Regulatory aspects of Pharmaceuticals and Bulk

drug Manufacturing, Regulation of drugs and

pharmaceuticals.

Under the guidance of

Sri B. Thangabalan Sir, M. Pharm
(Ph.D)
By
K. Sampath Kumar,
Y11MPH18060,
I/II M.Pharm,
2nd Semester,
Pharmaceutical Analysis,
Sims college of Pharmacy.
1
 Introduction:
Drugs play an important role in the health of both people and the
economy of a country.
Pharmaceutical drugs are available from a large number of sources.
People and Governments willing to spend money on drugs for many
reasons so, it must be safe, effective and good quality and used
appropriately.
This means, in turn, that development, production, importation,
exportation and subsequent distribution of drugs must be regulated
to ensure that they meet prescribed standards.
Therefore, effective drug regulation is required to ensure the safety,
efficacy and quality of drugs as well as accuracy and appropriateness
of the drug information available to the public
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 Regulatory requirements
►In an ideal world, the need for analysis should be driven by the
desire to assure the quality of a drug product.

►However, in the real world the need for pharmaceutical drug

analysis is driven largely by regulatory requirements.

►A team consisting of R&D, QC, and QA unit members develops

these quality and compliance systems.

►It should be one of the highest priorities of top management and

QA units to develop and monitor these systems to comply with the
cGMP and GLP expectations.

►Compliance documents are needed, in addition to the regulatory

and research documents, to demonstrate the integrity of the data.

►Compliance documents refer to those reports required by GMP

3and/or utilized during the course of inspection by a health
authority.
 Key function of regulatory agencies

Product registration (drug evaluation and authorization, and

monitoring of drug efficacy and safety);
Regulation of drug manufacturing, importation, and
distribution;
Regulation & Control of drug promotion and information.
Adverse drug reaction (ADR) monitoring.
Licensing of premises, persons and practices.

Goal of regulatory agency

Main goal of drug regulation is to guarantee the safety, efficacy
and quality of drugs available to public.

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 The drug regulation

Drug Laws

Drug Regulatory Agencies

Drug Regulatory Boards

Quality Control

Drug Information Centres etc.

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Drug regulatory system in India

Drugs and Health is in concurrent list of Indian Constitution It is

governed by both Centre and State Governments under the Drugs &
Cosmetics Act, 1940.

MAIN BODIES

Central Drug Standard Control Organization (CDSCO)

Ministry Of Health & Family Welfare (MHFW)
Indian Council Of Medical Research (ICMR)
Indian Pharmaceutical Association (IPA)
Drug Technical Advisory Board (DTAB)
Central Drug Testing Laboratory (CDTL)
Indian Pharmacopoeia Commission (IPC)
National Pharmaceutical Pricing Authority (NPPA)
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WELL DEFINED DRUG REGULATORY SYSTEM(Govt.
of India)

Ministry of health and family welfare

DTAB DCGI

 Enforcement & GMP audit Division

 Quality Control Division – CDTL
 Registration Division
 New Drug Division
 Pharmacovigilance

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 Trainings
 Approval of Investigational New Drug (IND)

IND Applicant Approval

CDSCO Recommendation
to DCG (I)

Examination Detailed review

by new drug by IND
division committee

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 Central licensing

Joint inspection
State licensing
Manufacturer by state and
authority central inspectors

CLAA approval License prepared Examination of

and grant of by state licensing
license
report
authority

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 CDSCO

Central Drug Standard Control Organization

Head quarters New Delhi

North Zone Ghaziabad
West Zone Mumbai
South Zone Chennai
East Zone Kolkata.
Other zonal offices Ahmedabad and Hyderabad.
Sub-Zonal Office 2
Port offices/Airports 7
Laboratories 6
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 CDSCO Drug Controller General (I)

Head Zonal & sub Port

Laboratory
Quarter Zonal office Office

New Drugs GMP Audits Import

CLAA
Testing of drug
Coordinates Export samples
Imports
DTAB/DCC
with states Validation of
Test Protocol

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Functions undertaken by Central Government
Statutory function:

Laying down standards of drugs, cosmetics, diagnostics and devices.

