ; or
c) if its label or container or anything accompanying cosmetic bears any statement which
is false.
21. Homoeopathic Medicines [Rule 2 (dd)]
It means any drug which is recorded in Homoeopathic provings or therapeutic
efficacy of which has been established through long clinical experience as recorded in
Homeopathic literature of India and abroad and which is prepared according to the
techniques of Homoeopathic pharmacy and covers the combination of ingredients of
such Homoeopathic medicines but does not include any medicine which is administered
by parenteral route.
22. Spurious Cosmetic [sec. 17-D]
Acosmetic shall be deemed to be spurious-
a) if it is imported under a name which belongs to another cosmetic; or
b) if it is an imitation of or is a substitute for another cosmetic or resembles to another
cosmetic in a manner likely to deceive or bear upon its label or container the name of
another cosmetic unless it is plainly or conspicuously marked so as to reveal its true
character and its lack of identity with such other cosmetic ;or
c) if its label or container bears the name of an individual or company purporting to be
manufacturer of cosmetic which individual or company is fictitious or does not exits; or
d) if it purports to be the product of a manufacturer of whom it is not truly a product.
23. New Homoeopathic Medicine [Rule 30A]
It means-
a) a Homoeopathic medicine which is not specified in Homoeopathic Pharmacopoeia of
India or United States of America or the United Kingdom or German Homoeopathic

Pharmacopoeia; or
b) which is not recognized in Homoeopathic literature as efficacious under the conditions
recommended; or
c) a combination of Homoeopathic medicines containing one or more medicine which are
not specified in any of the Pharmacopoeias referred above in (a) as Homoeopathic
medicine and also not recognized in authoritative Homoeopathic literature as
efficacious under the conditions recommended.
24. New Drug [Rule 122E]
It means-
a) a drug the composition of which is such that the drug is not generally recognized among
experts as safe for use under the conditions recommended or suggested in the label
thereof; and
b) includes any drug the composition of which is such that drug as result of investigations
for determining its safety for use under such conditions, is so recognized but which has
not, otherwise than during the course of such investigation been used to enlarge, extent
or for any appreciable length of time under the said conditions.
25. Registered Homoeopathic Medical Practitioner [Rule 2(6)]
It means a person who is registered in the Central Register or State Register of
Homoeopathy.
26.Adulterated cosmetic [sec. 17-E]
st
(As per the Drugs and CosmeticsAmendmentAct, 2008 as passed on 21 Oct.2008 )
Acosmetic shall be deemed to be adulterated,-
a. if it consists in whole or in part, of any filthy, putrid or decomposed substance; or
b. if it has been prepared, packed or stored under unsanitary conditions whereby it may
have been contaminated with filth or whereby it may have been rendered injurious to
health; or
c. if its container is composed, in whole or in part, of any poisonous or deleterious
substances which may render the contents injurious to health; or
d. if it bears or contains, for purposes of coloring only, a color other than one which is
prescribed; or
e. if it contains any harmful or toxic substance which may render it injurious to health; or
f. if any substance has been mixed therewith so as to reduce its quality or strength.
Chapter II Administrative Bodies

There are three administrative bodies which are as follows-
1. Advisory bodies Drug Technical Advisory Board and Drugs Consultative
Committee
2. Analytical bodies Central Drugs Laboratory, Drugs Control Laboratories in
States and Government Analyst
3. Executive bodies Controlling authorities, Licensing authority, Drug Inspector
A)Advisory bodies
I) Drug TechnicalAdvisory Board (DTAB) [sec. 5]
Drugs Technical Advisory Board is constituted by Central Government and its function
is to advise the Central Government and State Government on the technical matters arising out of
the administration of thisAct.
It is reconstituted after every 5 years. It has following members
A. Ex-officio Members
1. Director General of Health Services who shall be Chairman of the Board.
2. Drugs Controller of India.
3. Director of Central Drugs Laboratory, Calcutta.
4. Director of Central Research Institute, Kasauli.
5. Director of Indian Veterinary Research Institute, Izatnagar.
6. Director, Central Drugs Research Institute, Lucknow.
7. The President, Pharmacy Council of India.
8. The President, Medical Council of India.
B. Nominated Members:
1. One person is nominated by the Central Government from the Pharmaceutical
Industry.
2. Two persons are nominated by the Central Government from amongst the persons
who are in charge of the Drugs Control in the States.
3. Two Government Analysts are nominated by the Central Government.
C. Elected Members:
1. One person is elected by the Executive Committee of Pharmacy Council of India from
amongst teachers in pharmacy, pharmaceutical chemistry or pharmacognosy on the
staff of an Indian University or Colleges affiliated there to.
2. One person is elected by the Executive Committee of the Medical Council of India
from amongst the teacher in medicine or therapeutics on the staff of a University or
Colleges affiliated there to.
3. One Pharmacologist is elected by the Governing Body of the Indian Council of

Medical Research.
4. One Person is elected by the Central Council of Indian MedicalAssociation.
5. One Person is elected by the Council of the Indian PharmaceuticalAssociation.
II) Drug Consultative Committee (DCC)

It is constituted by the Central Government and its function is to advise the Central
Government, or State Government and DTAB on any matter tending to secure uniformity
throughout India in the administration of thisAct.
Constitution
1. Two persons are nominated by the Central Government.
2. One person from each State is nominated by that concerned State Government.
B)Analytical bodies
1) Central Drugs Laboratory (CDL)[sec.6]
Central Drugs Laboratory is established by the Central Government under the control of
Director.
Functions of CDL
1. To analyse or test the samples of drugs or cosmetics as may be sent to it by-
a) Customs collectors; or
b) any other authorized officer.
2. To carry out such other duties as may be entrusted to it by Central Government or by
State Government with the prior sanction of Central Government after consultation with
DTAB.
3.a)In case of sera, vaccines, toxins, antigens, antisera, solution of serum proteins for
injections, sterilized ligature and suture and bacteriophages, the functions of CDL is
carried out at the Central Research Institute, Kasauli and such functions are exercised by
the Director of the said institute.
The functions regarding Oral Polio Vaccine are exercised by the Deputy Director and
Head of the Polio Vaccine Testing Laboratory of Central Research Institute, Kasauli.
b) In case of antisera, vaccines, diagnostic antigens and toxoids for veterinary use, the
functions of CDL are carried out at the Indian Veterinary Research Institute, Izatnagar or
Mukteshwar and such function are exercised by the Director of the said institution.
c) In case of condoms, the functions of CDL are carried out at Central Indian
Pharmacopoeia Laboratory, Ghaziabad and such functions are exercised by Director of
the said laboratory.
d) In case of Veneral Disease Reference Laboratory (VDRL) antigens the function of CDL
is carried out at the Laboratory of Serologist and Chemical Examiner to Government of

India and such functions are exercised by Serologist and Chemical Examiner of the said
laboratory.
e) In case of IUCD (Intrauterine Contraceptive Devices) and felope rings, the functions of
CDL are carried out at Indian Institute of Technology, New Delhi and such functions are
exercised by Head of said department.
Dispatch of samples for test or analysis
Samples for the test or analysis are to be sent by the registered post in a sealed packet
enclosed with a memorandum in Form 1 accompanied with prescribed fee to the Director.
A copy of memorandum and specimen impression of the seal used to seal the packets are
sent separately by registered post.
On receipt of the sample, the authorized officer on behalf of the Director opens the
packet and records the conditions of the seal. After test or analysis the report of analysis is
supplied in the Form 2 together with full protocols of the tests applied. The report of analysis is
signed by the Director of the Central Drugs Laboratory.
2. Drugs Control Laboratories in the States [sec.7]

Every State shall establish Drugs Control Laboratories to analyse or test the samples of
drug from the licensed, manufacturing premises in their respective areas.
Sample of drugs taken by the Drug Inspectors from the manufacturing premises or retail
shops is analyzed in these laboratories.
These laboratories also undertake the testing or analysis of drug on the behalf of the
manufacturers who do not have their own facilities for testing or analysis of samples of drugs on
the payment of prescribed fees.
If a purchaser wants to analyse or test the samples of drugs or cosmetics he has to make
an application in Form 14A accompanying with the prescribed fees to Director and the report of
test or analysis shall be supplied in Form 14B.
3. GovernmentAnalyst
Government Analyst is a person appointed by Central Government or State Government
under section 20. A person to be appointed as Government Analyst should have no financial
interest.
Qualifications
A person to be appointed as Government Analyst should possess the following
qualifications.
1. Graduate in medicine or science or pharmacy or pharmaceutical chemistry of a
recognized University with not less than 5 years post Graduate experience ;or
2. Post graduate degree in medicine or science or pharmacy or pharmaceutical chemistry

of a recognized university with not less than 3 years experience.
3. Associateship Diploma of the Institution of Chemists with ‘Analysis of Drugs and
Pharmaceuticals’ as one of the subject and with not less than three years experience in
the testing of drugs in a laboratory under the control of-
a) Government Analyst; or
b) Head of an Institution of Testing laboratory approved for the purpose by the appointing
authority.
Provided that-
a. For the purpose of testing or analysis of drugs specified in schedule C, a person to be
appointed as Government Analyst should produce evidence of satisfactory training in
Physiology, Bacteriology, or Serology, or Pathology or Pharmacology or Microbiology
and should have the said experience.
b. For a period of four years from the date on which chapter IV of the Act takes effect in the
States, person whose qualification and experience are considered as adequate and
competent, such person may continue to remain in the services even after four years.
c. A person to be appointed as a Government Analyst should not be engaged directly or
indirectly in a trade or business connected with the manufacture of drugs.
d. For the purpose of examination of the veterinary biological products, person to be
appointed as Government Analyst should be graduate in Veterinary Science or General
Science or Medicine or Pharmacy with not less than five years experience in the
standardization of biological products or a person having post graduate degree in above
faculties with not less than three years said experience.
e. The person already appointed as Government Analyst may continue to remain in
service, if the appointing authority so desires even though he does not fulfill the said
qualification and experience.
Duties of Government Analyst

1. To analyse or test the samples of drugs and cosmetics sent to him by Drug Inspector or
other persons.
2. To furnish the reports of results of the test or analysis in accordance with the procedure.
3. To forward to the Government report of research or analytical work with a view to their
publication at the discretion of the Government.
Procedure to be followed by Government Analyst on receipt of Samples

1. On receipt of a package containing sample of drugs or cosmetic by Drug Inspector,
GovernmentAnalyst compares the seals on the packages with the specimen impression
of the seal received separately.

2. He records the condition of seal on the packets.
3. After the test or analysis, he supplies reports of analysis in triplicate in Form 13
together with full protocols of test applied.
Report of Government Analyst
The report of Government Analyst is held to be conclusive only if it is not challenged
according to the procedure given within 28 days of receipt of copy of the report by the person
from whom sample was taken.
C) Executive bodies
1. Drug Inspector
Drug Inspector is appointed by Central Government or State Government under section
21. He should have no financial interest in import, manufacture, distribution or sale of the drug or
cosmetic.
Qualification
A person to be appointed as drug inspector should be graduate in pharmacy or
pharmaceutical chemistry or medicine with specialization in Clinical Pharmacology or
Microbiology from recognized University established in India.
Provided that-
1. a person who has not less than 18 months experience in the manufacture of at least one
of the substances specified in Schedule C; or
2. who has not less than 18 months experience in testing of at least one of the substances
specified in schedule C; or
3. who has not less than 3 years experience in inspection of firms manufacturing at least
one of the substances specified in Schedule C.
Powers of Drug Inspector

Within the local limits for which the drug Inspector is appointed may
1. Inspect
a. any premises wherein any drug or cosmetic is being manufactured and the means
employed for testing and standardizing the drug or cosmetic.
b. any premises wherein any drug or cosmetic is being sold, stocked or offered for sale or
is being distributed.
2. Takes samples of any drug or cosmetic
a. From premises wherein any drug or cosmetic is being manufactured or sold or offered
for sale or is being distributed.
b. From any person who is in the course of conveying, preparing , delivering, preparing to
deliver any drug or cosmetic to a purchaser.

3. Search any person in connection with the offence under this chapter at all reasonable
time.
4. Enter and search any premises or any places in which he has reason to believe that an
offence has been committed or is being committed.
5. Stop and search any vehicle or vessel or any other conveyance which is used for carrying
any drug or cosmetic in respect of which offence has been committed or is being
committed.
6. Give order (in writing) in possession of drug or cosmetic in respect of which the offence
has been committed or is being committed; not to dispose stock of any drug or cosmetic
for a specified period not exceeding 20 days or unless the defects may be removed by the
possessor of the drug or cosmetic, if necessary he may seize it .
7. Examine any register or any record of drug or cosmetic which is in contravention of the
provisions of thisAct.
8. Exercise the powers of Drug Inspectors for carrying out the purpose of thisAct.
Duties of Drug Inspectors

Duties in relation to sale of drug
1. To inspect at least twice a year, all the premises licensed for sale of drugs and cosmetics.
2. To check whether the conditions of the licenses are being observed or not.
3. If he thinks necessary, to obtain and send the samples of drugs and cosmetic for test or
analysis.
4. To investigate any complaint made to him in writing.
5. To institute prosecutions in respect of breach of theAct.
6. To maintain records and actions taken by him and to submit the copies of such records to
controlling authority.
7. To make inquires and inspections regarding sale of drug, the sale of which is for time
being restricted.
8. To detain the imported packages, if import of such drug or cosmetic is for the time being
prohibited.
Duties in relation to manufacture of drug

1. To inspect at least twice a year, all premises licensed for the manufacture of drugs and
cosmetic.
2. To check whether the conditions of licenses are being observed or not.
3. For the manufacture of drugs specified in schedule C and C(i) to inspect-
a. Plant and process of the manufacture.
b.The means employed for testing and standardizing of drugs.

c.Method and place of storage.
d.Qualifications of the technical staff employed.
e.The location, construction and administration of the establishment which may affect
purity and potency of drugs.
4. To take the sample of drugs from the manufacturing premises and send them for test or
analysis.
5. To institute prosecutions in respect of the breach of theAct.
Procedure of Inspection (to be followed by Drug Inspector)

1. Where an Inspector takes the sample of drugs, he shall pay the fair price of it and may
give written acknowledgment there of.
2. Where a price is refused or where an Inspector seizes the stock of drugs, he shall give
receipt of it in Form 16.
3. Where an Inspector takes the sample of drug for test or analysis he shall intimate such
purpose in Form 17 in writing to a person from whom he takes it.
4. In presence of such person, unless he wilfully absents himself, the drug inspector shall
divide the sample into four portions, effectively seal and mark them and allow that
person to add his own seal and mark.
5. Where an Inspector takes the sample of drug or cosmetic from manufacturing premises
sample should be divided into three portions only.
6. Where a drug or cosmetic is made up in small volume containers and if drug is likely to
deteriorate or damage by exposure, drug inspector shall take three or more containers
after suitably marking the same and sealing them.
7. Drug inspector shall give one portion of sample to a person from whom he takes it and
divide the remaining three portions as follows:
a. He shall sent second portion to the Government Analyst for test or analysis.
b. He shall produce third portion in the court before which proceedings have been
instituted.
c. He shall send fourth portion to warrantor whose name, address and other particulars
have been disclosed.
8. The portion of sample or container shall be sent by registered post or by hand. A copy of
memorandum and specimen impression of seal used to seal the packets shall be sent
separately by registered post.
9. When an Inspector seizes the register, records or other document and samples of drugs
or cosmetics he shall inform Judicial Magistrate and take his order of custody.
2. LicensingAuthority
The Central Government may appoint an authority called as “Licensing Authority” to
issue licence for the import of drugs. Each State Government may appoint “Licensing Authority”
to issue licence for manufacture, distribution and sale of drugs. These authorities have power to
grant the license or refuse the license depending on the conditions of the applicant. These
authorities may also suspend the licence if the licensee has committed any offence in the
contravention of the provisions of thisAct.
Qualification
No person shall be appointed as LicensingAuthority unless:
1. He is graduate in pharmacy or pharmaceutical chemistry or in medicine with
specialization in clinical pharmacology or microbiology from recognized university
established in India by law.
2. He has experience in the manufacture or testing of drugs and cosmetics or
enforcement of provisions of theAct for a minimum period of five years.
Provided that the academic qualification shall not be applied to a person who is already
in service before the commencement of the Drugs and Cosmetics IX Amendment Act,
1989.
3. Qualifications of ControllingAuthority
No person shall be appointed as to be ControllingAuthority unless:
1. He is a graduate in pharmacy or pharmaceutical chemistry or in medicine with
specialization in clinical pharmacology or microbiology from recognized university
established in India by law.
2. He has experience in the manufacture or testing of drugs and cosmetics or
enforcement of provisions of theAct for a minimum period of five years.
Provided that the academic qualification shall not be applied to a person who is already
in the services before the commencement of the Drugs and Cosmetics IX Amendment
Act, 1989.
4. Customs Collector
The laws related to prohibition of import of drugs are applicable as that of customs and
goods. The customs collector or any other authorized officer in this behalf, may detain imported
packages which he suspects to contains any drug or cosmetic, import of which is for the time
being prohibited. He may report to Drugs Controller of India and if required, forward such
sample to Central Drug Laboratory.
Chapter III Import of Drug and Cosmetics

Import Licence
Import licence is a licence granted to a person for the import of drugs specified in
Schedule X, C and C(i). For the import of drugs specified in Schedule C, C(i) and X, the licence
shall be granted in Form 10 and 10A respectively. For the import of small quantities of drugs, a
licence is granted in Form 11.
Conditions of licence granted to a person for import of drugs for examination or test or
analysis
Licence in Form 11 is granted by licensing authority to import small quantities of drugs,
the import of which is otherwise prohibited, for the purpose of examination, test or analysis
subjected to the following conditions-
1. The importer shall use the substances imported for the purpose of examination, test or
analysis in the space specified in licence or at any other place authorized by licensing
authority.
2. The licensee shall allow inspector to enter with or without notice at the premises where
substances are kept and also, to inspect the premises and investigate manner in which
substances are being used and to take sample thereof.
3. The importer shall keep the records of quantities of substances imported with date, name
of manufacturer and shall report the same to licensing authority.
Import of drugs for personal use
Drugs may be imported for personal use under the following conditions even though the
import of which is prohibited under section 10 of theAct.
1. If that drug shall form the part of passengers bonafide baggage and shall be the property
of and be intended exclusively for personal use.
2. If customs authority directs and declares that drug is for personal use.
3. If the quantity of single dose so imported shall not exceed hundred doses.
Even if the imported drug is not forming part of passengers bonafide baggage, it may be
permitted for its import after getting permission from licensing authority in Form 12.
Conditions of import licence for Schedule C and Schedule X drugs

Import licence is granted under the following conditions-
1. The manufacturer shall at all times observe the undertaking given by him or on his behalf
in Form 9.
2. The licensee shall allow inspector to inspect the premises and check the records and take
samples for test or analysis.
3. The licensee shall not sell any drug if the licensing authority directs so.
4. The licensee shall recall the batch as early as possible from sale if it does not comply with
the prescribed standard.
Along with those conditions for Schedule C drugs the licensee shall maintain the
following particulars for Schedule X drugs-
1. Name of drug
2. Batch No.
3. Name and address of manufacturer
4. Opening stock
5. Date of transaction
6. Quantity of drug received, if any
7. Name of purchaser with address and licence number
8. Balance quantity of drug at the end of business
9. Signature of person under whose supervision the drugs have been supplied.
The licensing authority has right to grant the licence or cancel or suspend the licence
depending on conditions of licence. Any person who is aggrieved with the decisions of licensing
authority may appeal to court of law within three months whose decision will be final.
Import of new drugs

Those drugs whose composition is not recognized as safe by the experts will not be
allowed to import. The sanction of licensing authority will be required for the import of such new
drug. New drug may also include any patent and proprietary medicine containing any new drug.
Documentary evidence will be required for the permission of the import of new drugs regarding
purity, quality, efficacy and strength of new drug.
Places through which drugs may be imported into India

1. By railway
a. Ferozpur cantonment and Amritsar railway station in respect of drugs imported across
the frontier with Pakistan.
b. Ranghat, Bonagon and Mohiassan railway station in respect of drugs imported across
the frontier with Bangladesh
2. By sea
Madras, Calcutta, Bombay, Kochin and Vishakhapattanam
3. By air
Madras, Calcutta, Bombay, Delhi andAhmedabad.
Provisions of sea customs in respect of drugs and cosmetics

The laws related to custom for the import of certain goods under section18 of sea
customs Act are applicable to the import of drugs and cosmetics under section 13 of the Act. Any
officer authorized by Central Government or Customs Collector has authority to detain the
consignment or import package which he suspects to contain drugs, the import of which is
prohibited under the Act. After detaining the imported drugs or cosmetics, officer report it to
Drug Controller of India and if necessary, he may send such samples of suspected drugs for test or
analysis.
Classes of drugs and cosmetics to be imported

1. Drugs which may be imported under licence
2. Drugs which may be imported without licence
Classes of drugs which are prohibited for import in India

The following classes of drugs are prohibited for its import in India.
1. Adulterated, spurious, misbranded drugs or drugs which are not of standard quality.
2. Patent and proprietary medicine of which formula is not disclosed.
3. Drug imported in contravention of the provisions of theAct.
4. Drugs which may claim to cure any of the diseases as specified in the Schedule J.
5. Expired drugs.
6. Drugs which have not claimed therapeutic value.
7. Drugs which are likely to cause risk or injurious to human body or animal.
8. Drugs not intended for import.
Duration of Import Licence

Import licence is valid for three years from date of its issue unless it is suspended or
cancelled. Provided that if application for a fresh registration is made three months before the
expiry of existing licence the current licence shall deemed to continue in a force until orders are
passed.
Chapter IV Manufacture, Sale and Distribution of drugs and cosmetics

Provisions relating to Manufacturing of drugs
Following categories of licences are granted for the manufacture of drugs-
1. Licence for the manufacturing of Schedule C and C(i) drugs
2. Licence for the manufacturing of drugs other than Schedule C and C(i) and X drugs.
3. Licence for the manufacturing of Schedule X drugs.
4. Licence for the manufacturing of Schedule C, C(i) and X drugs
5. Loan licence for the manufacturing of above categories.
6. Repacking licence.
Conditions for the manufacture of drugs other than those specified in Schedule C, C(i) and
X drugs
A licence is required for the manufacture of drugs other than those specified in Schedule
C, C(i) and X drugs. For the manufacture of such drugs, an applicant has to make application to
the licensing authority in Form 24 and licence is granted in Form 25. Before granting such
licence, the licensing authority shall satisfy the following conditions-
1. The manufacture shall be conducted under the direction and supervision of competent
and technical staff consisting of at least one person who is whole time employee and
shall be -
a. Graduate in pharmacy or pharmaceutical chemistry of a recognized university with not
less than 18 months experience in manufacture of drugs after graduation; or
b. Graduate in medicine or science or pharmacy or pharmaceutical chemistry of a
recognized university with not less than 3 years experience in manufacture of drugs; or
c. Holds any other prescribed qualifications which is equivalent to (a) and (b) granted by an
authority outside India.
2. The factory premises shall be as per the guidelines of GMP and shall satisfy the
conditions specified in Schedule M.
3. Manufacturer shall provide adequate space, plant, equipments, etc for the manufacture
of variety of drugs as per the Schedule M.
4. Manufacturer shall provide a separate analytical laboratory along with staff and
equipments for testing the strength, quality and purity of raw materials and finished
products.
Conditions to be satisfied by licensee for the manufacture of drugs other than those
specified in Schedule C, C(i) and X drugs
1. The licensee shall maintain records and registers of the analytical test and manufacturing
as per Schedule U for five years from the date of manufacturing.
2. The licensee shall allow an inspector –

a.to enter the manufacturing premises.
b.to inspect the premises licensed for the manufacture and test of drugs.
c.to check all the registers and records used for the manufacture of drugs.
d.to take the samples of drugs , if necessary.
3. Licensee shall inform the licensing authority any change in the constitution of firm or
staff.
4. Licensee shall manufacture only such drugs that are directed by licensing authority.
5. Licensee shall maintain the inspection book in Form 35 and shall also reference sample
from each batch.
Conditions for the manufacture of drugs specified in Schedule C and C(i) drugs
A licence is required for the manufacture of drugs specified in Schedule C and C(i)
drugs. For the manufacture of Schedule C and C(i), an applicant has to make application to the
licensing authority in Form 27 and licence is granted in Form 28. Before granting such licence,
licensing authority shall satisfy the following conditions-
1. The premises meant for the manufacture of drugs specified in Schedule C, C(i) shall be
an adequate and equipped with the proper storage accommodations under the direction
and supervision of competent and technical staff along with separate analytical
laboratory and separate technical staff.
2. There shall be separate arrangements for the manufactured drugs.
3. For fixing expiry, there shall be a separate stability data.
4. A licence shall be granted for patent and proprietary medicine, if data is justifying that it
is safe, effective and stable.
Licensee shall satisfy the following special conditions
1. Licensee shall provide adequate technical staff for the manufacture and testing of
Schedule C and C(i) drugs.
2. Any licensee who is handling culture, pathogenic spore bearing organism shall provide
separate laboratory, utensil and apparatus.
3. Licensee shall maintain records and registers of the analytical test and manufacturing
as per Schedule U for five years from the date of manufacturing.
4. Licensee shall allow an inspector to enter and inspect any manufacturing premises,
process of manufacturing and means employed for testing and standardizing drugs.
5. Licensee shall maintain the inspection book in Form 35.
6. Licensee shall inform the licensing authority any change in the constitution of firm or
staff.
7. Licensee shall maintain reference sample from each batch of drug manufactured by him.
8. Licensee shall provide proper storage accommodations for preserving the properties of
drugs.
9. Licensee shall manufacture only standard quality drugs as per Schedule Second.
Conditions for the manufacture of drugs specified in Schedule X (Form 25 or 25F)

A separate licence is required for the manufacture of drugs specified in Schedule X. For
the manufacture of such drugs an applicant has to make application to the licensing authority in
Form 24-F accompanied with the prescribed fees and licence is granted in Form 25-F. Applicant
has to satisfy the following conditions -
1. The licensee shall forward to the licensing authority a statement of supply of drugs, sales
of drug to the manufacturer, wholesaler, retailer, hospital, dispensaries, nursing homes
and Registered Medical Practitioners every three months.
2. The licensee shall store drug in custody under direct supervision of responsible person.
3. The licensee shall maintain the accounts of all transactions for five years.
4 The licensee shall provide and maintain staff, premise and the equipment as specified .
5. The licensee shall comply with the provisions of theAct and of these rules.
6. The licensee shall either in his own laboratory or in any other laboratory approved by the
licensing authority test each batch or lot of the raw material used by him for the
manufacture of his products and shall maintain records or registers showing the
particulars in respect of such tests as specified in Schedule U. The records or registers
shall be retained for a period of 5 years from the date of manufacture.
7. The licensee shall allow an inspector to enter, any premises and to inspect the plant and
the process of manufacture and the means employed for standardizing and testing the
drugs.
8. The licensee shall allow an inspector to inspect all registers and records maintained
under these rules and to take samples of the manufactured drugs.
9. The licensee shall, from time to time, report to the licensing authority any changes in the
expert staff responsible for manufacture or testing of the drugs and any material
alterations in the premises or plant used for the purpose.
10. The licensee shall, on request, furnish to the licensing authority or the controlling
authority direct, from every batch or batches of drugs, a sample of such quantity as may
be considered adequate by such authority for any examination and if so required, also
furnish full protocols of tests which have been applied.
11. The licensee shall on being informed by the licensing authority that any part of any
batch of the drug has been found by the licensing authority not to confirm with the
standards of strength, quality or purity specified in these rules and on being directed so to
do, withdraw the remainder of the batch from sale.
12. The licensee shall maintain an Inspection Book in Form 35 to enable an Inspector to
record his impressions and the defects noticed.
13. The licensee shall maintain reference samples from each batch of the drugs
manufactured by him in a quantity which is at least twice the quantity of the drug
required to conduct all the tests performed on the batch. In case of drugs bearing an
expiry date on the label, the reference samples shall be maintained for a period of three
months beyond the date of expiry of potency and where no date of expiry of potency is
specified on the label, the reference samples shall be maintained for a period of three
years from the date of manufacture.
14. The licensee, who has been granted a license in Form 25-F, shall-
(i) forward to the licensing authority of the concerned States of manufacture and supply
of the drug a statement of the sales effected to the manufacturers, wholesalers, retailers,
hospitals, dispensaries and nursing homes and Registered Medical Practitioners every
three months;
(ii) maintain accounts of all transactions giving details as indicated below in a register
bound and serially page numbered and such records shall be retained for a period of five
years or one year after the expiry of potency, whichever is later:-
A. Accounts of the drugs specified in Schedule X used for the manufacture:-
1. Date of issue.
2. Opening balance of stock on the production day.
3.Quantity received, if any, and source from where received.
4. Quantity used in manufacture.
5. Balance quantity on hand at the end of the production day.
6. Signature of the person in charge.
B. Accounts of production:-
1. Date of manufacture.
2. Name of the drug.
3. Batch Number.
4. Quantity of raw material used in manufacture.
5.Anticipated yield.
6.Actual yield.
7. Wastage.
8. Quantity of the manufactured goods transferred.
C. Accounts of the manufactured drugs:

1. Date of manufacture.
2. Name of the drug.
3. Batch Number.
4. Opening Balance.
5. Quantity manufactured.
6. Quantity sold.
7. Name of the purchaser and his address.
8. Balance quantity at the end of the day.
9. Signature of the person in charge.
15. The licensee shall store drugs specified in Schedule X in bulk form and when any of such
drug is required for manufacture in a place other than its place of storage it shall be kept
in a separate place under the direct custody of a responsible person.
16. The licensee shall comply with the requirements of 'Good Manufacturing Practices' as
laid down in Schedule M.
Conditions of licence for the manufacture of drugs specified in Schedule C, C(i) (excluding
Schedule X and part XB ) and those specified in Schedule X
A licence to manufacture for sale or for distribution of drugs specified in Schedule C,
C(i) other than large volume parenterals, sera and vaccines, drugs specified in part XB and drugs
those specified in Schedule X shall be issued in Form 28 and a licence to manufacture for sale or
for distribution of drugs specified in Schedule C, C(i) and X (other than large volume
parenterals, sera and vaccines, drugs specified in part XB and drugs ) shall issue in Form 28B. A
licence to manufacture for sale or for distribution of large volume parenterals, sera and vaccines
shall be issued in Form 28D.
Before the grant of such licence, licensee shall comply with the general conditions
specified for grant of licence in Form 25 or 25F. Applicant shall provide information to the
licensing authority about data on stability of drugs which are likely to deteriorate for fixing the
data of expiry which shall be printed on the labels.
Conditions of Licence forAllopathic Loan Licence Manufacturing (Rule 74B)

A loan licensee, who avails the manufacturing facilities to a person for the manufacture
of drugs other than those specified in Schedule C, C(i) and X and for drugs other than those
specified in Schedule X shall be issued in Form 25Aand 28Arespectively.
Conditions of loan licence
1. The licence shall be deemed to be cancelled or suspended, if the license owned by the
licensee whose manufacturing facilities have been availed of by the licensee is
cancelled or suspended as the case may be, under these rules.

2. The licensee shall comply with the provisions of the Act and of these rules and with such
further requirements if any, as may be specified in any rules subsequently made under
Chapter IV of the Act. Provided that where such further requirements are specified in the
rules, these would come into force four months after publication in the Official Gazette.
3. The licensee shall test each batch or lot of the raw material used by him for the
manufacture of his products and also each batch of the final product and shall maintain
records or registers showing the particulars in respect of such tests as specified in
Schedule U.
4. The records or registers shall be retained for a period of five years from the date
of manufacture. The licensee shall allow an Inspector to inspect all registers and records
maintained under these rules and shall supply to the Inspector such information as he
may require for the purpose of ascertaining whether the provisions of the Act and rules
have been observed.
5. The licensee shall provide and maintain to the satisfaction of the licensing authority
adequate staff and adequate laboratory facilities for carrying out tests of strength, quality
and purity of the substances manufactured by him; or
6. The licensee shall make arrangements with some institution approved by the licensing
authority for such tests to be regularly carried out on his behalf by the institution.
7. The licensee shall maintain reference samples from each batch of the drugs
manufactured by him in a quantity which is at least twice the quantity of the drug
required to conduct all the tests performed on the batch. In case of drugs bearing an
expiry date on the label the reference samples shall be maintained for a period of three
months beyond the date of expiry of potency. In case of drugs where no date of expiry of
potency is specified on the label, the reference samples shall be maintained for a period
of three years from the date of manufacture.
8. The licensee shall maintain an Inspection Book in Form 35 to enable an Inspector to
Duration of loan licence

An original loan licence in Form 25-A or a renewed loan licence in Form 26-A unless
sooner suspended or cancelled, shall be valid for a period of five years on and from the date on
which it is granted or renewed.
Repacking Licence
Repacking licence means the licence which is granted by the authority for the purpose of
breaking up of any drug from the bulk container into a small packages and labeling of each
package with a view to its sale and distribution. Drugs specified in Schedule C and C(i) cannot be
repacked. Licence for repacking of drugs against application in Form 24-B (repacking of drugs
excluding those specified in Schedule X) shall be granted in Form 25-B.
Conditions to be satisfied by applicant before the grant of repacking licence

1. The repacking operations shall be carried out under hygienic conditions and under
supervision of competent person.
2. Factory premises shall comply with the Schedule M requirements.
3. Applicant shall have a separate drug testing unit at his own premises.
However, for test requiring sophisticated instrumentation technique or biological or
microbiological methods, licensing authority may permit such tests to be conducted by
the institution approved for that purpose by it.
Licensee should satisfy the following conditions:
1. Licensee shall make adequate arrangement for the storage of drugs.
2. Licensee shall allow any inspector to enter and inspect any premises where repacking of
drugs is carried out and allow to take samples from such premises.
3. Licensee shall maintain the inspection book in Form 35.
4. Licensee shall allow any inspector to inspect all registers, records and shall supply
necessary information whenever required.
5. Licensee shall maintain the reference samples from each batch of drug repacked by him.
6. Licensee shall test each batch or lot of raw materials used by him for repacking.
7. Licensee shall maintain records and registers repacked drugs as per Schedule U for five
years from the date of manufacturing.
Conditions for grant or renewal of licence

For the operation of blood bank/ processing of human blood for components and
manufacture of blood products
Applicant shall comply the following conditions before the grant of licence in Form 28-C
1. The processing of blood components shall be carried out under the active direction and
personal supervision of competent technical staff (who is a medical officer) and shall
have adequate knowledge and experience in blood group surgery.
2. Applicant shall provide adequate space, plant and equipment as per the Schedule F, Part
XII-B and /or XII-C for carrying out the operations related to blood.
3. Applicant shall provide and maintain adequate technical staff as per the Schedule F, Part
XII-B and /or XII-C.
4. Applicant shall provide adequate arrangements for storage of blood and blood
components.
5. Applicant shall provide information to the licensing authority about data on stability of
whole human blood or blood components which are likely to deteriorate for fixing the
data of expiry which shall be printed on the labels.
Further, licensee shall comply the following conditions
1. The licensee shall provide adequate space, plant and equipment as per the Schedule F,
Part XII-B and /or XII-C for carrying out the operations related to blood.
2. The licensee shall maintain adequate technical staff as per the Schedule F, Part XII- B
and /or XII-C.
3. The licensee shall test blood components in his own laboratory and shall maintain the
records as per the Schedule F, Part II- B and /or XII-C.
4. The licensee shall allow an inspector to enter with or without prior notice, premises and
plant and process of manufacture and means employed for testing and standardizing the
substances where processing on blood or blood components is carried out.
5. The licensee shall allow an inspector to inspect all registers and records maintained
under these rules and take the samples of manufactured product and shall provide the
necessary information.
6. The licensee shall from time to time inform to Licensing authority any changes in the
expert staff who is carrying operations related to blood and blood components.
Provisions relating to Sale of Drugs

Drugs and Cosmetics Act, 1940 and the rules made thereunder provides for the sale of
drugs only on the issue of licenses. State Government may appoint a licensing Authority to issue
the licenses for sale. Applicant has to make an application in the prescribed term. The granted
licences are required to be renewed within 6 months after its expiry.
Application for grant of licenses to sell, stock or exhibit for sale or distribute drugs shall
be made in the following different Forms-
1. For drugs other than those specified in Schedule X: Form 19
2. For Restricted (Applicants of a town with population of 5000 or less than 5000 where
services of qualified person not required) Licenses: Form 19A
3. For wholesale or distribution of drugs from a motor vehicle:- Form 19AA
4. For drugs specified in Schedule X: From 19C.
An applicant has to pay the prescribed fees of ` 40/- for the grant of licences to sell, stock
or exhibit for sale or distribute drugs (For itinerant vendors it is `10/-)
The granted licences are required to be renewed within 6 months after its expiry. For the
renewal of licences applicant has to pay ` 40/- plus additional charges at the rate of ` 30/- per
month. For itinerant vendor, applicant has to pay ` 10/- plus additional charges at the rate of ` 6/-
per month.
Issue of Licences
The licences shall be issued in various forms:
1. For retail sale
a) For drugs other than those specified in Schedule C, C(i) and X: Form 20
b) For drugs specified in Schedule C and C(i): Form 21 /or XII-C.
c) For drugs specified in Schedule X: Form 20 F.
2. For Restricted licences
a) For drugs other than those specified in Schedule C, C(i) and X : Form 20A
b) For drugs specified in Schedule C and C(i): Form 21A
c) For drugs specified in Schedule X: No licence shall be issued
3. For wholesale
a) For drugs other than those specified in Schedule C, C(i) and X: Form 20 B
b) For drugs specified in Schedule C and C(i): Form 21 B.
c) For drugs specified in Schedule X: Form 20 G.
4. For wholesale or distribution of drugs from a motor vehicle
a) For drugs other than those specified in Schedule C, C(i) and X: Form 20 BB
b) For drugs specified in Schedule C and C(i): Form 21 BB
c) For drugs specified in Schedule X: No licence shall be issued.
Duration of Licence
The licences are valid up to 31st December of the year, following the year it should be
renewed. The licences should be renewed within 6 months after its expiry. Even after 6 months
the licences can be renewed under specified conditions.
Renewal of Licences
The licences in Form 20, Form 21, Form 20B, Form 21B, Form 20F, Form 20G, Form
20C and Form 20D are valid for the period of five years from the date of granting them.
Before expiry of the licences applications for the renewal of the licences in the prescribed
Forms accompanied with the prescribed fees, paid through chalan, should be submitted to the
LicensingAuthority.
After expiry of the licences, but within six months of such expiry, the prescribed application
Forms accompanied by the prescribed fee plus an additional fee at the rate mentioned below per
month or part thereof, paid through chalan, should be submitted to the LicensingAuthority.
Licence for Licence of Application Licence fee Additional Fee per

retail sale wholesale form (`) Month ( ` )
Form 20 Form 20-B Form 19 1500 500
Form 21 Form 21-B Form 19 1500 500
Form 20-F Form 20-G Form 19-C 500 250
Form 20-C Form 20-D Form 19-B 250 50
Duplicate Licences
If the original licences defaced, damaged or lost, the duplicate licences may be issued on
application given by the licensee accompanied by the prescribed fee. The fees for different
licences have been mentioned below
Licence for retail sale Licence of wholesale Fees for Duplicate Licence
(`)
Form 20 Form 20-B 150
Form 21 Form 21-B 150
Form 20-F Form 20-G 150
Form 20-C Form 20-D 50
Conditions of Licences For wholesale of drugs other than those specified in Schedule C,
C(i) and X
a) The premises must be adequate and equipped with proper storage accommodation for
preserving the properties of drugs.
b) The premises should be under the control of competent person to supervise and control
the sale, distribution and preservation of drugs.
c) All drugs should be purchased from duly licensed manufacturers.
d) The licensee should sale the drugs only to a person who holds the licence. This condition
of licenses shall not be applied to the following:
1.An officer /Authority working on the behalf of Government.
2. Educational institute, hospital or R.M.P. who carries out the sale of drugs for patient.
e) The licence shall be displayed at the prominent place open to public.
f) If the licensee want to sell additional categories of drugs those which are not specified in
his licenses, he should have to take the permission of licensing authority for this purpose.
Conditions of Licence for the distribution of drugs from a motor vehicle (20 BB and 21 BB)
1. Purchase of drugs should be carried out from a duly licensed manufacturer.
2. The drugs should be sold to a person who holds licence. This condition of license shall
not applied to the following:
a) An officer /Authority working on behalf of Government.
b) Educational institute or hospital or RMP who sells the drugs for his patients.
3. The license shall be displayed at a prominent place in the vehicle.
4. If there is any change in the vehicle such change should be informed to the licensing
authority within one week.
5. For distribution of drugs from motor vehicle, there should be proper storage facilities
for preservation of drugs.
6. No licence is required for the public carrier vehicle or hired vehicle.
Restricted Licence (Form 20Aand 21A)

Restricted licence is a licence for the sale or distribution of drugs whose sale does not
require the supervision of a qualified person. This licence is granted to a bonafide traveling
agents of firm in such a rural area where other channels of distribution of drugs are not available.
Such licence is issued to vendors for sale of drugs other than those specified in Schedule X.
Conditions of Restricted licence

The premises in respect of which the licences are to be granted should be adequate and
equipped with proper storage accommodation for preserving the properties of drugs.
Before the grant of such licence, the licensing authority should take into account the
following:
1. The number of such licences granted in a locality during one year of the preceding year.
2. The occupation, trade or business carried on by the applicant.
Conditions to be satisfied by the licensee for Restricted licence

1. The premises should be adequate and equipped with the proper storage accommodation
for preserving the properties of drugs.
2. The premises should be under the control of registered pharmacist to supervise the sale,
distribution and preservation of drugs.
3. The licence shall be displayed at the prominent place open to the public.
4. The purchase of drugs should be carried out from duly licensed manufacturers or
dealers under cash or credit memo.
5. If there is a change in the constitution of firm, such change should be informed to the
licensing authority within one month.
Conditions to be satisfied by the applicant to issue licence in Form 20, 20B, 20F, 20G, 21,
21B
1 Licensing authority should satisfy that the premises in respect of which the licence is to
be granted are adequate and equipped with the proper storage accommodation for
preserving the properties of drugs.
2. In case of pharmacy, licence in the Form 20 and 21 shall be granted according to the
requirements of pharmacy which is specified in Schedule N.
3. A licence in Form 20 F shall be granted to pharmacy in such area and to pharmacy which
is not operating Chemists /Druggists.
While granting such licence, the licensing authority should consider the following
a) The average number of such licences granted during three years immediately
proceeding year.
b). The occupation, trade or business carried on by the applicant.
4. Where licence is granted for the wholesale (Form 20Bor 21B) and retail sale (Form 20 or
21) of drugs in such premises should be under the control of competent person i.e.
registered pharmacist and have an area of not less than 15 square meters.
Conditions of General Licence

The following conditions are required to be followed for the sale of drug in Form 20,
20B, 20F, 20G, 21, 21B:
[I] Dispensing and compounding of drugs
1. Any drug shall, if compounded or made on the licensee’s premises be compounded or
made under the direct and personal supervision of a registered pharmacist.
2. The drugs other than the sale by the way of wholesale dealing, shall be supplied only on
the prescription of a Registered Medical Practitioner and shall be under personal
supervision of a registered pharmacist.
3. (i) The supply of any drug [other than those specified in Schedule X] on a prescription of a
Registered Medical Practitioner shall be recorded at the time of supply in a prescription
register specially maintained for the purpose and the serial number of the entry in the
register shall be entered on the prescription. The following particulars shall be entered in
the register:
(a) serial number of the entry
(b) the date of supply
(c) the name and address of the prescriber
(d) the name and address of the patient, or the name and address of the owner of the
animal if the drug supplied is for veterinary use
(e) the name of drug or preparation and the quantity or in case of a medicine made up by
the licensee, the ingredients and quantities thereof

(f) in the case of a drug specified in Schedule C or Schedule H the name of the
manufacturer of the drug, its batch number and the date of expiry of potency, if any
(g) the signature of the registered pharmacist by or under whose supervision the
medicine was made up or supplied.
Provided that in the case of drugs which are not compounded in the premises and which
are supplied from or in the original containers, the particulars specified in items (a) to (g) above
may be entered in a cash or credit memo book, serially numbered and specially maintained for
this purpose.
Provided further that if the medicine is supplied on a prescription that medicine has
been already supplied on a previous occasion and entries made in the prescription register, it shall
be sufficient if the new entry in the register includes a serial number, date of supply, the quantity
supplied and a sufficient reference to an entry in the register regarding dispensing of the medicine
on the previous occasion.
[II] Supply of Schedule C drugs
The supply of Schedule C drugs by retail shall be recorded in the register. The register
should include the following details.
1. Serial number of entry
2. Date of expiry
3. Name and address of purchaser
4. Name of the manufacturer, batch number and expiry date
5. Sign of qualified person
6. Name and quantities of drugs
[III] Supply of other drugs
In case of drugs other than those specified in Schedule C is supplied by retail under cash
or credit memo that should include the following particulars:
a) Name, address and sale licence number of dealer
b) Serial number of cash or credit memo
c) Name and quantity of drug supplied
Carbon copies of cash and credit memos shall be maintained by the licensee. The records
shall be maintained and preserved for at least two years from the date of last entry.
[IV] Sale of Schedule H and X drugs
1. Schedule H and X drugs shall be sold by retail only on the prescription of Registered
Medical Practitioner. The prescription should be in duplicate form one copy of this
prescription should be preserved by the licensee for at least two years
2. Sale of Schedule H and X drugs to Registered Medical Practitioners, hospital,
dispensaries or nursing homes shall be made under the signed written prescription which
shall be preserved by the licensee for at least two years.

