ROLE AND FUNCTION OF DRUG REGULATORY

AUTHORITIES IN THE BACKDROP OF GOOD GOVERNANCE

Submitted by: Arvind Pardeshi

LL.B. (IPR) (Hons.) 4th Semester
Rajiv Gandhi School of Intellectual Property Law
IIT, Kharagpur
Mob: 09547144933
E-mail: lifeandlaw@gmail.com

Electronic copy available at: http://ssrn.com/abstract=1748629

TABLE OF CONTENTS

LIST OF ABBREVIATIONS ...................................................................................................2

CHAPTER I - INTRODUCTION ............................................................................................3
CHAPTER II -WHO.................................................................................................................5
CHAPTER III -ICH ..................................................................................................................9
CHAPTER IV -CFR ............................................................................................................... 11
CHAPTER V -FDA ................................................................................................................. 12
CHAPTER VI -ICMR............................................................................................................. 14
CHAPTER VII -CDSCO ........................................................................................................ 16
CHAPTER VIII -DCGI .......................................................................................................... 18
CHAPTER IX -ROLE TO BE EVALUATED FOR ............................................................. 19
CHAPTER X -CONCLUSION ............................................................................................... 27
BIBLIOGRAPHY ................................................................................................................... 29

Electronic copy available at: http://ssrn.com/abstract=1748629

LIST OF ABBREVIATIONS
CDSCO
CFR
DCGI
FDA
ICH

: Central Drugs Standard Control Organization

: Code of Federal Regulation
: Drugs Controller General of India
: Food and Drug Administration
: International Conference on Harmonization of technical
requirements for registration of pharmaceuticals for
human use

ICMR
WHO

: Indian Council of Medical Research

: World Health Organization

Role and Function of Drug Regulatory Authorities in the backdrop of Good Governance
CHAPTER I
INTRODUCTION
At present the Indian pharmaceutical sector enjoys the status of being the largest amongst the
developing nations. The Indian pharmaceutical industry is one of the worlds largest ranking,
fourth in terms of volume and thirteenth in terms of value, in the global pharmaceutical market.1
The main objective of regulations and good practices is the protection of public health.
Regulators and the general public are more and more sensitive to safety issues, leading to more
stringent ways of considering the benefit risk ratio of new products.2Presently, the following
Acts and Rules regulate the manufacture, export and Clinical research of Drugs and Cosmetics in
India:

Drugs and Cosmetics Act,1940

Drugs and Cosmetics Rules,1945

Pharmacy Act,1948

Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954

Narcotic Drugs and Psychotropic Substances Act, 1985

Medicinal and Toilet Preparations (Excise Duties) Act,1955

Drugs (Price Control) order, 1955 (under the Essential Commodities Act.)
There are some other laws which have a bearing on manufacture, distribution and sale of
Drugs and Cosmetic in India .The important ones are:

Industries (Development and Regulation) Act, 1951

Nishith Desai Associates_Indian pharmaceutical structure_Indian Pharma and Life Science Industry-Legal and Tax

Framework,p.1-020
2

Yves Juillet- Internationalization of regulatory requirements _Key Issues in Pharmaceutical Law Pharmaceuticals

policy and law_vol_9(3-4),2007,p369

Trade and Merchandise Marks Act,1958

Indian Patents and Designs Act,1970

Factories Act,19483

This paper reviews regulatory and administrative bodies /organizations at National and
International level and also in Indian states. It presents necessity, functioning by the below
mentioned regulatory and administrative authorities and their execution for governance for
healthcare is addressed. Following are the regulatory and administrative authorities in India for
drugs (medicines) that plays direct and indirect role, are reviewed in this paper. It includes
history, structure and functions of each of the regulatory and administrative authorities.