Laying down regulatory measures, amendments to Acts and rules.
To regulate market authorization of new drugs.
To regulate clinical research in India
To approve licenses to manufacture certain categories of drugs as
Central License Approving Authority(CLAA) i.e. for Blood Banks, Large
Volume Parenterals and Vaccines & Sera.
To regulate the standards of imported drugs.
Work relating to the Drugs Technical Advisory Board ( DTAB ) and
Drugs Consultative Committee (DCC).
Testing of drugs by Central Drugs Labs.
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 NIHFW

National Institute of Health and Family Welfare

NIHFW is an Apex Technical Institute, funded by Ministry of

Health and Family Welfare, for promotion of health and family
welfare programmers in the country through education, training,
research, evaluation, consultancy and specialized services.

The NIHFW was established on March 9, 1977 by a merger of the

National Institute of Health Administration and Education (NIHAE)
with the National Institute of Family Planning (NIFP)

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 List of Governing Body Members of NIHFW

• 18 members

1 Chairman
(ex-officio)

1 Vice 1 Member
Chairman NIHFW Secretary
(ex-officio) (ex-officio)

9 Member
6 Member
(ex-officio)

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 ACTIVITIES AND RESPONSIBILITIES

Measuring weight of children to assess the nutritional

status.
Assessment of diseases like level of anemia.
Testing of food material like cooking salt for level iodine.
To release fund on the advice of the Ministry.
It is responsible for all governmental programs relating to
family planning in India.

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 Structure and organization
ICMR
Union Health Minister

Governing body

Scientific Advisory
Board

Scientific advisory Expert groups

groups

Scientific advisory Steering

committee Committee

16 Task forces
 ACTIVITIES AND RESPONSIBILITIES

Extramural research is promoted by ICMR by establishing

Centers for Advanced Research in different research areas.
Open-ended research is conducted on the basis of applications
for grants-in-aid received from scientists in non-ICMR Research
Institutes, Medical colleges and Universities located in different
parts of the country.
Balancing of research efforts between different competing
fields, especially when resources are severely limited, is a typical
problem encountered in the management of medical research,
particularly in developing countries

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 IPA
The Indian Pharmaceutical Association (IPA) has demanded to
amend the Drugs &Cosmetics Act and Rules 1945 to make only the
pharmacy graduates eligible to become expert staffs in the pharma
manufacturing units.
In the resolutions passed during the just concluded IPA
Convention, the IPA also urged the government to expedite action to
amend the Rules in such way that all regulatory positions in the
country must be an exclusive area for experienced and qualified
pharmacists.
Indian Pharmaceutical Association (IPA) is the premier professional
association of pharmacists in India.
The association has more than 10,000 members from various
parts of the country and it operates in India through 17 state
branches & more than 33 local branches.
The association represents various facts of pharmaceutical
profession and in managing several academic programmes.

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 DTAB

DRUG TECHNICAL ADVISORY BOARD

The Central Government constitute a Board (to be called the
Drugs Technical Advisory Board) to advise the Central
Government and the State Governments on technical matters
arising out of the administration of D&C, Act 1940
The Board shall consist of the following members,
– 20 Members

10 ex-officio
Members

5
5 Elected
Nominated DTAB Members
Members
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 ACTIVITIES AND RESPONSIBILITIES

It advices matter related to Drugs.

The nominated and elected members of the Board shall hold
office for three years, but shall be eligible for re-nomination and
re-election.
The Board may, subject to the previous approval of the Central
Government, regulating its own procedure.

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 CDTL

CENTRAL DRUG TESTING LABORATORY

The central drug laboratory, Kolkata is national statutory

laboratory of the government of India for quality control of drug
and cosmetic and established under the D&C act ,1940.
Oldest quality control laboratory of the drug control
authorities in India.
Function under the director general of Health Services in the
Ministry of Health and Family Welfare.

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 FUNCTIONS UNDER TAKEN

► Statutory Function :

To Act as an Appellate authority.

