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Bangoriya Assistant professor Quality Assurance Department S. J. Takkar Pharmacy college Rajkot
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Contents
History and Objectives Definitions Administration of the act and rules Provisions related to Import Provisions related to Manufacture Provisions related to Sale Labeling and Packaging Schedules to the act and rules Recent amendment act, 2008 List of forms
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History
British misrule-Providing poor healthcare system to
Indian citizens
Observations made by-Drugs Enquiry Committee,
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Objectives
To regulate the import, manufacture, distribution
and sale of drugs & cosmetics through licensing. Manufacture, distribution and sale of drugs and cosmetics by qualified persons only. To prevent substandard in drugs. To regulate the manufacture and sale of Ayurvedic, Siddha and Unani drugs. To establish Drugs Technical Advisory Board(DTAB) and Drugs Consultative Committees(DCC) for Allopathic and allied drugs and cosmetics.
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Definitions
Drugs :
All medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals, including preparations applied on human body for the purpose of repelling insects like mosquitoes.
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Cosmetic :
Any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to, the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and includes any article intended for use as a component of cosmetic.
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Misbranded drugs : (a) if it is so coloured, coated, powdered or polished that damage is concealed or if it is made to appear of better or greater therapeutic value than it really is; or
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Adulterated drug :
(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 insanitary 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 substance which may render the contents injurious to 9 health. SJTPC
Spurious drugs :
(a) if it is imported under a name which belongs to another drug; or (b) if it is an imitation of, or a substitute for, another drug or resembles another drug in a manner likely to deceive or bears upon it or upon its label or container the name of another drug
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Manufacture :
In relation to any drug or cosmetic, it includes any process or part of a process for making, altering, ornamenting, finishing, packing, labelling, breaking up or otherwise treating or adopting any drug or cosmetic with a view to its sale or distribution but does not include the compounding or dispensing of any drug, or the packing of any drug or cosmetic, in the ordinary course of retail business.
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B) Analytical :
1)Central Drugs Laboratory - CDL 2)Drug Control Laboratory in states 3)Government Analysts
C) Executives :
1)Licensing authorities 2)Controlling authorities 3)Drug Inspectors
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Nominated:
1) Two persons by the Central Government.
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Elected: 1)one person, to be elected by the Executive Committee of the Pharmacy Council of India,
2)one person, to be elected by the Executive Committee of the Medical Council of India,
3)one pharmacologist to be elected by the Governing Body of the Indian Council of Medical Research;
4)one person to be elected by the Central Council of the Indian Medical Association; 5)one person to be elected by the Council of the Indian Pharmaceutical Association;
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Functions:
To advise the Central Government and the State Governments on technical matters. To carry out the other functions assigned to it by this Act.
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government.
Constitution:
Two
of of
the each
Central State
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Functions:
To advise the Central Government, the State Governments and the Drugs Technical Advisory Board on any other matter tending to secure uniformity throughout India in the administration of this Act.
The Drugs Consultative Committee shall meet when required Has power to regulate its own procedure.
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Functions:
Analysis or test of samples of drugs/cosmetics sent by
the custom collectors or courts. Analytical Q.C. of the imported samples. Collection, storage and distribution of internal standards. Preparation of reference standards and their maintenance. Maintenance of microbial cultures. Any other duties entrusted by Central Government. Acting as an appellate authority in matter of disputes.
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Function: Testing of drug sample Analysis of food sample Analysis of exicse sample
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Government analyst
These officers are appointed by the central or state
government and perform the duties. Qualification of government analysist 1 Persons having qualification for appointment as government as govermental Analysis for allopathic drugs ; 2 having a degree in medicine, ayurved, sidha or unani system and not less than three year post graduate experience in the analysis of drugs in a laboratory under control of a government analyst.
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Duties: 1) The Government Analyst shall cause to be analysed or tested such samples or drugs and cosmetics as may be sent to him by Inspectors. 2)A Government Analyst shall from time to time forward reports to the Government giving the result of analytical work and research with a view to their publication.
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Licencing authority
Qualification: (i) Graduate in Pharmacy on Pharmaceutical Chemistry or in Medicine with specialization in clinical pharmacology or microbiology from a University established in India by law; and (ii)Experience in the manufacture or testing of drugs a minimum period of five years, Provided that the requirements as to the academic qualification shall not apply to those inspectors .