WHO ( World Health Organization)

ICH (International Conference on Harmonization of technical requirements for

registration of pharmaceuticals for human use)

CFR (Code of Federal Regulation)

FDA (Food and Drug Administration)

ICMR (Indian Council of Medical Research)

CDSCO( central Drugs Standard Control Organization)

DCGI (Drugs Controller General of India)

Vijay Malik-Law relating to Drugs and Cosmetics_ Drugs Conroll in India_Historical perspective,p[A-17]

CHAPTER II
WHO:
History
The WHO's constitution states that its objective "is the attainment by all people of the highest
possible level of health."4 Its major task is to combat disease, especially key infectious diseases,
and to promote the general health of the people of the world.
The World Health Organization (WHO) is one of the original agencies of the United Nations, its
constitution formally coming into force on the first World Health Day, (April 7, 1948), when it
was ratified by the 26th member state. Jawaharlal Nehru, a major freedom fighter of India had
given an opinion to start WHO.5Prior to this its operations, as well as the remaining activities of
the League of Nations Health Organization, were under the control of an Interim Commission
following an International Health Conference in the summer of 1946 6 The transfer was
authorized by a Resolution of the General Assembly7 . The epidemiological service of the
French Office International d'Hygine Publique was incorporated into the Interim Commission
of the World Health Organization on January 1, 19478
Structure
The WHO has 193 Member States, including all UN Member States except Liechtenstein, and
two non-UN members, Niue and the Cook Islands. WHO Member States appoint delegations to
the World Health Assembly, WHOs supreme decision-making body. All UN member states are
eligible for WHO membership, and, according to the WHO web site, Other countries may be
4
5

http://whqlibdoc.who.int/hist/official_records/constitution.pdf
http://whqlibdoc.who.int/hist/chronicles/chronicle_1948.pdf

http://whqlibdoc.who.int/hist/chronicles/chronicle_1947.pdf

United Nations General Assembly Resolution 61 session 1 Establishment of the World Health Organization on 14

December 1946
8

Iriye, Akira (2002). Global Community: The Role of International Organizations in the Making of the

Contemporary World. Berkeley: University of California Press. ISBN 052023179.

admitted as members when their application has been approved by a simple majority vote of the
World Health Assembly.
The WHO Assembly generally meets in May each year. In addition to appointing the DirectorGeneral every five years, the Assembly considers the financial policies of the Organization and
reviews and approves the proposed programme budget. The Assembly elects 34 members,
technically qualified in the field of health, to the Executive Board for three-year terms. The main
functions of the Board are to carry out the decisions and policies of the Assembly, to advise it
and to facilitate its work in general.
The WHO is financed by contributions from member states and from donors. In recent years, the
WHO's work has involved increasing collaboration with external bodies; there are currently
around 80 partnerships with NGOs and the pharmaceutical industry, as well as with foundations
such as the Bill and Melinda Gates Foundation and the Rockefeller Foundation. Voluntary
contributions to the WHO from national and local governments, foundations and NGOs, other
UN organizations, and the private sector, now exceed that of assessed contributions (dues) from
the 193 member nations.9
Activities/Functions
Apart from coordinating international efforts to control outbreaks of infectious diseases, such
as SARS, malaria, Tuberculosis, swine flu, and AIDS the WHO also sponsors programs to
prevent and treat such diseases10. The WHO supports the development and distribution of safe
and effective vaccines, pharmaceutical diagnostics, and drugs. After over two decades of
fighting smallpox, the WHO declared in 1980 that the disease had been eradicated the first
disease in history to be eliminated by human effort.11 The WHO aims to eradicate polio within

http://ftp.who.int/gb/pdf_files/EB105/ee17a1.pdf

10

Collin N, de Radigus X; the World Health Organization H1N1 Vaccine Task Force. Vaccine production capacity

for seasonal and pandemic (H1N1) 2009 influenza. Vaccine. 2009 Jun 27. [Epub ahead of print]PMID: 19563891
11

Hayden FG, Howard WA, Palkonyay L, Kieny MP. Report of the 5th meeting on the evaluation of pandemic

influenza prototype vaccines in clinical trials: World Health Organization, Geneva, Switzerland, 1213 February
2009. Vaccine. 2009 Jun 24;27(31):407989. Epub 2009 May 9. PMID: 19406184

