The document provides an overview of drug regulation systems in India, the United States, and other countries. It discusses the key functions of drug regulatory agencies, which include product registration, regulating drug manufacturing and distribution, monitoring drug safety and efficacy, and regulating drug promotion and information. The main regulatory bodies in India are the Central Drugs Standard Control Organization and other organizations like the Indian Council of Medical Research. In the US, the main regulatory agency is the Food and Drug Administration, which aims to promote health by reviewing research and ensuring drugs are safe. The document also discusses regulatory agencies in other countries like Japan.

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2. CONTENTS
• Meaning
• Introduction
• Key function
• Agencies in INDIA
• Agencies in US
• Agencies in JAPAN
• Agencies in EU
• ICH
• References
2

3. MEANING OF DRUG REGULATION
• Drug
“All medicines for internal or external use of human beings or
animals and all substances intended to be used for diagnosis,
treatment, mitigation or prevention of any disease or disorder in
human beings or animals”
• Regulation
“To regulate means to control something so that it functions
properly”
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4. 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.
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5. INTRODUCTION
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.
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6. INTRODUCTION
• 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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7. KEY FUNCTIONS OF DRUG REGULATORY AGENCY
 Product registration (drug evaluation and authorization,
and monitoring of drug efficacy and safety)
 Regulation of drug manufacturing, importation, and
distribution;
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8. KEY FUNCTIONS OF DRUG REGULATORY AGENCY
 Regulation & Control of drug promotion and information.
 Adverse drug reaction (ADR) monitoring.
 Licensing of premises, persons and practices.
 Main goal of drug regulation is to guarantee the safety, efficacy
and quality of drugs available to public.
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9. THE DRUG REGULATION CONSISTS OF:
1. Drug Laws
2. Drug Regulatory Agencies
3. Drug Regulatory Boards
4. Quality Control
5. Drug Information Centers etc.
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10. DRUGS REGULATORY SYSTEM IN INDIA
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11. 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.
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MAIN BODIES: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)

13. INDIA – WELL DEFINED DRUG REGULATORY SYSTEM
GOVT. of INDIA
• Ministry of Health and Family Welfare
DGHS
CDSCO DCGI
13
DTAB
 Enforcement & GMP audit Div
 Quality Control Division – CDTL
 Registration Div
 New Drug Div
Pharmacovigilance
Trainings

14. APPROVAL OF INVESTIGATIONAL NEW DRUG
(IND)
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CENTRAL LICENSING

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Functions undertaken by Central GovernmentFunctions undertaken by Central Government
Statutory FunctionStatutory Function
1. Laying down standards of drugs, cosmetics, diagnostics and
devices.
2. Laying down regulatory measures, amendments to Acts and Rules.
3. To regulate market authorization of new drugs.
4. To regulate clinical research in India

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1. To approve licenses to manufacture certain categories of drugs as
Central Licence Approving Authority i.e. for Blood Banks, Large
Volume Parenterals and Vaccines & Sera.
2. To regulate the standards of imported drugs.
3. Work relating to the Drugs Technical Advisory Board (DTAB) and
Drugs Consultative Committee (DCC).
4. Testing of drugs by Central Drugs Labs.
5. Publication of Indian Pharmacopoeia.

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National Institute of Health and Family Welfare (NIHFW)
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 Chairman (ex-officio)
9 Member ( ex-officio)
6 Member
1 Member Secretary (ex-officio)

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ACTIVITIES AND RESPONSIBILITIESACTIVITIES 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
Union Health Minister
Governing Body
Scientific Advisory Board
Scientific
Advisory
Groups
Expert
Groups
Scientific
Advisory
Committee
Steering
Committee
Task Forces

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ACTIVITIES AND RESPONSIBILITIESACTIVITIES AND RESPONSIBILITIES
 Extramural research is promoted by ICMR by establishing Centers
for Advanced Research in different research areas.
 The ICMR also funds task force studies which emphasize a time-
bound, goal-oriented approach.

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 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.
 In the context of the changing public health scene.
 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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DRUG TECHNICAL ADVISORY BOARD (DTAB)
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,
18 Members
10 ex-officio Members
5 Nominated Members
5 Elected Members

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ACTIVITIES AND RESPONSIBILITIESACTIVITIES 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, make bye-laws fixing a quorum and regulating its
own procedure.

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CENTRAL DRUG TESTING LABORATORY (CDTL)
 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

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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 development of drug.