The premises should be under the control of registered pharmacist to supervise the sale,
distribution and preservation of drugs.
3. The licence shall be displaced at the prominent place open to the public.
4. The purchase of drugs should be carried out from duly licensed manufacturers or
dealers.
5. The drugs which are specified in schedule C and C(i) should be properly stored before its
sale.
6. In case of pharmacy, licence in the Form 20 and 21 shall be granted according to the
requirements of pharmacy which is specified in Schedule N.
7. A licence in Form 20 F shall be granted to pharmacy in such area and to pharmacy which
is not operating Chemists /Druggists.
8. The records / registers which are maintained shall be preserved for two years from the
date of last entry therein.
9. If there is a change in the premises, such change should be informed to licensing
authority within one month.
10. If the licensee wishes to sell an additional categories of drugs specified in Schedule C
and C(i) should take the permission of licensing authority.
[V] Dispensing of Schedule H and X drugs
1. The prescription shall not be dispensed more than once unless the prescriber have stated
that it may be dispensed for more than once.
2. If the prescriptions contains directions, it may be dispensed for the stated number of
times. It must be dispensed according to the directions.
3. While dispensing Schedule H and X drugs, signature, names and address of the seller
and date on which it is dispensed, shall be recorded
4. While dispensing Schedule H and X drugs, it should not contain other preparation or any
other drugs.
[VI] Storage of Schedule X drugs
In retail shops, Schedule X drugs shall be stored -
1. Under lock and key in a cupboard or in premises recorded for the storage of these
substances.
2. In a part of premises solely separated from the remainder of premises and qualified
person is responsible to access.
[VII] Records of Purchase
Records of purchase of drugs for retail sale shall be maintained by licensee and such
record shall contain following particulars
(i) Date of purchase
(ii) Name and address of person from whom purchased and his licence number
(iii) Name of drug , quantity and batch number
(ii) Name of manufacturer
Licensee shall serially number the purchase bills including cash or credit memos and
maintain it in chronological order.
[VIII] Wholesale supply of drug
Drugs for wholesale supplied under cash or credit memos should include the following
particulars:
a) Name, address and sale licence number of licensee to whom such drugs are sold
b) Serial number of cash or credit memo
c) Name, quantity and batch number of drug supplied
d) Name of manufacturer
Carbon copies of cash and credit memos shall be maintained by the licensee. The records
shall be maintained and preserved for at least two years from the date of last entry.
[IX] Records of Purchase
Records of purchase of drugs wholesale sale shall be maintained by licensee and such
record shall contain following particulars
(i) Date of purchase
(ii) Name and address of person from whom purchased and his licence number
(iii) Name of drug, quantity and batch number
(iv) Name of manufacturer
Licensee shall serially number the purchase bills including cash or credit memos and
maintain it in chronological order.
Licensee shall produce all registers and records for inspection on demand by inspector.
[X] Description for premises
i) Drug store
Licensee who do not require services of qualified person shall display description,
“Drug store”.
ii) Chemists and Druggists
Licensee who employ the services of qualified person shall display description,
“Chemists and Druggists” but where drugs are not compounded against
prescription.
iii) Pharmacy
Licensee who employ the services of qualified person shall display description,
“Pharmacy” and where drugs are compounded against prescription.
[XI] Storage of Veterinary medicine

1. Veterinary medicines are kept in retail shops or the premises reserved for this purpose
shall be labeled with direction.
“NOT FOR HUMAN USE” for the treatment of animals only.
The veterinary medicines shall be stored under lock and key in a cupboard or in premises
reserved for this purpose.
2. Part of the premises separated from the remainder of the premises and the customers will
not have to access veterinary medicines.
[XII] The licensee shall maintain an Inspection Book in Form 35 to enable an Inspector to
[XIII] The licensee shall not sell or stock expired drug which is registered on label, container or
wrapper. He shall keep such drugs in packages or cartons aside and label the top with the
words, “Not for sale”.
Classes of prohibited Drugs (sec.18)

The following classes of drugs are prohibited for its manufacture, sale, distribution, etc.
1. Adulterated, spurious, misbranded drug or drug which are not of standard quality.
2. Patent and proprietary medicine of which formula is not disclosed.
3. Drug imported or manufactured in the contravention of the provisions of theAct.
4. Drugs which may claim to cure any of the diseases specified in the Schedule J.
5. Expired drugs.
6. The drugs intended for its consumption by Employees State Insurance Scheme (E.S.I.S)
or Government Institutions.
7. Drugs intended for its distribution to the members of the medical profession as free
sample and bearing on the container the words “Physician sample , Not to be sold.”
8. Drugs not intended for sale.
Provisions Relating to Cosmetics

Sale of Cosmetics
The cosmetic which are not in the contravention of the provisions of the Act and Rules
may be sold without licence. Dealer of cosmetic require a licence for the sale of cosmetic.
Manufacture of Cosmetics
For the manufacture of cosmetics licence is required. Applicant has to make an
application to the licensing authority in Form 31 accompanied with prescribed fees and the
licence is granted in Form 32. It is valid up to 31st December of the year, following the year in
which it is granted.
Conditions for grant of licence for manufacture of Cosmetics

Manufacturer of cosmetics shall satisfy the following conditions for the manufacture of
cosmetics
1. The manufacture of cosmetics should be conducted under the personal supervision of a
competent technical staff with the following qualifications-
a. Diploma in pharmacy
b. Registered pharmacist
c. Passed intermediate examination with Chemistry as one of the subject or any other
examination approved by licensing authority.
2. Manufacturing premises shall be separated from rooms for private use and shall be clean
and maintain hygienic conditions during manufacturing.
3. The applicant shall provide adequate space, plant and equipments for the manufacture of
cosmetics.
4. The applicant shall provide adequate facilities for testing the manufactured
cosmetics and raw materials and should maintain the records thereof, as specified in
Schedule U(i).
5. Manufacturer of mother tincture shall provide adequate premises for staff and laboratory
equipments.
Import of Cosmetics
Statement to accompany imported cosmetics-
All consignments of cosmetics sought to be imported shall be accompanied by an
invoice or statement showing the name and quantities of each article of cosmetic included in the
consignment and the name and address of the manufacturer. Documents to be supplied to the
Customs Collector before any cosmetic is imported, a declaration signed by or on behalf of the
manufacturer or on behalf of the importer that the cosmetics comply with the provisions of
Chapter III of theAct, and the rules made thereunder, shall be supplied to the Customs Collector.
Procedure for the import of cosmetics
If the officer appointed at the post of entry by Central Government has reason to believe
that any cosmetic contravenes any of the provisions of the Act or the rules made thereunder may
take sample of the cosmetic from the consignment for inspection. On examination of the sample,
if defects are noticed the officer shall advise the Collector of Customs for further action to be
taken. If the suspected contravention of the provisions of the Act or the rules is such as may have
to be determined by test, the officer shall send the sample to the laboratory established for the
purpose for performing such that the test report on such sample is received from the Director of
the said laboratory or any other officer of the laboratory empowered by him in this behalf, with
the approval of the Central Government. Provided that if the importer gives an undertaking in
writing not to dispose of the cosmetic without the consent of the Collector of Customs and to
return the consignment or such portion thereof, he shall return the consignment or such portion
thereof as may be required, the Collector of Customs shall make over the consignment to the
importer. If the importer who has given an undertaking under the provisions to sub-rule (1) is
required by the Collector of Customs to return the consignment or portion thereof, he shall return
the consignment or portion thereof, within ten days of receipt of the notice.
Further procedure on receipt of the report of analysis
If the Director of the laboratory established for the purpose by Central Government or
any other officer of the laboratory empowered by him in this behalf with the approval of Central
Government, reports to the Collector of Customs or to the officer mentioned in sub-rule (1)
above that the sample of any cosmetic in a consignment contravenes the provisions of Chapter III
of the Act or the Rules made thereunder and that the contravention is such that it cannot be
remedied by the importer, the Collector of Customs shall communicate the report forthwith to the
importer who shall within two months of receiving such a communication either send back all
cosmetic of that description to the country in which it was manufactured or to the country from
which it was imported or hand it over to the Central Government which shall cause it to be
destroyed.
Classes of prohibited Cosmetics
The following classes of cosmetics are prohibited for its sale, distribution etc.
1. Spurious or misbranded cosmetics
2. Any cosmetic that is not of standard quality.
3. Cosmetic that is imported or manufactured in the contravention of the provision of the
Act.
4. Cosmetic that contain-
a. Hexachlorophene
b. Coal tar colour other than those prescribed
c. Mercury compounds
5 Cosmetic that is coloured with arsenic or lead compounds.
6. Cosmetic that is intended for use on eye lash, eye-brow containing coal tar dye, coal or
intermediates.
7. Cosmetic that contain such ingredients which are harmful for use.
Labeling and Packing of Cosmetics
Cosmetics should be labeled and packed in the prescribed manner.-
1. On both the inner and outer labels;
a. The name of the cosmetic,
b. The name of the manufacturer and complete address of the premises of manufacturer
where the cosmetic has been manufactured.
Provided that if the cosmetic is contained in a very small size container where the
address of the manufacturer cannot be given, the name of the manufacturer and his
principal place of manufacture shall be given along with pin code.
2. On the outer label-
A declaration of the net contents expressed in terms of weight for solids, fluid measure
for liquids, weight for semi solids, combined with numerical count if the content is sub-
divided:
Provided that this statement need not appear in case of a package of perfume, toilet water
or the like the net content of which does not exceed 60 ml or any package of solid or
semi-solid cosmetic the net content of which does not exceed 30 grams.
3. On the inner label, where a hazard exists-
a. Adequate direction for safe use.
b. Any warning, caution or special direction required to be observed by the consumer,
c. A statement of the names and quantities of the ingredients that are hazardous or
poisonous.
4. A distinctive batch number, that is to say, the number by reference to which details of
manufacture of the particular batch from which the substance in the container is taken
are recorded and are available for inspection, the figures representing the batch number
being preceded by the letter “B”, provided that this clause shall not apply to any in solid
or semi-solid state, and 25 milliliters or less if the cosmetic is in a liquid state.
Labeling of Hair dyes containing dyes, pigments and colours

Hair dyes containing paraphenylene di-amine shall be labeled with the following
legends in English or local languages.
Caution:- “This product contains such ingredients which may cause skin irritation in
certain cases, hence the preliminary test should be carried out to determine whether the
hypersensitivity may exists or not ; as such use may cause blindness”.
Each package of the Hair dyes should contain the following directions.
This preparation cause skin irritation or inflammation of the skin , hence the preliminary
test should be carried out to determine whether or not the sensitivity may exists. For this test,
cleanse a small area of the skin behind ear or inner surface of the forearm with soap and water or
alcohol. Then apply hair dye preparation on the skin and allow it to dry for 24 hours. After 24
hours, wash it with soap and water. If no irritation or inflammation occurs the hypersensitivity
does not exist. This test should be carried out before each and every application of the hair dye.
Chapter IV-A Ayurvedic, Siddha and Unani Drugs
Ayurvedic, Siddha and Unani Drugs TechnicalAdvisory Board (sec. 33C)

Constitution
It is constituted by Central Government. The function of board is to advise the Central
Government and State Government on the technical matters arising out of the chapter related to
such drugs and other functions assigned to it by Government.
It has the following members.
A. Ex- Offcio Member
1. Director General of Health Services
2. Drugs Controller of India
3. The Principal Officer of Indian systems of medicine
4. Director, Central Drugs Laboratory, Calcutta
B. Nominated Members
1. One Pharmacologist.
2. One Phytochemist
3. One GovernmentAnalyst.
4. Four persons –
a) Two fromAyurvedic Pharmacopoeia Committee
b) One from Siddha Pharmacopoeia Committee
c) One from Unani Pharmacopoeia Committee
C. One teacher in Dravyaguna and Bhaishajya Kalpana
D. One teacher in ILM-UL-ADVIAand TALIT-WA-DAWASAZI
E. One teacher in Gunapadam
F. Three practitioners, one each fromAyurvedic, Siddha and Unani Tibb systems of medicine.
G. Three person one each to represent theAyurvedic, Siddha and Unani drug industry.
Ayurvedic, Siddha and Unani Drug Consultative Committee (sec. 33D)
It is constituted by the Central Government. Its function is to advise the Central
Government and to a board on any matter arising the administration of this Act to secure
uniformity throughout India.
Constitution
1. Two representatives of Central Government
2. One representative of each State Government is to be nominated by that concerned
State Government.
Manufacture ofAyurvedic, Siddha and Unani Drugs
For the manufacture of Ayurvedic, Siddha and Unani Drugs licence is required.
Applicant has to make an application to the licensing authority in Form 24-D accompanied with
prescribed fees and the licensing authority on satisfying issue the licence in Form 25-D. A loan
licence may be granted in form 25E against an application in form 24E.
Conditions for grant of licence for manufacture ofAyurvedic, Siddha and Unani Drugs
The following conditions should be complied by the applicant for the manufacture of
Ayurvedic, Siddha and Unani Drugs-
1. The premises of factory shall be clean and maintain hygienic conditions during
manufacture.
2. Manufacturing shall be carried out in such premises and under hygienic conditions as
specified in Schedule T.
3. Manufacturing shall be carried out under direction and supervision of qualified person
who possesses-
a) A degree or diploma in Ayurveda, Ayurvedic pharmacy, Siddha or Unani systems of
medicine as the case may be
b) Degree in pharmacy or pharmaceutical chemistry or botany with two years post graduate
experience in the manufacturing ofAyurvedic or Unani drugs.
c) Vaidya or Hakim with four years manufacturing experience.
d) Pharmacist in Ayurvedic, Siddha or Unani systems of medicine with eight years
manufacturing experience.
Licensee shall observe the following conditions-
1. Licensee shall maintain the records of manufacture and test of raw materials and
finished products.
2. Licensee shall permit the inspector to take the samples of raw materials and finished
product for test and shall maintain the records of the same.
Sale ofAyurvedic, Siddha and Unani Drugs

No licence is required for the sale of Ayurvedic, Siddha or Unani drugs provided they
purchase the drugs from duly licensed manufacturer of Ayurvedic, Siddha or Unani systems of
medicine.
Prohibition for sale ofAyurvedic, Siddha and Unani Drugs

FollowingAyurvedic, Siddha or Unani drugs are prohibited for its sale-
1. Patent and proprietary medicines of which formulae are not disclosed and which are not
prepared according to Schedule First.
2. Ayurvedic, Siddha and Unani Drugs which are in the contravention of the provisions of
thisAct.
Labeling ofAyurvedic, Siddha and Unani Drugs

The label should contain the following details-

1. List of ingredients with their quantities and reference to method of preparation. In case
of large list, it may be printed separately.
2. Medicine for internal use containing poisonous substances specified i.e. Schedule E(i)
shall be labeled with words- “ Caution- To be taken under medical supervision” in
English and Hindi.
3.a)Name of drug as per First Schedule:
b) Net contents
c) Proper name of the substance in addition to any patent and proprietary name
d) Name and address of the manufacturer
e) Manufacturing licence number
f) Batch or lot number
g) Date of manufacture
h) The words “Ayurvedic medicine” or “Siddha medicine” or “Unani medicine”.
i) The words “For External use only”, if medicine is for external use.
j) Drugs for free distribution to members of medical profession shall bear on label “Not to
be sold”.
Packing ofAyurvedic, Siddha and Unani Drugs

1. Preparation (Asavas) with high content of alcohol as base
Name of drug Maximum size of packing

(i) KarpurAsava 15 ml
(ii)Ahiphensava 15 ml
(iii) Mrgamadasava 15 ml
2. Preparations containing self-generated alcohol
Name of drug Maximum content of ethyl Maximum size of packing

alcohol (v/v)
(i) Mritsanjivani Sura 16% 30 ml
(ii) Mahadrakshasava 16% 120 ml
Homoeopathic Medicines
Import of Homoeopathic medicines
For the import of Homoeopathic medicine licence is not required in India but for the
import of new Homoeopathic medicine, written permission from licensing authority is required.
The imported Homoeopathic medicines should be labeled and packed in accordance with the
rules.
Manufacture of Homoeopathic medicines

For the manufacture of Homoeopathic medicines licence is required. Applicant has to
make an application to the licensing authority in Form 24C accompanied with prescribed fees
and the licence is granted in Form 25C.
Conditions for grant of licence for manufacture of Homoeopathic medicine

Manufacturer should comply the following conditions for the manufacture of
Homoeopathic medicines-
1. Manufacturing of Homoeopathic medicines shall be conducted under the direction and
supervision of competent person who have at least five years experience in the
manufacture of Homoeopathic medicines.
2. The premises of factory shall be clean and maintain hygienic conditions during
manufacturing.
3. Manufacturing premises shall be separated from rooms for private use.
4. Manufacture of Homeopathic medicine shall be carried out with other systems of
medicine.
5. Manufacturer of mother tincture shall provide adequate premises for staff and laboratory
equipments.
6. Licensee shall permit inspector to enter and inspect manufacturing premises, processes,
records and to take samples of the products.
7. Licensee shall maintain the inspection record in Form 35.
8. Manufacturer shall make necessary arrangements for the storage of manufactured drugs.
Licensee of mother tincture should comply the following conditions-
1. Crude drugs for manufacture of mother tincture shall be tested and records of such test
shall be maintained for at least five years.
2. Records of total solid content and alcohol content shall be maintained.
3. Filling of mother tincture shall be done in neutral bottles.
4. Records of sale of mother tincture shall be maintained along with details such as name
and address of person.
Sale of Homoeopathic Medicines

1. State Government may appoint the licensing authority for this purpose.
2. The applicant has to pay the prescribed fees of ` 10/- for grant of licence to sale or
distribute Homoeopathic medicine.

3. The application for the grant of license to sale or distribute Homoeopathic medicine
shall be made in the Form 19 B.
4. For the renewal of such licence after its expiry (but before six months), the applicant has
to pay renewal fees of ` 10 and additional charges at the rate of ` 8 per month.
5. The granted licenses are issued in the Form 20C for retail sale and in the form 20D for
wholesale.
6. The granted license are valid up to 31st December of the year following the year it should
be renewed unless if it is suspended or cancelled.
Conditions of licence in Form 20C and 20 D

1. The premises for the sale of Homoeopathic medicine shall be clean and adequate.
2. The premises shall be under the control of qualified person to supervise and control the
sale and distribution of Homoeopathic medicine.
3. The licence shall allow Drug Inspector to inspect the premises.
4. The licence shall allow Drug Inspector to inspect the records and registers for the sale of
Homoeopathic medicine.
5. In case of potentised preparations packed in containers of 30 ml or less and mother
tinctures prepared in containers upto 60ml capacity, there is no need to maintain its
record for sale.
Labeling of Homoeopathic medicines

The following particulars shall appear on the label of Homoeopathic medicines-
1. The name of medicine as per pharmacopoeia or for other drugs, the name descriptive of
true nature of drug.
2. The word Homoeopathic medicines
3. Potency of medicine along with name of ingredients.
4. Percentage of alcohol by volume.
5. For mother tinctures following additional information should appear-
a) Batch or lot number
b) Manufacturing licence number
c) Proprietary name, if any
Chapter V Miscellaneous
Standards for veterinary drugs
The standards for veterinary use, shall be those given in the current edition for the time
being in force of the British Pharmacopoeia (Veterinary).
Standards for patent or proprietary medicines
The standards for patent or proprietary medicines shall be those laid down in Schedule V
and such medicines shall also comply with the standards laid down in the Second Schedule to the
Act.
Standards for Surgical Dressings
The standards for Surgical Dressing shall be such as are laid down in Schedule F (ii).
Standards for Sterilised Umbilical tapes
The standards for Sterilised Umbilical tapes shall be as laid down in Schedule F(iii).
Standards for substances (other than food) intended to affect the structure or any function
of human body contraceptives
1. The standards for mechanical contraceptives shall be such as are laid down in Schedule
R.
2. The standards which other contraceptives will have to comply with shall be in
conformity with the formulae approved as safe and efficacious by the Central
Government. Such formula shall be displayed on the label of every container of such
contraceptive.
Standards for Medical Devices
The standards for the Medical Devices shall be such as are laid down in Schedule R (ii).
Standards for substances intended to be used for the destruction of vermin or insects which
cause disease in human beings or animals.
The standards of disinfectants shall be such as are laid down in Schedule O.
Standards for ophthalmic preparations including Homoeopathic ophthalmic preparations
The standards for ophthalmic preparations including Homoeopathic ophthalmic
preparations shall be those laid down in Schedule FF, and such preparations shall also comply
with the standards set out in the Second Schedule to theAct.
Packing of drugs
1. The pack sizes of drugs meant for retail sale shall be as prescribed in Schedule P (i) to
these rules.
2. The pack sizes of drugs not covered by the Schedule P (i) shall be as given below:
Unless specified otherwise in Schedule P (i),
a. The pack sizes for Tablets/Capsules shall be-

Where the number of Tablets (coated or uncoated)/Capsules (hard or soft gelatin) is less
than 10, such packing shall be made by the integral number. For numbers above 10, the
pack size of Tablets /Capsules shall contain multiples of 5.
b. The pack sizes for liquid Oral preparations shall be 30ml (paediatric only) 60 ml/100
ml/200 ml/450 ml.
c. The pack sizes for Paediatric Oral Drops shall be 5 ml/10 ml/15 ml.
d. The pack sizes for Eye/Ear/Nasal drops shall be 3 ml/5 ml/10 ml.
e. The pack size for Eye Ointment shall be 3 gm/5 gm/ 10 gm.
Provided that the provisions of the pack sizes covered under this rule shall not apply to:
1. Pack sizes or dosage forms not covered by the foregoing provisions of this rule.
2. The imported formulations in finished form.
3. Preparations intended for Veterinary use.
4. Preparations intended for Export.
5. Vitamins/Tonics/Cough Preparations/Antacids/Laxatives in Liquid Oral forms, Unit
dose (including applicaps).
6. Pack sizes of dosage form meant for retail sale to Hospitals, Registered Medical
practitioners, Nursing Homes.
7. Physician's Samples.
8. Pack sizes of large volume intravenous fluids.
Provided also that pack sizes of any of the new drug as and when approved by the
Licensing Authority appointed under Rule 21 and if not covered under this rule, shall be
examined for the purpose of approval with the specific justification by the said
LicensingAuthority.
Packings of drugs specified in Schedule X.
The drugs specified in Schedule X shall be marketed in packings not exceeding-
a. 100 unit doses in the case of tablets/capsules.
b. 300 ml in the case of oral liquid preparations.
c. And 5 ml in the case of injections.
Provided that nothing in this rule shall apply to packing meant for use of a hospital or
a dispensary subject to the conditions that-
i. such supply is made by the manufacturers or distributors direct to the
hospital/dispensaries; and
ii. hospital packs shall not be supplied to a retain dealer or to a Registered Medical
Practitioner.
Packing and labeling of Umbilical tapes
The Umbilical Polyester Tape shall be packed in sealed Polythene bags or sealed plastic
containers which ensure that when packed, the tape is sterile. The packing shall protect the tape
from contamination and damage. Every packing offered for sale shall bear a clear and permanent
marking with the following particulars:
i. The proper name of the drug i.e. Umbilical Polyester Tape 'Sterile'
ii. Manufacturer's name and address.
iii. Batch number
iv. Licence number under which the tape is manufactured.
v. Date of manufacture and date of expiry.
vi. Length and width of the Tape
Packings of condoms
The condoms shall be individually wrapped and sealed in laminates containing at least
eight microns of aluminium foil. The individual condom shall be packed in square (non-squeeze
condition) / rectangular aluminium foil. The packing shall protect the condoms from
contamination and mechanical damage.
Labeling Conditions
1. Schedule H drugs and medicines: For internal use
a) The words caution: It is dangerous to take this preparation except under medical
supervision.
b) Those words shall be conspicuously printed and surrounded by a line within which there
shall be no other words.
2. Schedule H medicines:- made up ready for internal use
a) The symbol Rx conspicuously displayed on the left top corner of the label.
b) The words Schedule H drug should be written with the warning; “To be sold by retail on
the prescription of a Registered Medical Practitioner only.”
3. Schedule H Medicine for internal use and falling under dangerous Drugs Act,1930 (Now
Narcotic and Psychotropic substanceAct,1985)
a) The symbol NRx in red conspicuously displayed on the left top corner of the label.
b) The words Schedule H drug warning:-
“To be sold by retail on the prescription of a Registered Medical Practitioner only”.
4. Schedule X medicines for internal use
a) The symbol XRx in red conspicuously displayed on the left top corner of label.
b) The words; 'Schedule X drug – warning, “ To be sold by retail on the prescription of
R.M.P only”
5. Schedule X medicines in bulk form
The symbol XRx conspicuously displayed on the left top corner of the label in red ink.
6. Schedule D drug
a) Date of manufacture
b) Date of expiry of potency.
7. Schedule C medicine in original form
a) Proper name of the substance in addition to any patent and proprietary name.
b) Licence number under which manufactured or imported
c) Batch number
d) Statement of potency in unit wherever required by Rules.
e) Name and address of the manufacturer of final product
f) Date of manufacture
g) If a test for maximum toxicity is prescribed the statement that drug has passed the test.
h) Date of expiry, if any.
i) Nature and percentage of antiseptic added.
j) Precautions necessary for preserving the properties of drug.
8. Medicines for external applications (Liniments, lotions, ointments, creams, liquid
antiseptic)
The word in capital , “FOR EXTERNAL USE ONLY,”
9. Medicines made up ready only for the treatment of an animal
a) The words “Not for human use, for animal treatment only.”
b) The symbol depicting the head of domestic animal.
10. Medicines prepared for the treatment of human ailments and containing industrial
methylated spirit
a) The preparation contains industrial methylated spirit.
b) The words “For external use only”
11. Non sterile surgical ligature and suture
The words in conspicuous manner in red ink “Non sterile surgical ligature and suture,
not to be used for operation upon the human body unless efficiently sterilized.
12. Pharmacopoeial and other drugs
a) Name or synonym as specified in the Pharmacopoeia followed by the letters 'I.P, B.P,
U.S.P, N.F,’etc as the case may be indicating that the drugs in accordance with standard
set out in such pharmacopoeia
b) The proper name should not be less conspicuous than trade name if any
c) Net amount of drug
d) Amount of active ingredient.
e) Name and address of manufacturer.
f) Manufacturing licence number and batch number.

13. Patent and Proprietary medicines containing vitamins
The words indicating whether-
a) For therapeutic use
b) For prophylactic use
c) For pediatric use.
Age of child should be mentioned.
14. Ophthalmic solution and suspension
The following additional particulars shall be shown on the label of container:
a) The statement 'Use the solution within one month after opening the container.
b) The word 'NOT FOR INJECTION'.
c) Name and concentration of the preservative, if used.
d) Special instructions regarding storage, wherever applicable.
e) Warning:
i. “If irritation persists or increases, discontinue the use and consult physician”
ii. “Do not touch tip of the dropper or other dispensing tip to any surface since this may
contaminate solution”.
15. Ophthalmic ointments
a) Special instruction regarding storage wherever applicable.
b) Warning: “If irritation persists or increase discontinue the use and consult physician”.
Offences and Penalties

1. Penalty for the manufacture, sale, etc. of adulterated, misbranded or spurious drugs
a) Manufacture for sale or distribution
Manufacture for sale or distribution or offered for sale or distribution of adulterated
drugs, misbranded drugs, spurious drugs or drugs which are not of standard quality
which is likely to cause death or a grievous hurt, shall be punishable with an
imprisonment for not less than five years which may extend to life imprisonment and
fine of not less than ` 10000.
b) Manufacture for sale or distribution of adulterated drugs
Which is not likely to cause a death or grievous hurt shall be punishable with an
imprisonment for not less than one year but which may extend to three years and fine of
not less than ` 5000. On subsequent conviction he shall be punishable with an
imprisonment for not less than two years which may extend to six years and fine of not
less than ‘`’10000.
2. Penalty for non-disclosure of the name of the manufacturer
Any person who is not disclosing the name of manufacturer shall be punishable with an
imprisonment up to one year or with fine of ‘`’1000 or with both.
3. Penalty for not keeping documents or not disclosing the information
Any person who is not keeping documents or who is not disclosing the information shall
be punishable with an imprisonment up to one year or with fine up to ‘`’ 1000 or with
both.
4. Penalty for advertising the report of Government Analyst
Any person who advertises the report of Government Analyst shall be punishable with
fine up to ` 500 on first conviction and on subsequent conviction, he shall be punishable
with an imprisonment up to 10 years or with fine or with both.
5. Penalty for manufacture for sale or distribution of cosmetics which is in the
contravention of the provisions of thisAct
a) Any person who manufactures the cosmetic for its sale which is in the contravention of
the provisions of thisAct shall be punishable with an imprisonment up to three years.
b) Any person, who distributes the cosmetic in the contravention of the provisions of this
Act shall be punishable with an imprisonment upto one year.
6. Penalties relating to import of drugs
a) If any adulterated or spurious drug or drug that have not claimed therapeutic value, is
imported by a person and have caused risk to human beings or animals shall be
punishable with an imprisonment up to three years or with fine ` 5000 or with both on
first conviction and on subsequent conviction, he shall be punishable with an
imprisonment up to five years or with fine of not less than ` 10,000 or with both
b) Any drug or cosmetic, the import of which is prohibited under section 10 or any rule
made under this chapter, shall be punishable with imprisonment for a term up to six
months or with fine up to ` 500 or with both on first conviction and on subsequent
conviction an imprisonment up to 1 year or with fine ` 1,000 or with both.
c) Manufacture for sale or offered for sale or distribution of spurious drugs which is not
likely to cause death or grievous hurt shall be punishable with an imprisonment for not
less than three years which may extend upto five years or fine of not less than ` 5000 or
with both on subsequent conviction he shall be punishable with an imprisonment for not
less than six years which may extend upto ten years or fine of not less than ` 10000 or
with both.
d) Manufacture for sale or distribution of drugs without valid licence shall be punishable
with an imprisonment for not less than one year which may extend upto three years or
fine of ` 5000 or with both on subsequent conviction, he shall be punishable with an
imprisonment for not less than two years which may extend upto six years or fine of `
10000 or with both.

e) Manufacture for sale or distribution of drugs (except adulterated drugs) in the
contravention of the provisions of the Act, shall be punishable with an imprisonment for
not less than one year which may extend upto three years and fine of ` 5000.
7. Penalty for false warranty to purchasers
Any person, who gives false warranty to purchasers shall be punishable with an
imprisonment upto one year and fine upto ` 5000 on first conviction and on subsequent
conviction, he shall be punishable with an imprisonment up to two years or fine of not less than `
10,000 or with both.
8. Penalty for manufacture, sale, etc., of Ayurvedic, Siddha or Unani drug in contravention
of this Chapter
Any person who himself or by any other person on his behalf-
1. manufactures for sale or for distribution,
(a) anyAyurvedic, Siddha or Unani drugs–
(i) deemed to be adulterated under section 33EE, or
(ii) without a valid licence as required under clause (c) of section 33EEC, shall be
punishable with imprisonment for a term which may extend to one year and with fine
which shall not be less than ` 2000;
(b) any Ayurvedic, Siddha or Unani drug deemed to be spurious under section 33EEA, shall
be punishable with imprisonment for a term which shall not be less than one year but
which may extend to three years and with fine which shall not be less than ` 5000.
Provided that the Court may, for any adequate and special reasons to be mentioned in the
judgment, impose a sentence of imprisonment for a term of less than one year and of fine
of less than ` 5000;
2. contravenes any other provisions of this Chapter or of section 24 as applied by section
33H or any rule made under this Chapter, shall be punishable with imprisonment for a
term which may extend to three months and with fine which shall not be less than ` 500.
9. Penalty for manufacture, sale, etc., of cosmetics in contravention of this Chapter
Any person whoever himself or by any other person on his behalf manufactures for sale
or for distribution, or sells, or stocks or exhibits or offers for sale -
(i) any cosmetic deemed to be spurious under section 17D shall be punishable with
imprisonment for a term which may extend to three years and with fine;
(ii) any cosmetic other than a cosmetic referred to in clause (i) above in contravention of any
provision of this Chapter or any rule made thereunder shall be punishable with
imprisonment for a term which may extend to one year or with fine which may extend to
` 1000 or with both.
The First Schedule

[Section 3(a)]
A. Examples of books ofAyurvedic and Siddha systems of medicine
Books ofAyurveda
1. Arogya Kalpadruma 2. Arka Prakasha
3. Arya Bhishak 4. Ashtanga Hridaya
5. Ashtanga Samgraha 6. Ayurveda Kalpadruma
7. Ayurveda Prakasha 8. Ayurveda Samgraha
9. Bhaishajya Ratnavali 10. Brihat Bhaishajya Ratnakara
11. Bhava Prakasha 12. Brihat Nighantu Ratnakara
13. Charaka Samhita 14. Chakra Datta
15. Gada Nigraha 16. Kupi Pakva Rasayana
17. Nighantu Ratnakara 18. Rasa Chandanshu
19. Rasa Raja Sundara 20. Rasaratna Samuchaya
21. Rasatantra Sara Va Siddha Prayoga Sangraha-Part 1
22. Rasa Tarangini 23. Rasa Yoga Sagara
24. Rasa Yoga Ratnakara 25. Rasa Yoga Samgraha
26. Rasendra Sara Samgraha 27. Rasa Pradipika
28. Sahasrayoga 29. Sarvaroga Chikitsa Ratnam
30. Sarvayoga Chikitsa Ratnam 31. Sharangadhara Samhita
Books of Siddha
1. Agasthiyar Pin (80) 2. Agasthiyar (600)
3. Brahma Muni 4. Bala Vagadam
5. Bhogar (700) 6. Karukkadai (300)
7. Nagmuni (200) 8. Pulippani (500)
9. Siddha Formulary of India 10. Siddha Vaidya Thirathy
11. Thersyar Yamgam 12. Siddha Bhaishajya Manimala
13. Sidha Yoga Samgraha
B. Examples of books of Unani and Tibb System of medicine

1. Karabadin Qadri
2. Karabadin Kabir
3. KarabadinAzam
4. Ilaj-ul-Amraz
5. Al Karabadin
6. Biaz Kabir Vol. II
7. Karabadin Jadid
8. Kithalf-ul-Taklis
9. Sanat-ul-Taklis
10. Mifta-ul-Khazain
11. Madan-ul-Aksir
12. Makhzan-ul-murabhat
13. National Formulary of Unani Medicine (Part I)
The Second Schedule

Standards to be complied with by imported drugs and by drugs manufactured for sale,
sold, stocked or exhibited for sale or distributed
Standards of drugs
1. Patent or proprietary medicines [other than 1. The formula of list of ingredients
Homoeopathic medicines]. displayed in the prescribed manner on the
Class of drug label Standard to be complied
of the container withother
and such
standards as may be prescribed.
2. Substances commonly known as vaccines, 2. The standards maintained at the
sera, toxins, toxoids, antitoxins and antigens International Laboratory for Biological
and biological products of such nature for Standards, Stantans Serum Institute,
human use or for veterinary use. Substances Copenhagen and at the Central Veterinary
(other than food) intended to affect the Laboratory, Weybridge Surrey, U.K., and
structure or any function of the human body such other laboratories recognized by the
or intended to be used for the destruction or World Health Organization from time to
vermin or insect which cause disease in time, and such further standards of strength,
human beings or animals. quality and purity, as may be prescribed.
3. Substances (other than food) intended to 3. Such standards may be prescribed.

affect the structure or any function of the
human body or intended to be used for the
destruction or vermin or insect which cause
disease in human beings or animals.
4. Homoeopathic Medicines :
a. Drugs included in the Homoeopathic a. Standards of identity, purity and strength
Pharmacopoeia of India. specified in the edition of the Homoeopathic
Class of Drug Standards to be complied
Pharmacopoeia of the India for the time
being and such other standards as may be
prescribed.
b. Drugs not included in the Homoeopathic b. Standards of identity, purity and strength
Pharmacopoeia of India, but which are prescribed for the drug in the edition of such
included in the Homoeopathic Pharmacopoeia for the time being in which
Pharmacopoeia of United States of America they are given and such other standards as
or the United Kingdom or the German may be prescribed.
Homoeopathic Pharmacopoeia.
c. Drugs not included in the Homoeopathic c. The formula of list of ingredients displayed
Pharmacopoeia of India or the United States in the prescribed manner on the label of the
of America, or the United Kingdom or the container and such other standards as may be
German Homoeopathic Pharmacopoeia. prescribed by the Central Government.
5. Other drugs
(i) Drugs included in the Indian Standards of identity, purity and strength
Pharmacopoeia. specified in the edition of the Indian
Pharmacopoeia for the time being in force
and such other standards as may be
prescribed.
(ii). Drugs not included in the Indian Standards of identity, purity and strength
Pharmacopoeia but not included in the specified for drugs in the edition of such
official Pharmacopoeia of any other country. official Pharmacopoeia of any other country
for the time being in force and such other
standards as may be prescribed.
Schedule C
Biological products
1. Sera
2. Toxins
3. Insulin
4. Sterilized ligatures and sutures
5. Ophthalmic preparations
6. Pituitary extract
7. Various antibiotics and their parenteral preparations
Schedule C(i)
Other special products
1. Adrenaline and its non parenteral preparations
2. Digitalis and its non parenteral preparations
3. Ergot preparations containing ergot not in form to be administered parenterally
4 Erythromycin, neomycin, streptomycin and their preparations containing hormones not
in a form to be administered parenterally.
5. Fish liver oil and preparations containing fish liver oil.
6. Hormones and preparations containing hormones not in a form to be administered
parenterally.
7. In vitro blood grouping sera
8. In vitro diagnostic devices for HIV, HbsAg and HCV.
9. Liver extract and its non parenteral preparations.
10. Non parenteral vaccines.
11. Various antibiotics and their non parenteral preparations.
12. Vitamins and preparations containing any vitamin not in a form to be administered
parenterally.
C.S.R. No Year and date Subject
755(E) 23.10.2008 Considering the growing demand for Ayurvedic, Siddha
Schedule E1
or Unani (ASU) drugs and to increase palatability
longevity and stability of ASU drugs, the matter regarding
allowing excipients, preservatives, antioxidants,
flavoring agents, chelating agents in ASU drugs was taken
up and discussed in various forums. On the
recommendation of Ayurvedic, Siddha and Unani Drug
Technical Advisory Board (ASUDTAB), the amendment
to Rule 169 for permitting excipients, preservatives,
antioxidants, flavoring agents, chelating agents etc in
Ayurvedic, Siddha and Unani medicines was carried out.
The Final Notification has been issued in this regard on
23rd October, 2008.