the next few years. The organization has already endorsed the world's first official HIV/AIDS
Toolkit for Zimbabwe (from 3 October 2006), making it an international standard.12
In addition to its work in eradicating disease, the WHO also carries out various health-related
campaigns for example, to boost the consumption of fruits and vegetables worldwide and to
discourage tobacco use. Experts met at the WHO headquarters in Geneva in February, 2007, and
reported that their work on pandemic influenza vaccine development had achieved encouraging
progress. More than 40 clinical trials have been completed or are ongoing. Most have focused on
healthy adults. Some companies, after completing safety analysis in adults, have initiated clinical
trials in the elderly and in children. All vaccines so far appear to be safe and well-tolerated in all
age groups tested.13
The WHO also promotes the development of capacities in Member States to use and produce
research that addresses national needs, by bolstering national health research systems and
promoting knowledge translation platforms such as the Evidence Informed Policy Network EVIPNet. WHO and its regional offices are working to develop regional policies on research for
health -the first one being the Regional Office for the Americas PAHO/AMRO that had its
Policy on Research for Health approved in September 2009 by its 49th Directing
Council Document CD 49.10.
WHO also conducts health research in communicable diseases, non-communicable conditions
and injuries; for example, longitudinal studies on aging to determine if the additional years we
live are in good or poor health, and, whether the electromagnetic field surrounding cell
phones has an impact on health. Some of this work can be controversial, as illustrated by the
April, 2003, joint WHO/FAO report, which recommended that sugar should form no more than
10% of a healthy diet. This report led to lobbying by the sugar industry against the
recommendation14, to which the WHO/FAO responded by including in the report the statement
"The Consultation recognized that a population goal for free sugars of less than 10% of total

12

Xinhua-English

13

WHO | WHO reports some promising results on avian influenza vaccines

14

Boseley, Sarah (2003-04-21). "Sugar industry threatens to scupper WHO". The Guardian (London).

energy is controversial", but also stood by its recommendation based upon its own analysis of
scientific studies.15
Statistics:
Total population: 1,151,751,000
Gross national income per capita (PPP international $): 2,460
Life expectancy at birth m/f (years): 62/64
Healthy life expectancy at birth m/f (years, 2003): 53/54
Probability of dying under five (per 1 000 live births): 76
Probability of dying between 15 and 60 years m/f (per 1 000 populations): 276/203
Total expenditure on health per capita (Intl $, 2006): 109
Total expenditure on health as % of GDP Source: (2006): 4.9
Figures are for 2006 unless indicated.16

15

Diet, nutrition and the prevention of chronic diseases. Report of the joint WHO/FAO expert consultation. World

Health Organization and Food and Agriculture Organization of the United Nations, Geneva, 2003. See section 1.3 A
summary of population nutrient intake goals of Chapter 5, Population nutrient intake goals for preventing dietrelated chronic diseases
16

World Health Statistics 2008_ http://www.who.int/countries/ind/en/

CHAPTER III
ICH:
History
In the 1980s, what is today the European Union began harmonizing regulatory requirements. In
1989, Europe, Japan, and the United States began creating plans for harmonization; ICH was
created in April 1990 at a meeting in Brussels.
Structure
Six parties that represent the regulatory bodies and the research-based industries of the founding
members are responsible for the decision making process:
a)

the European Commission,

b)

the European Federation of Pharmaceutical Industries and Associations (EFPIA),

c)

the Ministry of Health, Labour and Welfare,

d)

the Japan Pharmaceutical Manufacturers Association(JPMA),

e)
f)

the Food and Drug Administration (FDA), and

the Pharmaceutical Research and Manufacturers of America (PhRMA)17

Activities/Functions

The International Conference on Harmonization of Technical Requirements for Registration of

Pharmaceuticals for Human Use (ICH) is a project that brings together the regulatory authorities
of Europe, Japan and the United States and experts from the pharmaceutical industry in the three
regions to discuss scientific and technical aspects of pharmaceutical product registration.
The purpose of ICH is to reduce or obviate the need to duplicate the testing carried out during the
research and development of new medicines by recommending ways to achieve greater
17