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Indian
Pharmacopoeia
Commission
(IPC)
General Body
19 Members
Governing Body 10
Members
Scientific Body
23 Experts
CIPL
Lab
IPC
Secretariat
Indian Pharmacopoeia was prepared by Indian
Pharmacopoeia Commission(IPC)

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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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DRUG REGULATORY AGENCIES IN US

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AGENCIES
 The Food and Drug Administration (FDA)
 National Institutes of Health (NIH)
 Centers for Disease Control and Prevention
 Department of Health and Human Services (DHHS)

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 Fed World - US Government Information
 National Center for Complementary and Alternative Medicine
(NCCAM)
 National Center for Infectious Diseases (NCID)
 National Library of Medicine
 National Science Foundation
 Office of Disease Prevention

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The Food and Drug Administration (FDA) is an agency within the
U.S. Department of Health and Human Services. It consists of six
product centers, one research center, and two offices.
FDA’s responsibilities extend to the 50 United States, the District of
Columbia, Puerto Rico, Guam, the Virgin Islands, American Samoa, and
other U.S. territories and possessions.
Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993-0002

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HISTORY
 1927 — The "Bureau of Chemistry" is reorganized into two separate
entities. Regulatory functions are located in the "Food, Drug, and
Insecticide Administration", and nonregulatory research is located
in the "Bureau of Chemistry and Soils".
 1930 — The name of the "Food, Drug, and Insecticide
Administration" is shortened to "Food and Drug Administration"
(FDA) under an agricultural appropriations act.

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MISSION
 The Food and Drug Modernization Act states that the FDA has 4
roles:
To promote health by reviewing research and approving new
products
To ensure foods and drugs are safe and properly labeled
To work with other nations to “reduce the burden of regulation”
To cooperate with scientific experts and consumers to effectively
carry out these obligations

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ORGANIZATION
 The agency currently has roughly 9,500 full-time employees and is
headquartered in Rockville, Maryland. The agency’s total budget in
financial year 2002 was about $1.4 billion (the federal government’s
financial year begins in September).
 The FDA is led by the Commissioner of Food and Drugs, who is appointed
by the President and confirmed by the Senate.
 Dr. Mark McClellan, a physician with a doctorate in economics, was
nominated to be commissioner by President George W. Bush in
September 2002 and confirmed by the Senate in October

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FDA IS RESPONSIBLE FOR
 Protecting the public health by assuring that foods are safe, wholesome,
sanitary and properly labeled;
 Assuring human and veterinary drugs, and vaccines and other biological
products and medical devices intended for human use are safe and
effective
 Protecting the public from electronic product radiation

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 Assuring cosmetics and dietary supplements are safe and properly labeled
 Regulating tobacco products
 Advancing the public health by helping to speed product innovations
 Helping the public get the accurate science-based information they need to use
medicines, devices, and foods to improve their health
 Initiation of a Recall. Includes voluntary, FDA requested, and FDA mandated.

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What doesn’t FDA regulate?
FDA does not regulate:
 advertising (except for prescription drugs, medical devices, and
tobacco products)
 alcoholic beverages
 illegal drugs of abuse,
 health insurance
 meat and poultry (except for game meats, such as venison, ostrich,
and snake)

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 The National Institutes of Health traces its roots to 1887, when a
one-room laboratory was created within the Marine Hospital
Service (MHS), predecessor agency to the U.S. Public Health Service
(PHS).
 The MHS had been established in 1798 to provide for the medical
care of merchant seamen. In the 1880s, the MHS had been charged
by Congress with examining passengers on arriving ships for clinical
signs of infectious diseases, especially for the dreaded diseases
cholera and yellow fever, in order to prevent epidemics.

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MISSION
NIH’s mission is to seek fundamental knowledge about the
nature and behavior of living systems and the application of
that knowledge to enhance health, lengthen life, and
reduce the burdens of illness and disability.

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 The goals of the agency are:
1. to foster fundamental creative discoveries, innovative research strategies, and
their applications as a basis for ultimately protecting and improving health;
2. to develop, maintain, and renew scientific human and physical resources that
will ensure the Nation's capability to prevent disease;
3. to expand the knowledge base in medical and associated sciences in order to
enhance the Nation's economic well-being
4. to exemplify and promote the highest level of scientific integrity, public
accountability, and social responsibility in the conduct of science

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DRUG REGULATORY AGENCIES IN JAPAN

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Agencies
 Ministry of Health and Welfare
 National Institute of Infectious Diseases
 National Institute of Health Sciences

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History
In January 1938, the Ministry of Health and Welfare was established
by integrating the administrations of the Sanitary Bureau and the
Social Affairs Bureau in the Ministry of Home Affairs.
In September 1947 The Ministry of Labour was established by
integrating labour administrations that had previously been conducted
by the Ministry of Health and Welfare.

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Make a Policy Regarding
1. Health and medical care-health, food, medical care, health
insurance
2. Children and childrearing
3. Long term care, health and welfare services
4. Employment security, labour
5. Pension
6. Other policy areas-international affairs, research project

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MHLW IN JAPAN
 The Ministry of Health, Labor, and Welfare (MHLW) was
established by a merger of the Ministry of Health and Welfare
(MHW) and the Ministry of Labor, on January 6, 2001.
 The MHLW, which was originally established in 1938, has been in
charge of the improvement and promotion of social welfare, social
security and public health, and the new organization has the same
tasks.
 It consists of the ministry proper, affiliated institutions, councils,
local branches, and an external organization.