893(E) 24.12.2008 Growing popularity and acceptability of ASU drugs
globally and adherence to various regulatory provisions
has led to the need for categorization of Ayurvedic, Siddha
and Unani drugs and other traditional medicines in India
and their Pre- Clinical safety guidelines. Since there were
no existing guidelines on the subject, a technical
Committee was constituted with members of Indian
Council of Medical Research (ICMR) and Research
Councils. As per suggestions of the Committee and
ASUDTAB recommendations, Rule 170 has been
amended regarding issuance of guidelines for evaluation
of Ayurvedic, Siddha and Unani Drugs and other
traditional medicines of India. The purpose of issue of
these guidelines is to develop methodologies for record
and valuation, improve quality, valuable research for
providing appropriate evaluation methods to facilitate the
development of regulation and registration. Draft
Notification has been issued on 24th December, 2008.
157(E) 04.03.2009 To establish the authenticity of raw drugs, minerals and
metals in processing of validation and quality control
parameters, it is ensured that these formulations are
processed and prepared in accordance with clinical tests
and for which safety measures are complied with in
accordance with GMP guidelines for manufacturing of
“Rasaushadhies or Rasamarunthukal and Kushtajat
(Herbo - mineral - metallic compounds)” used in
Ayurveda, Siddha and Unani medicines. The Final
Notification has been issued on 4th March, 2009.
764(E) 15.10.2009 The potency of ASU preparations is lost/reduced after a
certain period of time. Hence to make full use of these
preparations and as per textual reference, ASUDTAB has
recommended Shelf life /Expiry date forASU drugs. Shelf
life / Expiry date under rule 161(B) has been amended in
respect of Ayurveda, Siddha and Unani medicines.The
Final Notification has been issued on 15th October, 2009.

765(E) 16.10.2009 As per advice of the Subordinate legislation of Parliament,
Corrigendum of notification GSR No. 512(E) dated 9th
July, 2008 have been published on manufacturing records
of raw materials used by licensed manufacturing units of
ASU drugs.
16(E) 07.01.2010 The books entitled “Rastantra Sar Va Siddha Prayog

Samgraha Part II (Edition 2006), Ayurvedic
Pharmacopoeia of India and its part, Siddha
Pharmacopoeia of India and its part” have been amended
in Schedule I of the Drugs and Cosmetics Act, 1940. The
Final Notification has been issued on 7th January, 2010.
17(E) 07.01.2010 In response to demand of ASU drugs manufacturers for
increasing validity period of GMP license and
harmonization in date of issuance of GMP and Schedule
'T' license, and in accordance with ASUDTAB
recommendations, Amendment in Rule 155(B),
156,156(A), 157 and Form 13Aand Form 26E-I have been
carried out.
17(E) 07.01.2010 The validity of GMP Certificate has been extended to five
years from three years. GMP certificate in Form 26E-(I)
and grant or renewal of license in Form 25-D are proposed
for simultaneous issuance. Draft Notification has been
issued on 7th January, 2010.
322(E) 13.04.2010 Schedule E of Drugs and Cosmetics Rule 1945 contains
list of poisonous substances under the Ayurvedic
(including Siddha) and Unani Systems of medicine. In the
list, only some parts of the plants are found poisonous
whereas rest of the plant is not poisonous and some of the
names were found incorrect. The matter was examined in
detail and finally as per recommendations of ASUDTAB,
Schedule E (I) has been revised and necessary
amendments in the list of plants and names etc for
Ayurveda, Unani and Siddha poisonous drugs have been
carried out. Draft Notification has been issued on 13th
April, 2010.

337(E) 15.04.2010 The books entitled “Rastantra Sar Va Siddha Prayog
Samgraha Part II (Edition 2006), Ayurvedic
Pharmacopoeia of India and its part, Siddha
Pharmacopoeia of India and its part” have been amended
in Schedule I of the Drugs and CosmeticsAct, 1940.
The Final Notification issued on 15thApril, 2010.
338(E) 15.04.2010 As per advice of the Subordinate legislation of Parliament,
Corrigendum under Rule 157 (E) dated 9th March, 2009
have been issued on GMP guidelines for manufacturing of
“Rasaushadhies or Rasamarunthukal and Kushtajat
(Herbo - mineral - metallic compounds)” used in
Ayurveda, Siddha and Unani medicines.
376(E) 03.05.2010 Rules 155(B), 156, 156(A), 157, Form 13 A and Form
26E-I regarding validity of GMP Certificate for five years
and simultaneous issuance of Form 25-D and Form 26E-I
have been amended. The Final Notification issued on 3rd
May, 2010.
377(E) 03.05.2010 At present various kind of ASU products licensed in the
country are being sold claiming to be safe. These ASU
plant based medicines/products which are being used as
Nutraceutical, food supplement (Balya/Poshak) without
causing any systemic and topical adverse effects. In the
classical ASU texts references can be traced. The Drugs
and Cosmetics Act does not define these ASU products
which fall under category Nutraceutical, food supplement
and cosmetics etc. These ASU plants based
Medicines/Product are also marketed in different dosage
forms like extracts etc. There is urgent need to regulate
Standards and Quality etc. There is no regulation existing
regarding said ASU products under above said category.
The matter was debated in various committees. As per
recommendation of Ayurveda, Siddha and Unani Drug
Technical Board, the Amendment to Rule 158(B)
regarding guidelines for issue of licence in respect of
Ayurveda, Siddha or Unani drugs have been carried out.
Draft Notification has been issued on 3rd May, 2010.

377(E) 19.08.2010 Schedule E I of Rule 161 of Drugs and Cosmetics Rule,
1945 describe poisonous substances used in Ayurvedic
(including Siddha) and Unani System of Medicine.
Comments were invited on draft notification issued on
13th April, 2010. The comments received on the draft
were examined in the Department of AYUSH and in
corporated accordingly. The final Notification is under
issue.
Schedule G
1. Aminopterin 2. Antazoline
3. Bleomycin 4. Carbutamide
5. Chlorothiazide 6. Chlorocyclizine
7. Chlorpropamide and its salts 8. Diphenhydramine
9. Glibenclamide 10. Hydantoin
11. Insulin all types 12. Meclozine
13. Metformin 14. Phenformin
15. Pheniramine 16. Primodine
17. Promethazine 18. Tolbutamide
19. Tripolidine
Schedule H
1. Analgin 2. Atenolol
3. Antibiotics 4. Barbituric acid
5. Betamethasone 6. Chloral hydrate
7. Codeine 8 Clopamide
9 Chlordiazepoxide and its salts 10. Diazepam
11. Ibuprofen 12. Salbutamol sulphate
13. Vasopressin
Schedule J
1. AIDS 2. Arteriosclerosis
3. Asthma 4. Appendicitis
5. Blindness 6. Blood pressure (high/low)

7. Cancer 8. Deafness
9. Diabetes 10. Epilepsy
11. Gangrene 12. Glaucoma
13. Genetic disorder 14. Goitre
15. Hernia 16. Jaundice
17. Leprosy 18. Leukaemia
19. Myocardial infarction 20. Paralysis
21. Parkinsonism 22. Piles
23. Plague 24. Sexual impotence
25. Spondylitis
Schedule K
1. Drugs not intended for medicinal use and labeled conspicuously as “Not for medicinal
use”.
2. Drugs supplied by hospital.
3. Drugs supplied by Registered Medical practitioner
4. Retail sale of quinine and other antimalarial drugs for the eradication of malaria
undertaken by State Government.
Schedule M
GOOD MANUFACTURING PRACTICES AND REQUIREMENTS OF PREMISES,
PLANTAND EQUIPMENTS FOR PHARMACEUTICALPRODUCTS
PART I Good Manufacturing Practices for Premises and Materials

1. General Requirements
A. Location and surrounding
The factory shall be located in a sanitory place free from filthy surrounding and
pollution. It shall not be located in such place that are adjacent to an open sewage, drain, public
lavatory or any other factory which produces pollution.
B. Buildings and Premises
The building used for the factory shall be constructed according to the conditions laid
down under the Factories Act, 1948. The building used for the factory for the purpose of
manufacture shall be constructed at permit production under hygienic conditions. The part of
building used for the manufacture shall not be used as a sleeping place. The height of walls of
manufacturing premises shall upto six feet and shall be smooth, water proof and clean. The
flooring shall be smooth, washable and shall not permit retention or accumulation of dust. The
walls shall be devoid of cracks and holes.
C. Water system
There shall be validated system for treatment of water drawn from own or any other
source to render it potable in accordance with standards specified by the Bureau of Indian
Standards or Local Municipality, as the case may be, so as to produce purified water conforming
to Pharmacopoeial specification. Purified water so produced shall only be used for all operations
except washing and cleaning operations where potable water may be used. Water shall be stored
in tanks which do not adversely affect quality of water and ensure freedom from microbiological
growth. The tank shall be cleaned periodically and records shall be maintained by the licensee in
this behalf.
D. Disposal of waste
The disposal of sewage and effluents (solid, liquid and gas) from the manufactory shall
be done in accordance with the requirements of Environment Pollution Control Board.
All bio-medical waste shall be destroyed as per the provisions of the Bio-Medical Waste
(Management and Handling) Rules, 1996.
More precautions shall be taken for the storage and disposal of rejected drugs. Records
shall be maintained for all disposal of waste.
There shall be a separate provision for the proper and safe storage of waste materials that
includes hazardous, toxic substances and flammable materials in accordance with Central and
State legislations.
2. Warehousing area
Adequate areas shall be designed to allow sufficient and orderly warehousing of various
categories of materials and products like starting and packaging materials, intermediates, bulk
and finished products, products in quarantine, released, rejected, returned or recalled, machine
and equipment spare parts and change items.
Warehousing areas shall be designed and adapted to ensure good storage conditions.
They shall be clean, dry and maintained with acceptable temperature limits, where special
storage conditions required (e.g. temperature, humidity) shall be provided, monitored and
recorded. Storage areas shall have appropriate house-keeping and rodent, pests and vermin
control procedures and records shall be maintained. Proper racks, bins and platforms shall be
provided for the storage of materials.
Receiving and dispatch bays shall protect materials and products from adverse weather
conditions. Where quarantine status is ensured by warehousing in separate earmarked areas in
the same warehouse or store, these areas shall be clearly demarcated. Any system replacing the
physical quarantine, shall give equivalent assurance of segregation.Access to these areas shall be
restricted to authorized persons.
There shall be a separate sampling area in the warehousing area for active raw materials
and excipients. The sampling shall be conducted in such area which is free from contamination,
cross-contamination and mix-up.
Storage of rejected, recalled or returned materials or products shall be done separately.
Access to such areas and materials shall be restricted. There shall be separate safe and secure
areas for certain highly hazardous, poisonous and explosive materials such as narcotics,
psychotropic drugs and substances presenting potential risks of abuse, fire or explosion.
Sufficient fire protection measures shall be provided in conformity with the rules of the
concerned civic authority. Printed packaging materials shall be stored in safe, separate and
secure areas.
Dispensing areas for β (Beta) lactum, Sex Hormones and Cytotoxic substances or any
such special categories of product shall be separate that shall provide proper supply of filtered
air and suitable measures for dust control to avoid contamination.
Sampling and dispensing of sterile materials shall be conducted under aseptic conditions
conforming to Grade A, which can also be performed in a dedicated area within the
manufacturing facility.
Containers shall be checked regularly to ensure adequate steps are taken against
spillage, breakage and leakage.
Rodent treatments (Pest control) should be done regularly and at least once in a year and
record maintained.
3. Production area
The production area shall be designed to allow the production preferably in uni-flow and
with logical sequence of operations.
For the production of sensitive pharmaceutical products like penicillin or biological
products there shall be separate dedicated and self-contained facilities to avoid the cross-
contamination. For the manufacture of contamination causing and potent products such as β -
lactum, sex hormones and cytotoxic substances, separate dedicated facilities shall be provided.
Working and in-process space shall be adequate to permit orderly and logical
positioning of equipment and materials and movement of personnel to avoid cross-
contamination and to minimize risk of omission or wrong application of any manufacturing and
control measures.
Pipe-work, electrical fittings, ventilation openings and similar services lines shall be
designed, fixed and constructed to avoid creation of recesses. Service lines shall preferably be
identified by colours and the nature of the supply and direction of the flow shall be
marked/indicated.
4.AncillaryAreas
Rest and refreshment rooms shall be separated from production, storage and other
areas. There shall be separate areas for changing, storing clothes and for washing and toilet
purposes. There shall be written instructions for cleaning and disinfection of such areas.
Maintenance workshops shall be separate and away from production areas. The spares,
changed parts and tools shall be stored in the dedicated rooms or lockers. Tools and spare parts
for use in sterile areas shall be disinfected before use.
Whenever animals are required there shall be separate housing animals area that shall be
isolated from other areas.
5. Quality ControlArea
Quality control laboratories shall be independent of the production areas. Separate areas
shall be provided each for physico-chemical, biological, microbiological or radio-isotope
analysis. Separate instrument room with adequate area shall be provided for sensitive and
sophisticated instruments employed for analysis.
Quality control laboratories shall be designed appropriately for the operations to be
carried out in them. Adequate space shall be provided to avoid mix-ups and cross-contamination.
Sufficient and suitable storage space shall be provided for test samples, retained samples,
reference standards, reagents and records.
The design of the laboratory shall take into account the suitability of construction
materials and ventilation. Separate air handling units and other requirements shall be provided
for biological, microbiological and radioisotopes testing areas. The laboratory shall be provided
with regular supply of water of appropriate quality for cleaning and testing purpose.
There shall be separate sections for chemical, microbiological and biological testing
with adequate area for basin installation and for ancillary purposes. The microbiology section
shall have arrangements such as airlocks and laminar air flow work station.
6. Personnel
There shall be separate personnel as per the requirements of dosage forms in production,
quality control and quality assurance and shall have prescribed qualification and experience. All
the departments shall be under the strict supervision of qualified person.
7. Health, clothing and sanitary requirements of the staff

Workers shall be healthy and shall not suffer from contagious or non contagious disease.
They shall wear a clean white or colored uniform suitable to the nature of work and the climate.
Clean towels, soap or other suitable disinfectant shall be made available for each sex. The
workers shall wash and change into a clean footwear before entering into manufacturing
premises. They shall wear a clean cap or a suitable head gear, so as to avoid contamination by hair
or perspiration. The workers who are engaged in filling and sealing of containers for parenteral
preparations shall use suitable cotton masks to cover the nostrils and mouth during work.
8. Manufacturing Operations and Controls

All manufacturing operations shall be carried out under the supervision of technical staff
approved by the Licensing Authority. Each step in the process relating to the selection, weighing
and measuring of raw material addition during various stages shall be performed by trained
personnel under the direct personal supervision of approved technical staff.
Each vessel and container used in manufacture and storage during the various
manufacturing stages shall be labeled with the name of the product, batch number, batch size and
stage of manufacture along with dated initial of authorised technical staff. Products not prepared
under aseptic conditions are required to be free from pathogens like Salmonella, Escherichia
coli, Pyocyanea, etc.
The licensee shall take appropriate precautions to avoid mix-up of drug material and
drug products (from environmental dust) and cross-contamination during production stages and
packaging operations.
9 .Sanitation in the Manufacturing Premises

The manufacturing premises shall be cleaned and maintained in an orderly manner, so
that it is free from accumulated waste, dust, debris and other similar material. A validated
cleaning procedure shall be maintained.
A routine sanitation program shall be drawn up and observed, which shall be properly
recorded and which shall indicate-
(a) specific areas to be cleaned and cleaning intervals;
(b) cleaning procedure to be followed, including equipment and materials to be used for
cleaning; and
(c) personnel assigned to and responsible for the cleaning operation.
10. Raw materials

The licensee shall keep an inventory of all raw materials to be used at any stage of
manufacture of drugs and maintain records as per Schedule U.
All incoming materials shall be quarantined immediately after receipt or processing. All
materials shall be stored under appropriate conditions and in an orderly fashion to permit batch
segregation and stock rotation by a ‘first in/first expiry’- ‘first-out’ principle. All incoming
materials shall be checked to ensure that the consignment corresponds to the order placed.
All incoming materials shall be purchased from approved sources under valid purchase
vouchers. Wherever possible, raw materials should be purchased directly from the producers.
Personnel from the Quality Control Department, shall examine each consignment on
receipt and shall check each container for integrity of package and seal. Damaged containers
shall be identified, recorded and segregated.
If a single delivery of material is made up of different batches, each batch shall be
considered as a separate batch for sampling, testing and release.
Raw materials in the storage area shall be appropriately labeled. Labels shall be clearly
marked with the following information:
(a) designated name of the product and the internal code reference, where applicable, and
analytical reference number;
(b) manufacturer’s name, address and batch number;
(c) the status of the contents (e.g. quarantine, under test, released, approved, rejected); and
(d) the manufacturing date, expiry date and re-test date.
There shall be adequate separate areas for materials ‘under test’, ‘approved’ and
‘rejected’ with arrangements and equipment to allow dry, clean and orderly placement of stored
materials and products, wherever necessary, under controlled temperature and humidity.
The raw materials approved by QC department shall be released.
11. Equipments
Equipments shall be located, designed, constructed, adapted and maintained to suit the
operations to be carried out. The layout and design of the equipment shall aim to minimise the
risk of errors and permit effective cleaning and maintenance in order to avoid cross-
contamination, build-up of dust or dirt and, in general any adverse effect on the quality of
products. Each equipment shall be provided with a logbook, wherever necessary.
Balances and other measuring equipment of an appropriate range, accuracy and
precision shall be available in the raw material stores, production and in process control
operations and these shall be calibrated and checked on a scheduled basis in accordance with
Standard Operating Procedures and records maintained.
The parts of the production equipment that come into contact with the product shall not
be reactive, additive or adsorptive to an extent that would affect the quality of the product.
To avoid accidental contamination, wherever possible, non-toxic/edible grade
lubricants shall be used and the equipment shall be maintained in a such way that lubricants do
not contaminate the products being produced.
12. Documentation and Records

Documentation is an essential part of the Quality assurance system and, as such, shall be
related to all aspects Good Manufacturing Practices (GMP). Its aim is to define the specifications
for all materials, method of manufacture and control, to ensure that all personnel concerned with
manufacture know the information necessary to decide whether or not to release a batch of drug
for sale and to provide an audit trail that shall permit investigation of the history of any suspected
defective batch. Records and associated Standard Operating Procedures (SOP) shall be retained
for at least one year after the expiry date of the finished product.
13. Labels and other Printed Materials

Labels are absolutely necessary for identification of the drugs and their use. The printing
shall be done in bright colours and in a legible manner. The label shall carry all the prescribed
details about the product. Labeling of containers and vessels of each batch shall be done during
each and every process.
14. QualityAssurance
It is required to assure the quality of the all the matters individually or collectively that
influence the quality of a product. It is the totality of the arrangements made with the object of
ensuring that products are of the quality required for their intended use.
15. Self Inspection and Quality audit

It may be useful to constitute a self inspection team supplemented with a quality audit
procedure for assessment of all or part of a system with the specific purpose of improving it.
The concept of self inspection is required to evaluate the manufacturer’s compliance
with GMP in all aspects of production and quality control. The self inspection is done by a team
of independent, experienced, qualified persons from within or outside the company.
The program shall be designed to detect shortcomings during product recall or repeated
rejections in the implementation of Good Manufacturing Practice and to recommend the
necessary corrective actions.
Written instructions for self-inspection shall be drawn up which shall include the
following:
(a) Personnel
(b) Premises including personnel facilities
(c) Maintenance of buildings and equipment
(d) Storage of starting materials and finished products
(e) Equipment
(f) Production and in-process controls
(g) Quality control

(h) Documentation
(i) Sanitation and hygiene
(j) Validation and revalidation programmes
(k) Calibration of instruments or measurement systems
(l) Recall procedures
(m) Complaints management
(n) Labels control
(o) Results of previous self-inspections and any corrective steps taken.
16. Quality Control System

Quality control shall be concerned with sampling, specifications, testing,
documentation, release procedures which ensure that the necessary and relevant tests are
actually carried and that the materials are not released for use, nor products released for sale or
supply until their quality has been judged to be satisfactory. It is not confined to laboratory
operations but shall be involved in all decisions concerning the quality of the product. It shall be
ensured that all quality control arrangements are effectively and reliably carried out. The
department as a whole shall have other duties such as to establish, evaluate, validate and
implement all Quality Control Procedures and methods.
17. Medical services

The manufacturer shall provide
1. Adequate facilities of first aid.
2. Medical inspection of workers at the time of employment and periodic check up
thereafter at least once a year.
3. Facilities for vaccination and inoculation against the enteric or any other epidemic group
of diseases.
4. Adequate precautions for safeguarding the head of the workers, including measures to
avoid industrial accidents or diseases.
18. Working benches

Working benches shall be provided for carrying out operations such as filling, labeling,
packing, etc. Such benches shall be adequate. Arrangements, separated from the manufacturing
operations, for washing, cleaning and drying containers with suitable equipment for the purpose
be provided. Sterilising facilities where necessary should be provided.
Part II Requirements of Plant and Equipments

The following equipments are recommended, for the manufacture of

A. Ointments, emulsions or lotions and suspensions
1. Mixing tanks
2. Kettle, steam, gas or electrically heated.
3. Asuitable power driven mixer.
4. Storage tanks or pots.
5. Acolloid mill or a suitable emulsifier.
6. Atriple roller mill or an ointment mill.
7. Liquid filling equipment.
8. Jar or tube filling equipment.
An area of 30 square meters is recommended for the basic installation.
B. Syrups, elixirs and solutions

1. Mixing and storage tanks.
2. Portable mixer.
3. Filter press or other suitable filtering equipment, such as meta filter or sparklet filter.
4. Vacuum or gravity filter.
5. Water still or deioniser.
An area of 30 square meters is recommended for the basic installation.
C. Compressed tablets and pills

For efficient operation the tablet production department shall be divided into three
distinct and separate sections-
a. Granulation section
b. Tableting section
c. Coating section
Following equipments are recommended in each of the three sections
a. Granulation section
1. Disintegrator
2. Powder mixer
3. Mass mixer
4. Granulator
5. Ovens, thermostatically controlled
b. Tableting section
1. Tablet machine, single punch or rotary.
2. Pill machine
3. Punch and dies storage cabinet

4. Tablet counter
The tableting section shall be free from dust and floating particles. For this purpose,
it is desirable that each tablet machine is connected to an exhaust system or isolated into
cubicles.
c. Coating section
1. Jacketed kettle, steam, gas or electrically heated for preparing solution.
2. Coating pan
3. Polishing pan
4. Heater and exhaust system
The coating section shall be made dust free and suitable exhaust provided to remove
excess power and the fumes resulting from solvent evaporation. An area of 30 square
meter for each of the above three sections is recommended for basic installations.
The manufacturer of hypodermic tablets shall be conducted under aseptic conditions in a
separate air conditioned room, the walls of which shall be smooth and washable. The
granulating and packing shall be done in this room.
D. Powders
1. Disintegrator
2. Mixer
3. Sifter
4. Stainless steel vessels and scoops and scoops of suitable material
5. Filling equipment
6. Exhaust system (for fine powders)
A minimum area of 30 square meters is recommended to allow for the basic
installations. Workers should be provided with suitable masks during operation.
E. Capsules
1. Mixing and blending equipment (electrically or power driven)
2. Capsules filling units (preferably semi automatic or automatic filling machines)
3. Capsules counters (wherever applicable)
4. Weighing balance
5. Disintegration test apparatus
6. Capsule polishing equipment
7. Exhaust system (for fine powders)
A minimum area of 25 square meters for basic installation and ten square meters for
ancillary area each for penicillin and non-penicillin sections is recommended.
F. Surgical Dressing
1) Rolling machine
2) Trimming machine
3) Cutting equipment
4) Folding and pressing machine for gauze
5) Mixing tanks for processing medicated dressing
6) Hot air dry oven
7) Steam sterilizer or dry heat sterilizer or other suitable equipment
8) Work tables/benches for different operations
Aminimum area of 30 square meters is recommended to allow for the basic installations.
In case medicated dressings are to be manufactured, another room with a minimum area
of 30 square meters shall be provided.
G. Ophthalmic Preparations
1) Thermostatically controlled hot air ovens (preferably double ended)
2) Jacketted kettle/stainless steel tanks (steam, gas or electrically heated)
3) Mixing and storage tanks of stainless steel/Planetary mixer
4) Colloid mill or ointment mill
5) Tube filling and crimping equipment (semi-automatic or automatic filling machines)
6) Tube cleaning equipment (air jet type)
7) Tube washing and drying equipment, if required
8)Automatic vial washing machine
9) Vial drying oven
10) Rubber bung washing machine
11) Sintered glass funnel, Seitz filter and filter candle ( cartridge and membrane filters)
12) Liquid filling equipment (semi-automatic or automatic filling machines)
13)Autoclave (preferably ventilator autoclave)
14) Air conditioning and dehumidification arrangement (preferably centrally
airconditioned and dehumidification system)
15) Laminar airflow units
A minimum area of 25 square meters for basic installation and 10 square meters for
ancillary area is recommended. Manufacture and filling shall be carried out in air-
conditioned areas under aseptic conditions. The rooms shall be further
dehumidified as considered necessary if preparations containing antibiotics are

manufactured.
H. Pessaries and Suppositories

1) Mixing and pouring equipment
2) Moulding equipment
3) Weighing devices
Aminimum area of 20 square meters is recommended to allow for the basic installation.
I. Inhalers and Vitralle

1) Mixing equipment
2) Graduated delivery equipment for measurement of the medicament during filling
3) Sealing equipment
An area of minimum 20 square meters is recommended for the basic installations.
J. Repacking of Drugs and Pharmaceutical Chemicals.

1) Powder disintegrator
2) Powder sifter (electrically operated)
3) Stainless steel scoops and vessels of suitable sizes
4) Weighing and measuring equipment
5) Filling equipment (semi-automatic / automatic machines)
6) Electric sealing machine
7) Exhaust system (for fine particles)
An area of minimum 30 square meters is recommended for the basic installation.
K. Parenteral Preparations
The following separate operations may be required for whole process of manufacture of
parenterals
I Parenteral preparations in glass containers
1) Water management area: this includes water treatment and storage
2) Containers and closures preparation area: This includes washing and drying of
ampoules, vials, bottles and closures.
3) Solution preparation area: This includes preparation and filtration of solution.
4) Filling, capping and sealing area: This includes filling and sealing of ampoules and/or
filling, capping and sealing of vials and bottles.
5) Sterilization area
6) Quarantine area
7) Visual inspection area
8) Packaging area
The following equipments are recommended for different above-mentioned areas,
namely:
a) Water management area
1) De-ionised water treatment unit
2) Distillation (multi-column with heat exchangers) unit
3) Thermostatically controlled water storage tank
4) Transfer pumps
5) Stainless steel service lines for carrying water into user areas
b) Containers and closures preparation area
1) Automatic rotary ampoule/vial/bottle washing machine having separate air, water
distilled water jets
2)Automatic closures washing machine
3) Storage equipment for ampoules, vials, bottles and closures
4) Dryer/sterilizer (double ended)
5) Dust proof storage cabinets
6) Stainless steel benches/stools
c) Solution preparation area
1) Solution preparation and mixing stainless steel tanks and other containers
2) Portable stirrer
3) Filtration equipment with cartridge and membrane filters/bacteriological filters
4) Transfer pumps
d) Filling, capping and sealing area
1) Automatic ampoule/vial/bottle filling, sealing and capping machine under laminar air
flow workstation
2) Gas line (Nitrogen, Oxygen, Carbon dioxide) wherever required
3) Stainless steel benches / stools
e) Sterilization area
1) Steam sterilizer preferably with computer control for sterilization cycle along with
trolley sets for loading/unloading containers before and after sterilization
2) Hot air sterilizer (preferably double ended)
3) Pressure leak test apparatus
f) Quarantine area
1) Storage cabinets
2) Raised platforms/steel racks
g) Visual inspection area

1) Visual inspection units (preferably conveyor belt type and composite white and black
assembly supported with illumination)
h) Packaging area
1) Batch coding machine (preferably automatic)
2) Labelling unit (preferably conveyor belt type)
3) Benches/stools
A minimum area of 150 square meters for the basic installation and an
ancillary area of 100 square meters for Small Volume Injectables are recommended.
For Large Volume Parenterals, an area of 150 square meters each for the basic
installation and for ancillary area is recommended. These areas shall be partitioned into
suitable enclosures with airlock arrangements. Areas for formulations meant for
external use and internal use shall be separately provided to avoid mix up. Packaging
materials for large volume parenteral shall have a minimum area of 100 square meters.
II. Parenteral preparations in plastic containers by Form-Fill-Seal/Blow,

1) Water management area
2) Solution preparation area
3) Containers moulding-cum filling and sealing area
4) Sterilization area
5) Quarantine area
6) Visual inspection area
7) Packing area
The following equipments are recommended for different above mentioned areas
namely:
a) Water management area
1) De-ionised water treatment unit
2) Distillation unit (multi column with heat exchangers)
3) Thermostatically controlled water storage tank
4) Transfer pumps
5) Stainless steel service lines for carrying water into user areas.
b) Solution preparation area
1) Solution preparation and storage tanks

2) Transfer pumps
3) Cartridge and membrane filters
f) Container moulding-cum-filling and sealing area
1) Sterile Form-Fill-Seal machine (all operations in one station with built-in laminar air
flow workstation having integrated container output conveyor belt through pass box).
2) Arrangement for feeding plastic granules through feeding-cum-filling tank into the
machine.
g) Sterilization area
Super heated steam sterilizer (with computer control for sterilization cycle along with
trolley sets for loading/unloading containers for sterilization)
h) Quarantine area
Adequate number of platforms/racks with storage system
i) Visual inspection area
Visual inspection unit (with conveyor belt and composite type)
j) Packaging area
1) Pressure leak test apparatus (pressure belt or rotating disc type)
2) Batch coding machine (preferably automatic)
3) Labelling unit (preferably conveyor belt type)
A minimum area of 250 square meters for the basic installation of and ancillary area of
one 150 square meters for large volume parenteral preparations in plastic containers by
Form-Fill-Seal technology is recommended. These areas shall be partitioned into
suitable enclosures with airlock arrangements. Areas for formulations meant for
external use and internal use shall be separately provided to avoid mix up. Packaging
materials for large volume parenteral shall have a minimum area of 100 square meters.
Schedule N
Minimum Equipments to be possessed by Pharmacy
Entrance
The entrance of pharmacy shall bear an inscription “ pharmacy”.
Premises
The premises of pharmacy shall be separated from the rooms for private use. The
premises shall be dry, well built, well ventilated to allow the storage of stock of drugs. The area of
dispensing department shall not be less than six square meter for one pharmacist with additional
two square meters for each additional pharmacist. The height of dispensing department shall not
be less than 2.5 meter.
The walls of the premises shall be plastered or oil painted or tiled and shall be devoid of
cracks and holes. The floor shall be smooth and washable. There shall be an adequate quantity of
good quality water in pharmacy premises.
Furniture and apparatus

The furniture and apparatus shall be of an appropriate size. Glasswares and containers
shall be well closed to prevent the entry of dust. Pharmacy shall provide an adequate good quality
water. Drugs and Chemicals shall not be deteriorated or decomposed by the containers. Each
container shall be labeled properly along with the quantity. For the storage of poisons there shall
be special cupboard with lock and key. The containers of poisons shall be labeled with the name
“POISON' with red letters on white back ground. After the use of poison it shall be replaced in the
cupboard immediately. The concentrated preparations shall be labeled with the words, “To be
diluted”
Following minimum equipments are needed to possess by pharmacy:
1. Balance, sensitivity, 30 mg
2. Balance, counters sensitivity 1 kg
3. Beakers of various shapes
4. Burettes
5. Funnels (Glass)
6. Evaporating dishes, (porcelain)
7. Measuring cylinders 10 ml, 100 ml, 1000 ml
8. Pipettes 0.1 ml, 10 ml capacity
9. Mortars and Pestles (Porcelain)
10. Mortars and Pestles (Glass)
11. Porcelain dish
Reference books
1. Indian Pharmacopoeia (Current edition)
2. National Formulary of India
3. Drugs and CosmeticsAct, 1940
4. Drugs and Cosmetics Rules, 1945.
5. Narcotic Drugs and Psychotropic substanceAct, 1985
General provisions
Pharmacy shall be run under the continuos supervision of registered pharmacist whose
name shall be displayed in the premises from time to time. The premises of pharmacy shall be
clean and in good order. Pharmacist shall wear clean apron and he shall maintain all the records
and registers. He shall replace the containers of poisons after use and lock the cupboard
immediately. Medicament supplied by the pharmacist shall conform to the provisions of the law
in force.
Schedule P Shelf Life of Drugs (only part of list is given here)

Name of the Drug Period in months* Storage condition
Ampicillin 36 In a cool place
Ampicillin Capsules 24
Ampicillin Sodium 36 In a cool place
Ampicillin Trihydrate 30 In a cool place
Amoxycillin Trihydrate 36 In a cool place
Amoxycillin Trihydrate Capsule 24
Amoxycillin Trihydrate dry syrup 18
Bacitracin 18 In a cool place
Bacitracin Lozenges 12
Cephalexin 24 In a cool place.
Chloramphenicol 60 In a cool place.
Chloramphenicol Palmitate 48
*(unless otherwise specified) between date of manufacture and date of expiry which the labeled potency
period of the drug shall not exceed under the conditions of storage
Schedule P1 Pack Size of Drugs (only part of list is given here)
Name of the Drug Dosage form Pack size
Albendazole Suspension 10 ml
Atenolol Tablets 14
Anti-Haemmorhoidal Topicals Rectal Capsules 20
Aspirin (Low-dose) Tablets 14
Cholecalciferol or Ergocalciferol Granules 1 gm Sachet
Ciclopiroxolamine Vaginal Cream 30 gms.
Catalin Ophthalmic drops 15 ml
Famotidine Tablets 14
Glyceryl Trinitrate Spansules (Long Acting) 25
Isosorbide Dinitrate Spansules (Long Action) 25
Isoniazide Syrup 200 ml
Ipecacuanha Syrup 10 ml
Oral Rehydration Salt (ORS) Powder Pouches*
Piperazine Granules 5 gm.
Syrup 30 ml
Pyrantel Pamoate Syrup 8 ml or 10 ml

Potassium Chloride. Syrup 60 ml and 200 ml.
Colour Colour Index Chemical name of colour
* to be reconstituted to one litre in pack or in 5 unit doses in 5 unit dose sachets in onepack.
Guinea Green B 42085 Monosodium salt of 4-(N-ethyl-p-
Schedule Q List of Permitted coal tar colors
sulfobenzylamino) –diphenylmethylone-
(1-(N-ethyl-N-p-sulfoniumbenzyl) 2,5-
cyclohexadienimine)
Tartrazine 19140 Trisodium salt of 3-carboxy-5-hydroxy-
1-p- sulfophenyl-4- p- sulfophenylazo-
pyrazole
Sunset yellow FCF. 15985 Disodium salt of 1-p-sulfophenylazo-2-
naphthol-6- sulfonic acid
Ponceau 3R 16155 Disodium salts of a mixture of 1-alkyl-
phenylazo-2- napthol 3, 6-disulfonic
acids
Amarnath. 16185 Trisodium salt of 1-(4-sulfo-1- 2-
napthylazo) naphthol 3, 6- disulfonic
acid
Erythrosine 45430 Disodium salt of 9-0-carboxyphenyl-6-
hydroxy 2,4,5, 7- tetraiodo-3-
isoxanthone.
tetraiodo-3- soxanthone.
Eosin TS 45380 Disodium salt of 2,4,5,7-tetrabromo-9-0
Carboxyphenyl -6-hyroxy-3-
isoxanthone
Flaming Red 12085 I- (o-Chloro-p-nitrophenylazo)-2-
naphthol
Orange G 16230 Disodium salt of 1-phenylazo-2-
naphthol-6-8- disulfonic acid
Pigment Yellow 3 11710 2-(4-Chloro-2-nitrophenyl)-azo-N-(-2-
Chlorophenyl)- 3-Oxobutamide
Schedule W
List of drugs which are marketed under generic names only
1. Analgin
2. Aspirin and its salts

3. Chlorpromazine and its salts
4. Ferrous sulphate
5. Piperazine and its salts.
Schedule X List of habit forming drugs

1. Amobarbitol
2. Amphetamine
3. Barbital
4. Cyclobarbital
5. Dexamphetamine
6. Glutethimide
7. Methamphetamine
8. Meprobamate
9. Methylphenidate
10. Phencyclidine
11. Pentobarbital
12. Secobarbital
Schedule Y
Requirements and guidelines for permission to import and / or Manufacture of new drugs
for sale or to undertake clinical trials
1.Application for permission
(1) Application for permission to import or manufacture, new drugs for sale or to undertake
clinical trials shall be made in Form 44 accompanied with following data in accordance with the
appendices, namely:
(i) Chemical and pharmaceutical information as prescribed
(ii)Animal pharmacology data as prescribed
a. Specific pharmacological actions and demonstrating, therapeutic potential for humans
shall be described according to the animal models and species used. Wherever possible,
dose- response relationships and ED50s shall be submitted. Special studies conducted to
elucidate mode of action shall also be described.
b. General pharmacological actions.
c. Pharmacokinetic data related to the absorption, distribution, metabolism and excretion
of the test substance. Wherever possible, the drug effects shall be correlated to the
plasma drug concentrations;
(iii)Animal toxicology data.

