1

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

2

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”

3

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.

4

INTRODUCTIONPeople 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.

5

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.

6

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;

7

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.

8

THE DRUG REGULATION CONSISTS OF:

1. Drug Laws

2. Drug Regulatory Agencies

3. Drug Regulatory Boards

4. Quality Control

5. Drug Information Centers etc.

9

DRUGS REGULATORY SYSTEM IN INDIA

10

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.

11

12

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)

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 DivPharmacovigilanceTrainings

APPROVAL OF INVESTIGATIONAL NEW DRUG (IND)

14

15

CENTRAL LICENSING

16

16

17

17

18

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

19

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.

20

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).

21

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)

22

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.

23

STRUCTURE AND ORGANIZATION

Union Health Minister

Governing Body

Scientific Advisory Board

Scientific Advisory Groups

Expert Groups

Scientific Advisory

Committee

Steering Committee Task Forces

24

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.

25

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.

26

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

27

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

28

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.

29

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

30

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.

31

Indian Pharmacopoeia

Commission(IPC)

General Body 19 Members

Governing Body 10 Members

Scientific Body 23 Experts

CIPLLab

IPC Secretariat

Indian Pharmacopoeia was prepared by Indian Pharmacopoeia Commission(IPC)

32

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.

33

DRUG REGULATORY AGENCIES IN US

34

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)

35

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

36

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 Administration10903 New Hampshire AveSilver Spring, MD 20993-0002

37

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.

38

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

39

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

40

41

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

42

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.

43

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)

44

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.

45

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.

46

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

47

DRUG REGULATORY AGENCIES IN JAPAN

48

Agencies

Ministry of Health and Welfare

National Institute of Infectious Diseases

National Institute of Health Sciences

49

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.

50

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

51

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.

52

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

53

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.

54

Public Hygiene :

Appropriate medical services for diseases & injuriesEnsuring the safety of food, Water and medical suppliesResearch into health science in order to make technological advancesMaternal and child health

Job Security :

Promotion of employmentEmployment of elderly peopleEmployment of persons with disabilitiesManagement of the employment insurance system

55

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

56

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

57

Drug regulatory Agencies in EU

58

AGENCIES

EU Legislation - Eudralex

European Directorate for the Quality of Medicines and Healthcare (EDQM)

European Medicines Agency (EMEA)

Heads of Medicines Agencies (HMA)

59

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.

60

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;

61

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;

62

ORGANIZATION ORGANIZATION CHARTCHART

63

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.

64

office of executive director

Executive director

Legal service

Senior medical officer Internal audit

Information and

communicate ion

veterinary medicines

and product data

management

Patient health protection

Human medicines

development and

evaluation

65

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;

66

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.

67

68

The International Conference on Harmonisation of Technical Requirements for The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Registration 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.

69

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

70

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.

71

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

72

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.

73

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.

74

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

75

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

76

ICH STRUCTURE The ICH is composed of the following components:

Steering Committee,

ICH Secretariat,

Observers,

Expert Working Group (EWG).

77

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.

78

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.

79

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;

80

ICH GUIDELINES

The ICH topics are divided into four major categories:

A. Quality topics,

B. Safety topics,

C. Efficacy topics,

D. Multidisciplinary topics.

81

82

REFERENCES1. 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

83