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MHLW
Social insurance
agency
Ministry proper
Minister’s secretariat
Heath policy bureau
Heath service bureau
PFSB
Social welfare & war
victim’s relief bureau
Health and welfare
bureau for elderly
Equal employment
children & family
bureau
Insurance bureau
Pension bureau
Director general for
policy planning

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 Social Welfare :
Services for elderly people
Services for persons with disabilities
 Social Security :
Pension systems that will ensure income in elderly age
Long term insurance to provide nursing care services
Public assistance systems that guarantee minimum standards.

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Public Hygiene :
Appropriate medical services for diseases & injuries
Ensuring the safety of food, Water and medical supplies
Research into health science in order to make technological
advances
Maternal and child health
Job Security :
Promotion of employment
Employment of elderly people
Employment of persons with disabilities
Management of the employment insurance system

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WORKING ENVIRONMENT
Policy planning to improve the working environment
Policy planning to ensure the health and safety of workers
Measurement to secure equal opportunity, equal treatment
Measures to support the harmonization of working and family
life
Management of the worker’s compensation system

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HUMAN RESOURCES DEVELOPMENT
Promotion of human resources development that reacts to
changes in the industrial system
Encouragement of worker’s skill development under their own
initiative
Development of skilled human resources that support industrial
progress

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Drug regulatory Agencies in EU

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AGENCIES
 EU Legislation - Eudralex
 European Directorate for the Quality of Medicines and
Healthcare (EDQM)
 European Medicines Agency (EMEA)
 Heads of Medicines Agencies (HMA)

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European Directorate For The Quality Of Medicines
& Health Care
The EDQM (Council of Europe) is a key European Organisation
involved in Harmonisation & Co-ordination of Standardisation,
Regulation & Quality Control of Medicines, Blood Transfusion, Organ
Transplantation, Pharmaceuticals and Pharmaceutical Care.
In 1996 The European Directorate for the Quality of Medicines (EDQM)
is created.

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MISSION
To contribute to the basic human right of access to good quality medicines
and healthcare and to promote and protect human and animal health by:
Establishing and providing official standards which apply to the
manufacture and quality control of medicines in all signatory States of the
"Convention on the Elaboration of a European Pharmacopoeia" and beyond;
Ensuring the application of these official standards to substances used in the
production of medicines;

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 Co-ordinating a network of Official Medicines Control Laboratories (OMCL) to
collaborate and share expertise among Member States and to effectively use
limited resources;
 Proposing ethical, safety and quality standards:
- for the collection, preparation, storage, distribution and appropriate use
of blood components in blood transfusion;
- for the transplantation of organs, tissues and cells;

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ORGANIZATIONORGANIZATION
CHARTCHART

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E M A
 EMA is a European agency for the evaluation of medicinal product.
 EMA was set up in 1995.
 From 1995 to 2004, EMA was known as European agency for the
evaluation of medicinal product.
 The European Medicines Agency (EMA) is a decentralized body of
the European Union, located in London
 Mission: to foster scientific excellence in evaluation and supervision
of medicines.

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office of executive
director
Executive director
Legal service
Senior medical officer Internal audit
Information
and
communicat
e ion
veterinary
medicines
and product
data
management
Patient health
protection
Human
medicines
development
and
evaluation

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ACTIVITIES OF EMA
 provides independent, science-based recommendations on the
quality, safety and efficacy of medicines.
 applies efficient and transparent evaluation procedures to help
bring new medicines to the market.
 implements measures for continuously supervising the quality,
safety and efficacy of authorised medicines.
 provides scientific advice to stimulate the development and
improve the availability of innovative new medicines;

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recommends safe limits for residues of veterinary medicines used in
food-producing animals.
publishes impartial and comprehensible information about
medicines and their use;
develops best practice for medicines evaluation and supervision in
Europe, and contributes alongside the Member States and the
European Commission to the harmonization of regulatory standards at
the international level.

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 The International Conference on Harmonisation of Technical Requirements forThe International Conference on Harmonisation of Technical Requirements for
Registration of Pharmaceuticals for Human UseRegistration of Pharmaceuticals for Human Use (ICH) is unique in bringing
together the regulatory authorities and pharmaceutical industry of Europe,
Japan and the US to discuss scientific and technical aspects of drug registration.
 Since its inception in 1990, ICH has evolved, through its ICH Global Cooperation
Group, to respond to the increasingly global face of drug development, so that
the benefits of international harmonization for better global health can be
realized worldwide.
 ICH's mission is to achieve greater harmonization to ensure that safe, effective,
and high quality medicines are developed and registered in the most resource-
efficient manner.