(iv) Human Clinical Pharmacology data as stated below:
a. For new drug substances discovered in India, clinical trials are required to be carried out
in India right from Phase I and data should be submitted as required.
b. For new drug substances discovered in countries other than India, Phase I data as
required under items 1, 2, 3, 4, 5 (data from other countries) and 9 of Appendix I should
be submitted along with the application. After submission of Phase I data generated
outside India to the Licensing Authority, permission may be granted to repeat Phase I
trials and/or to conduct Phase II trials and subsequently Phase III trials concurrently
with other global trials for that drug. Phase III trails are required to be conducted in India
before permission to market the drug in India is granted;
c. The data required will depend upon the purpose of the new drug application. The number
of study subjects and sites to be involved in the conduct of clinical trial will depend upon
the nature and objective of the study. Permission to carry out these trials shall generally
be given in stages, considering the data emerging from earlier Phase(s);
d. application for permission to initiate specific phase of clinical trial should also
accompany Investigator's brochure, proposed protocol (Appendix X), case record form,
study subject's informed consent document(s) (Appendix V), investigator's undertaking
(Appendix VII) and ethics committee clearance, if available, (Appendix VIII);
e. Reports of clinical studies submitted under items 5-8 of Appendix I should be in
consonance with the format prescribed inAppendix II of this Schedule. The study report
shall be certified by the Principal Investigator or, if no Principal Investigator is
designated, then by each of the Investigators participating in the study. The certification
should acknowledge the contents of the report, the accurate presentation of the study as
undertaken and express agreement with the conclusions. Each page should be
numbered;
(v) Regulatory status in other countries as prescribed in item 9.2 of Appendix I, including
Information in respect of restrictions imposed, if any, on the use of the drug in other countries,
e.g. dosage limits, exclusion of certain age groups, warning about adverse drug reactions, etc.
(item 9.2 of Appendix I). Likewise, if the drug has been withdrawn in any country by the
manufacturer or by regulatory authorities, such information should also be furnished along with
the reasons and their relevance, if any, to India. This information must continue to be submitted
by the sponsor to the LicensingAuthority during the course of marketing of the drug in India;
(vi)The full prescribing information should be submitted as part of the new drug application for
marketing as prescribed in item 10 of Appendix I. The prescribing information (package insert)
shall comprise the following sections: generic name, composition, dosage form/s, indications,
dose and method of administration, use in special populations (such as pregnant women,
lactating women, pediatric patients, geriatric patients etc), contra-indications, warnings,
precautions; drug interactions, undesirable effects, overdose, pharmacodynamic and

pharmacokinetic properties, incompatibilities, shelf-life, packaging information; storage and
handling instructions. All package inserts, promotional literature and patient education material
subsequently produced are required to be consistent with the contents of the approved full
prescribing information. The drafts of label and carton texts should comply with provisions of
rules 96 and 97. After submission and approval by the Licensing Authority, no changes in the
package insert shall be effected without such changes being approved by the Licensing
Authority; and
(vii) Complete testing protocol/s for quality control testing together with a complete impurity
profile and release specifications for the product as prescribed in item 11 of Appendix I should be
submitted as part of new drug application for marketing. Samples of the pure drug substance and
finished product are to be submitted when desired by the regulatory authority.
(2) If the study drug is intended to be imported for the purposes of examination, test or analysis,
the application for import of small quantities of drugs for such purpose should also be made in
Form 12.
(3) For drugs indicated in life threatening/ serious diseases or diseases of special relevance to the
Indian health scenario, the toxicological and clinical data requirements may be abbreviated,
deferred or omitted, as deemed appropriate by the LicensingAuthority.
2. CLINICALTRIAL
1)Approval for clinical trial:
a. Clinical trial on a new drug shall be initiated only after the permission has been granted
by the Licensing Authority under rule 21 (b), and the approval obtained from the
respective ethics committee(s). The Licensing Authority as defined shall be informed of
the approval of the respective institutional ethics committee(s) as prescribed in
Appendix VIII and the trial initiated at each respective site only after obtaining such an
approval for that site. The trial site(s) may accept the approval granted to the protocol by
the ethics committee of another trial site or the approval granted by an independent
ethics committees (constituted as per Appendix VIII), provided that the approving
ethics committee(s) is/are willing to accept their responsibilities for the study at such
trial site(s) and the trial site(s) is/are willing to accept such an arrangement and that the
protocol version is same at all trial sites.
b. All trial Investigator(s) should possess appropriate qualifications, training and
experience and should have access to such investigational and treatment facilities as are
relevant to the proposed trial protocol. A qualified physician (or dentist, when
appropriate) who is an investigator or a sub-investigator for the trial, should be
responsible for all trial-related medical (or dental) decisions. Laboratories used for
generating data for clinical trials should be compliant with Good Laboratory Practices.
If services of a laboratory or a facilities outside the country are to be availed, its/their

name(s), address(s) and specific services to be used should be stated in the protocol to
avail Licensing Authority's permission to send clinical trial related samples to such
laboratory(ies) and/or facility(ies). In all cases, information about laboratories /facilities
to be used for the trial, if other than those at the investigation site(s), should be furnished
to the LicensingAuthority prior to initiation of trial at such site(s).
c. Protocol amendments if become necessary before initiation or during the course of a
clinical trial, all such amendments should be notified to the Licensing Authority in
writing along with the approval by the ethics committee which has granted the approval
for the study. No deviations from the charges to the protocol should be implemented
without prior written approval of the ethics committee and the Licensing Authority
except when it is necessary to eliminate immediate hazards to the trial Subject(s) or
when change(s) involve(s) only logistic or administrative aspects of the trial. All such
exceptions must be immediately notified to the ethics committee as well as to the
Licensing Authority. Administrative and/or logistic changes in the protocol should be
notified to the LicensingAuthority within 30 days.
2) Responsibilities of Sponsor
a. The clinical trial Sponsor is responsible for implementing and maintaining quality
assurance systems to ensure that the clinical trial is conducted and data generated,
documented and reported in compliance with the protocol and Good Clinical Practice
(GCP) Guidelines issued by the Central Drugs Standard Control Organization,
Directorate General of Health Services, Government of India as well as with all
applicable statutory provisions. Standard operating procedures should be documented
to ensure compliance with GCP and applicable regulations.
b. Sponsors are required to submit a status report on the clinical trial to the Licensing
Authority at the prescribed periodicity.
c. In case of studies prematurely discontinued for any reason including lack of commercial
interest in pursuing the new drug application, a summary report should be submitted
within three months. The summary report should provide a brief description of the study,
the number of patients exposed to the drug, dose and duration of exposure, details of
adverse drug reactions (Appendix XI), if any, and the reason for discontinuation of the
study or non-pursuit of the new drug application;
d. Any unexpected serious adverse event (SAE) (as defined in GCP Guidelines) occurring
during a clinical trial should be communicated promptly (within 14 calendar days) by
the Sponsor to the Licensing Authority and to the other Investigator(s) participating in
the study (seeAppendix XI).
3) Responsibilities of the Investigator(s)

The Investigator(s) shall be responsible for the conduct of the trial according to the
protocol and the GCP Guidelines and also for compliance as per the undertaking given in
Appendix VII. Standard operating procedures are required to be documented by the
Investigators for the tasks performed by them. During and following a subject's participation in a
trial, the investigator should ensure that adequate medical care is provided to the participant for
any adverse events. Investigator(s) shall report all serious and unexpected adverse events to the
Sponsor within 24 hours and to the Ethics Committee that accorded approval to the study
protocol within 7 working days of their occurrence.
4) Informed Consent
a. In all trials, a freely given, informed written consent is required to be obtained from each
study subject. The Investigator must provide information about the study verbally as
well as using a patient information sheet in a language that is non-technical and
understandable by the study subject. The Subject's consent must be obtained in writing
using an 'Informed Consent Form'. Both the patient information sheet as well as the
informed Consent Form should have been approved by the ethics committee and
furnished to the Licensing Authority. Any changes in the informed consent documents
should be approved by the ethics committee and submitted to the Licensing Authority
before such changes are implemented.
b. Where a subject is not able to give informed consent (e.g. an unconscious person or a
minor or those suffering from severe mental illness or disability), the same may be
obtained from a legally acceptable representative (a legally acceptable representative is
a person who is able to give consent for or authorize an intervention in the patient as
provided by the law(s) of India). If the Subject or his/her legally acceptable
representative is unable to read/write - an impartial witness should be present during the
entire informed consent process who must append his/her signatures to the consent
form.
c. A checklist of essential elements to be included in the study subject's informed consent
document as well as a format for the informed Consent Form for study Subjects is given
inAppendix V.
5) Responsibilities of the Ethics Committee

a. It is the responsibility of the ethics committees that reviews and accords its approval to a
trial protocol to safeguard the rights, safety and well being of all trial subjects. The ethics
committee should exercise particular care to protect the rights, safety and well being of
all vulnerable subjects participating in the study, e.g., members of a group with
hierarchical structure (e.g. prisoners, armed forces personnel, staff and students of
medical, nursing and pharmacy academic institutions), patients with incurable diseases,
unemployed or impoverished persons, and patients in emergency situation, ethnic
minority groups, homeless persons, nomads, refugees, minors or others incapable of
personally giving consent. Ethics committee(s) should get document 'standard operating
procedures' and should maintain a record of its proceedings.
b. Ethics Committee(s) should make, at appropriate intervals, an ongoing review of the
trials for which they review the protocol(s). Such a review may be based on the periodic
study progress reports furnished by the investigators and/or monitoring and internal
audit reports furnished by the Sponsor and/or by visiting the study sites.
c. In case an ethics committee revokes its approval accorded to a trial protocol, it must
record the reasons for doing so and at once communicate such decision to the
Investigator as well as to the LicensingAuthority.
6) Human Pharmacology (Phase I)

i. The objective of studies in this Phase is the estimation of safety and tolerability with the
initial administration of an investigational new drug into human(s). Studies in this Phase
of development usually have non-therapeutic objectives and may be conducted in
healthy volunteers subjects or certain types of patients. Drugs with significant potential
toxicity e.g. cytotoxic drugs are usually studied in patients. Phase I trials should
preferably be carried out by Investigators trained in clinical pharmacology with access
to the necessary facilities to closely observe and monitor the Subjects.
ii. Studies conducted in Phase I, usually intended to involve one or a combination of the
following objectives:
a. Maximum tolerated dose: To determine the tolerability of the dose range expected to be
needed for later clinical studies and to determine the nature of adverse reactions that can
be expected. These studies include both single and multiple dose administration.
b. Pharmacokinetics, i.e., characterization of a drug's absorption, distribution, metabolism
and excretion. Although these studies continue throughout the development plan, they
should be performed to support formulation development and determine
pharmacokinetic parameters in different age groups to support dosing
recommendations.
c. Pharmacodynamics: Depending on the drug and the endpoints studied,
pharmacodynamic studies and studies relating to drug blood levels
(pharmacokinetic/pharmacodynamic studies) may be conducted in healthy volunteer
Subjects or in patients with the target disease. If there are appropriate validated
indicators of activity and potential efficacy, pharmacodynamic data obtained from
patients may guide the dosage and dose regimen to be applied in later studies.
d. Early Measurement of Drug Activity: Preliminary studies of activity or potential
therapeutic benefit may be conducted in Phase I as a secondary objective. Such studies

are generally performed in later Phases but may be appropriate when drug activity is
readily measurable with a short duration of drug exposure in patients at this early stage.
7) Therapeutic exploratory trials (Phase II)
a. The primary objective of Phase II trials is to evaluate the effectiveness of a drug for a
particular indication or indications in patients with the condition under study and to
determine the common short-term side-effects and risks associated with the drug.
Studies in Phase II should be conducted in a group of patients who are selected by
relatively narrow criteria leading to a relatively homogeneous population. These studies
should be closely monitored. An important goal for this Phase is to determine the dose(s)
and regimen for Phase III trials. Doses used in Phase II are usually (but not always) less
than the highest doses used in Phase I.
b. Additional objectives of Phase II studies can include evaluation of potential study
endpoints, therapeutic regimens (including concomitant medications) and target
populations (e.g. mild versus severe disease) for further studies in Phase II or III. These
objectives may be served by exploratory analyses, examining subsets of data and by
including multiple endpoints in trials.
c. If the application is for conduct of clinical trials as a part of multi-national clinical
development of the drug, the number of sites and the patients as well as the justification
for undertaking such trials in India shall be provided to the LicensingAuthority.
8) Therapeutic confirmatory trials (Phase III)

a. Phase III studies have primary objective of demonstration or confirmation of therapeutic
benefits(s). Studies in Phase III are designed to confirm the preliminary evidence
accumulated in Phase II that a drug is safe and effective for use in the intended indication
and recipient population. These studies should be intended to provide an adequate basis
for marketing approval. Studies in Phase III may also further explore the dose-response
relationships (relationships among dose, drug concentration in blood and clinical
response), use of the drug in wider populations in different stages of disease, or the
safety and efficacy of the drug in combination with other drug(s).
b. For drugs intended to be administered for long periods, trials involving extended
exposure to the drug are ordinarily conducted in Phase III, although they may be
initiated in Phase II. These studies carried out in Phase III complete information
needed to support adequate instructions for use of the drug (prescribing information).
c. For new drugs approved outside India, Phase III studies needs to be carried out primarily
to generate evidence of efficacy and safety of the drug in Indian patients when used as
recommended in the prescribing information. Prior to conduct of Phase III studies in
Indian subjects, Licensing Authority may require pharmacokinetic studies to be
undertaken to verify that the data generated in Indian population is in conformity with
the data already generated abroad.
d. If the application is for the conduct of clinical trials as a part of multi-national clinical
development of the drug, the number of sites and patients as well as the justification for
undertaking such trials in India should be provided to the LicensingAuthority along with
the application.
9) Post Marketing Trials (Phase IV)

Post Marketing trials are studies (other than routine surveillance) performed after drug
approval and related to the approved indication(s). These trials go beyond the prior
demonstration of the drug's safety, efficacy and dose definition. These trials may not be
considered necessary at the time of new drug approval but may be required by the Licensing
Authority for optimizing the drug's use. They may be of any type but should have valid scientific
objectives. Phase IV trials include additional drug-drug interaction(s), dose-response or safety
studies and trials designed to support use under the approved indication(s), e.g.
mortality/morbidity studies, epidemiological studies etc.
Specimen Labels
1. Specimen label of 10 x 10Analgin tablets
ANALGIN TABLETS I.P (10 x 10 Tablets)

Each Tablet contains
Analgin I. P.-------------------- 500 mg
Schedule H drug
Warning: “ To be sold by retail on the prescription of a RMP only”
Dosage:
1 to 6 tablets in daily divided doses or
As directed by Physician
Mfg. Lic. No. ________ Mfg Date________
Batch No._________ Exp. Date ________
Retail Price not to exceed ` ________ (L. T Extra)
MAYUR PHARMACEUTICALS, MIDC, Satara (MS)

(Ared vertical line on the left side running through out the body of the label not
less than 1 mm in width.)
2. Specimen label of 10 x 10 Busulphan tablets
BUSULPHAN TABLETS I.P (10 x 10 Tablets)

Each Tablet contains:
Busulphan I. P. --------------------- 0.5 mg
Schedule G drug
Caution: It is dangerous to take this preparation except under medical supervision.
Direction: Replace the cap tightly after use; Protect from light.
Dosage: 1 to 4 tablets in daily divided doses orAs directed by Physician
Batch No._________ Exp. Date ________
Retail Price not to exceed `________ (L. T Extra)
RYAN PHARMACEUTICALS, MIDC, Satara (MS)

(Ared vertical line on the left side running through out the body of the label not less than
1mm in width.)
3. Specimen label for CompoundAntispasmodic Tablets
NRx
COMPOUND ANTISPASMODIC TABLETS I.P (10 x 10 Tablets)
Each Tablet contains:
Analgin I.P. ----------------------------- 500 mg
Atropine methonitrate B.P.------------ 320 mg
Ethyl Morphine hydrochloride I.P.- --11 mg
Phenolphthalin I.P.--------------------- 22 mg
Schedule X drug
Warning: To be sold by retail on the prescription of R.M.P only.
Direction: STORE PROTECT FROM LIGHT.
Dosage: 1 to 2 Tablet in daily divided doses orAs directed by Physician
Batch No._________ Exp. Date ________
Retail Price not to exceed `________ (L. T Extra)
SANCHITA PHARMACEUTICALS, MIDC, Satara (MS)

(ARed vertical line on the left side running through out the body of the label not less than
1mm in width.)
List of Forms
Sr. No. Purpose of Form Form No.
1. Grant of licence for the import of Schedule C and C(i)drugs 10
2. Grant of licence for the import of Schedule X drugs 10A
3. Grant of licence for the import of small quantities of drugs 11
4. Grant of licence for the import of such drug that is not forming
a part of passengers bonafide baggage 12
5. Report of test or analysis issued by GovernmentAnalyst to
Drug Inspector 13
6. Certificate of test or analysis issued by GovernmentAnalyst
under section 25(1) of theAct 13A
under section 33H of theAct 13B
under section 26 of theAct 14B
9. Order of Drug Inspector under section 22(1) to a person
not to dispose the stock of drugs and cosmetics in his possession 15
10. Receipt for a stock of drugs/ cosmetics seized by Drug Inspector
under section 22(1) 16
11. Intimation of purpose by Drug Inspector to a person from whom
sample is taken 17
12. Memorandum to GovernmentAnalyst 18
13. Application for the grant of licence to sell, stock or exhibit for
sale or distribute drugs other than those specified in Schedule X 19
14. Application for the grant of restricted licence 19A
15. Application for the grant of licence for the wholesale or
distribution of drugs from motor vehicle 19AA
16. Application for the grant of licence to sell, stock or exhibit for
sale or distribute drugs specified in Schedule X 19C
17. Issue of licence to sell stock or exhibit for sale or distribute drugs
by retail other than those specified in Schedule C, C(i) and X 20
18. Issue of restricted licence to sell stock or exhibit for sale or distribute
for drugs other than those specified in Schedule C, C(i) and X 20A
19. Issue of licence to sell stock or exhibit for sale by wholesale or distribute
drugs other than those specified in Schedule C, C(i) and X 20B
20. Issue of licence to sell stock or exhibit for sale by wholesale or

distribute drugs from motor vehicle other than those specified
in Schedule C, C(i) and X 20BB
21. Issue of licence to sell stock or exhibit for sale by retail or
distribute Homoeopathic Medicine 20C
distribute Homoeopathic Medicine 20D
23. Certificate of renewal or licence to sell, stock or exhibit for
sale or distribute Homoeopathic Medicine 20E
distribute drugs specified in Schedule X 20F
distribute drugs specified in Schedule X 20G
distribute drugs specified in Schedule C and C(i) 21
27. Issue of restricted licence to sell stock or exhibit for sale for
drugs specified in Schedule C and C(I) 21A
distribute drugs specified in Schedule C and C(i) 21B
distribute drugs specified in Schedule C and C(i) from
motor vehicle 21BB
30. Certificate of renewal of licence to sell, stock or exhibit for sale
or distribute drugs 21C
31. Certificate of renewal of licence to sell, stock or exhibit for sale
by wholesale or distribute drugs from motor vehicle 21CC
32. Application for the grant of licence to manufacture drugs other
than those specified in Schedule C, C(i) and X 24
33. Application for the grant of loan licence to manufacture
for sale of drugs other than those specified in Schedule C,
C(i) and X 24A
34. Application for the grant of licence for repacking of drugs 24B
35. Application for the grant of licence to manufacture Ayurvedic,
Siddha and Unani drugs 24D

36. Application for the grant of licence to manufacture
for sale of Schedule X drugs 24F
37. Grant of licence to manufacture drugs other than those specified
in Schedule C, C(i) and X 25
38. Grant of loan licence to manufacture drugs other than those
specified in Schedule C, C(i) and X 25A
39. Issue of licence for repacking of drugs 25B
40. Grant of loan licence for the manufacture ofAyurvedic, Siddha,
and Unani drugs 25D
41. Grant of licence for the manufacture drugs specified in
Schedule X 25F
42. Application for the manufacture of drugs specified in
Schedule C, C(i) 27
43. Issue of licence for the manufacture of drugs specified in
Schedule C, C(i) 28
44. Grant of licence to manufacture for examination, test or
analysis 29
45. Application for the grant of licence to manufacture for
examination, test or analysis 30
46. Application for the grant of licence to manufacture cosmetics 31
47. Issue of licence to manufacture cosmetics 32
48. Maintenance of inspection book by licensee 35
49. Application for the approval of the institution for carrying out
tests on drugs, cosmetics and raw materials 36
50. Report of institution for carrying out tests on drugs, cosmetics
and raw materials 39
Summary
Drugs and Cosmetics Act, 1940 governs the import, manufacture, sale, supply and
distribution of drugs and cosmetics. There are various bodies such as advisory, analytical and
drugs controlling authority that will control the quality and safety of drugs and cosmetics. This
Act focus on the various provisions for the import, manufacture, distribution and sale of
allopathic, homoeopathic, ayurvedic drugs and cosmetics. It also covers the labeling conditions
and information about the supply of different categories of drugs and cosmetics.

1. Schedule F(ii) prescribes the standards for_______.
a. Opthalmic preparations b. Cosmetics
c. Umbilical taps d. Surgical dressings
2. Schedule M(i)prescribes the requirements of factory premises, plant, equipments, etc for the
manufacture of ________ .
a. Homoeopathic medicine b. Cosmetics
c. Drugs d. Medical devices
3. Schedule H prescribes __________ .
a. the list of drugs to be sold by retail only on the prescription of RMP
b. the list of drugs to be taken only under the supervision of medical practitioner
c. the list of narcotic drugs and psychotropic substances
d. the list of diseases which drugs may not claim to cure
4. Requirements and guidelines on the clinical trials for the import and manufacture of new drug
is specified in __________.
a. schedule D b. schedule X
c. schedule K d. schedule Y
5. Drugs marketed under the generic names only are specified in _________.
a. Schedule V b. Schedule W
c. Schedule Y d. Schedule T
6. Standards of patent and proprietary medicine is specified in ________ .
a. Schedule M b. Schedule Q
c. Schedule V d. Schedule T
7. Schedule B is related with ___________ .
a. Forms b. GMP
c. Fees d. Pharmacy
8. List of permitted coal tar colors for use in cosmetics is specified in _________ .
a. Schedule X b. Schedule Q
c. Schedule S d. ScheduleT
9. Standards of quality in respect to drugs means the drug comply the standards as specified in _ .
a. Second Schedule b. Schedules
c. First Schedule d. None
10. ______ drugs are manufactured in accordance with the formulae described in the first
schedule.
a. Standard quality b.Ayurvedic, Siddha and Unani
c. Homoeopathic d.Allopathic
11. Repacking of drugs includes all the process except the following
a. labeling and packing of drugs for sale
b. breaking up the drugs from the bulk containers
c. distribution of drugs
d. compounding and dispensing of drug
12. Cosmetic includes the following articles except _____.
a. Soap b. Face powder
c. Shampoo d. Lipstick
13. Drug shall be deemed to be adulterated except if it ______.
a. is manufactured under in sanitary conditions.
b. contains different colors other than those prescribed.
c. is imported under a name that belong to another drug.
d. contains filthy, putrid or decomposed substances.
14. Drug store means a licensed premises for the sale of drugs that _______ .
a. requires the services of qualified person and where drugs are not compounded against
the prescription
b. do not require the services of qualified person and where drugs are not compounded
against the prescription
c. do not require the services of qualified person and where drugs are compounded
against the prescription
d. None
15. Drugs TechnicalAdvisory Board is purely ________ body.
a. administrative b. analytical
c. advisory d. none
16. Drugs Consultative Committee is constituted by __________.
a. DTAB b. Central Council
c. State Government d. Central Government
17. In case of _________, the function of Central Drugs Laboratory is carried out at Serologist
and Chemical Examiner to the Government of India.
a. Condoms b. Veneral disease reference laboratory
c. Polio Vaccine testing laboratory d. Intra-uterine Contraceptive devices
18. GovernmentAnalyst is appointed by Central Government or State Government under section
_____ in relation toAyurvedic, Siddha and Unani systems of medicine.
a. 20 b. 21
c. 33F d. 21A
19. Government Analyst has to submit his report of drug analysis in _________ copies in Form
____.
a. two, 1 b. three, 13
c. four, 13 d. five, 2
20. Report of Government analyst is held to be conclusive only if it is not challenged according to
the procedure given within _____ days of receipt of copy of report by person from whom sample
was taken.
a. 20 b. 30
c. 21 d. 28
21. Drug inspector after inspection of drug store can order to stop sale of drugs for ________
days.
a. 28 b. 21
c. 20 d. 30
22. Drug inspector shall inspect the premises licensed for sale of drugs at least _______ a year.
a. once b. twice
c. thrice d. none
23. For the import of drugs specified in schedule X, the licence shall be granted in ________.
a. Form 10A b. Form 10
c. Form 20A d. Form 21
24. If the imported drug is not forming part of the passenger’s baggage, such drug shall be
imported in________.
a. Form 10 b. Form10A
c. Form 20A d. Form 12
25. For the manufacture of drugs specified in schedule C and C(i) applicant has to make an
application to the licensing authority in Form ____and the licence is issued in Form_____.
a. 24, 25 b. 27, 28
c. 24F, 25F d. 25, 25A
26. Inspection book for the repacking of drugs shall be maintained in Form_____
a. 35 b. 24B
c. 25B d. 25A
27. Loan licence can be granted for the manufacture of drugs specified in Schedule_____
a. C and C(i) b. X
c. other than C, C(i) and X d. none
28. In pharmacy, a separate cupboard should be provided for storage of _________

a. poisons b. cosmetics
c. patent and proprietary medicine d.Ayurvedic, Siddha and Unani drugs
29. Prescriptions containing Schedule ________drugs should not be dispensed more than once
unless prescriber given the directions to do so.
a. G b. W
c. H and X d. C and C(i).
30. No __________ drugs should be supplied as physician sample.
a. Schedule H b. Schedule G
c. Schedule C and C(i) d. Schedule X.
Important questions
1. What are the objectives of the Drugs and CosmeticsAct, 1940?
2. Define the following-
i)Adulterated drug ii) Spurious drug
iii) Misbranded drug. iv) Cosmetics
v) Drug vi)Ayurvedic, Siddha and Unani drugs
vii) Manufacture viii) Loan licence
ix) Repacking of drugs x) Qualified person
xi) Drug Inspector xii) GovernmentAnalyst
xiii) Standards of quality xiv) Patent and proprietary medicine
3. Give constitution and function of Drugs TechnicalAdvisory Board.
4. Give the functions of Central Drugs Laboratory.
5. How the samples for test or analysis are dispatched to Central Drugs Laboratory?
6. What qualifications will be entitled to a person to be appointed as a GovernmentAnalyst?
7. Give duties of GovernmentAnalyst.
8. What procedure should be followed by Government Analyst on the receipt of sample from
Drug inspector?
9. What qualifications are required for a person to be appointed as a Drug inspector?
10. Describe duties of Drug inspector.
11. What are the powers of Drug inspectors?
12. What procedure should be followed by Drug inspectors while sending the samples for test or
analysis?
13. What do you mean by restricted licence? Describe the conditions of it and conditions to be
fulfilled by licensee.
14. In which forms the application shall be made for the grant of licence? Mention different forms
in which licence is to be issued.

15. What qualifications are required for a person to be appointed as licensing authority and
appointing authority?
16. Describe the general conditions of licence.
17. Give the labeling conditions for hair dyes containing dyes, colors and pigments.
18. Describe Schedule N.
19. Give the labeling conditions for ophthalmic preparations.
20. Prepare specimen label for 10X 10Analgin tablets I.P.
21. Prepare specimen label for 10X 10 Busulphan tablets I.P.
22. Give the offences and penalties under Drugs and CosmeticsAct,1940.
23. Describe Schedule M.
24. Write a note on -schedule Y.
25. Give the constitution ofAyurvedic, Siddha and Unani drugs TechnicalAdvisory Board.
26. Describe the labeling and packing ofAyurvedic, Siddha and Unani drugs.
26. Discuss the conditions for the manufacture ofAyurvedic, Siddha and Unani drugs.
27. Describe the conditions for the manufacture of Homeopathic medicines.
28. Discuss in brief sale of Schedule H and Schedule X drugs.
29. Write a note on import of drugs.
30. Discuss in brief conditions for the manufacture of drugs other than these specified in
Schedule C, C(I)and X.

1. d 2. a 3. a 4. d 5. b 6. c 7. c 8. b 9. a 10. b 11. d
12. a 13. c 14. b 15. c 16. d 17. b 18. c 19. b 20. d 21. c 22. b
23. a 24.d 25. b 26. a 27. c 28. a 29.c 30. d
Chapter 5
THE PHARMACY ACT, 1948
Learning objectives
When you have finished this chapter, you should be able to:
1. identify the objectives of the PharmacyAct, 1948 and define various terms under thisAct
2. explain the constitution and functions of Pharmacy Council of India and State Pharmacy
Councils.
3. know Education Regulations and its amendments
4. explain the process of approval of the institution
5. know about central register and procedure of registration
6. define and explain the preparation and maintenance of first register and subsequent register.
7. explain various offences and penalties under thisAct
Introduction
Before independence, there were no restrictions to practice the profession of pharmacy
in India. Anyone could practice this profession without any knowledge of the drugs causing great
harm to the health of people by wrong compounding and dispensing practices. Many cases were
brought to the notice of the Government wherein the compounding, mixing or dispensing of
medicines was being done by persons who were not adequately educated for this purpose. It was
found necessary to enact a law for the regulation of the profession and practice of pharmacy. As
per the recommendations of Drugs Enquiry Committee and Health Survey and Development
Committee regarding formation of Central Council and State Pharmacy Councils, for taking care
of education of pharmacists and for maintaining the register of pharmacist, the Pharmacy Act
came into existence on 4th March 1948. This Act extends to the whole of India except the State of
Jammu and Kashmir and has been amended in certain aspects by the Pharmacy Amendment Act,
1959 and PharmacyAmendmentAct, 1976.
Objectives of PharmacyAct, 1948

The major objective of this Act is to regulate the profession and business of pharmacy. In
addition to this other objectives are:
1. To provide the uniform education and training to all the new pharmacists and
2. To maintain the control over persons entering in the profession of pharmacy.
Definitions
1. Central Council
Central Council means the Pharmacy Council of India constituted under section 3.
| 117
2. Central register
Central register means the register of pharmacist maintained by Central Council under
section 15A.
3. Registered Pharmacist
Registered pharmacist means person whose name is for the time being entered in the
register of pharmacist for a State in which he is for the time being residing or carrying on
his profession or business of pharmacy.
4. Executive Committee
Executive Committee means the Executive Committee of Central Council or State
Council as the context may require.
5. State Council
State Council means State Pharmacy Council constituted under section 19 and also
includes Joint State Pharmacy Council constituted in accordance with an agreement
under section 20.
6. University Grants Commission
It means the University Grants Commission established under section 4 of the
University Grants CommissionAct, 1956.
7. Repatriate
Repatriate means any person of Indian origin who on account of civil disturbances or for
the fear of such disturbances now forming the part of Srilanka, Burma, Uganda or any
other such country has on or after 14th April 1957 left or has been displaced from his
place of residence and who has since then been residing in India.
8. Displaced Person
Displaced Person means
a) Person who on account of setting up the dominions of India and Pakistan or on account
of civil disturbances or for the fear of such disturbances now forming the part of Pakistan
has on or after 1st March 1947 left or has been displaced from his place of residence and
who has since then been residing in India; or
b) Person who on account of civil disturbances or for the fear of such disturbances now
forming the part of Bangladesh has on or after 14th April 1957 but before 25th March
1971 left or has been displaced from his place of residence and who has since then been
residing in India.
9. Registered Medical Practitioner
Registered Medical Practitioner means
a) Person holding qualification granted by an authority specified or notified under section 3
of the Indian Medical Degrees Act, 1916 or as may be specified in the Schedules to the
Indian Medical CouncilAct, 1956; or
The Pharmacy Act, 1948 | 119
b) Person who is registered or eligible for the registration in a medical register for a State
meant for the registration of person, practicing the modern scientific systems of
medicine; or
c) Person who is registered or eligible for the registration in a medical register for a State
who although not falling within sub clauses (i) or (ii), is declared by general or special
order made by the State Government, in this behalf as a person practicing modern
scientific systems of medicines; or
d) Person who is engaged in the practice of veterinary medicine and who possess the
qualification approved by the State Government; or
e) Person whose name is entered in the register of Dentist under DentistsAct, 1948.
The Pharmacy Act is covered under 5 chapters consisting of 46 sections. The major
amendment to the Act was made in 1976 to Section 42 of the Act wherein the drug stores in the
country would be run under the supervision of registered pharmacists only after 1st November,
1983. The chapters covered under theAct are as follows:
Chapter I: Introduction to theAct
Chapter II: Pharmacy Council of India
Chapter III: State Pharmacy Council
Chapter IV: Registration of Pharmacists
Chapter V: Miscellaneous
Pharmacy Council of India (PCI)

Pharmacy Council of India was constituted by Central Government on 9th March 1949
to fulfill the objectives of the PharmacyAct, 1948.
Composition of Central Council of PCI
Central Council PCI consists of following members:
1. Elected Members
a) Six persons are elected by the University Grants Commission from amongst the teaching
staff of Indian Universities or Colleges affiliated there to, of whom at least one teacher
shall be of each subject that is pharmacy, pharmaceutical chemistry, pharmacognosy and
pharmacology.
b) One person is elected from amongst themselves the members of Medical Council of
India.
c) One member is elected from amongst themselves the registered pharmacist of State.
2. Nominated Members
a) Six members are nominated by the Central Government of whom at least four shall
possess degree or diploma in pharmacy or pharmaceutical chemistry.
b) One member is nominated by each State Government who shall be a registered

pharmacist.
3. Ex-officio Members
a) Director General of Health Services or his/her nominee, who shall be a Chairman.
b) Drugs Controller of India or his/her nominee.
c) Director, Central Drug Laboratory, Kolkatta.
President and Vice-President of Central Council

1. The President and Vice-President of the Central Council shall be elected by the members
of Council from amongst themselves.
2. The President or Vice-President shall hold office as such for a term not exceeding five
years and not extending beyond the expiry of his term as member of the Central Council
but subject to being a member of the Central Council, he shall be eligible for re- election,
provided that, if his term of office as a member of the Central Council expires before the
expiry of the full term for which he is elected as President or Vice-President, and if he is
re-elected or re -nominated as a member of the Central Council continue to hold office as
President or Vice-President for the full term for which he is elected to such office.
3. The President or in his absence Vice- President chairs the meetings of the Central
Council and the Executive Committee.
The Executive Committee

l. The Central Council shall, as soon as may be, constitute an Executive Committee
consisting of the President (who shall be Chairman of the Executive Committee) and
Vice-President, ex-officio, and five other members elected by the Central Council from
amongst its members.
2. A member of the Executive Committee shall hold office as such until the expiry of his
term of office as member of the Central Council but subject to his being a member of the
Central Council, he shall be eligible for re-election.
3. In addition to the powers and duties conferred and imposed on it by this Act, the
Executive Committee shall exercise and discharge such powers and duties as may be
prescribed.
Functions of Pharmacy Council of India (PCI)

The main functions of Central Council are as follows:
1. To prescribe the minimum standards of education required for qualification as a
pharmacist by making and governing the Education Regulations throughout the country.
2. To ensure uniform implementation of the educational standards throughout the country
by appointing pharmacy inspectors to inspect the pharmacy institutions.

3. To grant approval or withdraw the approval of institutions which conduct the course of
study or holds an examination for pharmacists.
4. To approve the qualifications granted outside the territories to which the Pharmacy Act,
1948 extends i.e. the approval to foreign qualification.
5. To prepare and maintain a central register for pharmacists.
Other functions of Central Council are as follows:
1. To appoint a Registrar who shall act as a Secretary, and even as a Treasurer of Pharmacy
Council of India, with the prior sanction of Central Government.
2. To acquire and maintain the movable and immovable properties of the Government.
3. To appoint and fix the pay to be paid to the officers and servants to enable to carry out its
functions.
4. To fix the allowances to be paid to the President and Vice President of PCI.
5. To fix the place, date and time of meeting.
6. To get the accounts audited from theAuditor.
Education Regulations (ER)

As per the Section 10 of the Pharmacy Act 1948, Pharmacy Council of India with the
prior approval of the Central Government may make certain regulations prescribing the
qualification required for the registration of person as a pharmacist. These regulations are known
as education regulations. It prescribes:
a) The minimum qualification required for the course.
b) The nature and period of training which is given to the student before appearing to the
examination.
c) The nature and period of training which is to be given to the students after completion of
the academic training but before getting diploma or degree certificate.
d) The facilities to be provided by the institutions for the students undergoing the approved
course of study.
e) The facilities to be provided by the institutions for the students undergoing practical
training.
f) The subjects of examinations and standards to be attained therein.
g) Any other conditions for examination.
Copies of drafts of education regulations and all subsequent amendments thereof shall
be furnished by Central Council to all the State Governments. Central Council before submitting
the copies of education regulations to the Central Government for the approval shall consider the
comments of State Governments. The comments of State Government shall be received within
three months from furnishing the copies of education regulations and taken into consideration.
Education regulations are then published in the Official Gazette of India. Executive Committee
from time to time reports to the Central Council on the efficacy of education regulations and may
recommend any amendments. The first ER as approved by the Ministry of Health and Family
Welfare was notified on 11th July 1953, the second ER in 1972, third ER in 1981 while fourth ER
in 1991.
Approval of Institutions or Authority which conducts the course of study or holds an

Examination
1.Application
An institution or authority which conducts the course of study or holds an examination
for the pharmacist has to make an application to the Central Council for the approval of the
course or examination.
2. Inspection
Central Council, on the receipt of such application, deputes its inspector to visit that
institution or authority and ascertain that whether those institutions are having the prescribed
facilities for the conduct of course of study or hold an examination. Inspectors then reports to the
Central Council on the facilities available in the institute for the conduct of course or
examination.
3.Approval
On the receipt of report of inspectors, if the Central Council is satisfied that the
institution or authority which conducts the course of study or holds an examination is in
conformity with the education regulations, it may accord the approval and the said course is
deemed to be approved.
4. Declaration
Declaration of approval made by resolutions is passed at the meeting of Central Council
and is published in the Official Gazette.
Withdrawal ofApproval
If the Executive Committee reports to the Central Council that the institution or
authority which conducts the course of study or holds an examination does not continue to be in
conformity with the education regulation, Central Council may give a notice to that institution or
authority with the intention of withdrawing of approval. Such institution should make a
representation within three months from the date of receipt of such notice through the State
Government. If the Central Council is satisfied with the representation of institution it may
restore the approval and if not satisfied it may withdraw the approval of the institution. The
institution which is de-recognised by PCI can apply afresh for getting the approval after fulfilling
the conditions required as per ER.
Central Register
1. Central register is a register of pharmacists maintained by the Central Council under
section 15A.
2. It contains the names and addresses of all persons whose name is for time being entered
in the register of pharmacists for a State.
3. Registrar of each State Council shall supply to the Central Council five copies of register
as soon as after 1stApril of every year.
4. Registrar shall also inform to the Central Council all the additions and amendments
made in the register from time to time.
5. Registrar of Central Council shall keep the central register in accordance with the orders
made by Central Council, amend and publish it in the Official Gazette of India.
6. Central register shall deem to be public document within the meaning of Indian
EvidenceAct, 1872.
State Pharmacy Council

Pharmacy Act under Chapter III provides for the constitution of State Pharmacy Council
by State Government. It is reconstituted after every five years. It consists of the following
Members.
1. Elected Members
a) Six persons are elected from amongst themselves by the registered pharmacists of the
State.
b) One member is elected from amongst themselves by the members of Medical Council of
the State.
a) Five members are nominated by State Government of whom at least three shall possess
degree or diploma in pharmacy or pharmaceutical chemistry or be registered pharmacist
of State.
a) ChiefAdministrative Medical Officer of the State.
b) The officer- in-charge of drug control organization of the State.
c) GovernmentAnalyst appointed under Drugs and CosmeticsAct, 1940.
President and Vice-President of State Pharmacy Council

1. The President and Vice-President of State Council shall be elected by the members of the
Council from amongst themselves. Provided that, for five years from the first
constitution of State Council the President shall be a person nominated by State
Government who shall hold office at the pleasure of State Government and where he is
not already a member, shall be a member of State Council in addition to the members
referred to in section 19 or 21, as the case may be.
2. The President or Vice-President shall hold office as such for a term not exceeding five
years and not extending beyond the expiry of his term as a member of State Council, but
subject to his being a member of State Council, he shall be eligible for re-election.
Provided that, if his term of office as a member of State Council expires before the expiry
of the full term for which he is elected as President or Vice-President, and if he is
reelected or re-nominated as a member of State Council, continue to hold office for the
full term for which he is elected as President or Vice-President.
Functions of State Pharmacy Council

1. Preparation and maintenance of register
State Pharmacy Council of each State shall prepare and maintain the register of
pharmacists as per the provisions of the PharmacyAct, 1948.
2. Entry and removal of name from register
Registrar of each State Council shall enter the names of such persons qualified by
Registration Tribunal appointed by State Council. Under certain circumstances State Pharmacy
Council may remove the name of registered pharmacist from the register.
Joint -State Pharmacy Council

Two or more State Governments may come together to constitute Joint State Pharmacy
Council under Section 20.
1. Elected Members
a) Three to Five members are elected from amongst themselves by the registered
pharmacist of each participating State.
b) One member is elected from amongst themselves by the members of Medical Council of
each participating State.
a) Two to four members are nominated by each State Government of whom at least half
shall possess degree or diploma in pharmacy or pharmaceutical chemistry or shall be a
registered pharmacist of each participating State.
a) ChiefAdministrative Medical officer of each participating State.
b) The Officer- in-charge of drug control organization of each participating State.
c) Government Analyst appointed under Drugs and Cosmetic Act, 1940 of each
participating State.
Inter-StateAgreement
Two or more State Governments may enter into an agreement:
1. to provide for the constitution of Joint State Pharmacy Council; or
2. that the State Pharmacy Council shall serve as the need of other participating States.
In addition to this, interstate agreement
a) provides for the apportionment between the participating States of an expenditure in
connection with the Joint State Pharmacy Council.
b) determines which of the State Government shall exercise more powers of State Council.
c) provides for the considerations between the participating States either generally or with
reference to the particular matters arising out of the administration of thisAct.
d) makes such provisions as may be necessary for giving the effect to an agreement.
Registration of Pharmacists
Registration of pharmacist is required to maintain the standards of pharmacy profession.
1. First Register
When the Pharmacy Act, 1948 is enforced in a State, registration of person is carried out
by the Registration Tribunal; the register so prepared by the Registration Tribunal is called as
first register.
Preparation and maintenance of first register
1. Constitution of Registration Tribunal
For the purpose of preparing the first register, State Government shall by notification in
the Official Gazette constitute a Registration Tribunal consisting of three persons and shall
appoint a registrar who shall act as Secretary of Registration Tribunal.
2.Appointment of date for the application
State Government shall by same or similar notification appoint a date on or before which
the application for registration accompanied with the prescribed fees shall be made to the
Registration Tribunal.
3. Scrutiny
Registration Tribunal shall examine each and every application received on or before the
appointed date. If it is satisfied, the applicant is qualified and his name will be directly entered in
the first register.
4.Appeal
First register so prepared shall be published in such manner as the State Government
may direct and if any person who is aggrieved with the decisions of Registration Tribunal may
appeal within 60 days of such publication to the authority appointed thereupon above.
5. Issue of a certificate of registration

Registrar of State Council shall keep the register in accordance with the orders made by
Registration Tribunal and shall thereupon, issue to every person a certificate of registration in the
prescribed form.
6. Upon the constitution of State Council, the register shall be given into its custody and the
registration fees shall be paid to the credit of State Pharmacy Council.
Qualifications for entry on the first register

A person, who has attained his 18 years of age, resides or carries on his profession or
business of pharmacy and has been paid the prescribed fees for the registration, shall be entitled
to have his/ her name to be entered on the first register and if he/she
a) holds a degree or diploma in pharmacy or pharmaceutical chemistry or 'Chemists and
Druggists' diploma of an Indian University or any other prescribed qualification granted
by an authority outside India.
b) holds a degree other than degree in pharmacy or pharmaceutical chemistry of a
recognized University with not less than three years experience in compounding of
drugs in a hospital or at any other place where drugs are dispensed on the prescription of
c) has passed an examination recognized as an adequate by State Government for the
Compounders and Dispensers.
d) is engaged in compounding and dispensing of drugs for a total period of not less than five
years in a hospital or dispensary where drugs are dispensed regularly on the prescription
of Registered Medical Practitioner.
2. Subsequent Register
When the expiry date for first register is fixed for receiving the application and either
before or after the education regulation came into effect, the register of a qualified person is
prepared, such register is called as a subsequent register.
Qualifications for entry on the Subsequent register
A) Before the education regulation taken into effect
business of pharmacy and has been paid the prescribed fees for the registration shall be entitled to
have his/ her name to be entered on the subsequent and if he/she
a) satisfies the conditions prescribed with the prior approval of Pharmacy Council of India
and where no such conditions have been prescribed, satisfies those conditions which are
required for registration on the first register and has passed matriculation or its
equivalent examination.
b) is a registered pharmacist of another State.

c) holds any other prescribed qualification granted by an authority outside India.
B)After the education regulation taken into effect
business of pharmacy and has been paid the prescribed fees for the registration shall be entitled to
have his/ her name to be entered on the subsequent register and if he/she
a) has passed matriculation or its equivalent examination.
b) is a registered pharmacist of another State.
c) holds any other prescribed qualification granted by an authority outside India.
After Education Regulations came into force, only a diploma in pharmacy holder of an
institution approved by PCI who has undergone 500 hours of practical training after completion
of D. Pharm course is only eligible for registration as pharmacist.
3. Special provisions for registration of certain persons

The Pharmacy Amendment Act, 1959 provided that State Pharmacy Council may permit
to enter on the subsequent register the names of the following classes of persons:
a) Displaced person who has been carrying on his profession or business of pharmacy from
a date prior to 4th March 1948 and who satisfies the necessary conditions for the
registration on the first register of State.
b) Citizen of India who has been carrying on his profession or business of pharmacy in any
country outside India and who satisfies the necessary conditions for the registration on
the first register .
c) Displaced person who has resided or carried on his profession or business of pharmacy
and who satisfies the necessary conditions for the registration on the first register of
pharmacist for a State.
d) Person who resides or carries on his profession or business of pharmacy and satisfies the
necessary conditions for the registration on the first register of pharmacist for a State and
had applied for the registration but did not get registered due to some reason.
e) Person who resides or carries on his profession or business of pharmacy and who is
engaged in compounding and dispensing of drugs for a total period of not less than five
years in a hospital or dispensary where drugs are handled regularly on the prescription of
f) Person who is registered in a State existing before 1st Nov.1956 and later on it became a
part of another State, such person who resides or carries on his profession or business of
pharmacy in later State.
g) Person who resides or carries on his profession or business of pharmacy in such area
where the chapter relating to the registration applies after the commencement of the
Pharmacy Amendment Act, 1959 and who satisfies the necessary conditions for the
registration on the first register.
4. Special provisions for registration of Displaced persons, Repatriates and other persons
The Pharmacy Amendment Act, 1976 provides that State Pharmacy Council may permit
to enter on the subsequent register the names of the following classes of persons-
1.Aperson who
a) holds a degree or diploma in pharmacy or pharmaceutical chemistry; or
b) 'Chemists and Druggists' diploma of an Indian University; or
c) any other prescribed qualification granted by an authority outside India; or
d) has passed an examination recognized as an adequate by State Government for the
Compounders and Dispensers; or
e) were eligible for the registration between the close of first register and the date when
education regulations came into effect.
2. A person who is approved as a “Qualified Person” on or before 31st December 1969 for
compounding and dispensing of drugs.
3. Displaced persons who were carrying on the profession or business of pharmacy as their
principal means of livelihood and has applied for the registration on or before the appointed date
prior to the date of application for registration.
Removal of Name from the register

Subject to the provisions of Section 36 of the Act, the Executive Committee may order
the removal of name of a person from register under the following conditions:
1. If his name is entered in the register by an error or due to misrepresentation or due to
suppression of material facts.
2. If a registered pharmacist has been convicted of an offence or has been guilty of an
infamous conduct in respect of professional activity which in the opinion of Executive
Committee renders him unfit to keep his name on the register.
3. If a person employed by the registered pharmacist has been convicted of an offence or
has been guilty of an infamous conduct in respect of any other business activity which in
the opinion of Executive Committee renders him unfit to keep his name on the register.
Provided that, such orders shall be made only if the Executive Committee is satisfied that
a) The offence or infamous conduct was instigated or connived at by the registered
pharmacist
b) The registered pharmacist during the period of twelve months preceding a date on which
offence or infamous conduct took place have been committed a similar offence.
c) A person employed by the registered pharmacist, who is a registered pharmacist during
the period of 12 months preceding a date on which offence or infamous conduct took
place has committed a similar offence.
d) Offence or infamous conduct is continued over long period of time and the registered
pharmacist had knowledge of continuing such offence or infamous conduct.
e) The offence is an offence under Drugs and Cosmetics Act, 1940 and the registered
pharmacist had not used his due knowledge to avoid such offences.
Renewal Fees
The prescribed renewal fees shall be paid annually to the State Pharmacy Council after
31st December of every year. Such renewal fees shall be paid before 1stApril of the year to which
it relates. If the prescribed renewal fees have not been paid the registrar shall remove the name
from the register. The name so removed from the register can be restored on the prescribed
conditions. After renewal of the register, registrar of State Council shall issue receipt of it which
shall be considered as a proof of renewal of registration.
Issue of Duplicate Certificate of Registration

Registrar of State Council shall issue duplicate certificate of registration on the payment
of the prescribed fees, if original is lost or damaged.