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Duties: (1) to inspect all establishments licensed for the sale of drugs within the area assigned to him; (2) to satisfy himself that the conditions of the licences are being observed; (3) to procure and send for test or analysis, if necessary, imported packages. (4) to investigate any complaint.
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(5) to maintain a record of all inspections made and action taken by him in the performance of his duties, (6) to make such enquiries and inspections as may be necessary to detect the sale of drugs in contravention to the Act;
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Controlling authority
Qualification: graduate in Pharmacy or Pharmaceutical Chemistry or in Medicine with specialization in clinical Pharmacology or microbiology from a University established in India by law and experience in the manufacture or testing of drugs or enforcement of the provisions of the Act for a minimum period of five years:
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Drug Inspector
Qualification 1 Persons having qualification for appointment as government as govermental Analysis for allopathic drugs ; or 2 having a degree in ayurved, sidha or unani system and not less than three year post graduate experience in the analysis of drugs in a laboratory under control of (a) a government analyst, or (b) a chemical examinar, or (c) head of an institution specially approved for this purpose.
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Power:
a) Inspect, -(i) any premises where in any drug or cosmetic is being manufactured. (ii) any premises where in any drug or cosmetic is being sold, or stocked or exhibited or offered for sale, or distributed ; (b) Take samples of any drug or cosmetic,-(i) which is being manufactured or being sold or is stocked or exhibited or offered for sale, or is being distributed; (ii) from any person who is in the course of conveying, delivering or preparing to deliver such drug or cosmetic to a purchaser or a consignee.
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Import
Sales
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IMPORT
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IMPORT of drugs
Classes of drugs prohibited to import Import of drug under license
1)Specified in Schedule-C/C1 2)Specified in Schedule-X 3)Imported for Test/Analysis 4)Imported for personal use 5)Any new drugs Drugs exempted from provisions of import Offences and Penalties
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Adulterated drugs
Spurious drugs Drugs
whose manufacture, sale/distribution are prohibited in original country, except for the purpose of test, examination and analysis. Patent/Proprietary medicines whose true formula is not disclosed.
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withdrawn and he is advised not to sale, and recall the batch from the market.
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Applicant must be reputable in the occupation, trade or business. The license granted even before should not be suspended or cancelled. The licensee has not been convicted any offence under the Drugs and Cosmetics Act or Narcotic and Psychotropic Substances Act.
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License is necessary under form-11 Must use imported drugs only for said purpose
medicinal use. Substances which are both drugs and foods such as: Condensed/Powdered Milk Malt Lactose Farex/Cereal Oats Predigested foods Ginger, Pepper, Cumin, Cinnamon
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Import of spurious OR a) 3 years imprisonment and adulterated drug OR drug which 5000 Rs. fine on first involves risk to human beings or conviction animals OR drug not having b) 5 years imprisonment OR therapeutic values 1000 Rs. fine OR both for subsequent conviction
a) 6 months imprisonment OR 500 Rs. fine OR both for first conviction b) 1 year imprisonment OR 1000 Rs. fine for subsequent offence
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MANUFACTURE
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Manufacture
Prohibition of manufacture
Loan license
Repackaging license Offences & Penalties
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Drug not of standard quality or misbranded, adulterated or spurious. Patent or Proprietary medicine Drugs in Sch-J Risky to human beings or animals
Prohibition of manufacture
facility for testing, separate from manufacturing Adequate storage facility Records maintained for at least 2 years from date of Exp. Should provide sample to authority Furnish data of stability Maintain the inspection book Maintain reference samples from each batch
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glass or suitable container Containers should comply with Sch-F Some classes tested for aerobic & anaerobic microorganism.eg. Sera ,Insulin, Pituitary hormones. Serum tested for abnormal toxicity Parentral in doses of 10 ml or more should be tested for freedom from Pyrogens Separate lab. for culture & manipulation of spore bearing Pathogens Test for sterility should be carried out.