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HISTORY
The Need to Harmonise
 The realization that it was important to have an independent
evaluation of medicinal products before they are allowed on the
market
 However in many cases the realization was driven by tragedies,
such as that with thalidomide in Europe in the 1960s.
 For most countries, whether or not they had initiated product
registration controls earlier, the 1960s and 1970s saw a rapid
increase in laws, regulations and guidelines for reporting and
evaluating the data on safety, quality and efficacy of new medicinal
products

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Initiation of ICH
Harmonization of regulatory requirements was pioneered by the European
Community (EC), in the 1980s, as the EC (now the European Union) moved
towards the development of a single market for pharmaceuticals
At the same time there were bilateral discussions between Europe, Japan
and the US on possibilities for harmonization.

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It was, however, at the WHO Conference of Drug Regulatory
Authorities (ICDRA), in Paris, in 1989, that specific plans for action
began to materialize.
Soon afterwards, the authorities approached IFPMA to discuss a
joint regulatory-industry initiative on international harmonization, and
ICH was conceived.
The birth of ICH took place at a meeting in April 1990, hosted by
EFPIA in Brussels

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Objectives
 Better consumer information.
 Post marketing safety.
 New product review.
 Keep watch on safe manufacturing and handling.
 Monitoring for new risk.
 Standardization and regulation.
 Enforcement and corrective problem.

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MissionMission
ICH’s mission is to make recommendations towards achieving
greater harmonization in the interpretation and application of
technical guidelines and requirements for pharmaceutical product
registration, thereby reducing or obviating duplication of testing
carried out during the research and development of new human
medicines.

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 To maintain a forum for a constructive dialogue between
regulatory authorities and the pharmaceutical industry on the real
and perceived differences in the technical requirements for product
registration in the EU, USA and Japan in order to ensure a more
timely introduction of new medicinal products, and their
availability to patients.
MissionMission

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To contribute to the protection of public health from an international perspective;
To monitor and update harmonised technical requirements leading to a greater
mutual acceptance of research and development data;
To avoid divergent future requirements through harmonization of selected topics
needed as a result of therapeutic advances and the development of new
technologies for the production of medicinal products;
To facilitate the adoption of new or improved technical research and development
approaches which update or replace current practices, where these permit a more
economical use of human, animal and material resources, without compromising
safety;
To facilitate the dissemination and communication of information on harmonised
guidelines and their use such as to encourage the implementation and integration of
common standards.
MissionMission

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ICH STRUCTURE
The ICH is composed of the following components:
 Steering Committee,
 ICH Secretariat,
 Observers,
 Expert Working Group (EWG).

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The ICH receives support from the following organizations:
 In the European Union, the European Agency for the Evaluation of
Medicinal Products (EMEA) and the European Federation of
Pharmaceutical Industries’ Associations (EFPIA) represent both
regulatory agencies and industry associations, respectively;
 In the United States, the Food and Drug Administration (FDA) and
Pharmaceutical Research and Manufacturers of America (PhRMA)
are included; and
 In Japan, the Ministry of Health, Labour, and Welfare (MHLW1) and
the Japan Pharmaceutical Manufacturers Association (JPMA) are
the respective organizations.

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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, rotating meeting
sites among the three regions.
 The topics identified for harmonization by the Steering Committee are
selected.
 Working Groups also meet during the same week as the Steering
Committee meetings and report on their progress to the Committee.
Considerable work also occurs between meetings.

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Current ICH Terms of Reference (2000)
 To maintain a forum for a constructive dialogue between regulatory authorities
and the pharmaceutical industry on the real and perceived differences in the
technical requirements for product registration in the EU, USA and Japan in order
to ensure a more timely introduction of new medicinal products, and their
availability to patients;
 To contribute to the protection of public health from an international
perspective;
 To monitor and update harmonized technical requirements leading to a greater
mutual acceptance of research and development data;
 To avoid divergent future requirements through harmonization of selected
topics needed as a result of therapeutic advances and the development of new
technologies for the production of medicinal products;

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ICH GUIDELINES
The ICH topics are divided into four major categories:
A. Quality topics,
B. Safety topics,
C. Efficacy topics,
D. Multidisciplinary topics.

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REFERENCES
1. www.cdsco.nic.in
2. www.mohfw.nic.in
3. www.health.cg.gov.in
4. www.icmr.nic.in
5. www.dst.gov.in
6. http://www.nppaindia.nic.in/index1.html
7. http://www.nihfw.org/
8. http://indianmedicine.nic.in/
9. http://www.nih.gov/
10. http://www.mhlw.go.jp/
11. http://www.edqm.eu
12. http://www.ich.org
13. http://www.infoahmedabad.com/2009/11/gujarat-fdca-to-set-up-6-more-district.html

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