1. Falsely claiming to be registered pharmacist
If a person who is not registered pharmacist but he uses in connection with his name
certain titles, words or combination of words such as “Chemists and Druggists”, “Pharmacist”,
“Pharmaceutical Dispenser”, etc, it is presumed that such person is falsely claiming to be
registered pharmacist. Such person on a first conviction shall be liable for punishment of a fine
up to ` 500 and on subsequent conviction shall be liable for punishment of fine up to ` 1000 and
with an imprisonment upto six months or with both. Cognizance of an offence punishable under
this section shall not be taken except upon complaint made by the order of State Government or
the Executive Committee of State Council.
2. Dispensing by Unregistered Persons
The Person other than registered pharmacist, dispensing any medicine for patients is
liable for punishment with imprisonment up to six months or fine up to ` 1000 or with both.
3. Failure to Surrender Certificate of registration
If any person whose name has been removed from the register fails without sufficient
cause forthwith to surrender his certificate of registration shall be punishable with fine which
may extend to ` 50. Cognizance of an offence punishable under this section shall not be taken
except upon complaint made by an order of the Executive Committee.
4. Willful obstruction to a State Pharmacy Council Inspector

Any person who is willfully obstructing an Inspector in the exercise of the powers shall
be punishable with an imprisonment up to six months or with fine `1000 or with both.
Summary
The major objective of this Act is to regulate the profession and business of pharmacy.
This Act provides for the constitution of Central Council and State Pharmacy Councils. The State
Pharmacy Councils shall be responsible for preparing and maintaining the register of
pharmacists for State and shall exercise such other controls over the persons practicing
pharmacy. This Act extends to the whole of India except the State of Jammu and Kashmir and has
been amended in certain aspects by the Pharmacy Amendment Act, 1959 and Pharmacy
AmendmentAct, 1976.
Composition of Councils under PharmacyAct, 1948

Composition of Central Council
Elected Members Nominated Members Ex-officio Members

1) Six members of whom one 1) Four members out of six 1) Director General of Health
teacher should be each subject members nominated by Services.
i.e. Pharmacy, Pharmaceutical Central Government 2) Drugs Controller of India.
chemistry, Pharmacology, 2) One member from the 3) Director, Central Drugs
Pharmacognosy. registered pharmacist of State Laboratory, Kolkata
2) One member from Medical
Council of India
3) One member from
registered pharmacist of State.
Composition of State Pharmacy Council

1) Six members from the 1) Three members out of five 1) Chief Administrative
registered pharmacist. members nominated by Medical Officer of State
2. One member from Medical Central Government possess 2) Officer In charge of Drugs
Council of State. degree/ diploma in pharmacy Control Organization of State
or registered pharmacist 3) Government Analyst under
D and CAct, 1940.
Composition of Joint State Pharmacy Council

1) Three to five members Half members out of two to 1) Chief Administrative
from the registered four members nominated by Medical Officer of each
pharmacist of each each participating State or participating State
participating State registered pharmacist of each 2) Officer In charge of Drugs
2. One member from Medical participating state. Control Organization of each
Council Of each participating participating State
State 3) Government Analyst under
D and C Act, 1940 of each
participating State
Offences & Penalties

Sr. No. Offences Penalties
1 Falsely claiming to be registered on a first conviction fine up to ` 500 and on
pharmacist subsequent conviction fine up to ` 1000 and with
an imprisonment up to six months or with both
2 Dispensing by Unregistered imprisonment up to 6 months or with fine up to
Persons
` 1000 or with both
3 Failure to Surrender Certificate of
registration ` 50
4 Willful obstruction to a State

Pharmacy Council Inspector imprisonment up to 6 months or with fine up to
` 1000 or with both

1. Central Council means..........
a) State Pharmacy Council constituted under section 19
b) Pharmacy Council of India constituted under section 15A
c) Pharmacy Council of India constituted under section 3
d) State Pharmacy Council constituted under section 20
2. ......... is constituted by Central Government.
a) Pharmacy Council of India b) State Pharmacy Council
c) Joint State Pharmacy Council d) None
3. In India, the Pharmacy Council of India was firstly constituted in the year ......
a) 1948 b) 1949 c) 1950 d)1951
4. ......... is maintained by Central Council
a) Subsequent register b) Central register c) Both d) None
5. Education Regulation is framed by........

a) PCI Inspector b) State Pharmacy Council
c) Joint State Pharmacy Council d) Central Council
6. The elected and nominated members hold the office for ....... years.
a) Three b) Four c) Five d) Six
7. Register of each State Council shall supply to the Central Council ....... copies of the
register as soon as after ......... of every year.
a) Two, 1st Dec b) Three, 14th April
c) Four, 25th March d) Five, 1st April
8. Central register shall be deemed to be public document within the meaning of .........
a) Indian Patent Act, 1970 b) Indian Evidence Act, 1872
c) Dangerous Drugs Act, 1930 d) None
9. Education Regulation is published in ........
a) Official Gazette b) Parliament
c) Loksabha assembly d) Rajyasabha assembly
10. If the approval of the institution is withdrawn by PCI that institution should make a
representation within ......... months from receipt of such notice through ..........
a) Three, Central Government b) Two, State Government
c) Three, State Government d) Two, Central Government
11. ....... members are nominated by State Government in State Pharmacy Council.
a) Three to five b) Two to four
c) Six d) Five
12. Inter-state agreement is made for the constitution of ........
a) Central Council b) Joint State Pharmacy Council
c) State Pharmacy Council d) None
13. First register is prepared by .........
a) Central Government b) Registrar of State Pharmacy Council
c) Registration Tribunal d) State Government
14. A person who is aggrieved with the decision of Registration Tribunal may appeal within
..... days.
a) 30 b) 60 c) 90 d) 120
15. The prescribed renewal fees should be paid before ...... of every year.
a) 31st Dec b) 25th March
c) 14th April d) None
16. Following of which is the ex-officio member of PCI
a) Chief Administrative Medical Officer of State
b) Director General of Health Services

c) Government Analyst
d) Officer incharge of Drug Control organisation.
17. Following of which is not ex-officio member of State Pharmacy Council.
a) Director, Central Drugs Laboratory
b) Chief Administrative Medical Officer of State
c) Officer incharge of Drug Control organisation
d) Government Analyst.
18. A person who have attained his ....... years, residing or carrying on his profession or business
of pharmacy and has been paid the prescribed fees for registration shall be eligible for
registration on first register.
a) 21 b) 15 c) 18 d) 35
19. State Council is constituted by ...........
a) Central Government b) Central council
c) State Government d) None
20. ....... of pharmacist is essential for maintaining the standards of pharmacy profession.
a) Registration b) Licence c) Qualification d) None
Important questions
1. What are the objectives of the PharmacyAct, 1948?
a) State Council.
b) Registered pharmacist
c) Registered Medical Practitioner
d) Displaced person
e) Repatriates
3. Give constitution of Pharmacy Council of India.
4. Give the functions of Pharmacy Council of India.
5. Write a note on Education regulation or what is E.R.? What does it prescribe?
6. How the approval of the institutions or authorities which conduct the course of study or holds
an examination for the pharmacist is granted?
7. Write a note on – Central register
8. Give the constitution and functions of State Pharmacy Council
9. Give the constitution of Joint State Pharmacy Council.
10. How the First Register is prepared and maintained?
11. What qualification will entitle a person to have his name in the First Register?
12. What qualification will entitle a person to have his name in the subsequent Register?
13. What are the special provisions given to the certain persons for registration of their name in
the register?
14. What are the special provisions given to the displaced persons, repatriates and other persons?
15 Under what conditions the name of the registered Pharmacist can be removed the first
register?
16. Give the offences and penalties under the PharmacyAct, 1948.

1. c 2. a 3. b 4. b 5.d 6.c 7.d 8.b 9. a 10.c
11. d 12.b 13.c 14. b 15. a 16. b 17. a 18. c 19. c 20. a
Chapter 6
DRUGS AND MAGIC REMEDY (OBJECTIONABLE ADVERTISEMENTS)
ACT, 1954 AND RULES, 1955
Learning objectives
1. identify the objectives of the Drugs and Magic RemediesAct, 1954.
3. explain the classes of prohibited and exempted advertisements of drug.
Introduction
Advertisement is a media though which the manufacturer introduces his product in the
market. In today's era, advertisement is essential for the sale of any item including drugs. There
are various media of advertisement such as audio-visual media like radio, television, newspaper,
journal, magazines, etc. The fundamental difference between advertisement of consumer goods
and that of drugs is that the drugs are not directly advertised to consumers but are addressed to
doctors, pharmacists and nurses, so that the potential hazards of self medication can be avoided.
Hence, the control of the advertisements relating to drugs and medicines is important.
Most of the advertisements give misleading information about the drug and makes false
claims for the magic remedies. Hence to prevent the misleading of the public, The Drugs and
Magic Remedies (Objectionable Advertisements) Act was enacted on 30th April, 1954 and
amended in 1963.
Objectives
This is anAct to:
a) control the advertisements in certain cases.
b) prohibit the advertisement in certain purposes of magic remedy alleged to possess the
miraculous power for diagnosis or cure of disease, and
c) provide for the matters connected therewith.
Definitions
1. Advertisement
It includes any notice, circular, label, wrapper or any other document or any other
announcement made orally or by transmitting light, sound or smoke.
| 135
2. Drug
It means:
a) Amedicine for internal or external use; or
b) A substance intended for diagnosis, treatment, mitigation, prevention or cure of diseases
in human beings or animals; or
c) Any article other than food intended to affect the structure or any organic function of the
body of the human beings or animals; or
d) Any article intended to be used as a component of drug as referred in (a), (b) or (c) above.
3. Magic remedy
It includes 'talisman', 'mantras', 'kavachas' or any other charm of any kind which is
alleged to possess the miraculous power for or in the diagnosis, treatment, mitigation,
prevention or cure of disease in human beings or animals or intended to affect or alter the
structure or any organic function of the body of the human beings or animals.
R. M. P. means a person:
a) holding qualification granted by an authority specified or notified under sec. 3 of the
Indian Medical Degrees Act, 1916 or as may be specified in the Schedules to the Indian
Medical CouncilAct,1956; or
b) who is entitled to be registered as a Medical Practitioner under any law in any State to
which thisAct extends relating to the registration of person as a Medical Practitioner.
5. Taking part in publication of advertisement
It includes:
a) printing of the advertisement and
b) publication of the advertisement outside India
6. Veneral disease
It includes syphilis, gonorrhea, soft chancre, etc.
Classes of ProhibitedAdvertisements
Following classes of advertisements of drugs are prohibited:
1. No person shall take part in the publication of the advertisements of drugs which may lead to
their use in the treatment of the following:
a) for the procurement of miscarriage or prevention of conception in women.
b) for the correction of menstrual disorders in women.
c) for the improvement or maintenance of the capacity of the human being for the sexual
pleasure.
d) for diagnosis, treatment, prevention, mitigation or cure of diseases specified in the
Drugs and Magic Remedy Act, 1954 and Rules, 1955 | 137
Schedules to theAct.
2. Advertisements of magic remedy which may claim to be efficacious for the conditions
recommended as referred in (a), (b), (c) or (d) above
3.Advertisements of drugs which may:
a) directly or indirectly gives a false impression regarding true characters of drugs.
b) make false claim for the drugs.
Classes of ExemptedAdvertisements
Following classes of advertisements of drugs are exempted:
1. Any advertisement relating to section 3 of the Schedule made by Registered Medical
Practitioner at his own premises.
2. Any book or treatise written with the scientific or social standpoint.
3. Any advertisement made by the Government.
4. Any advertisement made by any person with the prior sanction of State Government but
only up to specified period.
5. Any advertisement sent to Registered Medical Practitioner in the confidential manner.

1. Any person who contraverses any of the provisions of this Act shall be punishable with an
imprisonment or with fine or with both. The penalty for first conviction is imprisonment for six
months or fine or both. For subsequent conviction, the penalty is imprisonment for one year or
fine or both.
2. In case of contravention of the provisions of this Act by a company, every person who at the
time of commission of the offence was in charge and responsible for the commission of the
offence, shall be punishable.
Provided that such person will not held to be guilty only if it is satisfied that the offence has been
committed without his due knowledge and he has tried to avoid such offence.
List of Diseases under the Schedule of thisAct

The diseases, disorders or conditions under the Schedule for which uncontrolled and
misleading advertisements are prohibited are:
Appendicitis, Blindness, Blood Poisoning, Blood Pressure, Cancer, Cataract, Deafness,
Diabetes, Diseases and disorders of Brain, Disorders of menstrual flow, Epilepsy, Female
disorders, Gangrene, Heart diseases, Leprosy, Obesity, Paralysis, Plague, Typhoid fever, Ulcers
of GIT, Venereal diseases, etc.
Import or Export of BannedAdvertisement

The involvement of a person in import or export activities pertaining to documents of
objectionable advertisements is punishable under thisAct.
Summary
In our society, there are various kinds of people like mantrikas or sadhus who claim that
they can cure any disease with the help of mantras or kavachas. Therefore, this Act is necessary to
have control on the advertisements of drugs which makes false claim for drug or which gives
misleading information about the drugs.

1.Taking part in the publication of advertisement means_______.
a. printing and publication of the advertisement in any country.
b. advertising any notice.
c. advertising magic remedy.
d. none of above.
2. Advertisement means any ______ circular, label, wrapper or any other document made orally
or by transmitting _______ sound or smoke.
a. notice, like b. notice, light
c. paper, like c. paper, light
3. Magic remedy includes ________
a. any drug b. any article
c. mantras kavachas or talisman d. None of above
4. Substance which claim to affect or alter any ________ or _______ of the body are deemed to
be drug.
a. structure, part b. structure, physiology
c. structure, physical d. structure, organic function
5. Which one of the following is exempted advertisement.
a. advertisement made by any person.
b. advertisement made by the Government.
c. advertisement made for the treatment of diabetes.
d. None of above.
6. Advertisement made by the company for the treatment of rheumatism, is permitted by
Government for six months and if the company is making advertisement after this specified
period, then it will be _____ advertisement.
a. prohibited b. exempted
Drugs and Magic Remedy Act, 1954 and Rules, 1955 | 139
c. permitted d. a &b.
Important questions
1. What are the objectives of the Drugs and Magic RemedyAct, 1954?
a. advertisement b. magic remedy c. drug d. R.M.P.
e. taking part in publication of advertisement
3. Give the classes of advertisements of drugs to which DMR (OA)Act,1954 is made applicable.
4. Give the classes of advertisements of drugs to which DMR (OA) Act,1954 is not made
applicable.
5. Give the offences and penalties under thisAct.

1. a 2. b 3. c 4. d 5. b 6. a
Chapter 7
MEDICINAL AND TOILET PREPARATIONS ACT, 1955 AND RULES, 1956
Learning objectives
1. identify the objectives of the Medicinal and Toilet preparationsAct, 1955.
2. define the various terms under thisAct.
3. explain the plan of bonded and non bonded manufactory.
4. know the procedures of obtaining the alcohol from warehousing.
5. know the various offences and penalties under thisAct.
Introduction
Alcohol consumption has occured for thousands of years ago. Approximately, two
billions of people consume alcohol worldwide. Regular consumption of alcohol leads to its habit.
Therefore, there is a restriction for the use of alcohol but its use for preparing medicine is a
necessity. Alcohol used for drinking purpose or for the manufacture of toilet preparations such as
perfumes requires to pay higher rate of excise duty than that which is used for the manufacture of
medicinal preparations. While manufacturing the medicinal and toilet preparations there are
chances of misuse of alcohol for drinking purpose. Therefore, it is necessary to have control on
the issue and transport of alcohol. Previously, each State had its own rules to control the issue and
transport of alcohol that led to a lot of difficulty in the inter-state transport of medicinal
preparations. Therefore, present Act is an improvement that overcomes this difficulty and
maintains the uniformity in duties of excise on medicinal preparations throughout a country.
ThisAct extends to the whole of India and provides a legal binding on the use of alcohol.
Objective
The objective of this Act is to provide for the levy and collection of duties of excise on
the medicinal and toilet preparations containing alcohol, Indian hemp, narcotic drugs or other
narcotics.
Definitions
1. Alcohol
Alcohol means ethyl alcohol of any strength and purity having chemical composition
C2H5OH.
2. Dutiable Goods
It means the medicinal and toilet preparations as being subject to duties of excise levied
140 |
Medicinal and Toilet Preparations Act, 1955 and Rules, 1956 | 141
under thisAct.
3. Medicinal preparations
It means a drug which is a remedy or prescription prepared for internal or external use of
human beings or animals or intended to be used for or in diagnosis, treatment,
mitigation, prevention or cure of diseases in human beings or animals.
4. Toilet preparation
It means the preparation which is intended to be used in the toilet of human body or in
perfuming the apparel of any description or any substance intended to alter the
complexion, skin, hair or teeth and also includes deodorants and perfumes.
5. Bonded manufactory
It means the premises or part of premises approved and licensed for the manufacture and
storage of medicinal and toilet preparations containing alcohol, Indian hemp, narcotic
drugs or other narcotics on which duty has not been paid.
6. Non bonded manufactory
It means the premises or part of premises approved and licensed for the manufacture and
storage of medicinal and toilet preparations containing alcohol, Indian hemp, narcotic
drugs or other narcotics on which duty has been paid.
7. Denatured Spirit
It means alcohol of any strength which has made unfit for the human consumption by the
addition of substances approved by Central Government or State Government with the
prior approval of Central Government.
8. Restricted preparations
It means the preparations which are not capable of being misused as ordinary alcoholic
beverages.
9. Unrestricted Preparations
It means the preparations which are capable of being misused as ordinary alcoholic
beverages.
10. Substandard preparations
It means –
a) Pharmacopoeial preparations containing amount of any of the ingredients below the
minimum i.e prescribed; or
b) Proprietary medicine not conforming to the formula or the list of ingredients disclosed
on the label.
11. Spirit store
It is a part of the bonded or non bonded manufactory used for the storage of alcohol,
Indian hemp, narcotic drugs or other narcotics purchased free of duty or at prescribed
rates of duty specified in the Schedules to theAct.
12. Finished stores

Finished stores means portion of bonded or non bonded manufactory used exclusively
for storage of finished preparations.
Manufacture of medicinal and toilet preparations containing alcohol

Manufacture of medicinal and toilet preparations containing alcohol is classified into
manufacture in bond and manufacture outside bond.
Medicinal and toilet preparations containing alcohol are manufactured under the
conditions of licence granted by licensing authority as per the provisions of Drugs and Cosmetics
Act, 1940. For this purpose, applicant has to make an application in the prescribed form and has
to fulfill all the conditions made under this Act and rules. On receipt of such applications, the
licensing authority shall enquire about-
1. The qualification and experience of the technical staff
2. Equipments in the laboratories
3. Suitability of building for the establishment of laboratory.
If the licensing authority is satisfied with the application of applicant, it may issue the
licence and approve the plan of building. Licensee has to display the licence in a prominent place
open to public. Licensee has to inform the licensing authority the actual need of alcohol so that
licensing authority will fix the quantity of alcohol. Manufacturer can procure alcohol from
distillery or warehouse of State.
Procedure for obtaining licence for manufacture

A licence is required to every person who desires to manufacture medicinal and toilet
preparations containing alcohol or narcotics from-
a) Excise Commissioner in case of a manufacture in bond or
b) The officer as the State Government may authorize in this behalf in case of a
manufacture outside bond.
The application for grant of licence should be provided in the prescribed form together
with prescribed fee (treasury chalan) so as to reach the licensing authority at least two months
before the proposed date of commencement of the manufacture.
Following particulars should be included in the application
1. The name and address of applicant. In case of partnership firm, the name and address of
every partner and in case of a company, its registered name and address of its Directors,
managers and Managing agents.
2. Name and address of the place and the site on which the bonded or non bonded
laboratory is situated or to be constructed.
3. The amount of capital proposed to be invested.
4. Approximate date from which the applicant desires to start the manufacture if the
required licence is granted.
5. The number and full description of vats, stills and other permanent apparatus and
machinery which the applicant wishes to set up.
6. The maximum quantities in L.P. litres of alcohol and alcoholic content in unfinished and
finished preparations likely to remain in the laboratory at one time.
7. Maximum quantities by weight of opium, Indian hemp or other narcotics in unfinished
and finished preparations likely to remain in the laboratory at one time.
8. In case of bonded laboratory whether proposed bonded manufactory will require the
services of whole time or part time officer.
9. Alist of all preparations that licence propose to manufacture showing –
a. The percentage or proportion of alcohol in such preparation containing alcohol.
b. The quantities of opium, Indian hemp or narcotic drugs in terms of weight in
preparations containing these substances.
10. The kind and number of licences held by the applicant under Drugs and Cosmetics Act,
1940.
11. Site and elevation plans of manufactory building showing location with doors and
windows therein.
12. In case of firm, a true copy of the partnership deed. In case of a company, the list of
Directors, Managers together with copies of Memorandum of Association and Articles
ofAssociation.
13. On receipt of such application,, the licensing authority makes the following inquiries-
i) The qualification and experience of technical persons
ii) The equipment of bonded and non bonded laboratories
iii) Suitability of the proposed building for the establishment of laboratory
14. After satisfying that the applicant is eligible for the issue of licence, the licensing
authority shall issue the licence and approve the plans of building submitted along with
the application submitted by the applicant. After constructing the buildings and
establishing the laboratories as per the approved plans, the planning authority shall
verify the plans to ascertain whether the construction is as per the approved plan or not.
15. In case where the security is required to be furnished the licensing authority shall fix the
amount of such security before granting the licence. The security shall be either in cash
or in interest bearing securities like Government Promissory Notes, National Savings
Certificates, etc.
Bonded manufactory or bonded laboratory

Bonded manufactory or bonded laboratory is premises or part of premises approved and
licensed for the manufacture and storage of the medicinal and toilet preparations containing
alcohol, Indian hemp, narcotic drugs or other narcotics on which duty has not been paid. In this,
alcohol is stored and used under supervision of excise officers.
Requirements of bonded manufactory

1. Spirit store
2. Separate room/rooms for the manufacture of medicinal and toilet preparations.
3. Separate room/rooms for the storage of finished medicinal and toilet preparations.
4. Accommodation near the entrance for officer-in-charge with necessary furniture.
5. Every room should bear a board indicating the name of the room and serial number.
6. The pipe of sink or wash basins should be connected to the common drainage pipe of
laboratory.
7. The gas and electric connection supply should be cut off at the end of day's work.
8. Every room should provide specific arrangements of malleable rods of prescribed
dimensions and windows should be covered outside with strong netting of mesh of less
than 25 mm.
9. There shall be only one entrance in the laboratory and one door to each of its
compartments.
10. The vessels which are intended to hold alcohol and other liquid preparations should bear
a distinct serial number and full capacity.
11. Vessels containing alcohol, narcotic and finished preparations should be secured with
excise ticket locks.
12. For any additions or alterations in bonded premises, the manufacturer should take the
prior permission of Excise commissioner.
Procedure for obtaining rectified spirit from distillery or warehouse:

The spirit required for the manufacture in bond shall be obtained on an indent in
triplicate countersigned by the officer-in-charge of the laboratory of approved spirit store or
distillery. On the receipt of such indent, distillery or warehouse officer shall issue the spirit under
appropriate permit and send advise portion of such permit to officer-in-charge. Excise officer of
bonded manufactory shall verify the strength and volume of rectified spirit. He shall make the
entry of such supply in register. Rectified spirit shall be then verified in volume, strength, entered
in the register and then store in spirit store. Spirit shall be stored in permanent vessels of spirit
stores of bonded laboratory. The cost of rectified spirit shall be paid by the licensee to the
respective distillery or warehouse officer.
Issue of rectified spirit from the spirit store

Manufacturer shall calculate the quantity of spirit based on the label and shall hand it
over to the officer-in-charge. Then the officer-in-charge shall issue the spirit to the manufacturer.
The spirit issued shall be immediately added to other ingredients of preparations in presence of
officer-in-charge. After completion of manufacture of medicinal reparation or toilet preparation,
it shall be removed to finished goods store.
Storage of finished products

When the medicinal reparation or toilet preparation so manufactured enters in finished
store it should be measured and stored in vessels, jars or bottles after making entry in register.
Each jar or bottle should contain not less than 2273 ml of finished preparation. Each container
shall bear the label with following particulars-
a) Name of preparation
b) Batch number
c) Alcoholic strength
d) Name of manufacturer
e) Actual contents in litres.
f) Date of storage
The containers or vessels should be arranged so as to follow easy identification of each
batch. The finished preparation should be stored for three years or more with the permission of
Excise Commissioner.
Issue of preparations from bonded laboratory

For the issue of medicinal and toilet preparations licensee should make an application to
Excise officer-in-charge. Excise officer-in-charge after checking the entries and ensuring the
duty payable shall issue a permit and allow required quantities to be removed. Medicinal and
toilet preparations should be issued in bottles or containers of not less than 57 ml capacity.
However, in exceptional cases, such preparations may be filled in smaller capacity bottles or
containers with the prior written order of Excise Commissioner. Dutiable goods are delivered
from 6 a.m. to 6 p.m. except Sundays and holidays. Alcoholic preparations are issued on the
payment of excise duty.
Non bonded manufactory or non bonded laboratory

Non bonded manufactory or non bonded laboratory is premises or part of premises
approved and licensed for the manufacture and storage of the medicinal and toilet preparations
containing alcohol, Indian hemp, narcotic drugs or other narcotics on which duty has been paid.
In this, manufacture and sale of preparations are allowed from sunrise to sunset and on such days
hours are fixed by the Excise Commissioner. Alcohol is stored and used under supervision of
excise officers.
Requirements of non bonded manufactory

1. The premises of non bonded manufactory should be separated from the other portion.
2. There should be a separate 'spirit store', 'laboratory' and 'finished store' with windows
fitted with malleable iron rods and windows should be covered on the inside with strong
netting of mesh of less than 25 mm.
3. There should be only one entrance in the laboratory and one door to each of its
compartments.
4. The pipes from sink or wash basins should be connected to the common drainage pipe of
laboratory.
5. The gas and electric connection supply should be cut off at the end of day's work.
6. There should be a separate spirit stores for spirit purchased at different rates of duty.
7. There should be a separate finished stores for medicinal and toilet preparations.
In case of small scale manufacture where the consumption of alcohol is less than 500
liters and for those who dispense medicinal preparations to their patients only, above conditions
will be relaxable.
Manufacture and storage of Non- bonded preparations

Manufacture of non bonded preparations should be carried out only at the licensed
premises. Each preparation should be given batch number and should be registered. Finished
preparations should be stored at respective finished stores and arranged in such way that it can be
easily checked from the accounts register. The entry regarding storage of bulk drugs should be
made in stock register from time to time.
Procedure for obtaining rectified spirit in non bonded laboratory

The rectified spirit required for medicinal and toilet preparation is obtained from
distillery or spirit warehouse approved by Excise Commissioner. The manufacturer shall
calculate the required quantity of spirit based on formula of the preparations in pharmacopoeia or
formula on the label and hand it over to the officer in charge. Then officer-in-charge shall issue
spirit to the manufacturer. The spirit issued shall be immediately added to other ingredients of
preparations in presence of officer-in-charge. After completion of manufacture of medicinal
preparation or toilet preparation, it shall be removed to finished goods store.
Exemption from excise duty

Government may in public interest exempt any dutiable goods form excise duty. The
supply of medicinal preparations containing alcohol is exempted from excise duty to the
following institutions-
a) hospitals and dispensaries supervised by the Central Government or State Government.
b) Charitable hospitals and dispensaries under local bodies.
c) medical stores of Central Government or State Government.
d) any institution certified by District Medical officer supplying medicines free to the poor
patients.
e) medical store depot of Central Government or State Government.
Warehousing of alcoholic preparations

Bonded warehouses can be established any where in India to deposit dutiable goods.
Duty paid goods or other than dutiable goods can not be deposited in bonded warehouses.
Manufacturers or dealers should make an application to Excise Commissioner to get the licence
for bonded warehouse. They should furnish a bond in prescribed form along with security for
payment of excise duty on the removal of medicinal and toilet preparations as per the terms and
conditions ofAct and rules.
When the goods are to be removed from one warehouse to another the consigner should
make an application in triplicate to the officer in-charge with necessary information at least 24
hours before the removal of medicinal and toilet preparations. The Officer in-charge should take
the accounts of those preparations and send the duplicate copy to the Officer in-charge of the
warehouse of destination and triplicate copy will be sent to the consignee. When such
preparations are received to another warehouse, the consignee should present such preparations
along with the triplicate application and transport it with the permission of Officer in-charge.
Then he prepares rewarehousing certificate in duplicate and triplicate and returns the application
to the Officer in-charge of warehouse and triplicate to the consigner. The consigner shall present
such triplicate copy of application with warehousing certificate to the officer in-charge of
warehouse within 90 days of the issue of transport permit to him.
Classification of Medicinal and Toilet Preparations ContainingAlcohol

1. Allopathic preparations
a. Official allopathic preparations
b. Non-official allopathic preparations
2. Homoepathic preparations
3. Ayurvedic preparations
Medicinal and Toilet preparations are also classified as
a. Restricted preparations
b. Unrestricted preparations
Allopathic preparations
Official preparations are made according to the formulae given in Official books like
I.P., B.P., U.S.P., B.P.C., etc.
Non-official preparations are prepared according to the allopathic system of medicine
and conform strictly to the formula displayed on the label. Proprietary preparations that is newly
put in the market is presumed to be restricted preparation unless declared by Central
Government.
Homoeopathic preparation
American, British and general pharmacopoeias shall be recognized as standard
pharmacopoeia for Homoeopathic preparation.
Ayurvedic preparation
There are two types ofAyurvedic preparations containing alcohol
1. Those containing self generated alcohol e.g.Asavas andAristas
2. Those containing added alcohol at the time of manufacture.
Duty shall not be charged on Ayurvedic preparations containing less than 2 % self
generated alcohol and where the self generated alcohol is more than 2 % and if it is capable of
being misused as an ordinary alcoholic beverages, the duty shall be paid otherwise not.
Registered Ayurvedic Practitioners are allowed to manufacture and dispense such
preparations free of duty, if
1. they have obtained a licence.
2. they are using such preparations only for their patients and not for general sale to public.
3. they permit Excise Officers to take the samples.
4. they maintain accounts of preparations manufactured and dispensed to the patients.
Export of Medicinal and Toilet Preparations

Medicinal and toilet preparations can be exported by two methods
1. Duty paid goods shall be exported under the claim for rebate of duty.
2. Goods shall be exported under bond only.
Export of Duty Paid Goods

Duty paid goods can be exported under claim for rebate of duty. The owner of non-
bonded laboratory who wishes to export goods, should give at least 48 hours notice to proper
Excise Officer, to supervise the packing of goods. The manufacturer should present the entire
consignment to the Excise Officer who shall take samples of goods and send them to Chemical
Examiner for ensuring their alcoholic strengths. On receipt of reports of Chemical Examiner the
Officer shall enter the strengths of preparations on duplicate copy of the application. This copy of
the application should be presented by the exporter to the Excise Commissioner for claiming
rebate on duty.
After verifying the particulars, the Excise Officer may get the following particulars
noted on the label.
1. Name and address of the consignee.
2. Quantity and description of goods.
3. Alcoholic content of goods in L.P. liters.
4. Gross weights of each package.
He may seal each package with his official seal in such a way that package cannot be
opened without breaking the seals. The exporter must issue the export certificate to him in order
to obtain rebate of duty so that Excise Officer claim rebate from the Excise commissioner. If the
Excise commissioner is satisfied with the validity of claim, it may order refund of duty.
Export Under Bond

Those persons who have bonded laboratory or bonded warehouse can export alcoholic
preparations under bond. The exporter should present an application in triplicate to the Excise
officer in-charge of the laboratory or warehouse for the export of alcoholic preparations from
India, stating whether the goods are to be exported by land, air or parcel post. The packages of the
goods to be exported should be marked in ink or oil colors with the particulars like serial number,
owner’s name, special mark, if any and total quantity of dutiable goods with their alcoholic
strength in L.P. liters.
After verifying the particulars in the application, the officer in-charge also note the
following particulars.
1. Name and address of consignee.
2. Description of goods.
3. Gross weight of the package.
The officer may seal each package with his official seal. The packages can be exported in
the same way as that of duty paid goods.

1.a.Any person who contravenes any of the provisions relating to the terms and conditions
of licence under thisAct; or
b. Failure to pay any duty of excise payable under thisAct; or
c. Failure to supply information; or
d. Attempt to commit any of the above offences.
Shall be punishable with imprisonment upto six months or with fine upto ` 2000 or with
both.
2. Offences relating to the warehousing are punishable with a fine upto ` 2000 and goods
related to offence are liable to confiscation.
3. Maintaining a false account of stocks of goods in a warehouse or manufactory or not
following the provisions of thisAct shall be punishable with a fine upto ` 2000.
4. Sale of dutiable goods except in prescribed containers bearing a label shall be punishable
with a fine upto ` 1000 and goods related to offence are liable to confiscation.
5. Keeping the stocks of dutiable goods in disorderly manner shall be punishable with a
fine upto `1000.
6. Disclosure of information by Excise officers learned by him in his official capacity shall
be punishable with a fine upto `1000.
7. Obstruction to the officers while exercising their powers regarding entry, search and
seizure shall be punishable with a fine upto ` 600.
8. Breach of the rules, where no punishment is provided shall be punishable with a fine
upto ` 1000 and confiscation of goods.
Summary
Medicinal preparations are used for diagnosis, treatment, mitigation, prevention or cure
of diseases in human beings or animals while toilet preparations are used in the toilet of human
body or may be used to alter the complexion, skin, hair or teeth and it also includes deodorants
and perfumes. For the manufacture of such preparations, the manufacturer shall apply to
licensing authority in the prescribed form to obtain a licence. Depending on the type of
manufacture i.e. manufacture in bond and manufacture outside the bond, the manufacture is
carried out with or without excise duty between sunrise and sunset. Warehousing of such
preparations should be done carefully in a finished goods store.
Multiple choice Questions

1. In bonded manufactory duties of excise has been ______.
a. paid b. not paid c. paid and not paid d. none
2.Alcohol means_______ with chemical composition________.
a. methyl alcohol, CH3OH b. ethyl alcohol, C2H5OH
c. methyl alcohol, C2H5OH d. propyl alcohol, C2H5OH
3. Medicinal and Toilet preparations can be issued to the licensee in the containers of _____ml
capacity.
a. 25 b. 250 c. 57 d. 500
4. The windows of non bonded manufactory should be covered on the inside with strong netting
of mesh of _____________.
a. less than 25 mm b. less than 50 mm

c. more than 25 mm d. more than 50 mm
5. Substandard preparations include all the following except
a. Pharmacopoeial preparation containing the amount of ingredients below minimum
b. Proprietary medicine not conforming to the formula displayed on the label.
c. Proprietary medicine conforming to the formula displayed on the label.
d. None
6. For manufacture of medicinal and toilet preparation containing alcohol or other narcotics
licence is required to be obtained from ______ in case of manufacture in bond.
a. Excise Commissioner b.Authorised officer of State Government
c. State Commissioner d. Director of the laboratory
7. The Excise officer may take sample at least _____ in a month for analysis.
a. thrice b. twice
c. once d. many times
8. The capacity of jar or bottle should not be less than ____ of finished preparation for its storage.
a. 57 ml b. 500 ml
c. 250 ml d. 2273 ml
Important questions
1. Give the objectives of Medicinal and Toilet preparationsAct, 1955.
a. Dutiable goods b. medicinal preparations
c. denatured spirit d. substandard preparations.
3. Differentiate between bonded and non bonded manufactory or laboratory.
4. Give the requirements of bonded manufactory or laboratory.
5. Give the procedure for obtaining the spirit from distillery or warehouse
6. Give the procedure for obtaining licence to manufacture medicinal and toilet preparations.
7. Describe the plan of non bonded laboratory.
8. Describe in brief about the warehousing of alcoholic preparations.
9. How the rectified spirit is obtained in non bonded manufactory?
10. Give the classification of medicinal and toilet preparations.
11. Discuss in brief about the export under bond.
12. How the medicinal and toilet preparations shall be exported? Explain about export of duty
paid goods.