To function as Government Analyst for such states who do not have
their own testing facilities.
Analytical quality control of majority of the imported drugs.
Analytical quality control of drug formulations manufactured
within the country on behalf of the Central & State Drug standard
control organization

►Other Functions:

Procurement, establishment, maintenance, Storage and distribution

of I.P & International Reference standards.
Preparation and standardization of I.P. reference standards against
USP, BP primary standards.
To undertake analytical research in standardization and
methodology
22 development of drug.
 IPC
Indian Pharmacopoeia Commission

General body
(19 Members)

CIPL lab IPC Governing body

(10members)

IPC Scientific body

secretariat 23 experts

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 ACTIVITIES AND RESPONSIBILITIES

Development of comprehensive monographs.

Accord priority to monographs of drugs included in the
national Essential Drug List and their dosage forms.
Preparation of monograph for products that have normally
been in the market for not less than 2 years.
Collaborate with pharmacopoeias like the BP, USP, JP and
International Pharmacopoeia with a view to harmonizing with
global standards.

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 NPPA
National Pharmaceutical Pricing Authority
• For the purpose of implementing provisions of DPCO, powers of
the Government have been vested in the National Pharmaceutical
Pricing Authority (NPPA).
• Drugs have been declared as essential and accordingly put under
the Essential Commodities Act.
• Only 74 out of 500 commonly used bulk drugs are kept under
statutory price control.
• However, the prices of other drugs can be regulated, if warranted
in public interest.
• The NPPA was established on 29th August 1997 as an
independent body of experts following the Cabinet Committee’s
decision
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in September 1994 while reviewing the Drug Policy.
 NPPA

The Authority, inter alia, has been entrusted with the task of

fixation/revision of prices of pharmaceutical products (bulk

drugs and formulations),

enforcement of provisions of the Drugs (Prices Control) Order

monitoring the prices of controlled and decontrolled drugs in

the country.

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 Features

Ceiling and Non Ceiling Prices of drugs and medicines in the

controlled category regulated .

Ceiling Price is the single maximum selling price fixed that is

applicable throughout the country in the case of each bulk drug,

which is under price control.

Non-Ceiling Price fixed by NPPA are specific to a particular

pack size of scheduled formulation of a particular company.

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 GMP

Good Manufacturing Pratices

GMP guidelines are not prescriptive instructions on how to

manufacture products.
They are a series of general principles that must be observed
during manufacturing.
When a company is setting up its quality program and
manufacturing process, there may be many ways it can fulfill
GMP requirements.
It is the company's responsibility to determine the most effective
and efficient quality process.
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 REQUIREMENTS

 To ensure that their products are safe, pure, and effective.

To minimize or eliminate contamination, mix up and errors.
Issues including recordkeeping, personnel
qualifications, sanitation, cleanliness, equipment verification, process
validation, and complaint Handling.
GMP is also sometimes referred to as "cGMP”.
Failure of firms to comply with GMP regulations can result in very
serious consequences including recall, fines, and even
imprisonment.

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WHO GUIDELINES (World Health Organization):

Who is an agency of United Nations. It is a specialised agency and its

primary responsibility includes international health matters so that
the goal, health for all, can be achieved.
The WHO GMP and the certification scheme was accepted by WHA
(world health assembly) in solution no WHA 28.65, as the revised
version in 1975.
With appearance of ISO (International Organization For
Standardization) the WHO GMP needed next revision. The revised text
contains 3 parts.

Part I: out lines the general concepts of quality assurance and salient
components of GMP’s.
Part II: outlines on actions to be taken by production & quality control
personnel separately for implementing general principles of quality
assurance.
Part III: supporting and supplementary guidelines.

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 The revised text of GMP appears as annex.