Structure of ICH

harmonization in the interpretation and application of technical guidelines and requirements for
product registration.
Harmonization would lead to a more economical use of human, animal and material resources,
and the elimination of unnecessary delay in the global development and availability of new
medicines while maintaining safeguards on quality, safety, and efficacy, and regulatory
obligations to protect public health.
ICH guidelines have been adopted as law in several countries, but are only used as guidance for
the U.S. Food and Drug Administration.18
ICH Gu id e line s:
The ICH Topics are divided into four major categories and ICH Topic Codes are assigned
according to these categories.
Q: Quality topics, i.e., those relating to chemical and pharmaceutical Quality Assurance
(Stability Testing, Impurity Testing, etc.
S: Safety topics, i.e., those relating to in vitro and in vivo pre-clinical studies (Carcinogenicity
testing, genotoxicity testing, etc.)
E: Efficacy topics, i.e., those relating to clinical studies in in human subject (dose response
studies, good clinical practices, etc.)
M: Multidisciplinary topics, i.e., cross-cutting topics which do not fit uniquely into one of the
above categories (MedDRA, ESTRI, M3, CTD, M5)19

18

Bankert, Elizabeth A; Robert J. Amdur (2006). Institutional Review Board. Jones & Bartlett Publishers. p. 281

19

(HTTPS://WWW.ICH.ORG/CACHE/HTML/250-272-1.HTML)

10

CHAPTER IV
CFR:
History
The Code of Federal Regulations (CFR) is the codification of the general and permanent rules
and regulations (sometimes called administrative law) published in the Federal Register by the
executive departments and agencies of the Federal Government of the United States. The CFR is
published by the Office of the Federal Register, an agency of the National Archives and Records
Administration (NARA). 20
Structure:
It is divided into 50 titles that represent broad areas subject to Federal regulation. Each volume
of the CFR is updated once each calendar year and is issued on a quarterly basis.

Titles 1-16 are updated as of January 1st

Titles 17-27 are updated as of April 1st

Titles 28-41 are updated as of July 1st

Titles 42-50 are updated as of October 1st

Each title is divided into chapters, which usually bear the name of the issuing agency. Each
chapter is further subdivided into parts that cover specific regulatory areas. Large parts may be
subdivided into subparts. All parts are organized in sections, and most citations in the CFR are
provided at the section level. A list of agencies and where they appear in the CFR may be found
in Appendix C of the U.S. Government Manual. 21

20

http://www.gpoaccess.gov/cfr/about.html

21

Ibid

11

CHAPTER V
FDA:
History
Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within
the United States for the Food and Drug Administration (FDA), the Drug Enforcement
Administration (DEA), and the Office of National Drug Control Policy (ONDCP).
It is divided into three chapters:

Chapter I Food and Drug Administration

Chapter II Drug Enforcement Administration

Chapter III Office of National Drug Control Policy22

Structure:
The Food and Drug Administration (FDA or USFDA) is an agency of the United States
Department of Health and Human Services, one of the United States federal executive
departments, responsible for protecting and promoting public health through the regulation and
supervisionof foodsafety, tobaccoproducts, dietarysupplements, prescription and overthecounter
pharmaceuticaldrugs (medications),vaccines, biopharmaceuticals, blood

transfusions, medical

devices, electromagnetic radiation emitting devices (ERED), veterinary products, and cosmetics.
The FDA also enforces other laws, notably Section 361 of the Public Health Service Act and
associated regulations, many of which are not directly related to food or drugs. These
include sanitation requirements on interstate travel and control of disease on products ranging
from certain household pets to sperm donation for assisted reproduction.
The FDA is led by a Commissioner of Food and Drugs, appointed by the President with
the advice and consent of the Senate. The Commissioner reports to the Secretary of Health and
Human Services. The 21st and current Commissioner is Dr. Margaret A. Hamburg. She has
served as Commissioner since February 2009.

22

http://www.fda.gov/

12

The FDA has its headquarters at Silver Spring, Maryland and has 223 field offices and
13 laboratories located throughout the 50 states, the United States Virgin Islands, and Puerto
Rico.23
In 2008 the FDA started opening offices in foreign countries, including China, India, Costa
Rica, Chile, Belgium, and the United Kingdom.24
Legal Authority:
Most federal laws concerning the FDA are part of the Food, Drug and Cosmetic Act, 25first
passed in 1938 and extensively amended since and are codified in Title 21, Chapter 9 of the
United States Code. Other significant laws enforced by the FDA include the Public Health
Service Act, parts of the Controlled Substances Act, the Federal Anti-Tampering Act, as well as
many others. In many cases these responsibilities are shared with other federal agencies.
Functions/Regulatory programs
The programs for safety regulation vary widely by the type of product, its potential risks, and the
regulatory powers granted to the agency. For example, the FDA regulates almost every facet of
prescription drugs, including testing, manufacturing, labeling, advertising, marketing, efficacy
and safety, yet FDA regulation of cosmetics is focused primarily on labeling and safety. The
FDA regulates most products with a set of published standards enforced by a modest number of
facility inspections. Inspection observations are documented on Form 483.26

23
24

FDA 2008 ORA Field Activities" (PDF).USFDA. Retrieved 2008-09-13.