Chapter 8
NARCOTIC DRUGS AND PSYCHOTROPIC SUBSTANCES ACT, 1985 AND
RULES, 1985
Learning objectives
1. identify the objectives of the Narcotic Drugs and Psychotropic SubstancesAct, 1985.
3. know the powers of Central Government and State Government to control the operations.
Introduction
Narcotic drugs and psychotropic substances are the habit forming substances which may
produce a sleep. At higher concentration, those substances proved to be toxic and therefore, there
is a restriction for the cultivation, collection, import, manufacture, purchase, sale, transportation
of narcotic drugs and psychotropic substances. For this purpose, this Act came into existence to
control the various operations related to the narcotic drugs and psychotropic substances.
Before independence, there were Opium Act, 1857, the Opium Act, 1878, Dangerous
Drugs Act, 1930 that were not effective due to changing circumstances and developments in the
field of drug abuse at the national and international level. Therefore, the Government of India has
repealed thoseActs and passed “Narcotic Drugs and Psychotropic SubstancesAct, 1985”.
Objectives
The objectives of thisAct are as follows-
1. To consolidate (unite) and amend (improve) the laws related to narcotic drugs and
psychotropic substances.
2. To make a stringent provision for the control of the operations related to the narcotic
drugs and psychotropic substances.
3. To provide for the matters connected therewith.
Definitions
1. International convention
It means-
a) A single convention on narcotic drugs, 1961 adopted by the United Nation's Conference
at New York in March 1961
b) Protocol amending the convention mentioned above adopted by the United Nations
152 |
Narcotic Drugs and Psychotropic Substances Act,1985 and Rules, 1985 | 153
Conference at Geneva in March 1972; or

c) The convention on psychotropic substances adopted by the United Nations Conference
at Vienna in February1971, or
d) Any other convention or protocols relating to the narcotic drugs or psychotropic
substances.
2. Illicit traffic
Illicit traffic in relation to narcotic drugs and psychotropic substances includes-
a) Cultivating Coca plant or gathering any portion of Coca plant; or
b) Cultivating Opium plant or gathering any portion of Opium; or
c) Engaging in production, manufacture, sale, purchase, supply, distribution,
transportation, import inter State, export inter State of any narcotic drug and
psychotropic substance; or
d) Financing any one of the activities as referred in (i), (ii) or (iii) above; or
e) Handling or letting out any premises for carrying on any one of the activities as referred
above; or
f) dealing in any activities in narcotic drugs or psychotropic substances other than those
referred to in (a) to (b) above.
3.Addict
Addict means a person who is habitual to the regular use of narcotic drugs and
4. Cannabis
It means-
a) Charas i.e. a separated resin whether crude or purified obtained from Cannabis plant and
also includes concentrated preparations and resin known as hashish oil or liquid hashish,
or
b) Ganja i.e. flowering and fruiting tops of Cannabis plant excluding from seeds and
leaves, or
c) Any mixture with or without neutral material of any above forms of Cannabis or any
drink prepared from them.
5. Coca derivatives
It means-
a) Crude cocaine which can be used directly or indirectly for the manufacture of cocaine; or
b) Ecgonine and all the derivatives of ecgonine from which it can be recovered; or
c) Cocaine i.e. methyl ester of benzoyl ecgonine; or
d) All the preparations containing more than 0.1% cocaine
6. Coca Leaf
It means-
a) the leaf of coca plant except a leaf from which cocaine and all the derivatives of ecgonine
have been removed.
b) any mixture with or without neutral material but does not include any preparation
containing not more than 0.1% cocaine.
7. Coca Plant
It means the plant of any species of the genus Erythroxylon.
8. Medicinal Cannabis (hemp)
It is an extract or tincture of Cannabis (hemp).
9. Manufactured drugs
It includes-
a) Coca derivatives, medicinal cannabis, opium derivatives, poppy straw concentrate; or
b) any other narcotic substance or preparation which Central Government may declare to
be a manufactured drug but does not include any other narcotic substance or preparation
which the Central Government may declare not to be manufactured drug.
10. Opium derivatives
It includes-
a) Prepared opium
b) Medicinal opium
c) Phenanthrene alkaloids like morphine, codeine and thebaine
d) Diacetylmorphine, the alkaloid is also known as diamorphine or heroin and its salt
e) All the preparations containing more than 0.2% morphine.
11. Opium
It means-
a) the coagulated juice of Opium poppy, or
b) any mixture with or without neutral materials of coagulated juice of Opium poppy but
does not include any preparation containing not more than 0.2% morphine.
12. Prepared opium
It means the opium which is obtained by any series of operations design to transform
opium into an extract suitable for smoking and the dross or other residue remaining after
the opium is being smoked.
13. Medicinal opium
It means the opium which has undergone the processes necessary to adopt it for its
medicinal use in accordance with the requirements of Indian Pharmacopoeia or any
other Pharmacopoeia notified, whether in powder form or granulated or mixed with the
neutral material.
14. Opium poppy
It means-
a) the plant of species Papaver somniferum or
b) the plant of any other species of Papaver from which opium or any other phenanthrene
alkaloids can be extracted and Central Government may declare to be Opium poppy.
15. Poppy straw
It means all the parts of Opium poppy after harvesting them in their original form, cut or
crushed and whether or not the juice has been extracted therefrom.
16. Poppy straw concentrate
It means the material arising when the poppy straw has entered into processes for the
concentration of its alkaloids.
17. Psychotropic substance
It includes any substance, salt or any preparation which is included in the list of narcotic
substance as specified in the Schedules to theAct.
Prohibition, control and regulation (Sec. 8)

Power of State Government to control various operations (u/s 3)
No person shall –
1. Cultivate Coca plant or gather any portion of Coca plant, or
2. Cultivate Opium poppy or gather any portion of Cannabis, or
3. Engage in production, manufacture, sale, purchase, supply, distribution, transportation,
import inter State, export inter State of any to narcotic drug and psychotropic substance;
except-
a) For medical and scientific purposes
b) With the condition of licence.
Operations controlled, permitted and regulated by Central Government (Sec. 9)

Central Government has power to permit and control the various following operations -
1. Cultivation and gathering any portion of Coca plant only on account of Central
Government
2. Cultivation of Opium poppy only on account of Central Government
3. Production and manufacture of opium and production of poppy straw
4. Sale of opium and opium derivatives from Central Government factories for export from
India or sale to State Government
5. Manufacture of manufactured drugs other than prepared opium
6. Manufacture, possession, transport, import inter State, export inter State of any
psychotropic substances
7. Import into India, export from India and transshipment of any psychotropic substances.
Power to issue warrant and authorization

l) A Metropolitan Magistrate or a Magistrate of the first class or any Magistrate of the
second class specially empowered by the State Government in this behalf, may issue a
warrant for the arrest of any person whom he has reason to believe to have committed
any offence punishable under this Act, or for the search, whether by day or by night, of
any building, conveyance or place in which he has reason to believe any narcotic drug or
psychotropic substance or controlled substance in respect of which an offence
punishable under this Act has been committed or any document or other article which
may furnish evidence of the commission of such offence or any illegally acquired
property or any document or other article which may furnish evidence of holding any
illegally acquired property which is liable for seizure or freezing or forfeiture under
Chapter VAof thisAct is kept or concealed:
2) Any such officer of gazetted rank of the departments of central excise, narcotics,
customs, revenue intelligence or any other department of the Central Government
including the paramilitary forces or the armed forces as is empowered in this behalf by
general or special order by the Central Government, or any such officer of the revenue,
drugs control, excise, police or any other department of a State Government as is
empowered in this behalf by general or special order of the State Government if he has
reason to believe from personal knowledge or information given by any person and
taken in writing that any person has committed an offence punishable under this Act or
that any narcotic drug or psychotropic substance in respect of which any offence under
this Act has been committed or any document or other article which may furnish
evidence of the commission of such offence or any illegally acquired property or any
document or other article which may furnish evidence of holding any illegally acquired
property which is liable for seizure or freezing or forfeiture under Chapter VA of this Act
is kept or concealed in any building, conveyance or place, may authorize any officer
subordinate to him but superior in rank to a peon, sepoy or a constable to arrest such a
person or search a building, conveyance or place whether by day or by night or himself
arrest such a person or search a building, conveyance or place.
3) The officer to whom a warrant under sub-section (1) is addressed and the officer who
authorised the arrest or search or the officer who is so authorised under sub-section (2)
shall have all the powers of an officer acting under section 42.
Power of entry, search, seizure and arrest without warrant or authorisation

l) Any such officer (being an officer superior in rank to a peon, sepoy or constable) of the
departments of central excise, narcotics, customs, revenue intelligence or any other
department of the Central Government including para-military forces or armed forces as
is empowered in this behalf by general or special order by the Central Government, or
any such officer (being an officer superior in rank to a peon, sepoy or constable) of the
revenue, drugs control, excise, police or any other department of a State Government as
is empowered in this behalf by general or special order of the State Government, if he has
reason to believe from persons knowledge or information given by any person and taken
down in writing that any narcotic drug, or psychotropic substance, in respect of which an
offence punishable under this Act has been committed or any document or which may
furnish evidence of the commission of such offence or any illegally acquired property or
any document which may furnish evidence of holding any illegally acquired property
which is liable for seizure or freezing or forfeiture under Chapter VA of this Act is kept or
concealed in any building, conveyance or enclosed place, may between sunrise and
sunset,
a) enter into and search any such building, conveyance or place;
b) in case of resistance, break open any door and remove any obstacle to such entry;
c) seize such drug or substance and all materials used in the manufacture thereof and any
other article which he has reason to believe to be liable to confiscation under this Act
and any document which he has reason to believe may furnish evidence of the
commission of any offence punishable under this Act or furnish evidence of holding any
illegally acquired property which is liable for seizure or freezing or forfeiture under
Chapter VAof thisAct; and
d) detain and search, and, if he thinks proper, arrest any person whom he has reason to
believe to have committed any offence punishable under thisAct:
Provided that, if such officer has reason to believe that a search warrant or authorization
cannot be obtained without affording opportunity for the concealment of evidence or
facility for the escape of an offender, he may enter and search such building, conveyance
or enclosed place at any time between sunset and sunrise after recording the grounds of
his belief.
2) Where an officer takes down any information in writing under subsection (1) or records
grounds for his belief, he shall within seventy-two hours send a copy thereof to his
immediate official superior.
Power of seizure and arrest in public place
Any officer of any of the departments mentioned in section 42 may-
a) seize in any public place or in transit, any narcotic drug or psychotropic substance or
controlled substance in respect of which he has reason to believe an offence has been
committed, and, along with such drug or substance, or article liable to confiscation under
this Act, any document or other article which he has reason to believe may furnish
evidence of the commission of an offence punishable under this Act or any document or
other article which may furnish evidence of holding any illegally acquired property
which is liable for seizure or freezing or forfeiture under Chapter VAof thisAct; .
b) detain and search any person whom he has reason to believe to have committed an
offence punishable under this Act, and if such person has any narcotic drug or
psychotropic substance or controlled substance in his possession and such possession
appears to him to be unlawful, arrest him and any other person in his company.
Explanation: For the purposes of this section, the expression "public place" includes any
public conveyance, hotel, shop, or other place intended for use by, or accessible to, the
public.
Authorities and Officers

I) Preventive measures for abuse of Narcotic drugs and illicit traffic therein
Central Government may take the measures with respect to following matters
a. Identification, treatment, education, rehabilitation and social re-interaction of addicts.
b. Obligations under the International conventions.
c. Co-ordination of actions amongst the officers, State Governments and other authorities
under this Act or any other law for the time being in force relating to the enforcement of
the provisions of thisAct.
d. Assistance to the concerned authorities in foreign countries and concerned international
organizations to prevent and suppress the illicit traffic in narcotic drugs and
e. Such other matters for effective implementation of this Act and preventing the abuse of
narcotic drugs and psychotropic substances.
II)AdministrativeAgencies
A. Narcotic Commissioner
Central Government appoints a Narcotic Commissioner and such other officers-
i) to supervise the cultivation of Opium poppy and production of Opium.
ii) to give effect to other provisions of the law.
State Government also appoints such officers to implement the provisions of the Act in
their respective territories of State.
B. Deaddiction Centres
Central Government and State Government establish necessary centres for
identification, treatment, etc of person addicted to narcotic drugs and psychotropic substances
and to control the supply of drugs to such persons.

C. Narcotic Drugs and Psychotropic Substances Consultative Committee
Narcotic Drugs and Psychotropic Substances Consultative Committee is appointed by
Central Government to advice on matters related to the administration of this Act. It consists of a
Chairman and maximum 20 other members. The Committee may appoint sub-committees for
consideration of any particular matter.
III) National Fund for Control of DrugAbuse

l) The Central Government may, by notification in the Official Gazette, constitute a
National Fund for Control of DrugAbuse and there shall be credited thereto-
a. an amount which the Central Government may, after due appropriation made by
Parliament by law in this behalf, provide;
b. the sale proceeds of any property forfeited under Chapter VA;
c. any grants that may be made by any person or institution;
d. any income from investment of the amounts credited to the Fund under the aforesaid
provisions.
2) The Fund shall be applied by the Central Government to meet the expenditure incurred
in connection with the measures taken for
a. Combating illicit traffic in narcotic drugs, psychotropic substances or controlled
substances;
b. Controlling the abuse of narcotic drugs and psychotropic substances;
c. Identifying, treating, rehabilitating addicts;
d. Preventing drug abuse;
e. Educating public against drug abuse;
f. Supplying drugs to addicts where such supply is a medical necessity.
3) If necessary, Central Government may constitute a Governing Body to advise that
Government and to sanction money out of the said Fund within limit notified by the
Central Government in the Official Gazette.
4) The Governing Body shall consist of a Chairman (not below the rank of an Additional
Secretary to the Central Government) and Central Government may appoint such other
six members.
5) The Governing Body shall have the power to regulate its own procedure.
Annual report of activities financed under the fund
The Central Government shall, as soon as may be, after the end of each financial
year, cause to be published in the Official Gazette, a report giving an account of the
activities financed under section 7-Aduring the financial year, together with a statement
of accounts.

1. Offence
For the following offences such as-
a) contravention in relation to poppy straw
b) contravention in relation to opium poppy or opium
c) contravention in relation to prepared opium
d) contravention in relation to coca plant and coca leaves
e) contravention in relation to manufactured drugs and preparations
f) contravention in relation to psychotropic substances
g) contravention in relation to import, export, transshipment or external dealing in narcotic
drugs and psychotropic substances
h) contravention in relation to allowing premises for commission of offences
i) contravention in relation to cannabis other than ganja.
Penalty
A person shall be liable for rigorous imprisonment of 10 to 20 years and a fine of ` one to
two lacs on first conviction and on subsequent conviction, he shall be punishable with an
imprisonment of 15 to 30 years and a fine of ` 1.5 to 3 lacs.
2. Offence
Any person who contravenes any of the provisions of this Act and rules there under in
respect to ganja or cultivation of cannabis plant.
Penalty
Shall be punishable for rigorous imprisonment of five years and a fine of ` 15,000 on
first conviction and on subsequent conviction, he shall be punishable with an
imprisonment of 10 years and a fine of ` one lac.
3. Offence
Any person who consumes or possesses any narcotic drug or psychotropic substances
illegally.
Penalty
Shall be punishable for rigorous imprisonment upto one year and a fine or with both.
4. Offence
Any person who attempts or abets in commission of any offence .
Penalty
Shall be liable for rigorous imprisonment of 10 to 20 years and a fine of ` one to two lacs
on first conviction and on subsequent conviction, he shall be punishable with an
imprisonment of 15 to 30 years and a fine of ` 1.5 to 3 lacs.
APPEDNIX I
Narcotic drugs specified under Schedule I
1. Coca leaf 2. Cannabis
3. Diacetylmorphine 4. Heroin
5.Acelorphine 6. Etorphine
7. Ketobemindone 8. Dihydrodesoxymorphine
APPEDNIX II
Psychotropic Substances
A) specified under Schedule I
1. Methaqualone 2. Camazepam
3. Medazepam 4. Oxazepam
5. Mescocarb
B) specified under Schedule II
1.Amphetamine 2. Dexamphetamine
3. Mecloqualone 4. Glutethimide
5.Amobarbitol
C) specified under Schedule II
1. Buprenorphine 2. Butalbital
3. Cathine 4.Amobarbitol
Summary
Operations related to narcotic drugs and psychotropic substances are prohibited to
control its misuse. In exceptional cases, certain operations are controlled, permitted and
regulated by Central Government. Also, State Government has power to control certain
operations for specific purposes.
Schematic representation of narcotic drugs
Narcotic Drugs
Coca leaf Cannabis Opium Poppy Manufactured

straw drug
Charas Ganja Mixtures
Coca Medicinal Cannabis Opium

derivatives (Hemp) derivatives
Crude Ecgonine Cocaine Other preparations

Cocaine containing more
than 1% cocaine
Prepared Medicinal Phenanthrene Diacetyl Other preparations

opium opium alkaloid morphine containing 0.2 % morphine

1. Geneva convention was held on _________ in ___________.
a) narcotic drugs, March 1961 b) psychotropic substances, March 1972
c) narcotic drugs, March 1972 d) psychotropic substances, February 1971
2. Cocaine is a ___________
a) methyl ester of benzoyl ecgonine b) methyl ether of benzyl ecgonine
c) methyl ether of benzoyl ecgonine d) ethyl ester of benzyl ecgonine
3. Coca leaf contains more than______________
a) 0.2% cocaine b) 0.1 % cocaine
c) 0.02 % cocaine d) 0.01 % cocaine
4. Opium derivatives includes all the following except ______.
a) prepared opium b) medicinal opium
c) heroin d) charas
5. Medicinal cannabis means_____.
a) extract of cannabis b) injection of cannabis
c) spirit of cannabis d) none
6. Operations related to narcotic drugs under section 8 are controlled by _____.
a) Central Government b) State Government
c) Excise Commissioner d) None
Important questions
1. What are the objectives of Narcotic drugs and psychotropic substancesAct, 1985?
a. addict b. alcohol c. opium poppy
d. cannabis e. coca leaf f. coca derivatives
g. opium derivatives h. opium j. poppy straw
k. prepared opium l. medicinal opium m. poppy straw concentrate
n. medicinal cannabis o. manufactured drug p. narcotic drugs
3. Discuss the power of State Government to control various operations.
4. Give the power of Central Government to control various operations.
5. Describe the offences and penalties under thisAct.
6. Explain the procedure to issue the warrant to person punishable under this act.
7. What preventive measures should be taken for abuse of narcotic drugs and psychotropic
substances?
8. Describe in brief administrative agencies under thisAct.
9. Write a note on national fund for control of drug abuse.

1. c 2. a 3. b 4. d 5. a 6. b
Chapter 9
DRUGS AND PRICE CONTROL ORDER, 1995
Learning objectives
1. identify the objectives of the Drugs and Price Control Order, 1995.
2. define the various terms under this Order.
3. know how the maximum sale price of bulk drugs is calculated.
4. get the information for the calculation of retail sale price of the formulation.
5. know the provisions for the prices of scheduled formulation.
6. get the information about the drug price equalization account.
7. know how the prices of wholesalers and retailers are decided.
Introduction
Drugs Price Control order (DPCO) is a part of new drug policy announced by Central
Government. Central Government is empowered under section 3 of the Essential Commodity
Act, 1955 to control the production, supply, distribution and sale of goods including drugs.
DPCO, 1970
This Order was first passed on 16th May, 1970. This order had a direct control on the
profitability of a pharmaceutical business and an indirect control on the prices of
pharmaceuticals. The Government directed to the manufacturers that a company's pre-tax profit
from its pharma business should not exceed 15% of its pharma sales (net of excise duty and sales
tax). In case profits exceeded this sum, the surplus was deposited with the Government. So, a
pharma company had the freedom to decide the prices of its products.
DPCO, 1979
The Drugs Prices Control Order was revised on 31st March 1979 in which ceiling prices
for controlled categories of bulk drugs and their formulations were fixed in fixing the price, the
Government continued to advocate the profitability ceiling and an upper limit was put on the
return on net worth or capital employed for pharma companies. DPCO, 1979 put 370 drugs under
price control. These drugs were segregated into three categories, having different maximum
allowable post manufacturing expenses ( MAPE). See the table below.
Category MAPE
I 40%
II 50%
III 100%
IV 60%
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Drug and Price Control Order, 1995 | 165
The most important drugs, including lifesaving drugs were put in Category I which had the least
MAPE. Through this DPCO, around 80% of the Indian pharma industry (in value terms) was
brought under strict price control.
DPCO, 1987
The DPCO, 1987 was promulgated on 26th August on the basis of the Drug Policy of
1986 and the Kelkar Committee Report. In DPCO, 1987 the number of bulk drugs under price
control was significantly reduced from 370 to 142. 20 drugs were taken off from Category I and
122 from Category II. In addition, the categories of control were reduced to two and higher
MAPE was provided for each category of controlled drugs. See the table below.
The MAPE for Category I and category II was increased from 40% and 55%
respectively to 75%. The MAPE for Category IV was increased from 60% to 100%. Even the
new drugs that were brought under price control got a liberal 75% MAPE.
Category MAPE
I 70%
II 100%
DPCO, 1995
The latest Drug Price Control Order was passed on 6th January 1995 which was notified
by Ministry of Chemicals and Fertilizers, Department of Chemicals and Petro Chemicals. The
basic structure of this DPCO is the same as that of the earlier two orders. Nevertheless, the span
of price control under DPCO 1995 has been liberalized considerably from 142 drugs to just 76.
Its first schedule contains 74bulk drugs, the prices of which including their formulations are
regulated and controlled. Only 20% drugs are under the price control and there is no control at
entry level prices in respect of the balance 80 per cent of the market comprising non-scheduled
drugs and their formulations. Since 1999, duty at the rate of 16 per cent was levied on
pharmaceutical products. There was no change in the rate of duty upto 29th February 2008. It was
reduced to eight per cent from 1st March 2008. From 9th July 2004, education cess at the rate of
two per cent of the duty and from 1st March 2007 secondary and higher education cess at the rate
of one per cent of the duty is also leviable. With effect from 8th January 2005, pharmaceutical
products were brought under section 4A of Central Excise Act, 1944 and were to be assessed,
accordingly, on the basis of MRP less abatement allowed from time to time.
Objectives
The various objectives of this order are-
a) to regulate an equal distribution of bulk drugs and to make these drugs available at fair
prices from different manufacturers;
b) to fix the maximum retail sale price of the formulation;
c) to fix the maximum sale price of the bulk drugs in order to avoid the huge profiteering in
drug manufacturing and distribution.
Definitions
1. Bulk drug
It means any pharmaceutical, chemical, biological or plant product including its salts,
esters, sterio-isomers confirming to the pharmacopoeial or any other standard specified
in the Second Schedule to Drugs and Cosmetics Act, 1940 and which may be used as
such or as ingredient in any formulation.
2. Ceiling Price
It means the price fixed by the Government for the Scheduled formulations in
accordance with the provisions of paragraph 'g' of this Order.
3. Wholesaler
It means a person who is carrying on his profession or business of purchase or sale
whether as a wholesaler and whether or not in conjunction with his business.
4. Distributor
It means distributor of drug or stockist appointed by the manufacturer for stocking his
drug.
5. Formulation
It means a medicine processed out containing one or more bulk drug/ drugs with or
without use of pharmaceutical aids for internal or external use for or in diagnosis,
treatment prevention or cure of diseases in human beings or animals but does not
include-
a) Any medicine which is included in any bonafide Ayurvedic, Siddha or Unani systems of
medicine, or
b) Any patent and proprietary medicine of which formula is not disclosed.
c) Any medicine to which the provisions of Drugs and CosmeticsAct, 1940 do not apply.
6. Free reserve
Free reserve means the reserve created by appropriation of profits but shall not include
reserve provided for contingent liability, disputed claims, goodwill and includes such
other reserves.
7. Net worth
Net worth means the paid up share capital of company plus free reserve, if any.
8. Pre-tax return
Pre-tax return means the profit before the payment of income tax and surtax and includes
such other expenses which do not form part of cost of formulation.
9. Landed cost
Landed cost means the cost of import of formulation inclusive of customs duty and
clearing charges.
10. Retail price
Retail price means the price fixed by the Government for the scheduled formulation in
accordance with the provisions of this Order.
11. Scheduled bulk drug
Scheduled bulk drug means the bulk drug specified in the First Schedule of Drugs and
Price Control Order, 1987.
12. Non Scheduled bulk drug
It means the bulk drug which is not specified in the First Schedule of Drugs and Price
Control Order, 1987.
13. Scheduled Formulation
It means a formulation containing a bulk drug specified in the First Schedule either
individually or in combination with other drug, including one or more bulk drugs
specified in First Schedule except single ingredient formulation based on bulk drugs
specified in First Schedule and sold under the generic name.
14. Non-scheduled Formulation
It means a formulation not containing any bulk drug specified in the First Schedule.
15. Sale turn-over
It means the product of units of formulations sold by a manufacturer or an importer, as
the case may be, in an accounting year multiplied retail price inclusive of sales tax, if any, paid or
direct sales by the manufacturer or importer but does not include excise duty and local taxes, if
any;
Maximum sale price of bulk drugs

To regulate an equitable distribution of bulk drugs and to make the drugs available at fair
prices, the Government may from time to time fix the maximum sale price of bulk drugs. While
fixing the maximum sale price of bulk drugs Government shall consider-
a) Post tax return of 14% on net worth, or
b) Areturn of 22% on the capital employed, or
c) In case of new plant, an internal rate of 12% based on long term marginal costing.
Where the production is from the basic stages, the Government shall consider-
a) Post tax return of 18% on net worth, or
b) Areturn of 24% on the capital employed.
No manufacturer shall sale any bulk drug at prices exceeding the maximum sale price of
bulk drug plus local taxes extra, if any.
Where the price of bulk drug is not fixed by the Government, the price of bulk drug shall
be the price which is prevailed immediately before the commencement of this Order.
If any manufacturer commences the production of bulk drugs specified in the First
Schedule, he shall inform to Government in Form I within 15 days of commencement of his
production and Government may after receipt of such information fix the maximum sale price of
bulk drug.
Revision of sale price of bulk drug

For the revision of the sale price of bulk drug, the manufacturer of such bulk drug has to
make an application to Government in Form I. Government may within four months after receipt
of such information revise the sale price of bulk drug or it may reject the application.
Prices of Non Scheduled bulk drug

Government may after making such enquiry as it may deem necessary in public interest
fix the sale prices of non scheduled bulk drug. Manufacturer or importer of such bulk drug shall
furnish to Government a list of such bulk drugs produced by him within 30 days of
commencement of this order and indicate the details of costs in Form II.
Calculation of retail sale price of formulation
The retail sale price of the formulation is calculated by using the following formula-
R.P. = [(M.C. + C.C. + P.C. + P.M.) X (1+ MAPE/100)] + E.D.
Where
R.P. means retail price
M.C. means material cost including the cost of drugs and other pharmaceutical aids
including overages, if any plus process loss which shall be fixed as a norm every year
from time to time.
C.C. means conversion cost worked out in accordance with the established procedures
of costing and shall be fixed as a norm every year from time to time.
P.C. means packaging charges worked out in accordance with the established process of
costing and shall be fixed as a norm every year from time to time.
P.M. means cost of packing material which includes the cost of packaging of the
formulation which shall be fixed as a norm every year from time to time.
MAPE means Maximum allowable post manufacturing expenses.
MAPE shall not exceed-
a. 75% in case of drugs specified in Category I ( Category I drugs are the drugs
which are used in National Health Programme)
b. 100% in case of drugs specified in Category II (Category II drugs are the
drugs other than category I drugs)
E. D. means excise duty

In case of the imported formulation, the landed cost shall form basis along with such
margin to cover distribution and selling expenses including interest and importers profit which
shall not exceed 50 % of the landed cost.
Prices of imported formulation
The prices of imported formulation is calculated by considering the landed cost that shall
form basis along with such margin to cover distribution and selling expenses including interest
and importers profit which shall not exceed 50% of the landed cost.
Prices of Scheduled formulations

Prices of scheduled formulation is calculated by using the following formula-
R.P. = [(M.C. + C.C. + P.C. + P.M.) X (1+ MAPE/100)] + E.D.
Where the Government fixes the maximum sale price of bulk drug and if any
manufacturer utilizes such bulk drugs in his scheduled formulation, he has to make an
application to the Government within 30 days of commencement of such production in Form III.
Once the price of Scheduled formulation is fixed by Government, no manufacturer shall sale
such formulation at prices exceeding the maximum sale price except with the prior approval of
the Government.
Where the price of Scheduled formulation is not fixed by the Government, the price of
such formulation will be the price which is prevailed immediately before the commencement of
this Order.
Ceiling Price of Scheduled Formulation

The Government may from time to time, fix the ceiling price of the scheduled
formulation specified in category I and II of Third Schedule and such leader price shall operate as
ceiling price for every manufacturer including those packs which are sold under generic name.
The Government may by notification, fix a revised ceiling price for a scheduled formulation. For
those packs of formulations for which ceiling prices are not notified, the Government may fix
norms and manufacturers shall work out the price for their respective formulation packs in
accordance with such norms and market those formulation packs after 60 days of intimation to
the Government in this behalf.
Provided that, if once the Government revised the ceiling price no manufacturer shall
sell such formulation at a prices exceeding the revised price.
Power to Revise Price of Bulk drugs formulations

Government may fix or revise the retail price of one or more formulations marketed by
any manufacturer or importer including a non scheduled formulation and no manufacturer or
importer shall exceed the prices of such scheduled or non scheduled formulations including pre-
tax return specified in the schedule.
Drugs Price EqualisationAccount
Government may direct the importers, manufacturers, distributors to deposit a specified
amount into the account within the specified time called as Drugs Price Equalisation Account.
The amount so deposited may be utilized for-
a) paying to the importers and manufacturers shortfall between his retention price and
common selling prices.
b) promoting the higher education and research in pharmaceutical technology and
sciences.
c) meeting the expenses incurred by the Government during discharging its function
Government may also direct the importers, manufacturers, distributors, wholesalers,
retailers to deposit such amount which is accrued due to the overcharging of the
products.
Sale of split quantities of formulations

No dealer shall sale any loose quantity of formulation at pro rate price of the formulation
plus 5% thereof.
Display of Price
Every manufacturer, importer, or distributor of formulation intended for sale shall
display on the label of container, the retail price of formulation with the words “Retail price not to
exceed” preceding it and “Local taxes extra” succeeding it.
For non-scheduled formulation the manufacturer, importer or distributor shall display
on the label of container of the formulation with the words “Maximum Retail Price” preceding it
add the words “inclusive of all taxes” succeeding it.
Display of Price List

Every manufacturer or importer shall issue a price list and supplementary price list to the
dealer, State Drug Controllers and Government in Form V.
Every retailer or dealer shall display the price list and the supplementary price list on the
conspicuous part of the premises of his business.
Prices to wholesaler and retailer

No manufacturer or dealer shall sale any formulation to the wholesaler at prices higher
than-
a) for ethical drugs: Retail Price - 20 %
b) for non ethical drugs: Retail Price - 17 %

No manufacturer, wholesaler, distributor or dealer shall sale any formulation to the
retailer at prices higher than-
a) for ethical drugs: Retail Price - 18 %
b) for non ethical drugs: Retail Price - 15%
Ethical drugs are the drugs which are specified in Schedule C, C(i), G and H, and non
ethical drugs include other essential drugs.
First Schedule
The First Schedule prescribes the list of bulk drugs required for the following National
Health programs, used in category I formulations appearing in III Schedule e.g.
1. National tuberculosis eradication programme.
2. National leprosy eradication programme.
3. National trachoma control programme and National programme for control of
blindness.
4. National malaria eradication programme.
5. National Filaria eradication programme.
Second Schedule
Second Schedule gives different types of forms
Form I This form gives information regarding application for fixation or revision of
prices of Scheduled bulk drugs.
Form II This form gives information regarding prices of non-Scheduled bulk drugs.
Form III This form gives information regarding application for approval or revision of
prices of Scheduled formulations.
Form IV This form gives information regarding application for approval or revision of
prices of imported Scheduled formulations.
Form V This form prescribes the price list
Form VI This form gives information about the yearly turnover and expenses.
Third Schedule
It specifies the maximum pre-tax return on sales turnover of manufacturers or importers
of formulations.
Offence and Penalty

Any contravention of the provisions of this order shall be punishable in accordance with
the provisions of the Essential CommodityAct, 1955.
Summary
The prices of drugs and formulations should be reasonable. For that purpose, the prices
of bulk drugs and excipients should be low and there should be an equal distribution of bulk drugs
to all the manufacturers. According to the code of pharmaceutical ethics, the prices of drugs and
pharmaceuticals should be fair. The overcharging of drugs should be avoided and if such
overcharging is done that amount should be paid into Drugs Price Equalization account. By
considering the manufacturing expenses such as cost of the raw materials and packaging
materials, packing charges, the manufacturer should decide the price of his formulations.

1. Maximum allowable post manufacturing expenses should not exceed _________ % in the
case of category I formulation and _____ % in the case of category II formulation.
a. 50, 75 b. 75, 50 c. 100, 75 d. 75, 100
2. For calculation of price of bulk drugs a return of 12 % is allowed on ____
a. Long term marginal costing b. short term marginal costing
c. both d. None of above
3. Bulk drug includes any________
a. pure drug.
b. pharmaceutical, chemical, biological conforming to the standards specified in First Schedule.
c. pharmaceutical, chemical, biological not conforming to the standards specified in Second
Schedule.
d. none of above.
4. Drug and Price Control Order, 1987 is a part of _______ and is announced by _______.
a. New Drug, State Government b. Old Drug Policy, State Government
c. Old Drug Policy, central Government d. New Drug Policy, Central Government
5. For the revision of sale price of bulk drug, the manufacturer should make an application in
_____ and the Government may within ______ months revise the prices of such bulk drugs or
reject the applications.
a. Form I, four b. Form III, three
c. Form I, three d. Form II, four
6. In case of the imported formulation, the _____ cost shall form basis and profit of importer shall
not exceed _______ % of landed cost .
a. landed, 50 b. landed, 75
c. landed, 100 d. landed, 100
7. Manufacturer of scheduled formulation should make an application within _____ days of

commencement of his production in _____.
a. 30, Form I b. 60, Form II
c. 60, Form III d. 30, Form III
Important questions
1. What are the objectives of Drugs and Price Control Order, 1987?
a. bulk drug
b. formulation
c. net worth
d. free reserve.
e. landed cost
f. ceiling price
g. Scheduled formulation
3. How the maximum sale price of bulk drug is fixed by Government?
4. Give the formula to calculate the retail sale price of the formulations.
5. How the sale price of Scheduled formulation is fixed by Government?
6. How the pricing should be done for the sale of drugs to wholesalers and retailers?
7. How the split quantities of formulation should be done?
8. Write a note on – Drugs Price EqualisationAccount
10. Discuss in brief about the ceiling price of scheduled formulation.

1. d 2.a 3. c 4. d 5. a 6. a 7. d
Chapter 10
NATIONAL PHARMACEUTICAL POLICY, 2002
Learning objectives
1. explain the important developments after liberalization process.
2. identify the objectives of National Pharmaceutical Policy, 2002.
3. know the approaches adopted in this policy.
Introduction
On the basis of knowledge skills, growing enterprise, low costs, improved quality and
demand (domestic and international) the pharmaceuticals sector has witnessed a tremendous
growth over the past few years. Exports also have grown very significantly to over 16700 crores
during this period. Today, India is recognized as a leader in the manufacture of pharmaceuticals
and the lowest cost manufacturer in the world. It holds third position in terms of volume and 13th
in terms of value of production. However, the drug and pharmaceutical industry in the country
today faces new challenges on account of liberalization of the Indian economy, the globalization
of the world economy and new obligations undertaken under the WTO Agreements. These
challenges require a change in emphasis in the current pharmaceutical policy and the need for
new initiatives beyond those enumerated in the Drug Policy 1986, as modified in 1994, so that
policy inputs are directed more towards promoting more internationally competitive. The need
for radically improving the policy framework for knowledge-based industry has also been
acknowledged by the Government. The Prime Minister's Advisory Council on Trade and
Industry has made important recommendations regarding knowledge-based industry. The
knowledge -based pharmaceutical industry industries has a comparative advantage in India.
The process of liberalization set in motion in 1991 has considerably reduced the scope of
industrial licensing and demolished many non-tariff barriers to imports.
Important steps already taken in this regard are
1. Industrial licensing for the manufacture of all drugs and pharmaceuticals has been
abolished except for bulk drugs produced by the use of recombinant DNA technology,
bulk drugs requiring in-vivo use of nucleic acids, and specific cell/tissue targeted
formulations.
2. Reservation of five drugs for manufacture by the public sector was abolished in
February 1999, thus opening them up for manufacture by the private sector also.
3. Foreign investment through automatic route was raised from 51% to 74% in March 2000
and the same has been raised to 100%.
4. Automatic approval for Foreign Technology Agreements is being given in the case of all
174 |
National Pharmaceutical Policy, 2002 | 175
bulk drugs, their intermediates and formulations except those produced by the use of
recombinant DNA technology, for which the procedure prescribed by the Government
would be followed.
5. Drugs and pharmaceuticals manufacturing units in the public sector are being allowed to
face competition including competition from imports. Wherever possible, these units
are being privatized.
6. Extending the facility of weighted deductions of 150% of the expenditure on in-house
research and development(R and D) to cover as eligible expenditure, the expenditure on
filing patents, obtaining regulatory approvals and clinical trials besides R and D in
biotechnology.
7. Introduction of the Patents (Second Amendment) bill in the Parliament provides for the
extension in the life of a patent to 20 years.
The impact of the policies enunciated, from time to time, by the Government has been
salutary. It has enabled the pharmaceutical industry to meet almost entirely the country's demand
for formulations and substantially for bulk drugs. In the process the pharmaceutical industry in
India has achieved global recognition as a low cost producer and supplier of quality bulk drugs
and formulations to the world. In 1999-2000, drugs and pharmaceutical export was Rs. 6631
crores out of a total production of Rs. 19,737 crores. However, two major issues have surfaced on
account of globalization and implementation of our obligations under TRIP's which impact on
long-term competitiveness of Indian industry. These have been addressed in the Pharmaceutical
Policy -2002. A reorientation of the objectives of the current policy has also become necessary on
account of these issues:-
a. The essentiality of improving incentives for research and development (R and D) in the
Indian pharmaceutical industry, to enable the industry to achieve sustainable growth
particularly in view of anticipated changes in the Patent Law, and
b. The need for reducing further the rigours of price control particularly in view of the
ongoing process of liberalization.
c. It is against this backdrop, that Pharmaceutical Policy-2002 is being enunciated.
Objectives
The main objectives of this policy are
a. To ensure availability of good quality essential pharmaceuticals of mass consumption at
reasonable prices within the country.
b. To strengthen the indigenous capability for cost effective quality production and exports
of pharmaceuticals by reducing barriers to trade in the pharmaceutical sector.
c. To strengthen the system of quality control over drug and pharmaceutical production
and distribution to make quality an essential attribute of the Indian pharmaceutical
industry and to promote rational use of pharmaceuticals.

d. To encourage R and D in the pharmaceutical sector in a manner compatible with the
country's needs and with particular focus on diseases endemic or relevant to India by
creating an environment conducive to channelizing a higher level of investment into R
and D in pharmaceuticals in India.
e. To create an incentive framework for the pharmaceutical industry that promotes new
investment into pharmaceutical industry and encourages the introduction of new
technologies and new drugs.
Approaches adopted in the review