ANNEX I: Quality Management in the Drug Industry

– Philosophy & Essential Elements

Quality Assurance
Good Manufacturing Practice
Quality Control
Sanitation & Hygiene
Validation
Complaints
Product recalls
Contract Production & Analysis
Self inspection and quality audits
Personnel
Premises
Material
Documentation

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 ANNEX II:
Good Practices – Production & Quality Control

Good Practices in Production

Good Practices in Quality Control

ANNEX III:
Supporting and Supplementary Guidelines

Sterile pharmaceutical Products

Good Manufacturing Practice for Active
Pharmaceutical Ingredients

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WHO GMP Certification
Originally established in 1969 and revised in 1975.
Main objectives were :

 To inspect drug manufacturing facilities

 To assess compliance of GMP

This would facilitate implementation of the scheme.

WHO GMP ensures the following:

Avoidance of Cross- Contamination

Prevention of Mix-ups
Provide Traceability
Accountability of actions
Responsibility
Product Performance Guarantee

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 FDA

DEFINITION
The U.S. Food and drug administration is an agency of the
United States Department of Health and Human services and is
responsible for the safety regulation of most type of foods

dietary supplements
Drug
Vaccines
Biological medical products
blood products
medical devices
radiation – emitting devices
veterinary products and
Cosmetics

The agency of the U.S. Department of Health and Human Services.

Established in 1927.
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How does ICH work?

ICH operates through the ICH Steering Committee with

administrative support from the ICH Secretariat and ICH
Coordinators.
The Steering Committee meets at least twice a year . During these
meetings, new topics will be considered for adoption, reports are
received on the progress of existing topics, and maintenance and
implementation of the guidelines are discussed.
The topics identified for harmonization by the Steering Committee
are selected from Safety, Quality, Efficacy, and Multidisciplinary
matters.

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 Your Responsibilities Under The Law
1. Before searching any person, explain him that he has a right to be
searched before a gazetted officer or a magistrate. If he so
requires, take him to a gazetted officer or a magistrate before whom
he can be searched. (Section 50.) without giving him a chance to
part with the drug, controlled substance, etc. you can search him
under Section 100 of the Cr. P. C. (Section 50(5) and 50 (6)).
2. Take down any information given by any person in writing before
authorizing a search (Section 41). If the search is under Section
42, also send a copy of the information taken in writing or the
grounds of belief for search within 72 hours to your immediate
superior officer.
3. Inform the arrested person, as soon as may be, the grounds of his
36
arrest (Section 52 (1)).
4. If a person is arrested or an article has been seized under a
warrant issued by a magistrate, forward the person/seized article
to that magistrate (Section 52 (2)).
5. If the person has been arrested or the article has been seized
otherwise than under a warrant , forward it to the nearest police
station or any other officer empowered under section 53 (Section
52 (3)).
6. If the person has been arrested or the article has been seized
otherwise than under a warrant , forward it to the nearest police
station or any other officer empowered under section 53 (Section
52 (3)).
7. Whenever you arrest any person, make a full report to your

37
superior within 48 hours ( Section 57)
 IMMUNITIES IN DRUG CASES
1. Officers Officers acting in discharge of their duties in good faith
under the Act are immune from suits, prosecution and other
legal proceedings ( Section 69).
2. Addicts Addicts charged with consumption of drugs (section 27)
or with offences involving small quantities will be immune from
prosecution if they volunteer for de addiction. This immunity
may be withdrawn if the addict does not undergo complete
treatment (Section 64 A ).
3. Offenders Central or state governments can tender immunity to
an offender in order to obtain his evidence in the case. This
immunity is granted by the government and not by the court
(Section 64).
4. Minors All offences committed under any law by persons under
the age of 18 will be covered by the Juvenile Persons (Care and
protection) Act. This Act seeks to reform such juveniles rather
than punish them under the respective Acts. It prevails over any
other Act in respect of persons below the age of 18.

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 References

1. DRUG REGULATORY AFFAIRS by sachin itkar, Dr.S.wyavahare

2. www.fda.gov/cder/guidance/index.htm
3. www.fda.gov/cber/cberftp.html.

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40
41
 End of 2nd semester

Thank you all for your cooperation and

appreciation. All the best for the exams &
your future

Ur’s
K. Sampath Kumar

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