"FDA's International Posts: Improving the Safety of Imported Food and Medical Products". USFDA. Retrieved

2010-04-10
25

Food, Drug and Cosmetic Act Web Version

26

http://www.fda.gov/

13

CHAPTER VI
ICMR:
History
The Indian Council of Medical Research (ICMR), New Delhi, the apex body in India for the
formulation, coordination and promotion of biomedical research, is one of the oldest medical
research bodies in the world. As early as in 1911, the Government of India set up the Indian
Research Fund Association (IRFA) with the specific objective of sponsoring and coordinating
medical research in the country. After independence, several important changes were made in the
organization and the activities of the IRFA. It was redesignated in 1949 as the Indian Council of
Medical Research (ICMR) with considerably expanded scope of functions.
Structure
The ICMR is funded by the Government of India through the Department of Health Research,
Ministry of Health & Family Welfare.
Functions
The Council's research priorities coincide with the National health priorities such as control and
management of communicable diseases, fertility control, maternal and child health, control of
nutritional disorders, developing alternative strategies for health care delivery, containment
within safety limits of environmental and occupational health problems; research on major noncommunicable diseases like cancer, cardiovascular diseases, blindness, diabetes and other
metabolic and hematological disorders; mental health research and drug research (including
traditional remedies). All these efforts are undertaken with a view to reduce the total burden of
disease and to promote health and well-being of the population. The Governing Body of the
Council is presided over by the Union Health Minister. It is assisted in scientific and technical
matters by a Scientific Advisory Board comprising eminent experts in different biomedical
disciplines. The Board, in its turn, is assisted by a series of Scientific Advisory Groups,
Scientific Advisory Committees, Expert Groups, Task Forces, and Steering Committees etc.
which evaluate and monitor different research activities of the Council (chart).

14

The Council promotes biomedical research in the country through intramural as well as
extramural research. Over the decades, the base of extramural research and also its strategies
have been expanded by the Council.
Intramural

research

is

carried

out

currently

through

the

Council's

29

Research

Institutes/Centers/Units. These include (i) 18 mission-oriented national institutes located in

different parts of India that address themselves to research on specific areas such as tuberculosis,
leprosy, cholera and diarrhoeal diseases, viral diseases including AIDS, malaria, kala-azar,
vector control, nutrition, reproduction, immunohaematology, oncology, medical statistics, etc;
(ii) 6 Regional Medical Research Centers that address regional health problems, and also aim to
strengthen or generate research capabilities in different geographic areas of the country; and (iii)
5 Unit/Centre dealing with food & drug toxicology, viral diseases, handling microorganisms of
highly infectious nature, prenatal diagnosis for neonatal retardation etc and supply of various
animal models and feeds for experimental purposes.
Extramural research is promoted by ICMR through (i) Setting up Centers for Advanced Research
in different research areas around existing expertise and infrastructure in selected departments of
Medical Colleges, Universities and other non-ICMR Research Institutes.(ii) Task force studies
which emphasize a time-bound, goal-oriented approach with clearly defined targets, specific
time frames, standardized and uniform methodologies, and often a multicentre structure.(iii)
Open-ended research on the basis of applications for grants-in-aid received from scientists in
non-ICMR Research Institutes, Medical colleges, Universities etc. located in different parts of
the country. The Council is alert to new diseases and new dimensions of existing diseases, as
exemplified by the rapid organization of a network of Surveillance Centers for AIDS in different
states of India in 1986. 27