In order to strengthen the pharmaceutical industry's R and D capabilities and to identify
the support required by Indian pharmaceutical companies to undertake domestic R and D, a
Committee was set up in 1999 by the name of Pharmaceutical Research and Development
Committee (PRDC) under the Chairmanship of Director General of Council of Scientific and
Industrial Research (CSIR).
To qualify as R and D intensive company in India the PRDC has suggested following
conditions (gold standards):
1. Invest at least 5% of its turnover per annum in R and D.
2. Invest at least Rs. 10 Crore per annum in innovative research including new drug
development, new delivery systems etc. in India.
3. Employ at least 100 research scientists in R and D in India.
4. Grant at least 10 patents for research done in India.
5. Own and operate manufacturing facilities in India.
The recommendations of the PRDC in so far as they relate to the Pharmaceutical Policy
have been taken into account while formulating the proposals on pricing aspects.
The Pharmaceutical Research and Development Committee has recommended in its
report, submitted interalia, the setting up of a Drug Development Promotion Foundation (DDPF)
and a Pharmaceutical Research and Development Support Fund (PRDSF). Necessary action in
this regard has been initiated.
As far as the question of price control is concerned, the span of control has been
gradually reduced since 1979. Presently, under DPCO, 1995 there are 74 bulk drugs and their
formulations under price control covering approximately 40% of the total market. The
functioning of the Drugs (Price Control) Order, 1995, has brought to light some problems in the
administration of the price control mechanism for drugs and pharmaceuticals. In order to review
the current drug price control mechanism, with the objective, inter-alia, of reducing the rigours of
price control, where they have become counter-productive, a committee, called the Drugs Price
Control Review Committee (DPCRC), under the Chairmanship of Secretary, Department of
Chemicals and Petrochemicals was set up in 1999, which has given its report. The
recommendations of DPCRC have been examined and taken into account while formulating the
“Pharmaceutical Policy – 2002”.
It has emerged that the domestic drugs and pharmaceuticals industry needs reorientation
in order to meet the challenges and harness opportunities arising out of the liberalization of the
economy and the impending advent of the product patent regime. It has been decided that the
span of price control over drugs and pharmaceuticals would be reduced substantially. However,
keeping in view the interest of the weaker sections of the society, it is proposed that the
Government will retain the power to intervene comprehensively in cases where prices behave
abnormally.
In view of the steps already taken and in the light of the approach indicated in the
foregoing paragraphs, the decisions of the Government are detailed below:
A. Industrial Licensing
Industrial licensing for all bulk drugs cleared by Drug Controller General (India), all
their intermediates and formulations will be abolished, subject to stipulations laid down from
time to time in the Industrial Policy, except in the cases of
1. Bulk drugs produced by the use of recombinant DNAtechnology.
2. Bulk drugs requiring in-vivo use of nucleic acids as the active principles, and
3. Specific cell/tissue targeted formulations.
B. Foreign Investment
Foreign investment upto 100% will be permitted, subject to stipulations laid down from
time to time in the Industrial Policy, through the automatic route in the case of all bulk drugs
cleared by Drug Controller General (India), all their intermediates and formulations, except
those, referred to in para 12.1 above, kept under industrial licensing.
C. Foreign TechnologyAgreements
Automatic approval for Foreign Technology Agreements will be available in the case of
all bulk drugs cleared by Drug Controller General (India), all their intermediates and
formulations, except those referred to in para 12.1 above, kept under industrial licensing for
which a special procedure prescribed by the Government would be followed.
D. Imports
Imports of drugs and pharmaceuticals will be as per EXIM policy in force. A centralized
system of registration will be introduced under the Drugs and Cosmetics Act and Rules made
thereunder. Ministry of Health and Family Welfare will enforce strict regulatory processes for
import of bulk drugs and formulations.
E. Encouragement to Research and Development (R and D)
a. In principle approval to the establishment of the Pharmaceutical Research and
Development Support Fund (PRDSF) under the administrative control of the
Department of Science and Technology, this will also constitute a Drug Development
Promotion Board (DDPB) on the lines of the Technology Development Board to
administer the utilization of the PRDSF.
b. With a view to encouraging generation of intellectual property and facilitating
indigenous endeavours in pharma R and D, appropriate fiscal incentives would be
provided.
F. Pricing
1. Span of Price Control
The guiding principle for identification of specific bulk drugs for price regulations
should continue, as per DPCRC's recommendation, to be:
(i) mass consumption nature of the drug and
(ii) absence of sufficient competition in such drugs.
However, the DPCRC's recommendation regarding the new criteria for ascertaining the
mass consumption nature of a bulk drug on the basis of the top selling brand is not acceptable as it
gives rise to anomalies. In this context, it may be noted that there is no tailor made data available
for the purpose of ascertaining the mass consumption nature and absence of sufficient
competition with reference to a particular bulk drug. There is only one source namely, “Retail
Store Audit for Pharmaceutical Market in India” published by ORG-MARG, which lists out all
major brands and their sale estimates on All India basis. This publication contains data for single
ingredient as well as multi-ingredient formulations. However, it does not give complete
description of all the ingredients of the pharmaceutical product listed therein. Hence, there is
need to obtain information in regard to composition of each brand, dosage form wise and pack
wise, from various other publications /sources viz.,
a. Indian Pharmaceutical Guide (IPG)
b. Current Index of Medical Specialities (CIMS).
c. Monthly index of Medical Specialities (MIMS).
d. Drug Today
e. Information provided by some manufacturers.
f. Label composition as indicated on market samples.
Though none of these sources can be said to be exhaustive and comprehensive in regard
to market information, yet under the given circumstances, these are the best available. It has also
been noted that the sale value of any combination formulation is not directly relatable to a single
particular bulk drug forming part of the combination formulation. Combination formulations
involve too many variables, viz., strength of a particular bulk drug and its proportion with respect
to other bulk drugs used in the combination formulation, price difference between bulk drugs
used in combination formulation; pack sizes, dosage forms etc. In view of these facts, ORG-
MARG sales data for combination formulations does not yield information in regard to mass
consumption nature and absence of sufficient competition with reference to a particular bulk
drug. Also, it is to be borne in mind that processing of such data, which requires cross-checking
with other publications and sources of information in regard to composition of each brand,
dosage form-wise and pack –wise may involve instances of omission / commission.
In view of above, it would be logical to conclude that although ORG-MARG sale
estimates available in regard to all single-ingredient formulations of a particular bulk drug would
not yield the sale value of that bulk drug in the form of all its formulations, yet it would
adequately reflect the mass consumption nature of that bulk drug in the form of single ingredient
formulations, which may be used as a practical indicator for formulating the policy. The
Department through NPPA, with the help of NIPER has developed the desired database for
single ingredient formulations from the retail store audit data as published by ORG-MARG. On
this basis, the Department proposes to undertake the exercise of identifying the bulk drugs of
mass consumption nature and having absence of sufficient competition according to the
following methodology:
1. The 279 items appearing in the alphabetical lists of Essential Drugs in the National
Essential Drug List (1996) of the Ministry of Health and Family Welfare and the 173
items, which are considered important by that Ministry from the point of view of their
use in various Health Programmes, in emergency care etc., with the exclusion, as in the
past, thereform of sera and vaccines, blood products, combinations etc. should form the
total basket out of which selection of bulk drugs be made for price regulation.
2. The ORG-MARG data of March 2001 would form the basis for determining the span of
price control as suggested by DPCRC.
3. The Moving Annual Total (MAT) value for any formulator in respect of any bulk drug
will be arrived at by adding the MAT values of all his single-ingredient formulations of
that bulk drug, its salts, esters, stereo-isomers and derivatives, covering all the strengths,
dosage forms and pack sizes listed against that formulator in all groups / categories of the
OR-MARG (March 2001).
4. The MAT value for all the formulators, as defined in sub-para (iii) above, in respect of a
particular bulk drug will be added to arrive at the total MAT value in the retail trade.
5. The MAT value for an individual formulator, in respect of any bulk drug, as arrived at in
sub-para (iii) above, will be the basis for calculating the percentage share of that
formulator in the total MAT value arrived at as in sub-para (iv) above, in respect of that
bulk drug.
6. Bulk Drugs will be kept under price regulation if:
a. The total MAT value, arrived at as in sub-para (iv) above, in respect of any particular
bulk drug is more than Rs 2500 lakhs (Rs 25 Crores) and the percentage share, as defined
in sub-para (v) above, of any of the formulators is 50% or more.
b. The total MAT value, arrived at as in sub-para (iv) above, in respect of any particular
bulk drug is less than Rs 2500 lakhs (Rs 25 Crores) but more than Rs 1000 lakhs (Rs 10
Crore) and the percentage share, as defined in sub-para (v) above, of any of the
formulators is 90% or more.
7. All formulations containing a bulk drug as identified above, either individually or in
combination with other bulk drugs, including those not identified for price control as
bulk drug, will be under price control. The Government shall, however, retain the
following over-riding power:
In cases of drugs / formulations listed by the Ministry of Health and Family Welfare,
mentioned in sub-para (i) above, and those presently under price control, having significant MAT
value as per ORG-MARG but not covered under the criteria in sub-para (vi) above, as a result of
this proposal, the NPPA would specially monitor intensively their price movement and
consumption pattern. If any unusual movement of prices is observed or brought to the notice of
the NPPA, the Authority would work out the price in accordance with the relevant provisions of
the price control order.
2. MaximumAllowable Post-manufacturing Expenses (MAPE)
Maximum Allowable Post-manufacturing Expenses (MAPE) will be 100% for
indigenously manufactured formulations.
3. Margin for Imported Formulations
For imported formulations the margin to cover selling and distribution expenses
including interest and importer's profit shall not exceed fifty percent of the landed cost.
4. Pricing of Formulations
a. For Scheduled formulations, prices shall be determined as per the present practice. The
time frame for granting price approvals will be two months from the date of the receipt of
the complete prescribed information.
b. The present stipulation that manufacturer, distributor or wholesaler shall sell a
formulation to a retailer, unless otherwise permitted under the provisions of Drugs
(Prices Control) Order or any other order made thereunder, at a price equal to the retail
price, as specified by an order or notified by the Government, (excluding excise duty, if
any) minus sixteen percent thereof in case of Scheduled drugs, will continue.
c. The present provision of limiting profitability of pharmaceutical companies, as per the
Third Schedule of the present Drugs (Prices Control) Order, 1995, would be done away
with. However, if necessary so to do in public interest, price of any formulation
including a non-Scheduled formulation would be fixed or revised by the Government.
5. Ceiling prices
Ceiling prices may be fixed for any formulation, from time to time, and it would be
obligatory for all, including small-scale units or those marketing under generic name, to follow
the price so fixed.
6. Exemptions
a. A manufacturer producing a new drug patented under the Indian Paten Act, 1970, and
not produced elsewhere, if developed through indigenous R and D, would be eligible for
exemption from price control in respect of that drug for a period of 15 years from the date
of the commencement of its commercial production in the country.
c. A manufacturer producing a drug in the country by a process developed through
indigenous R and D and patented under the Indian Patent Act, 1970, would be eligible
for exemption from price control in respect of that drug till the expiry of the patent from
the date of the commencement of its commercial production in the country by the new
patented process.
d. A formulation involving a new delivery system developed through indigenous R and D
and patented under the Indian Patent Act, 1970, for process patent for formulation
involving new delivery system would be eligible for exemption from price control in
favour of the patent holder formulator from the date of the commencement of its
commercial production in the country till the expiry of the patent.
e. The DPCRC has suggested that the low cost drugs measured in terms of “cost per day per
medicine” may be taken out of price control. Any formulator can represent to NPPA with
proof of per day cost to consumer-patient. NPPA will be authorized to exempt such
formulation from price control if its cost to consumer-patient does not exceed Rs.2/- per
day, under intimation to the Government. All orders passed by the NPPA will be
prospective in operation. Whenever the concerned formulator wishes to revise the price,
he, before effecting any change in price, would be bound to inform NPPA and seek fresh
exemption and in case the cost to consumer-patient, on the basis of the proposed revised
price, exceeds beyond the limit of Rs.2/- per day, obtain the necessary price approval.
7. Pricing of Scheduled Bulk Drugs
a. For a Scheduled bulk drug, the rate of return in case of basic manufacture would be
higher by 4 per cent over the existing 14 per cent on net worth or 22 per cent on capital
employed. The time frame for granting price approvals will be 4 months from the date of
receipt of the complete prescribed information.
b. The Government shall, however, retain the overriding power of fixing the maximum
sale price of any bulk drug, in public interest.
8. Monitoring
a. The DPCRC's recommendations to have effective monitoring and enforcement system
and to move away from the “controlled regime” to a recommendation as imports will
increasingly compete with local drugs and pharmaceuticals in the domestic market. A
new system based on solely market prices data is required to be evolved and controls
applied selectively only to cases where, either profiteering or monopoly profit seeking is
noticed. The National Pharmaceutical
Pricing Authority, set up in August, 1997, would need to be revamped and reoriented for
this purpose. It will continue to be entrusted with the task of price fixation / price revision
and other related matters, and would be empowered to take final decisions. It would also
monitor the prices of decontrolled drugs and formulations and over-see the
implementation of the drug prices control orders. The Government would have the
power of review of the price fixation / and price revision orders / notifications of NPPA.
b. Although the prices of some bulk drugs have been steadily decreasing, yet the same do
not get reflected in the retail price of non-Scheduled formulations. Also, there is need to
check high margin/commission offered to the trade by printing high prices on the labels
of medicines to the detriment of the consumers. It is, therefore, proposed to strengthen
the National Pharmaceutical Pricing Authority by providing appropriate powers under
the DPCO which would make it mandatory for the manufacturer to furnish all
information as called for by NPPAand also to regulate such prices, wherever, required.
c. The other recommendations of DPCRC like giving powers to drug control authorities to
dispose of small and petty offences etc., will required an amendment to the Essential
Commodities Act. This suggestion is considered not practicable. Monitoring price
movement of drugs sold in the country as well as that of imported formulations will
require developing appropriate mechanism in the NPPA.
9. Drug Price EqualizationAccount (DPEA)
Provision would be made in the new Drugs (Prices Control) Order (DPCO) to ensure
that amounts which have already accrued to the DPEA and those which are likely to accrue as a
result of action in the past, are protected and used for the purpose stipulated in the existing
DPCO.
10. Quality aspects
The Ministry of Health and Family Welfare would:
a. progressively benchmark the regulatory standards against the international standards for
manufacturing.
b. progressively harmonize standards for clinical testing with international practices.
c. streamline the procedures and steps for quick evaluation and clearance of new drug
applications, developed in India through indigenous R and D, and
d. set up a world class Central Drug Standard Control Organization (CDSCO) by
modernizing, restructuring and reforming the existing system and establish an effective
net work of drugs standards enforcement administrations in the States with the CDSCO
as a nodal centre, to ensure high standards of quality, safety and efficacy of drugs and
pharmaceuticals.
11. Pharmaceutical Education and Training
The National Institute of Pharmaceutical Education and Research (NIPER) have been
set up by the Government of India as an institute of “national importance” to achieve excellence

in pharmaceutical sciences and technologies, education and training. Through this institute,
Government's endeavor will be to upgrade the standards of pharmacy education and R and D.
Besides tackling problems of human resources development for academia and the indigenous
pharmaceutical industry, the institute will make efforts to maximize collaborative research with
the industry and other technical institutes in the area of drug discovery and pharma technology
development.
Recently the Government of India, Ministry of Chemicals and Fertilizers, Department

of Chemicals and Petro Chemicals have announced national pharmaceutical policy on 28th
Dec.2005. It focuses on the following aspects-
1. The Expert Committee set up by Government under the Chairmanship of Dr R A
Mashelkar, Director CSIR in its report submitted in 2003 has made comprehensive
recommendations for strengthening the drug regulatory system including the problem of
spurious drugs both at the Centre and the States.
2. Under IPR both product as well as process patents can now be granted for
pharmaceuticals. New Rules which would be the endeavor of the Government to
simplify procedures and shorten the timelines for various approvals would be notified
soon and patent
3. Under D and C rules, 1945, clinical trials have been defined and it has been made
mandatory to take approval for conducting any type of clinical trials in the country. Also
Good Clinical Practices (GCP) guidelines have been published and made mandatory.
4. Government would evolve a public – private partnership programme to make available
anti-cancer and anti-HIV/AIDS drugs at reasonable prices to a much larger section of the
population.
5. Drugs for other life threatening diseases requiring lifelong treatment, whether part of
National List of Essential Medicines, 2003 or outside it, would also be identified and
brought under the public-private partnership model
6. The patented drugs (formulations under product patent) that are launched in India
after1st January, 2005 would be subjected to mandatory price negotiations before
granting them marketing approval.
7. Based on the recommendations of this Committee following trade margins are
recommended for different drugs-
(1) CategoryADrugs (drugs under cost based price control)-
Both Branded and Generics - 8% wholesaler, 16% for retailer
These margins are already prescribed under the present system of price control
(2) Other Drugs (Not under cost based price control)
a) Branded – 10% wholesaler , 20 % for retailer

These margins are prevailing as per an agreement between the industry and trade.
Branded generics (5 to 7%) would also be put in this category
b) Generics – 15% wholesaler, 35% for retailer
These margins are not prescribed at present and vary largely across various drugs.
Generics form account for 5 to 7 % of the total market
8. Excise duty on pharmaceuticals continues to be at the rate of 16%. With effect from 7th
January, 2005, it was made applicable on MRP of drugs with an abatement of 40%. This
has increased the burden on the small scale industry. The high rate of excise duty is
particularly visible since the State Governments reduced the applicable VAT rate to 4%
in recognition of the essential nature of pharmaceutical products.
9. Under the provisions of Packaged Commodities Rules, 1977, all commodities sold in
prepackaged form are required to have a label declaration of retail sale price in the form
of MRP inclusive of all taxes. This concept is well accepted and is being used for all
packaged consumer goods in India except drugs. DPCO requires 'Retail Price not to
exceed Rs ……local taxes extra ,'' so that basic MRP is strictly followed and only actual
taxes, which vary, are charged extra.
10. Immediately after the approval of the new pricing system under this policy a new Drug
Price (Control) Order (DPCO) replacing the existing DPCO,1995 would be issued under
the Essential CommoditiesAct , 1955,
11. Drugs and Therapeutics (Regulation) Act (DATA) would be enacted to replace the
existing system of Drug Price (Control) Orders under the EC Act. The main features of
thisAct would be
a) empowering Government authority to impose a price or limit or control the price for
indigenous manufactured or imported drugs.
b) requiring the Government or its authority to clearly lay down the principles governing
leading to imposition of any such price control or any deviations permitted there from.
c) authorizing the Government or its authority to seek or compel disclosure of any
information or data relevant to its functioning from all manufacturers, marketers,
distributors or retailers of drugs and therapeutic products.
d) requiring all companies involved in the manufacture or marketing of drugs and
therapeutic products to submit authenticated price lists of all their products.
e) granting the Government or its authority the power to approve a brand name for a
specific product, to prevent changes in the composition of a branded product.
f) providing penalties, for violation or non-compliance with the provisions of theAct or the
Rules framed and orders issued under theAct.
g) other relevant provisions with regard to production and prices as mentioned in the EC
Act, 1955 would be incorporated in theAct to the extent possible.

h) greater role and accountability of State Drug Controllers would be specifically provided
for under theAct.
12. National Pharmaceutical Pricing Authority was set up as envisaged in the Drug Policy of
1994 as per the provisions of the Drugs (Prices Control) Order, 1995 and in accordance
with the powers delegated to it.In order to enable NPPA discharge its responsibilities
more effectively there is an immediate need to bring about some fundamental changes in
its working.
13. Following would be the main guiding factors for procurement of bulk purchase of
medicines by various Government agencies :
a) Procurement of generic drugs only from pre-qualified manufacturers of drugs
b) Technical and price bids to be invited in separate envelopes.
c) Schedule M for GMP compliance of the manufacturer to be ensured.
d) Minimum three years of track record of the manufacturer in sustained production and
marketing of the concerned drug.
e) Post-award inspection of manufacturing facilities to be carried out by the purchasing
agency
f) Batch-wise sample testing of drugs from Government approved laboratories.
g) Packaging specifications may be prescribed for better shelf life
h) Expired drugs must be destroyed by the hospitals as per the norms.
14. For the bulk purchases made by Government for public health requirements
(Government hospitals/programmes, health insurance etc.) ceiling prices as follows
would be fixed within which purchase prices would be charged by the manufacturers
through open tenders.
15. One of the ways to make available cheaper drugs to people at large and to the public
health system could be to promote the production of generic drugs in the country. This
could be done through the public health system would preferably be for generic drugs.
Quality certification would be provided free of cost to generic drug manufacturers
through an appropriate scheme.
16. It is, suggested that branding of drugs and other therapeutics should be brought under the
Central drug regulatory system. In particular, no change should be permitted in the
composition of a given brand. Necessary changes would be made in the Drugs and
CosmeticsAct, 1940 in this regard.
17. Government would institute a method of widely publicizing GMP certification as a
guarantor of quality of the certified drug. In addition a quality mark like the ISI or
Agmark approvals would be evolved through industry involvement .
18. A Pharma Development Fund would be created to help these units to conduct drug
development including clinical trials, patent filing and up gradation of technology.

19. Public Sector Pharma enterprises have in the past served a very useful purpose in
providing some of the essential drugs required in the country. A Coordination
Committee in the Department of Chemicals and Petrochemicals would be constituted to
sort out various issues pertaining to the pharma PSUs.
20. Consumer Awareness Campaigns through print and electronic media on price fixation,
revision, use of generics including consumer education and empowerment will be
carried out.
21. Schemes for providing accessibility of drugs to the Poor (Below Poverty Line (BPL)
families) families recommended are as under
a) Rashtriya Swasthya Bima Yojna for BPL families
b) National IllnessAssistance Fund, State IllnessAssistance Funds & District
c) Rajasthan Model of Medicare Relief Societies to be replicated
d) District level Drug Banks
22. A health cess of 2% would be levied on various central taxes on the lines of education
cess which is likely to provide approx. Rs 6500 crores to the Government . This amount
is proposed to be spent primarily on schemes meant for the poor people.
23. Certain community based organizations like LOCOST and SEWA (Self Employed
Women's Associations, Ahmadabad) are engaged in providing medicines to the needy at
low prices , preventive health care, health insurance etc. Encouragement would be
provided to more such bodies to function in the area of healthcare services.
24. To be front runner in pharmaceuticals R&D which is knowledge based, India needs
highly trained human resources in the area of medicinal chemistry, computational
biology in silico drug design, in vivo pharmacology, regulatory toxicology,
pharmaceutical analysis, formulation, clinical trials, intellectual property protection,
drug regulatory affairs and pharmaceutical care.
25. With a view to encourage R and D in this sector it is essential to provide suitable
incentives to industry. At the same time it is also necessary that the incentives are made
use of by those units which are genuinely engaged in R and D. It recommended that R
and D intensive companies fulfilling certain conditions should be given price benefits
for the drugs under DPCO.
26. Several drugs have been discovered and developed by Central Drug Research Institute
(CDRI) and other organizations in the past could not be marketed due to one reason or
the other such drugs would be identified and efforts made to further develop and launch
these in the market.
27. Scheme of Interest Subsidy for implementation of Schedule M of Drugs and Cosmetics
Rules for Good Manufacturing Practices would be created for providing interest subsidy
(5 percent) on borrowings to small scale/medium pharma units going in for Schedule M

implementation for GMP for Drugs and Cosmetics Rules. Promotional activity to
motivate industry.
28. In order to effectively control the abuse of narcotic drugs and psychotropic drugs and to
prevent misuse of such drugs as intoxicants Department of Health and Family Welfare
would evolve an effective mechanism under the provisions of Drugs and Cosmetics Act,
1940.
29. Drug Price Equalization Account (DPEA) under DPCO, 1979 are being disputed by
industry and these are under litigation in various courts in the country. Efforts would be
made to settle these complicated cases through a One-Time Settlement scheme on the
lines ofAmnesty schemes under Income tax .
30. A fund under DPCO,1979 has been set up by the name of Drug Price Equalisation
Account (DPEA) wherein amount recovered on account of overcharging on the
formulations / bulk drugs sold by companies prior to the DPCO of 1987 as per the
assessment of the Department of Chemicals and Petrochemicals is deposited ..
31. On the lines of Scheme for Integrated Textile Parks, Pharma Parks/SEZs for Pharma
industry would be set up to achieve a leading position as the Drug Maker of the World.
For that purpose, World class infrastructure would be provided for the accelerated
growth of the industry.
32. Although exports of pharma products from India are growing at a healthy rate there is
need to accelerate this further in view of the vast potential existing in some of the
countries.
33. Pharmaceutical distribution system in India needs much to be desired as retailing in
India is highly unorganized. Proper storage, cold chain and organized retailing would be
encouraged.
34. In order to have a meaningful dialogue amongst all stakeholders on various issues
concerning policy the Pharmaceutical Advisory Forum should be constituted under the
chairmanship of Minister , Chemicals and Fertilizers would play an important role.
Summary
Indigenous pharmaceutical industry is knowledge based industry which is succeeded in
production of generics after the applicability of drug policy. Subsequently, Price Control order
has controlled the prices of bulk drugs and formulations. However, still the essential drugs are
not readily accessible and affordable to the poor population in the country. After liberalization
process in1991, the important developments in the various components like industrial licensing,
foreign direct investment, EXIM policy, product patent in pharmaceuticals, excise duty, etc have
took place that played an important role in drug manufatcuring.

1. India holds_____ position in terms of volume and ____ in terms of value of production.
a. 3rd , 13th b. 4th, 13th
c. 3rd, 14th d. 4th, 14th
2. Now days the foreign investment has been raised upto ____%.
a. 25 b.50
c. 75 d.100
3. Following are the objectives of National Pharmaceutical Policy, 2002 except___.
a. Ensuring good quality drug at reasonable price.
b. Strengthening the indigenous capability for cost effective quality production
c. Promoting R and D in pharmaceutical sector
d. Import and export of drugs and pharmaceuticals without EXIM Policy
4. The provision of corpous fund is set up by ________.
a. PRDSF, DDPF
b. Central Government, State Government
c. NPPA, DDPB
d. DPPB, NPPA
5. Drugs Price Control Review Committee (DPCRC) was set up to _____.
a. minimize the prices of drugs
b. review the current drug price control mechanism
c. permit the prices of drugs as per the wish of manufacturer.
d. none
6. Foreign TechnologyAgreement is for _______ cleared by Drugs Controller General (India)
a. bulk drugs b. formulations
c. imported drugs d. none
7. Maximum Allowable Post-manufacturing Expenses (MAPE) will be ___% for indigenously
manufactured formulations.
a. 25 b.50
c. 75 d.100
8. The National Pharmaceutical PricingAuthority was set up in ____.
a. 1970 b. 1987
c. 1995 d. 1997
Important questions
1. What are the objectives of National Pharmaceutical Policy, 2002?
2. Describe in brief the important steps taken before the liberalization process.
3. What actions will be taken by Ministry of Health and Family Welfare to improve the quality of
manufacturing process?
4. Discuss in brief - the span of price control
5. Enlist the important features of monitoring.
6. Write in brief about the gold standards suggested by PRDC.
7. Discuss in brief about the classes of drugs exempted from price control.

1. a 2. d 3. d 4. a 5. b 6. a 7. d 8. d
Chapter 11
THE POISONS ACT, 1919
Learning objectives
1. identify the objective of the Poison Act, 1919.
2. define poison.
3. explain various provisions for the import, possession, possession for sale and sale of any
poison.
Introduction
This Act was passed with a view to control, import, possession and possession for sale of
poisons. According to this Act, Central Government is authorized to make rules regarding the
import of poisons within their respective territories while State Government is held responsible
for the possession and possession for sale of poisonous substances.
Poisons
All substances specified as poisons under theAct are to be deemed as poisons.
Objective
This is an Act to regulate and control the import, possession and possession for sale of
any specified poison.
Import, possession, possession for sale and sale of any poison

Import of poison
Import of poisons is allowed only under the authority of licence granted for the purpose
by Central Government. Any person who possess licence should import the poisons across
defined customs frontier.
Possession for sale and sale of any poison
The State Government may regulate the possession and possession for sale either
wholesale or retail sale of any specified poison within whole or specified areas of their territories.
State Government makes such rules which may provide for-
1. Grant of licence for the possession for sale either wholesale or retail sale of any specified
poison and fixing of fees to be charged for such license.
2. Classes of person to whom the licenses for the possession for sale and sale of poisons are
190 |
The Poison Act, 1919 | 191
to be granted.
3. Maximum quantity of any poison that may be sold to a person.
4. Maintenance of registers for sale of poisons and inspection of the same.
5. Safe custody of poisons and the labeling of the vessels, covering or packages in which
such poison is sold.
6. Inspection and examination of any such poison by any vendor.
Possession of any poison

State Government has power to make the rules regarding the possession of any specified
poison in such local area where such poison may be used for murder or for poisoning cattle in
such local area where such occurrences are very frequent.
Power to issue search warrant

1. District Magistrate, the Subdivisional Magistrate and in a Presidency town, the
Commissioner of Police may issue a warrant for the search of any place in which he has
reason to believe or suspect that any poison is possessed or sold in contravention of this
Act or any rule thereunder or that any poison liable to confiscation under this Act is kept
or concealed.
2. The person to whom the warrant is directed may enter and search the place in accordance
therewith and the provisions of the code of criminal procedure, relating to such warrants,
shall be deemed to apply execution of the warrant.
Penalties for offences

Any person-
1. Who possess poison and also sell the poison unlawfully.
2. Who import any poison without a licence.
3. Who break any condition of licence for the import of poison granted to him is
punishable-
a) with an imprisonment up to 3 months or with a fine up to ` 500 /- or with both on first
conviction.
b) with an imprisonment up to 6 months or with a fine up to ` 1000 /- or with both on
subsequent conviction.
The poison in connection with the offence, together with the vessels, packages is liable
for confiscation.
ListAPoisonous Substances
Aconite, Aconine, Arsenic, Atropine, Belladona, chloral hydrate, Coca, Potassium

cyanide, Diamorphine (Heroin), Digitalis, Ecgonine, Ergot of rye, Lead, Nux-vomica,
strychnine, Barbituric acid, Morphine, Strophanthus, Strophanthin, Tetraethyl lead.
List B Poisonous Substances

Essential oil of almond, Barium sulphate, Tincture of cantharides, Carbolic acid,
Chloroform, Mercuric sulphocyanide, Oxalic acid, Poppies, all oxides of mercury, sulphonal and
zinc chloride
Summary
This Act is necessary to have control on import, possession and possession for sale of
poisons. Central Government regulates and controls the import of poisons. State Government
has made certain rules for possession and sale of poison either for wholesale or retail sale. The
person is not liable for possession and sale of such poison that may cause health hazards. Any
person who contravenes any provisions of this rules shall be liable for the punishment.

1. Import of poison is regulated by _______.
a) State Government b) Central Government
c) State Council d) Central Council
2. Possession and possession for sale of poison is regulated by ________.
a) State Government b) Central Government
c) State Council d) Central Council
3. The objective of The PoisonsAct 1919 is all the following except________.
a) To control the import of poison b) To control the possession for sale of poison
c) To control the possession of poison d) To control the manufacture of poison
4. The PoisonsAct came in to existence in ________.
a) 1920 b) 1919
c) 1930 d) 1985
5. Penalty for the import of poison without licence is punishable with fine upto ` _______ on first
conviction.
a) 1000 b) 500
c) 2000 d) 5000
Important questions
1. What is the objective of the PoisonsAct, 1930?
The Poison Act, 1919 | 193
2. Define 'poison' under the PoisonsAct, 1930.

3. What implications are regulated by State Government for possession for sale of any specified
poison?
4. How the import of poisonous substances is regulated by Central Government?
6. Enlist listAand list B poisonous substances.

1. b 2. a 3. d 4. b 5. b
Chapter 12
PREVENTION OF FOOD ADULTERATION ACT, 1954 AND RULES, 1955
Learning objectives
1. know the objective of the Prevention of FoodAdulteration Act, 1954.
3. know about the Central Committee for Food standards.
4. get the information about the functions of Central food laboratory.
5. know about the qualifications required for PublicAnalyst and his duties.
6. explain powers and duties of food inspectors.
Introduction
Adulterants are the substances which do not have any therapeutic value but these are
added to increase the bulk of materials. In food articles, adulterants are added by some vendors to
earn more profit. Adulterants have similar external appearance i.e. colour, odour, taste as that of
genuine food articles but have less caloric values. Some adulterants that have toxic or harmful
effect on the health of human being or they may cause undesirable effect. Sometimes misbranded
or spurious food articles are sold in the market that may also have undesirable effect. Therefore, it
is necessary to protect the public from such adulterated, misbrandedand spurious food articles.
For that purpose, Prevention of Food Adulteration Act, 1954 came into existence in 1954. This
Act provides for the constitution of Central Committee for Food Standards to have a control on
the quality of food articles. It also provides for the establishment of Central Food Laboratory to
analyse or test the samples of food articles from food inspectors and public analysts.
Objective
The objective of this Act is to make the provisions for the prevention of adulteration of
food.
Definitions
1. Food
It includes any article used as food or drink for human consumption other than drugs and
water and also includes
a) any article used in the preparation of human food.
b) condiments or any flavouring material.
194 |
Prevention of Food Adulteration Act, 1954 and Rules, 1955 | 195
c) any other article which the Central Government may by notification declare as food for
the purpose of thisAct.
2. Adulterated food article

Article shall be deemed to be adulterated food article if
a) it is sold by a vendor which is not of the nature, substance or quality demanded by the
purchaser or which is not of the nature, substance or quality that it claims or represents;
or
b) it is substituted by any inferior or cheaper substance wholly or partly so as to affect
injuriously the nature, substance or quality thereof; or
c) it is obtained from diseased animal; or
d) it contains any poisonous or other ingredients which may render the contents injurious to
the health; or
e) its container is composed of wholly or partly poisonous or deleterious substances
rendering the contents injurious to the health; or
f) any of its constituents has been wholly or partly abstracted so as to affect injuriously the
nature or quality thereof; or
g) it contains in whole or in part of filthy, putrid decomposed or diseased animal or
vegetable substance or which is insect infected ; or
h) it is prepared, packed or stored under unsanitary conditions whereby it may have
contaminated with filth or which may render the contents injurious to the health, or
i) it contains or bears a color for the purpose of coloring only, a color other than those
prescribed; or
j) the quality and purity of which falls below the prescribed standard; or
k) it contains any prohibited preservative or permitted preservative in excess of the
prescribed limit; or
l) the constituents of which are not within the prescribed limit; or
m) any other substance which affects or the article so processed as to affect injuriously the
nature, substance or quality thereof.
3. Misbranded food article

Article shall be deemed to be misbranded if-
a) it is an imitation of or is a substitute for or resembles in a manner likely to deceive or bear
upon its label or container the name of another food article under the name of which is
sold and is not properly labeled so as to indicate its true character; or
b) it is sold under a name which belong to another food article ;or
c) it is falsely stated to be the product of any place or country; or
d) it is so coloured, coated, powdered or polished that it appears better or greater

therapeutic value than it really is; or
e) it makes a false claim upon the label or package; or
f) it purports to be, or is represented as being dietary uses, unless its label bears such
information as may be prescribed concerning its vitamin, mineral or other dietary
properties in order to inform its purchaser so as to its value for such use; or
g) if it is not labeled in the prescribed manner; or
h) it contains artificial flavouring, artificial colouring or chemical preservative without
indicating on the label or in contravention of the requirements of this Act or rules made
there under.
4.Adulterant
Any substance which could be employed for the purpose of adulteration.
5. Package
It means a box, bottle, casket tin, barrel case, bag, wrapper or any thing in which food
articles are placed or packed.
6. Primary food
It means any food article being a product of agriculture or horticulture in its natural form.
Administrative bodies
1. Central Committee for Food Standards
2. Central Food Laboratory
3. PublicAnalysts
4. Food Inspectors
Central Committee for Food Standards

It is constituted by Central Government to advise the Central Government and State
Government on the matters arising out of the administration of this Act and to carry out other
functions assigned to it under thisAct.
Constitution
A. Ex-officio Member
1. Director General of Health Services who shall be Chairman.
2. Director of the Central Food laboratory.
B. Nominated Members
1. One person each of the departments of Food and Agriculture nominated by the Central
Government
2. Two experts nominated by the Central Government
3. One member each of Central Ministries of Commerce, Defence, Industry and Supply
and Railways nominated by the Central Government
4. One representative of each State nominated by that State concerned
5. One representative nominated by Central Government to represent the Union territories
6. One representative each nominated by Central Government to represent agricultural,
industrial and commercial interest
7. Five representatives nominated by Central Government to represent the consumers
interest, one of whom shall be from hotel industry
8. One representative of medical profession nominated by Indian Council of Medical
Research
9. One representative each nominated by the Indian Standards Institution.
The nominated members shall hold the office for three years and shall be eligible for
renomination. Central Government shall appoint a Secretary to the Committee. The clerical and
other staff shall be provided by Central Government.
Central Food Laboratory

Central Food Laboratory is established by the Central Government by notification in the
Official Gazette to carry out functions entrusted to it by this Act. Central Government may
declare any laboratory or institute as Central Food Laboratory.
Functions
1. To analyse or test the samples of foods as may be sent to it by any other authorized officer
and submission of certificate of analysis to the authorities concerned.
2. To investigate for the purpose of fixation of standard of any article of food
3. To investigate for the purpose of standardizing methods of analysis.
PublicAnalyst
Public Analyst is appointed by Central Government or State Government in a particular
area. The person to be appointed as Public Analyst should have no financial interest in the
manufacture, import or sale of any food article.
Qualifications
Aperson appointed as PublicAnalyst should possess the following qualifications.
1. Graduate in science with chemistry or biochemistry or food technology or food and
drugs from a recognized University or its equivalent examination with not less than five
years experience in the analysis of food ;or
2. Post Graduate degree in science with chemistry or biochemistry or food technology or
food and drugs from a recognized University or its equivalent examination with not less
than three years experience in the analysis of food ;or.
3. Associate of the Institution of Chemists (India) by examination with the section of

analysis of food or its equivalent examination with not less than three years experience
in the analysis of food ; or
4. Has been declared qualified by a board appointed for this purpose by Central
Government.
Duties of PublicAnalysts
1. To analyse the samples sent to him by food inspectors or any other authorized person
under thisAct.
2. To compare on the receipt of a package containing a sample for test or analysis from a
Food Inspector, the seals on the container and outer cover with specimen impression
received separately and to note conditions of the seals on thereon.
3. To furnish the reports of results of such analysis to the concerned authority within forty
days of receipt of the samples for test or analysis.
Food Inspector
Food Inspector is appointed by Central Government or State Government in a particular
area. The person to be appointed as Food Inspector should have no financial interest in the
manufacture, import or sale of any food article. Every food inspector is a public servant within
the meaning of Section 21 of the Indian Penal Code.
Qualification
Aperson appointed as Food Inspector should possess the following qualifications
1. A graduate in medicine with one months training in food inspection and sampling work
approved for this purpose by Central Government or State Government; or
2. A graduate in science with chemistry or graduate in agriculture or public health or
pharmacy or in veterinary science or a graduate in food technology or dairy technology
or diploma in food technology from university or institution established in India by laws
or its equivalent qualification recognized and notified by Central Government for the
purpose with three months training in food inspection and sampling work under a food
authority or in an institution approved for the purpose by Central Government.
However, the training in food inspection and sampling work obtained prior to the
commencement of Rule 3 of the prevention of Food Adulteration Rules, 1976 in any one
of the laboratories under the control of-
a) PublicAnalyst; or
b) Afellow of Royal Institute of Chemistry of Great Britain.
3. Any Director, General, Food Laboratory or the training obtained under a food authority.
Duties of Food Inspector

1. To inspect all the premises licensed for the manufacture, storage or sale of food article in
the area assigned to him.
2. To satisfy himself whether the conditions of the licenses are being observed or not.
3. To obtain and send the samples of food articles for test or analysis.
4. To investigate any complaint made to him in writing regarding any contravention of the
provisions of theAct and rules made there under.
5. To maintain records and actions taken by him and to submit the copies of such records to
the controlling authority.
6. To make inquires and inspections regarding the sale of food article, sale of which is
prohibited.
7. To detain the imported packages, if he suspects the import of such food article is
prohibited.
8. To perform such other duties as may be entrusted to him by the concerned health officer.
Powers of Food Inspector
Within the local limits for which the Food Inspector is appointed he may
1. Take samples of any food article from
a) any person selling any food article ; or
b) any person who is in the course of conveying, delivering, preparing to deliver any food
article to a purchaser; or
c) a consignee (other than person who purchases or receives any article of food for his own
consumption) after delivery of such article to him.
2. Send the samples of food articles to the PublicAnalyst for test or analysis.
3. Prohibit the sale of any article of food in the interest of public health, with the previous
approval of local authority or food authority.
4. Search any person in connection with the offence under this chapter at all reasonable
time.
5. Enter and search any premises or any places where any food article is manufactured sold
or stored or where adulterant is manufactured or kept and take samples of such food
articles for test or analysis.
6. Seize and carry away any food article where he suspects that the food article is to be
adulterated or misbranded and take such samples for test or analysis. If such food article
is deteriorated and unfit for human consumption, the food authority may destroy it after
giving notice to the vendors.
7. Break open any package in which any food article may be contained or break open the
door of any premises where any article of food may be kept for sale.
8. Seize any adulterant found in possession of manufacturer, distributor or dealer or any
food article found in premises occupied by him and may also seize any record, register
or any other document of the same.
9. Exercise the powers of police officer for the purpose of ascertaining the true name and
residence of the person from whom sample is taken or food article is seized.
Procedure of taking food samples by Food inspector
1. Where food inspector takes the sample of food articles, he shall intimate purpose to
person from whom he takes sample by giving notice in writing and to the person, if any
whose name, address, etc has been disclosed.
2. Where food inspector takes the sample of food , he shall divide the sample in presence of
such person from whom he takes it and effectively seal, mark them and take the signature
or thumb impression of such person. If such person refuses to sign or put his thumb
impression, inspector shall call one or more witnesses and take their signatures or thumb
impressions in the lieu of signatures or thumb impression of that person.
3. Where food inspector takes the sample of food articles, he shall send one part to the
Public Analyst for the test or analysis and send remaining two parts to the local (Health)
authority for the following purpose.
a) To send to the PublicAnalyst on request if the previous sample is lost or damaged.
b) To produce in the court on request if required by the court.
c) To send such sample to other public analyst if the report sent by the public analyst is
erroneous.
If the seized food article found to be unfit for use of human beings, in accordance with
the report of public analyst, such seized articles of food shall be produced before a magistrate as
soon as possible or not later than seven days after the receipt of public analyst. Magistrate may
take further action, if think necessary.
Prohibition of Import of certain food articles

The following classes of food articles are prohibited for its import sale, distribution etc.
1. Adulterated food articles
2. Misbranded food articles
3. Food article, where the licence for import is prescribed except in accordance with the
conditions of licence
4. Food article, the import of which is for time being prohibited by food authority
5. Any food article in the contravention of the provision of theAct.
Prohibition of Sale, Manufacture, etc of certain food articles

The following classes of food articles are prohibited for its sale, manufacture, etc.
1. Adulterated food articles
2. Misbranded food articles

3. Food article where the licence for its sale, manufacture, etc is prescribed except in
accordance with the conditions of licence
4. Any food article in the contravention of the provision of theAct
5. Any adulterant
6. Food article, the sale of which is time being prohibited by the food authority in the
interest of health.
Offences and penalties

a) Manufacture, sale, storage or distribution of adulterated food articles or other food
articles in the contravention of the provisions of thisAct.
b) Import, manufacture for sale or distribution of any non-injurious adulterant.
c) Preventing a food inspector from taking a sample and exercising any other power.
d) Possession of any adulterant which is not injurious to health by a manufacturer of food
article.
e) Use of any report or certificate of test or analysis for the purpose of advertising any food
article.
f) Giving a false warranty to the vendor in writing in respect of any sold food article.
All above offences are punishable with imprisonment for six months which may extend
to three years and with fine up to ‘`’1000/- .
Summary
This Act prevents the manufacture, sale, and distribution of adulterated food articles. As
like Drugs and Cosmetics Act, there are administrative bodies that include Central Committee
for Food Standards, Central Food Laboratory, Public Analysts and Food Inspectors. This Act
enumerates the classes of drugs that prohibit the import, manufacture, sale, etc of certain food
articles.

1. Central Committee for Food Standards consists of ___ representatives to represent consumers
interest.
a. two b. one c. three d. five
2. Primary food is product of agriculture or horticulture in its _____ form.
a. artificial b. natural c. both d. none
3. Following classes of food articles are prohibited for its import except_____food article.
a. adulterated b. misbranded c. patent and proprietary d. none
4. Food does not include______.

a. drink b. condiment c. flavouring matter
d. article that is not approved by Central Government
5. Misbranded food article includes all the following except ______.
a. It is sold by name of another food article
b. It has false claim on the label or package
c. it is not labeled according to requirement of thisAct
d. Its quality and purity falls below the prescribed standard
6. The function of Central Committee for Food standards is to __________.
a. To advise the Central Government and State Government on the matters related toAct
b. To carry out the functions entrusted by thisAct
c. To analyse the samples of food
d. None
7. Following food articles are prohibited for import, sale, manufacture etc except ____.
a. adulterated food article b. misbranded food article
c. food article which is in contravention of provisions of thisAct
d. food article which is not in contravention of provisions of thisAct
Important questions
1. What is the objective of the Prevention of FoodAdulterationAct, 1954?
a. Food b.Adulterated food article c. Misbranded food article d.Adulterant
e. Primary food
3. Give the constitution and functions of Central Committee for Food Standards.
4. Describe the functions of Central food laboratory.
5. What qualifications are required of a person to be appointed as Food Inspector? Describe his
duties.
6. What qualifications are required of a person to be appointed as Public Analyst? Describe his
duties.
7. What are the powers of Food Inspectors? Describe the procedure to be followed by food
inspector while taking a sample.
8. Describe the classes of certain food articles that are prohibited for its import, manufacture,
sale, etc.
9. Describe the offences and penalties under thisAct.