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be maintained in serially.(Preserved for 5 years) Have to sent invoice of sale to licensing authority every 3 months Store drugs in direct custody of responsible person. Preparation must be labeled with XRx Marketed in packings not exceeding 100 unit dose Tablets/Capsules 300 ml- Oral liquid 5 ml - Injection
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Loan License
Definition:
A person(applicant) who does not have his own arrangements(factory) for manufacture but who wish to manufacturing facilities owned by another licensee. Such licenses are called Loan licenses. Loan licenses are issued for: 1) Drugs other than specified in C/C1 & X. 2) Drugs specified in Schedule-C/C1
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Repackaging license
Definition:
Process of breaking up any drug from a bulk container into small packages and labeling with a view to their sale and distribution. Repackaging of drugs is granted of drugs other than Schdule-C/C1 and X.
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PENALTIES
a) 1-3 years imprisonment and Rs.5000 fine b) 2-6 years imprisonment & Rs.10000 fine on subsequent conviction a) 1 year imprisonment & Rs.2000 fine b) 2 years imprisonment & Rs.2000 fine for subsequent conviction
Manuf. of drugs in contravention of a) Imprisonment up to 3 months & the provisions Rs.500 fine b) Imprisonment up to 6 months & Rs.1000 fine on subsequent conviction
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Manufacture of cosmetics
Prohibited for the following classes of drug:
Misbranded or spurious cosmetics and of substandard
quality Cosmetics containing hexachlorophene or mercury compounds Cosmetics containing color which contain more than- 2 ppm of arsenic - 20 ppm of lead - 100 ppm of heavy metals Eye preparations containing coal-tar color
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SALE
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Sale of Drugs
Classes of drugs prohibited to be sold
Wholesale of biological (C/C1) Wholesale of other than those specified in C/C1
and X
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of standard quality Patent/Proprietary drugs with undisclosed formula Sch-J drugs Expired drugs. Drugs used for consumption by government schemes such as, Armed force. Physicians samples
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area, with proper storage facility Drugs sold only to retailer having license Premises should be in charge of competent person who is Reg. Pharmacist. Records of purchase & sale Records preserved for 3 years from date of sale License should displayed on premises
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labeling and packaging specified to all classes of drugs and cosmetics should be as per the provisions made under the act.
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For allopathy
Label
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with by imported drugs and by drugs manufactured for sale, sold, stocked or exhibited for sale or distribution
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A B C C1
Performa for forms( Application, issue, renewal, etc.) Rates of fee for test or analysis by CDL or Govt. analysts List of Biological and special products (Injectable) applicable to special provisions. List of Biological and special products (nonparenteral) applicable to special provisions. List of drugs that are exempted from provisions of import List of poisonous substances under the Ayurvedic , Siddha and Unani systems Provisions applicable to blood bank
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D E1 F
F1
Special provision applicable to biological and special products, eg. Bacterial and viral vaccines, sera from living animals, bacterial origin diagnostic agents Standards for surgical dressings Standards for umbilical tapes Standards for ophthalmic preparations
F2 F3 FF
G
H
under medical
List of substances (prescription) that should be sold by retail only on prescriptions of R.M.P.
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J
K
M M1
List of diseases and ailments that drug should not claim to cure
List of drugs that are exempted from certain provisions regarding manufacture
Requirements of manufacturing premises, GMP requirements of factory premises, plants and equipments Requirements of factory premises for manufacture of Homeopathic medicines
M2
M3 N O
CONTENT
R
R1 S T U
U1
V
W
X
manufacture, sale and distribution of spurious and adulterated drug likely to cause grievous hurt
Minimum punishment of seven years which may extend to life imprisonment Provision for compensation to affected person
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QUESTIONS
Describe the functions of Central Drug Laboratory. Sale of drugs according to Drugs and Cosmetic Act. Describe the administration of Drug and cosmetics act Manufacture of drugs according to Drugs and
Cosmetics Act.
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References
www.cdsco.nic.in
Pharmaceutical Jurisprudence, Jani GK, Atul prakashan; Fifth edition(2005-06); 28.
Forensic Pharmacy, Kokate CK and Gokhle SB, Pharma Book Syndicate; 152
Laboratories http://www.gujhealth.gov.in/fdc-
laboratory.htm
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