27

http://icmr.nic.in/abouticmr.htm

15

CHAPTER VII
CDSCO:
History
Under the Drug and Cosmetics Act, the regulation of manufacture, sale and distribution of Drugs
is primarily the concern of the State authorities while the Central Authorities are responsible for
approval of New Drugs, Clinical Trials in the country, laying down the standards for Drugs,
control over the quality of imported Drugs, coordination of the activities of State Drug Control
Organizations and providing expert advice with a view of bring about the uniformity in the
enforcement of the Drugs and Cosmetics Act. Drug Controller General of India is responsible for
approval of licenses of specified categories of Drugs such as blood and blood products, I. V.
Fluids, Vaccine and Sera.28
Structure
Central Drugs Standard Control Organization functions under the Directorate General of Health
Services. 29
Functions
Functions undertaken by Central Government: Statutory Functions:
a) Laying down standards of drugs, cosmetics, diagnostics and devices.
b) Laying down regulatory measures, amendments to Acts and Rules.
c) To regulate market authorization of new drugs.
d) To regulate clinical research in India.
e) 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.
f) To regulate the standards of imported drugs.
g) Work relating to the Drugs Technical Advisory Board (DTAB) and Drugs Consultative
Committee (DCC).
h) Testing of drugs by Central Drugs Labs.
28
29

http://cdsco.nic.in/html/CDSCO%20Contact%2025-9-08.htm
ibid

16

i) Publication of Indian Pharmacopoeia.

Other Functions:
i) Coordinating the activities of the State Drugs Control Organizations to achieve uniform
administration of the Act; and policy guidance.
ii) Guidance on technical matters.
iii) Participation in the WHO GMP certification scheme.
iv) Monitoring adverse drug reactions (ADR).
v) Conducting training programmes for regulatory officials & Govt. Analysts.
vi) Distribution of quotas of narcotic drugs for use in medicinal formulations.
vii) Screening of drug formulations available in Indian market.
viii) Evaluation/Screening of applications for granting No Objection Certificates for export of
unapproved/banned drugs.
Functions undertaken by State Government: Statutory Functions:
a) Licensing of drug manufacturing and sales establishments.
b) Licensing of drug testing laboratories.
c) Approval of drug formulations for manufacture.
d) Monitoring of quality of Drugs & Cosmetics, manufactured by respective state units and those
marketed in the state.
e) Investigation and prosecution in respect of contravention of legal provisions.
f) Administrative actions.
g) Pre- and post- licensing inspection.
h) Recall of sub-standard drugs.30

CHAPTER VIII
30

http://cdsco.nic.in/html/Drugs_ContAd.html

17

DCGI:
Drug Controller General of India is responsible for approval of licenses of specified categories of
Drugs such as blood and blood products, I. V. Fluids, Vaccine and Sera. 31

31

Suppra 26

18

CHAPTER IX
ROLE TO BE EVALUATED FOR:
1. Recent work done by above mentioned Authorities:

WHO:

i) Dengue control:
WHO guidelines for dengue prevention and control
ii) Flash floods in Leh:
WHO supported the Ministry of Health and Family Welfare, Government of India, in
augmenting medical relief supplies to Leh.
iii) World Health Day 2010: Urbanization and Health:
The World Health Day theme this year focuses on Urbanization and Health addressing health
issues of the rapidly increasing urban population32.
Year - 2010
o

Guidelines for Law Enforcers for effective implementation of tobacco control laws

Brainstorming Workshop on Interface between Water Technology Developers and

Other Stakeholders- NEERI, Nagpur

Good Agricultural Practices for Medicinal Plants, 2009

Guidelines on Good Field Collection Practices for Indian Medicinal Plants, 2009

Health Status of Tribal

o National Consultation on Public Health Workforce in India

o Report of Consultation on history of health care in India
o Guidelines for Water Safety Plans for Rural Water Supply Systems
o

Market Study On Alternatives of Mercury Measuring Devices in Health Care in India

o Toward Mercury-Free Medical Devices Transforming Indias Production And

Consumption Of Thermometers And Sphygmomanometers
o

Bio- medical waste management Dos and Donts

Standard for treatment and disposal of Bio-medical waste

o Bio- medical waste management- Stickers

32

http://whoindia.org/EN/Index.htm

19

Bio- medical waste management self Learning document for Dayas, aayas and class iv
employees 2009