1. d 2. b 3. c 4. d 5. d 6. a 7.d
Chapter 13
THE PREVENTION OF CRUELTY TO ANIMALS ACT, 1960
Learning objectives
1. know the objective of the Prevention of Cruelty toAnimalsAct, 1960
3. know about the animal welfare board.
4. get the information about the experimentation on animals.
Introduction
In living world, the animals are most akin to the man and the sensations and feelings of
them are some what similar as that of human being. The use of animals was increased extensively
for the evaluation of new drug molecule or formulations as the responses given by certain
animals are similar to the human beings. For that purpose, experimentation was done on the
various animals like frogs, rabbits, guinea pig, rats, etc. It was observed that there were an
unnecessary pains or suffering to the animals due to careless handling. Therefore, the prevention
of cruelty to animals Act came into existence to minimize the unnecessary pains or suffering on
the animals.
In India, there were different rules in different regions, most of them were not effective
and in practice.
Objective
This is anAct to prevent the infliction of unnecessary pain or suffering on animals and to
prevent the cruelty to animals.
Definitions
1.Animal
Animal means any living creature except human being.
2. Cruelty
It means the infliction of unnecessary pain or suffering on the animals.
3. Phooka or Doom Dev
It includes any process in which any substance or air is introduced into the female organ
of milch animal with the intention of drawing of any secretion of milk.
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Animal Welfare Board

Animal Welfare Board is established by Central Government in order to
a) protect the animal from the unnecessary pain or suffering.
b) promote the animal generally.
Constitution
Animal Welfare Board consists of the various members. Central Government nominates
one of the members to be its Chairman and another member to be its Vice- Chairman. Central
Government may also appoint Secretary of the Board.
Functions
1. To prevent cruelty to the animals by keeping the laws in force and advise Government
regarding the amendments to be undertaken in thisAct from time to time.
2. To suggest the Government any improvement in the design of the vehicle so as to lessen
the burden on draught animals.
3. To advise Central Government on making of the rules for preventing infliction of
unnecessary pain especially when they are being transported or when they are kept in
captivity or confinement.
4. To take the steps for the amelioration of animals by providing facilities like shades,
water, troughs, etc along with veterinary assistance.
5. To encourage the animal welfare associations by providing financial assistance or
forming rescue homes, shelter to the old animals and birds.
6. To advise the Government on medical care and attention to be provided in animal
hospitals.
7. To cooperate with the various associations established to prevent the infliction of
unnecessary pains or sufferings to the animals.
8. To impart the education relating to the handling of animals by human beings by means of
lectures, books, posters, etc.
9. To advise the Government on any other such matters relating to animal welfare.
Experimentation on animals
In medical and pharmaceutical sciences the experimentation on animals have great
importance. Usually, the experimentation on animals are carried out to develop a new drug
molecules, biological products like vaccines sera and hormones that will be useful for saving or
for increasing life or reducing suffering or treating diseases of human beings, plants or animals.
During the experimentation animals shall be handled with due care and humanity. They shall not
get suffered from pains or there shall not be any harm to the health of animals during and after
The Prevention of Cruelty to Animals Act, 1960 | 205
experimentation. Therefore, Central Government has constituted Committee to control and

supervise the experiments performed on animals.
It has the following members:
Nominated members
1. Two members nominated by Central Government from each of the-
a) Indian Council of Medical research
b) Indian Council ofAgricultural Research
c) Council of Scientific and Industrial Research
2. Two members from Universities giving medical and veterinary degrees nominated by
Central Government.
3. Five non official members from the persons who are actively engaged in the promotion
of animal welfare are nominated by Central Government.
Elected members
One member each of Lok Sabha and Rajya Sabha is to be elected by the Houses
respectively.
Rules made by the Committee
The Committee shall ensure that the animals are not suffering from the unnecessary pain
or suffering, during or after the experimentations. For the experimentations on the animals, the
Committee shall make the rules that may provide for the registration of persons or institutions
performing the experiments on the animals. In addition to this, Committee shall make the
following rules in this regard
1. If possible, the experiments on the animals shall be avoided, if other teaching aids
like books, models, films, etc are available.
2. If possible, the use of large animals shall be avoided, if same results can be
obtained by using small animals like rats, frogs, rabbits, etc.
3. Usually the experiments on the animals shall not be performed to have a practice.
4. The experiments on the animals shall be performed under the influence of anaesthetic
with due care and humanity.
5. Where the experiments are performed under the influence of anaesthetic and if the
animal is so injured that if they can not be recovered shall be destroyed still
unconscious.
6. That where the experiments are performed in any institution, the person in charge of the
institution is responsible and where the experiments are performed by the individual
outside institution, he himself shall be responsible for avoidance of cruelty to the
animals.
7. That the animals used for experimentation shall be looked after, before and after the
experiments.
8. That the proper records regarding experimentation shall be maintained.
Entry and Inspection

The Committee may authorize any of its Officers to inspect any institution or place
where experiments are being carried on. Such officer has power to enter at any reasonable time
any place or institution where the experiments are being carried on and require any person to
produce the respective record.
Prohibition of experimentation on animals

While inspecting the places used for the experimentation on animals, if the Committee
observed that rules are not being followed by the institution or individual, it may prohibit the
individual or institution from carrying on experiments for a specified period or indefinitely. In
some case, the Committee may permit to carry on the experiments under certain conditions.

1. Any person who is treating the animal cruelly shall be punishable with fine not less than
` 10 which may extend to ` 50 on first conviction and on subsequent conviction, he shall
be punishable with fine not less than ` 25 which may extend to ` 100.
2. Any person who is performing operations like phooka or doom dev or any other
operations to improve the lactation which is injurious to the health of the animal is
punishable with fine up to ` 1000 or with imprisonment up to two years or with both.
The animal subjected to such operation is liable to forfeiture to the Government.
3. Any person who breaches any condition imposed by Committee or contravenes any
order made by the Committee shall be punishable with fine upto ` 200.
Summary
Usually, the experimentation on animals are carried out for the development of new drug
entity, biological products for diagnosis, treatment or cure of diseases in human beings or
animals. While experimentation, if proper care is taken in animal handling the unnecessary pains
or sufferings to the animals will be avoided. The experimentation should be carried out with due
care and humanity to minimize the pains to the animals by the experts. Animal welfare board
established by the Central Government may protect animal from unnecessary pains or
sufferings. Central Government may also constitute a Committee to control and supervise
experiments performed on animals. For the experimentation purpose, the Committee shall make
provision of registration of persons or institutions.
The Prevention of Cruelty to Animals Act, 1960 | 207

Offences Penalties
1.Treating the animal cruelly Fine not less than ` 10 to ` 50 on first
conviction and on subsequent
conviction ` 25 to ` 100 .
2. Performing operations like phooka or doom dev Fine up to `1000 or with imprisonment
or any other operations to improve the lactation up to two years or with both
that is injurious to the health of animal
3. Breach of any of the condition imposed by Fine up to ` 200
Committee

1.Animal means any living creature except______.
a. Birds b. Human beings
c. Insects d. microorganisms
2.Animal welfare board is established by_______ .
a. State Government b. State Council
c. Central Council d. Central Government
3. ____ member/s who is/are actively engaged in the promotion animal welfare is nominated by
Central Government.
a. Five b. Six
c. Two d. One
4. In phooka or doom dev, ______ or any substance is introduced into female organ of milch
animal with the intention of drawing off any secretion of _______.
a. air, water b. water, milk c. air, milk d. water, milk
5. Experimentation on animals is carried out for the following purposes except-
a. development of new drug b. production of vaccines and sera
c. development in medical field d. to have the practice
Important questions
1. What is the objective of the Prevention of the Cruelty to theAnimalsAct, 1960?
2. Define the following
i)Animal ii) Phooka or Doom Dev iii) Cruelty
3. Give constitution and functions ofAnimal welfare board.
4. Write a note on- Experimentation on animals.
5. Why the experimentation is carried out on the animals? Give the constitution of Committe that
supervise and control the experimentation of animals.

6. Describe the rules made by the Committee while performing the experimentation on animals.
7. Give the powers of Committee for the inspection of premises where experimentation is carried
out.
8. Under what condition the Committee will prohibit the experimentation of animals?

1. b 2. d 3. a 4. c 5. d
Chapter 14.
THE PATENTS ACT, 1970
Learning objectives
When you have finished this chapter you should be able to
1. know about the intellectual property rights .
2. know the various types of patents.
3. know the history of thisAct in India.
4. know about the salient features of PatentsAct, 1970.
5. know the salient features of Patents (Amendments)Act.
6. know the procedure for patent registration.
Introduction to Intellectual Property Rights

Intellectual property refers to property created with the use of intellect. The intellectual
creations like inventions, literary and artistic works, symbols, names, images, and designs have
certain commercial value and therefore can be protected using Intellectual Property
Rights(IPRs). The law that involves the creation, vesting and the use of IPRs is the intellectual
property law. The intellectual property laws that are recognized internationally are:
1. Patents
2. Copyrights
3. Trademarks
4. Geographical indicators
5. Protection of undisclosed information (Trade Secrets)
6. Layout designs of integrated circuits
7. Industrial designs.
Barring trade secrets, all IPs are disclosed to the public in return of the monetary rewards
for using it during the period of its protection.
Introduction to Patents
A patent is a document, issued, upon application, by a Government office for disclosing
a new invention by the applicant/s.Apatent describes an invention and creates a legal right for the
owner to manufacture, use, sell or import the invention. The right created by a patent is a
monopoly right granted to the owner by which others are excluded from making, using or selling
his invention. This right is vested by the State on the owner in return for the disclosure of the
invention.
Patents are given only for inventions. Inventions are solutions to specific problems in the
| 209
field of technology. The protection given by patent is limited for the statutorily specified period
of time. It is important to understand that inventions can be patented if they satisfy three tests of
patentability. They are:
1.An invention should be novel
2. It should be non-obvious with an inventive step and
3. It should be useful.
Sr. Intellectual Property
What can be protected? Term of Protection in India
No. Laws
1 Patents Law Inventions 20 years protection
2 Copyrights Law Literary works, musical works, Copyright: Lifetime of
artistic works, sound recordings authors plus 60 years.
Cinematograph films: 60
years from publication
3 Trademarks Law Words, letters and numerals, 10 years which can be
devices, colored marks, three renewed every 7 years
dimensional signs, sound
marks, smell marks, touch
marks, etc.
4 Protection of Goods or services belonging to Protection is for indefinite
Geographical specific origin, collective period
indicators marks, certification marks.
5 Protection of A trade secret relating to a Protection is for indefinite
undisclosed production method, a sales period
information method or any other
information on technology or
business that is unknown to the
public.
6 Protection of Layout design of the circuit 10 years
Layout designs of
integrated circuits
7 Protection of Features of shape, Maximum period of 15
Industrial designs configuration, pattern or years
ornament.
8 Protection of Plant New plant varieties, extant Maximum 18 years for trees
Varieties varieties, seeds and vines; extant varieties
15 years; other crops 6 years
The Patents Act, 1970 | 211
Types of patent
1. Product Patent
A product patent allows rights (including exclusive manufacturing and marketing
rights) relating to the object. A product patent grants more benefits to the owner. Product patent
provides for absolute protection in patented product.
2. Process Patent
Process patent provides for protection only to the technology and method of
manufacture. Process patent promotes competitive environment and strong check on prices, as
against monopoly created through product patent system wherein resource power used for
snuffing out competition fleecing of consumer by charging high price.
3. Utility patents
It protects useful processes, machines, articles of manufacture, and compositions of
matter, or improvements to any of the above. e. g. fiber optics, computer hardware, medications.
The requirements are less strict but the duration of the protection is shorter.
4. Design patents
It guards the unauthorized use of new, original, and ornamental designs for articles of
manufacture. The look of an athletic shoe, a bicycle helmet, and the Star Wars characters are all
protected by design patents. One can file for both a utility and a design patent for the different
aspects of the same invention.
5. Plant patents
It protect invented or discovered, asexually reproduced plant varieties. Hybrid tea roses,
Silver Queen corn, Better Boy tomatoes are all types of plant patents. However, plant patents are
not given in India.
6. Reissue Patent
Issued to correct an error in an already issued utility, design, or plant patent, it does not
affect the period of protection offered by the original patent.
History of Patents Law in India

In India, the first Act relating to patent rights was passed in 1856 (Act VI of 1856) which
granted certain exclusive privileges to inventors of new manufacture for a period of 14 years.
This Act was re-enacted with modifications under Act No. XVI of 1859. In 1872, the Patterns and
Design Protection Act was passed followed by Invention and Designs Act 1888. Subsequently,
Indian Patents and Designs Act was passed replacing all previous Acts. During the period from
1911 to 1970, various amendments were made to this Act. Later on, based on the interim report
submitted by a Committee headed by Dr. Bakshi Tekchand, amendments were made to this Act
by the Act 32 of 1950. Subsequently, in 1959 Ayyangar's report was submitted containing
recommendations for effecting radical changes to the Patent law prevailing in India. Eventually,
The PatentsAct, 1970 was passed and it came into force on 20thApril 1972.
On March 26, 1999, Patents (Amendment) Act came into force with retrospective effect
from 1st January 1995, so as to make India Trade Related Intellectual Property Rights (TRIPS)
compliant by providing Exclusive Marketing Rights (EMR) till product patents are brought. The
Patents (Amendment) Act 2002 came into force from 20th May 2003, making the term of every
patent which is in force to 20 years from the date of filing. The Patents (Amendment) Act, 2005
with effect from 1st Jan 2005 removed the provision of prohibiting product patent for food,
medicine, drug and chemical processes and the product patent regime was implemented fully.
The Patent System in India is governed by the Patents Act, 1970 (No. 39 of 1970) as
amended by the Patents (Amendment) Act, 2005 and the Patents Rules, 2003, as amended by the
Patents (Amendment) Rules, 2006 effective from 05-05-2006.
PatentAct, 1970
Under the Patents Act, 1970 any new and useful invention qualifies for a patent under
section 2(j). Section 2(j) details that an invention has to be a new product or process involving an
inventive step and capable of industrial application; and includes a new and useful improvement
over any of them.
TheAct under section 3 defines what cannot be termed as an invention. These are:
a) an invention which is frivolous or which claims anything obviously contrary to well
established natural laws.
b) the primary or intended use or commercial exploitation of invention which could be
contrary to public order or morality or which causes serious prejudice to human, animal
or plant life or health or to the environment.
c) the mere discovery of a scientific principle or the formulation of an abstract theory (or
discovery of any living thing or non-living substances occurring in nature).
d) the mere discovery of a new form of a substance which does not result in the
enhancement of a known efficacy of that substance or the mere discovery of a new
property or new use unless it results in a new product.
e) a substance obtained by a mere admixture resulting only in the aggregation of the
properties of the components thereof or a process for producing such substance.
f) the mere arrangement or re-arrangement or duplication of known devices each
functioning independently of one another in a known way.
g) omitted
h) a method of agriculture or horticulture.
i) any process for the medicinal, surgical, curative, prophylactic, diagnostic, therapeutic or
other treatment of human beings or any process for a similar treatment of animals to
render them free of disease or to increase their economic value or that of their products.
j) plants and animals in whole or any part thereof other than micro-organisms but
including seeds, varieties and species and essentially biological processes for
production or propagation of plants and animals;
k) a mathematical or business method or a computer programme per se or algorithms;
l) a literary, dramatic, musical or artistic work or any other aesthetic creation whatsoever
including cinematographic works and television productions.
m) a mere scheme or rule or method of performing mental act or method of playing game
n) a presentation of information;
o) topography of integrated circuits;
p) an invention which in effect, is traditional knowledge or which is an aggregation or
duplication of known properties of traditionally known component or components.
Salient Features of PatentAct, 1970

The important features of the Patents Act 1970 relating to access to pharmaceuticals
were as follows:
1) In the field of pharmaceuticals, food, insecticides, chemicals, etc the Act provided only
for process patent and not for product patent.
2) The term of the process patent was only 7 years from the date of application or 5 years
from the date of sealing of the patent, whichever was shorter. Patents protection for other
inventions was available for a period of fourteen years.
3) The process patent regime wherever applicable was covered by 'licenses of right' which
provided a legal right to any enterprise to exploit the patent, if the patents are not worked
for the benefit of the people. Only the terms of these licenses were required to be
mutually agreed upon between the patent holder and the licensee. In case the parties did
not mutually agree to the terms of the license, the Controller had the right to settle the
terms.
4) The royalty payment for any invention used by the Central Government or any other
person authorized by Government for such use was to be compensated by royalty and
other remuneration not exceeding 4% of the net ex-factory sale price in bulk.
5) The onus of proving infringement was upon the plaintiff and not the defendant. The
plaintiff not only has to prove the patent in his favor but also that the patent is being
infringed by using a process patented by the plaintiff.
The Patents Act, 1970 during its operation for over 30 years on the basis of the above
provisions helped the pharmaceutical industry to grow very rapidly. Not only the domestic
demands for pharmaceuticals were met by the industry at the lowest price in the world, but also
the industry developed significant potential for export of pharmaceuticals to various developed
and developing countries. The cost of the drugs in India was amongst the highest in the world
before 1970 but now India is the cheapest and quality producer of medicines in the world. In 30
years, the Indian pharmaceutical industry is valued at US$ 70 billion compared to a mere US$ 2.1
million before 1970. Currently 24000 pharmaceutical companies are licensed in India. Of the
465 bulk drugs used in India, approximately 425 are manufactured within the country. Indian
industry has emerged as a world leader in the production of several bulk drugs.
Amendments to PatentAct, 1970
After India became a signatory to World Trade Organization (WTO) agreement, it was
obligatory under Trade Related Intellectual Property Rights(TRIPS) to provide patent protection
for any invention, whether products or processes, in all fields of technology without
discrimination based on the place of invention or production or field of technology. Therefore,
the first amendment to the Act was brought in 1999 so as to provide mailbox mechanism and an
exclusive marketing right (EMR) for inventions during interim period till the product patent
regime is enacted (until 2005).
Patent FirstAmendmentAct of 1999
This Act authorized the grant of an EMR for five years for inventions made in India on or
after January 1, 1995 and for which a claim for process patent has been made and granted.
Patent FirstAmendment Rules of 1999
The Patent Rules of 1972 provide the details of patent procedures. The first amendment
to these rules was made to incorporate several amendments in tune with the Patent Co-operation
Treaty, 1970. This provided the inventor a facility of making single application to get patent
protection in several countries. This reduced the burden on the inventors by saving the cost of
applications and facing procedural requirements in each country.
Patents (Amendment)Act, 2002
The second amendment to the Patents Act known as The Patents (Amendment) Act,
2002 came into force from 20th May 2003.
Salient Features of Patents (Amendment)Act, 2002
1. The definition of the term “invention” was modified and now requires that an invention
should have an “inventive step” and is “capable of industrial application”.
2. Section 3 of the Act was modified to include exclusions permitted by TRIPS agreement
and also to specifically exclude the inventions which in effect are traditional knowledge.
3. Uniform term of patent protection of 20 years for all categories of invention was
prescribed.
4. A provision for reversal of burden of proof in case of infringement was added. Now the
proof of non-infringement of the patent is to be given by the defendant and not by the
plaintiff.
5. The provisions relating to compulsory licensing was modified to comply with the TRIPS
agreement but also to suit the public interest.
6. A provision was incorporated for enabling parallel import of patented products at lowest
international prices.
7. Several provisions for protecting bio-diversities and traditional knowledge were
incorporated.
8. Several provisions were incorporated with a view to simplify and rationalize the
procedures.
Patents (Amendment)Act, 2005
Patents (Amendment) Act, 2005 (15 of 2005) is the third amendment which came into
effect from 1st Jan. 2005 and was amended on 4thApril 2005.
Salient Features of Patents (Amendment)Act, 2005
1. In the definition of what are not inventions, the word “mere” is added to the line “new use
for a known substance is not an invention”. This means new use for a known substance
with some technical input can now be patented.
2. A computer program is not patentable but its technical application to industry or a
combination with hardware is patentable.
3. Amathematical method or business method or algorithms are not patentable in India.
4. The product patent is now available for medicine, drug, chemical processes and food.
5. If a patent is accompanied by a provisional specification, the complete specification
should be filed within 12 months of filing the application or otherwise the application is
deemed to be abandoned.
6. Apatent application shall be examined only on a request in prescribed manner.
7. As product patents are now available for medicine, drug, chemical processes and food,
the provision relating to Exclusive Marketing Rights (EMR) has been removed.
8. When a patent has been published but has not been granted, any person can make the
representation to refuse the application on the grounds of lack of novelty, inventive
steps and industrial applicability.
9. Only after the grant of patent the application, specification and documents related
thereto are opened for public inspection.
10. The aggrieved party from the order of decision of the Controller can appeal to
Intellectual PropertyAppellate Board (IPAB).
The Patents (Amendment) Rules, 2006
India notified the Patents (Amendment) Rules, 2006 with effect from 5th May 2006,
bringing in changes to provide transparency, decentralization of the functioning of patent offices
and simplified the procedures making them user-friendly. As per the changes notified under the
Patents (Amendment) Rules, 2006, patent applications are now to be mandatory published
within one month after expiry of the statutory period of 18 months. In case of request for an early
publication, the application is to be published within one month from the date of request.
Procedure for Patent Registration

Types of PatentApplications
a) OrdinaryApplication
b) Application for Patent of Addition (granted for Improvement or Modification of the
already patented invention, for an unexpired term of the main patent).
c) Divisional Application (in case of plurality of inventions disclosed in the main
application).
d) Convention application, claiming priority date on the basis of filing in Convention
Countries.
e) National PhaseApplication under Patent Cooperation Treaty (PCT).
The first step to get a patent is the registration of the patent application. The steps to the
registration of the Patent application are:
1. Filing of a patent application Patent application is filed in India as follows :
a. Provisional application : A provisional application is filed without a set of claims and its
main purpose is to claim an earliest priority date.
b. Complete specification: A complete application is filed within 12 months from the
date of the priority application. A complete specification should consist of a set of claims
for which the legal protection is sought by the applicant.
c. PCT application: PCT application is filed within 12 months from the priority date to
all the designated countries under PCT, unless specified by the applicant.
d. Conventional application under Paris Convention: Conventional application is filed in
India within 12 months from the date of filing of the priority application.
e. National phase application through PCT: National phase application is filed in India
within 31 months from the date of filing the priority application.
2. Publication
A patent application is published in the Indian patent website after 18 months from the
date of filing of the priority application.
3. Examination
The applicant or any interested third party should file a request for examination by
paying the prescribed fees in order to examine the application. The time period for filing a request
for examination is 48 months from the date of filing the priority application. The application will
be treated as withdrawn in case of failure to file the request for examination within given time
period of 48 months.
4. First Examination Report (FER)
It is the examination report accompanying objections and requirements sent to an
applicant by the controller within six months from the date of request for examination or date of
publication. This report of examination is referred to as First examination report in India. The
response to the FER should be made within twelve months. Failure to respond within the given
time period will lead to the abandonment of the patent application.
5. Pre-grant opposition
Any interested person by way of representation can file a pre-grant opposition in the
Indian patent office within six months from the date of publication. Opposition can be filed on the
grounds of non compliance of patentability requirements such as novelty, obviousness and
industrial applicability, nondisclosure or wrongful mentioning of genetic resources or traditional
knowledge and wrongful obtaining of the invention.
6. Notice of allowance/ rejection of a patent application
Notice of allowance is issued if the Controller is satisfied with the reply of the applicant
subject to the requirements and objections.
7. Renewal fees
After the grant of the patent, the applicant is liable to pay the maintenance fee in order to
enforce the patent. Renewal fees are payable every year.
Documents Required for Filing anApplication

1) Application form in duplicate (Form 1).
2) Provisional or complete specification in duplicate. If the provisional specification is
filed, it must be followed by the complete specification within 12 months (Form 2).
3) Drawing in duplicate (if necessary).
4) Abstract of the invention in duplicate.
5) Information and undertaking listing the number, filing date and current status of each
foreign patent application in duplicate (Form 3).
6) Priority document (if priority date is claimed) in convention application, when directed
by the Controller.
7) Declaration of inventor-ship where provisional specification is followed by complete
specification or in case of convention/PCT national phase application (Form 5).
8) Power of attorney (if filed through PatentAgent).
9) Fee (to be paid in cash/by cheque / by demand draft)
Provisional Specification
Application for patent may be accompanied by the provisional specification. It should
contain the description of invention with drawing, if required. It is not necessary to include
claims, however, the complete specification should be fairly based on the matter disclosed in the
provisional specification and should be filed within 12 months. If the complete specification is
not filed within 12 months the application is deemed to have been abandoned.
Complete Specification
The complete specification is an essential document in the filing of patent application
along with the drawing to be attached according to the necessity. Complete specification shall
fully describe the invention with reference to drawing, if required, disclosing the best method
known to the applicant and end with Claim/Claims defining the scope of protection sought. The
specification must be written in such a manner that person of ordinary skill in the relevant field, to
which the invention pertains, can understand the invention. Normally, it should contain the
following matter-
1) Title of invention,
2) Field of invention,
3) Background of invention with regard to the drawback associated with known art,
4) Object of invention,
5) Statement of invention,
6) Asummary of invention,
7) Abrief description of the accompanying drawing,
8) Detailed description of the invention with reference to drawing/examples,
9) Claim(s),
10) Abstract.
Description
The specification must be written in good and clear English or Hindi. The specification
should indicate those features which are essential for the operation of the invention as well as
those features for which a choice can be made. The description must be sufficiently detailed for
someone who works in the same area of technology to be able to perform the invention from the
information given in the description. The best method of putting the invention into effect is
required to be described.
Claims
A set of properly drafted claims is an important part of complete specification. The
complete specification must have at least one Claim. The first claim is the main claim. The
subsidiary claims refer to the main claim and include qualifying or explanatory clauses on the
various integers of the main claim or optional features. They may also contain independent
claims. A claim is a statement of technical facts expressed in legal terms defining the scope of the
invention sought to be protected.
Abstract
The abstract is the concise summary of the invention preferably within 150 words and
shall commence with the title of the invention. It should be prepared in such a way that one can
understand the technical problem and solution with its usefulness.
Drawing
Drawing should be filed on standard A4 size sheet in duplicate. Drawing should be
drawn on the sheet with margin of 4 cm on top and left hand and 3 cm at the bottom and right hand
side. Figure should be shown clearly on sufficient scale in upright position with respect to top and
bottom position of the sheet.
List of forms with requisite fees for Patent filing

Form Title Fees for natural Fees for legal Comment
No. person person
1 Application for Grant of 1000 4000 Mandatory
Patent
2 Provisional/Complete
No fee* No fee* Mandatory
Specification
3 Statement and undertaking No fee* No fee* Mandatory
under Section 8
5 Declaration as to Inventor No fee* No fee* Mandatory
ship
9 Request for Publication 2500 10000 Optional
18 Request for Examination of Mandatory

2500 10000
Application for Patent
*A fee of 100/sheet (natural person) and 400/sheet (other than natural person) is applicable for each sheet
exceeding 30 sheets in a patent specification. Further, a fee of 200/claim (natural person) and 800/claim
(other than natural person) is applicable for each claim exceeding 10 claims in the patent specification.
Application is required to be filed according to the territorial limits where the applicant
or the first mentioned applicant in case of joint applicants, for a patent normally resides or has
domicile or has a place of business or the place from where the invention actually originated. The
four patent offices are located at Kolkatta, Mumbai, New Delhi and Chennai.
Patent
Office
Address Jurisdiction
Intellectual Property Office, Intellectual Property Rest of India
Kolkata Office Building, CP-2 Sector V, Salt Lake City,
Kolkata-700091, Phone : 23671945, 1946, 1987,
FAX-033-2367-1988,
Email:- kolkata-patent@nic.in
Intellectual Property Office, Intellectual Property States of Haryana, Himachal
Office Building, Plot No. 32, Sector 14, Dwarka, Pradesh, Jammu & Kashmir,
New Delhi New Delhi-110075, Phone : 011-28034304, Punjab, Rajasthan, Delhi and
28034305 28034306, FAX:011- 28034301,02 Chandigarh
Email: delhi-patent@nic.in
Intellectual Property Office, Boudhik Sampada The States of Maharashtra,
Bhawan, Near Antop Hill Post Office, S.M.Road, Gujarat, Madhya Pradesh,
Antop Hill, Mumbai - 400 037. Goa, Chhattisgarh, Daman
Mumbai Phone : 24137701, 24141026, 24150381, 24148165, and Diu & Dadra and Nagar
24171457 FAX : 24130387 Haveli
Email: mumbai-patent@nic.in
Intellectual Property Office, Intellectual Property The States of Andhra Pradesh,
Office Building, G.S.T. Road, Guindy, Karnataka, Kerala, Tamil
Chennai Chennai-600032, Nadu and the Union
Phone: 044-22502081-84 FAX: 044-22502066, Territories of Pondicherry and
Email: chennai-patent@nic.in Lakshadweep
Patent infringement
Patent infringement in India is the commission of a prohibited Act with respect to a
patented invention without permission from the patent holder. Whenever the monopoly rights of
the patentee are violated, the patentee has to institute a suit for infringement. The relief in terms
of Interlocutory/interim injunction, damages or account of profits and/or permanent injunction
may be awarded in such a suit.
Summary
Patent: A patent is a document, issued, upon application, by a Government office for
disclosing a new invention by the applicant/s. A patent describes an invention and creates a legal
right for the owner to manufacture, use, sell or import the invention.
Tests of patentability:
1.An invention should be novel
2. It should be non-obvious with an inventive step and
3. It should have industrial application.
The Patent System in India is governed by the Patents Act, 1970 (No. 39 of 1970) as
amended by the Patents (Amendment) Act, 2005 and the Patents Rules, 2003, as amended by the
Patents (Amendment) Rules 2006 effective from 05-05-2006.
Term of Protection:
The term of patent is 20 years uniformly for all inventions.
Procedure for Registration of Patent in India with timeframe
ProvisionalApplication Non provisionalApplication

18 months
Pre-Grant Opposition
Publication 48 months
Institution of Proceeding
Request for examination
Hearing 06 months
03 months First Examination Report
Decision
Placing Application in 12 months
Appeal to IPAB order to Grant
Refused Granted Decision to Grant Patent
Appeal to IPAB Granted Refused
1 yr from 03 months
Decision to Refuse notification Appeal Refused
Appeal to IPAB Grant Notified Granted
Decision to Refuse Post Grant Opposition Refused
Granted Appeal
Refused

1. The patent system was first introduced in India in ________.
a. 1859 b. 1856 c. 1911 d. 1970
2 Following inventions are patentable except________.
a. Machines made by human beings
b. New process developed by manufacturer
c. Theoretically developed process of manufacture
d.All
3. Topography of integrated circuit is__________ type of invention.
a. Patentable b. Non patentable c. Both d. None
4. PCT stands for________.
a. Patent Cooperation Treaty
c. Patent Convention Treaty
b. Patent Corporation Treaty
d. none
5. Term of protection for new invention is ________years.
a. 7 b. 10 c. 15 d. 20
6. In Patents Amendment, ________the word “mere” is added to the line “new use for a known
substance is not an invention”.
a. 2002 b. 2005 c. 2006 d. 2008
7. The invention can be defined under section ________ of the PatentAct, 1970.
a. 39 b. 4 c. 3 d. 1
8. The royalty payment for any invention used by the Central Government or any other person on
the behalf of Government for such use was to be compensated by royalty and other remuneration
not exceeding _______% of the net ex-factory sale price in bulk.
a. 39 b. 4 c. 3 d. 1
9. Third amendment of PatentAct came into effect was amended on ________.
a. 1st Jan. 2005 b. 20th May 2003
c. 4thApril 2005 d. 20th Jan.2005
10. If a patent is accompanied by a provisional specification, the complete specification should
be filed within _____ months of filing the application.
a. 3 b. 6 c. 9 d. 12
11. National phase application is filed in India within_______ months from the date of filing the
priority application
a. 6 b. 12 c. 31 d. 9
12. Information and undertaking listing the number, filing date and current status of each foreign
patent application should be made in _______in Form _______.
a. duplicate, 3 b. triplicate, 3
c. duplicate, 5 d. triplicate, 5
Important questions
1. What do you mean by intellectual property? What does the Intellectual property right cover?
2. What does the following laws protect and for how much period?
a. Patents law b. copyrights law c. trademarks law
3. Enlist the tests of patentability. Explain types of patent.
4. Discuss in brief history of patents law in India.
5.According to section 3 of PatentsAct, 1970 what cannot be termed as an invention?
6. What are the salient features of PatentsAct, 1970?
7. Enumerate the various amendments of PatentsAct, 1970.
8. What are the salient features of Patents (Amendment)Act, 2002?
9. What are the salient features of Patents (Amendment)Act, 2005?
10. Describe in detail procedure of patent registration.
11. Enlist the documents required for filing an application.
12. What do you mean by patent infringement?
13. Name the places where the patent offices are located.

1. b 2. c 3. b 4. a 5. d 6. b 7. c 8. b 9. c 10. d
11. c 12. a
Chapter 15
MEDICAL TERMINATION OF PREGNANCY ACT, 1971
Learning objectives
1. identify the objective of the Medical Termination of PregnancyAct, 1971.
3. explain the conditions under which the pregnancy may be terminated by Registered Medical
Practitioner.
Introduction
Medical Termination of Pregnancy Act was passed by the parliament in 1971 with the
objective to provide for the termination of pregnancy by Registered Medical Practitioner
(R.M.P.) for bonafide reasons. Termination of pregnancy during certain period is harmful to the
health of pregnant woman or it may have serious effects on the child of such woman. Pregnancy
should be terminated under hygienic conditions along with the required facilities in specified
premises under the supervision of Registered Medical Practitioner.
Objective
The objective of this Act is to provide for the termination of pregnancy by R.M.P. and to
provide for matters connected there with.
Definitions
1. Guardians
It means a person who have to take care of a minor or lunatic.
2. Minor
Minor means a person who under the provisions of the Indian Majority Act,1875 is to be
deemed not to have attained in his majority.
Registered Medical Practitioner means a person holding qualification granted by an
authority specified or notified under sec. 3 of the Indian Medical Degrees Act, 1916 as
may be specified in the Schedule to the Indian Medical Council Act, 1956 and who has
such experience or training in gynecology and obstetrics as may be prescribed by the
rules made under thisAct.
224 |
Medical Termination of Pregnancy Act, 1971 | 225
Circumstances under which pregnancy may be terminated by Registered Medical

Practitioner
1. The pregnancy may be terminated by R.M.P. where the length of pregnancy does not
exceed 12 weeks, and if such Medical Practitioner of opinion (formed in good faith) that
the continuance of pregnancy would involve a grave danger to the life of woman or to her
physical and mental health or the child to be born would be seriously handicapped due to
physical and mental abnormalities.
2. A pregnancy may be terminated by R.M.P. where the length of pregnancy exceeds 12
weeks but does not exceed 20 weeks, two Registered Medical Practitioners are of such
opinion. The pregnancy which is alleged to have been caused due to rape or due to
failure of contraceptive device used by a woman or her husband for purpose of family
planning which may be presumed to constitute a grave risk to mental health of the
woman.
3. In determining health hazard, the pregnant woman’s actual condition in the foreseeable
future may be taken in to account.
4. The Registered Medical Practitioner may terminate a pregnancy of a woman who have
attained 18 years of age with her consent and the woman who have not attained 18 years
of age the consent of her guardian in writing is necessary.
Places for the termination of pregnancy

Pregnancy may be terminated by Registered Medical Practitioner at –
1. Hospital established by the Government; or
2. Any other place approved by the State Government for this purpose.
Those places should provide –
a) Operation table and surgical instruments for performing abdominal and gynecological
surgery.
b) Anaesthetic equipment, resuscitation equipment and sterilised equipment.
c) Drugs and parenteral fluids for emergency use.
Inspection ofAPlace for Termination of Pregnancy

A place approved for termination of pregnancy may be inspected by the Chief Medical
Officer of the District, with a view to verify whether termination of pregnancy is being done
under safe and hygienic conditions. If Chief Medical Officer is not satisfied due to safety and
hygienic condition of the place, he may call for any information, or may seize any article,
medicine, ampule, admission register or other document maintained kept or found at the place.
The provisions of code of Criminal Procedures may also apply in case of seizures.
Cancellation or Suspension of Certificate ofApproval

If Chief Medical Officer of the District is not satisfied with the facilities provided under
the rules, he shall report to the Government with details of deficiencies or defects found at the
place. On receipt of such report, the Government may either cancel the certificate of approval or
suspend the same for such period as it may think fit. However, the owner of the place shall be
given a reasonable opportunity of being heard.
Maintenance ofAdmission Register
Medical termination of pregnancy rules, 1975 provides for the maintenance of
admission register. Such register should be maintained by the head of hospital or owner of the
approved place in prescribed form of the admissions of women for termination of their
pregnancies.
Serial number should be given to each entry in the Admission Register. A fresh serial
should be given to each calendar year. The serial number of particular year should be
distinguished from the serial numbers of other years. e.g. serial number 7 of 1987 and serial
number 7 of 1988 should be as 7/1987 and 7/1988. The Admission Register is a secrete
document. The details regarding the name and other particulars of the pregnant woman should
not be disclosed to any person.

Any person who is not a Registered Medical Practitioner but engaged in termination of
pregnancy, such person shall be punishable with an imprisonment or with a fine or with both.
Any contravention of the provisions of this Act shall be punishable with an
imprisonment or with a fine up to `1000 or with both.
Summary
Medical termination of pregnancy Act, 1971 provides for the termination of pregnancy
by Registered Medical Practitioner. The pregnancy should not be terminated where the total
period of it exceeds 12 weeks. Where such period is more than 12 weeks, Registered Medical
Practitioner who is expert may terminate such pregnancy. When the total period of pregnancy
exceeds from 12 to 20 weeks, two Registered Medical Practitioners may terminate such
pregnancy. Pregnancy should be terminated with the consent of pregnant woman who have
completed her 18 years of age and when the woman have not attained her 18 years of age, the
consent of her guardian in writing form is required. Pregnancy should be terminated by
Registered Medical Practitioner at places approved by Government where there are adequate
facilities for termination. Such place should be inspected by Chief Medical Officer of the
District. Head of the hospital or owner should maintain the admission register for termination of
pregnancy.
Medical Termination of Pregnancy Act, 1971 | 227

1. Pregnancy may be terminated by Registered Medical Practitioner at _________
a. any other place b. hospital approved by State Government
c. any hospital d. none of above
2. The pregnancy may be terminated by RMP with the consent of women who have attained her
___ years of the age.
a. 18 b. 21 c. 35 d. 16
3. When the length of pregnancy exceeds from 12 to 20 weeks, _______ RMP /(s)may terminate
such pregnancy.
a. one b. Two c. Three d. Four
4. Registered Medical Practitioner in the context of thisAct have experience in _______
a. surgery b. medicine c. obstetrics and gynecology d. pediatrics
5.The admission register and its maintenance is regulated under Medical Termination of
Pregnancy Regulations, _______.
a. 1971 b. 1972 c. 1973 d.1975
Important questions
1. What is the objective of the medical termination of pregnancyAct, 1971?
a. Guardian
b. Minor
c. Registered Medical Practitioner
3. Under what conditions the pregnancy may be terminated by Registered Medical Practitioner?
4. Name the places where pregnancy may be terminated by Registered Medical Practitioner.
6. Write a note on maintenance of admission register.
7. Discuss in brief about inspection of a place for termination of pregnancy.

1. b 2. a 3. b 4. c 5. d
Textbook of Computer Applications and
Biostatistics aims to provide the basic knowledge
of computer and biostatistics in view of helping
pharmacy undergraduate students to understand
various concepts in both computers and
biostatistics. Most of the times, pharmacy
students neglect both these important subjects
just because they consider these subjects either
as allied or harder to understand due to complex
mathematics involved in it. Authors have taken
care to keep mathematics to minimum and
focused on conceptual understanding of subject,
as statistical operations can also be best handled
by using computers.
The features of this textbook include:

It provides a set of learning objectives at the beginning of each topic.
It provides basic concepts needed in computers and biostatistics.
It reviews mathematical tools required for calculations of various statistical procedures.
It provides the applications of both computers and biostatistics to pharmacy field.
It provides the detailed account of how to use MS-Office and Internet.
It provides the steps for estimating statistics using Microsoft Excel for both descriptive and
inferential statistics.
It provides the choice of statistical tests for various situations.
It provides a set of multiple choice questions and exercises at the end of every chapter.
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Book · January 2012

Remeth J Dias Vijay Havaldar

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Provides a set of learning objectives at the beginning of

About this book

would work under the guidance of Central Drugs Laboratory.

The Indian PatentsAct, 1970

Sr No Pharmaceutical Legislations Rules to the Act Subsequent Amendments

Multiple Choice Questions

b. political system d. none

Answers to multiple choice questions

Pharmaceutical Code of Ethics

2. Pharmacist in relation to his trade

1. Pharmacist in relation to his job

2. Pharmacist in relation to his trade

b) Fair trade practice

3. Pharmacist in relation to medical profession

4. Pharmacist in relation to his profession

standard of the profession.

Multiple Choice Questions

Answers to multiple choice questions

Schedules to the Rules

12. Pharmacy [Rule 65 (15(c)]

19. Spurious Drug [sec. 3(h)]

India or United States of America or the United Kingdom or German Homoeopathic

Chapter II Administrative Bodies

3. One Pharmacologist is elected by the Governing Body of the Indian Council of

II) Drug Consultative Committee (DCC)

is carried out at the Laboratory of Serologist and Chemical Examiner to Government of

2. Drugs Control Laboratories in the States [sec.7]

2. Post graduate degree in medicine or science or pharmacy or pharmaceutical chemistry

Duties of Government Analyst

Procedure to be followed by Government Analyst on receipt of Samples

of the seal received separately.

Powers of Drug Inspector

deliver any drug or cosmetic to a purchaser.

Duties of Drug Inspectors

Duties in relation to manufacture of drug

b.The means employed for testing and standardizing of drugs.

Procedure of Inspection (to be followed by Drug Inspector)

Chapter III Import of Drug and Cosmetics

Conditions of import licence for Schedule C and Schedule X drugs

Import of new drugs

Places through which drugs may be imported into India

Provisions of sea customs in respect of drugs and cosmetics

Classes of drugs and cosmetics to be imported

Classes of drugs which are prohibited for import in India

Duration of Import Licence

Chapter IV Manufacture, Sale and Distribution of drugs and cosmetics

2. The licensee shall allow an inspector –

Conditions for the manufacture of drugs specified in Schedule X (Form 25 or 25F)

C. Accounts of the manufactured drugs:

Conditions of Licence forAllopathic Loan Licence Manufacturing (Rule 74B)

cancelled or suspended as the case may be, under these rules.

Duration of loan licence

Conditions to be satisfied by applicant before the grant of repacking licence

Conditions for grant or renewal of licence

Provisions relating to Sale of Drugs

Licence for Licence of Application Licence fee Additional Fee per