Bio-medical waste management self Learning document for Doctors, superintendents

and Administrators

Bio- medical waste management self learning document for Nurses and Paramedical

Report on Inventorization of e-waste in two cities in Andhra Pradesh and Karnataka

Vulnerability to Heat Stress: Scenario of Western India

Development of Training module for WSP in Urban Areas

Water Safety Plan-Manual for Pilot Study Areas of Hyderabad

Application of Composite Correction Programme for Improvement in Efficiency of

Water Treatment Plant

Impact of Inadequate Sanitation and Poor Level of Hygiene Perception and Practices on
Community Health

Andhra Pradesh Total Diet Study, A Report on Dietary Exposure Assessment of

Chemical Contaminants

West Bengal- Total Diet Study, A Report on Dietary Exposure Assessment of Chemical
Contaminants

Assessment of risk and putative biomarkers for oral pre- cancers/ cancer among the
chewers of areca nut and non-tobacco Pan Masala

o Study on microbiological aspects of fresh fruit and vegetables (including green leafy
vegetables) in and around national capital region (NCR)
o
o

Training Manual on Health Insurance (with Facilitators Guide)

Andhra Pradesh Total Diet Study, A Report on Dietary Exposure Assessment of
Chemical Contaminants

West Bengal- Total Diet Study, A Report on Dietary Exposure Assessment of Chemical
Contaminants

Assessment of risk and putative biomarkers for oral pre- cancers/ cancer among the
chewers of areca nut and non-tobacco Pan Masala

Health Committee and Commission Reports, 1946-2005

Guidance manual for drinking water quality monitoring and assessment (second edition)
20

Water Safety Plan-Manual for Pilot Study Areas of Hyderabad

Application of Composite Correction Programme for Improvement in Efficiency of

Water Treatment Plant

National Health Accounts India 2004-05

Training Manual for Implementing NHA in India

Year - 2009
o

Guidelines for Accreditation of Private Health Facilities for Providing SBA Training

World Health Statistics Report 2009

Public Health Workforce In India: Career Pathways for Public Health Personnel

As We See It: Life work stories of health workers

Textbook on Public Health and Community Medicine

World No Tobacco Day

Influenza A (H1N1) - Swine Origin

Nutrition for Health and Development

Understanding the Role & Impact of CBR in Mandya District of Karnataka Research
Initiative Report of First Meeting of Scientific Advisory Group AIFO Office, Bangalore
(India) 15 17 April 2009

14th World Conference on Tobacco or Health

Global Leprosy Meeting33

ICH:

i) 2010 Training workshop on Quality Guidelines Q8,Q9 and Q1034

ii) Public Meetings:
ICH Japan Symposium, Tokyo, Japan, Friday June 12, 2009
Brussels, Belgium, Friday November 14, 2008
Washington DC, Tuesday October 21, 2008
ICH Tokyo Symposium: Hot Topics and Influence on Asia, Tokyo, Japan, November 2, 200735

33

http://whoindia.org/EN/Section363.htm

34

http://www.ich.org/cache/compo/276-254-1.html

35

ibid

21

CFR:

i)

Legal Information Institute:

This front-end to the Code of Federal Regulations (CFR) is generated from and links to the most
recent version of the CFR placed on the Internet by the Government Printing Office. It contains
the federal regulations in force as of specific revision dates which vary from title to title. That for
each title is shown on its table of contents.36 [For guidance on how to determine if a particular
regulation has since been amended]

FDA:

i) October, 2010:
o FDA approves injectable drug to treat opioid-dependent patients
o

Abbott Laboratories agrees to withdraw its obesity drug Meridia

o FDA: Potentially harmful stimulant found in Slimming Beauty capsules

o

FDA seeks to stop Juice Companys processing, distribution

o FDA Issues Regulatory Science Report37

O FDA 2009 H1N1 (SWINE) FLU
FDA is working to address human infection with the 2009 H1N1 flu virus as part of a team led
by the Department of Health and Human Services. 38

ICMR:

o An overview of International Collaborative projects in Biomedical Research

o ICMR Postdoctoral Research Fellowship
o Junior Research Fellowships
o

Ad hoc Research Projects

o Guidance for International Collaboration39

36

http://www.law.cornell.edu/cfr/

37

http://www.fda.gov/

38
39

http://www.fda.gov/NewsEvents/default.htm
http://icmr.nic.in/grants/shemes.htm

22

CDSCO:

o Draft Rules regarding Umbilical Cord Blood

o Gazette Notification regarding Import & Registration of Cosmetics
o Suspension of import / manufacture of rosiglitazone in the country
o Guidance Document on Common Submission Format for Import License in Form 10 of
Medical Devices in India
o

Draft Guidance for Industry on Fixed Dose Combinations

o Guidance Document on Common Submission Format for Registration of Medical

Devices in India
o

Requirements for Conducting Clinical Trial(s) of Medical Devices in India Guidance

document on application for grant of License in Form-28 for manufacture of Medical
Devices in India under CLAA Scheme

National list of Drug manufactures /Loan licensee and COPPs holders in the country40

2. What is the statistics for health in India and role of Administration therein (trends in
health status?
I] Life expectancy:
Life expectancy at birth has increased for male and female in India. It is 64.1 years for males
and 65.8 years for females (2005). This has revealed the decrease in death rate and the better
improvement of quantity and quality health services in India. However, there are inter-state,
inter-district and rural-urban differences in life expectancy at birth due to low literacy,
differential income levels and socio-economic conditions and beliefs. In Kerala, a person at birth
is expected to live for 73 years while in states like Bihar, Assam, Madhya Pradesh, Uttar
Pradesh, etc, the expectancy is in the range of 55-60 years.
Healthy life expectancy at birth in India was estimated to be 53.5 in 2002. This was 53.3 for
males and 53.6 for females (WHO, World Health Report 2005).

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http://cdsco.nic.in/

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II] Mortality:
The incidence or prevalence of the diseases or conditions, as well as issues related to etiology,
prevention efforts, prognosis and possibilities for control or elimination this could also be
derived from country burden of disease estimates, and condition specific indicators.
The infant mortality rate has declined in India from 70 infants per 1000 live births in 1999 (SRS)
to 57 in 2005-06 per 1000 live births. Under-five mortality rate per 1000 live births is 85 in 2002.
According to MMR-RG, maternal mortality ratio per 100,000 live births is 301 in 2001-03.
A diverse set of factors are thought to be associated with maternal mortality: factors that
influence delays in deciding to seek medical care, in reaching a place where care is available, and
in receiving appropriate care. The tenth plan document of India has targeted to reduce the IMR to
45 per 1000 live births by 2007 and 28 per 1000 live births by 2012. The main causes of high
MMR being socioeconomic status of women, inadequate antenatal care, the low proportion of
institutional deliveries, and the non-availability of skilled birth attendants in two-thirds of cases.
A World Health Report (1999) gives the main causes of mortality in India as non-communicable
diseases (48 percent), communicable diseases (42 percent) and injuries (10 percent). The
dominant communicable diseases are infectious and parasitic diseases, respiratory diseases,
maternal conditions, prenatal conditions and nutritional deficiencies. Non-communicable
diseases are malignant neoplasm, diabetes mellitus, neuropsychiatric disorders, sense organ
disorders, cardiovascular diseases, respiratory diseases, digestive diseases, musculo-skeletal
diseases, congenital anomalies, oral diseases and other non-communicable diseases.

III] Morbidity:
NFHS-II conducted a study on four major diseases prevailing in India, i.e., asthma, tuberculosis,
jaundice, malaria. In India around 2,468 persons per 100,000 populations were reported to be
suffering from asthma at the time of survey. The prevalence of asthma is high in rural areas than
in urban areas and is slightly higher in males than in females. The overall prevalence of
tuberculosis in India is 544 per 100,000 populations. This is 16 percent higher than the survey
done by NFHS-I (467 per 100,000). It is more in case of rural areas than in urban areas and more
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for male than females. It is more in males because of males are in contact with more people who
might have TB and smoking is more in men. The prevalence of TB increases with age. Jaundice
cases were reported to be 1361 persons per 100,000 populations. This is more prevalent in rural
areas than in urban areas. However, it decreases with age. Thus, highest numbers of jaundice
patients are in the age of 0-14. 3,697 persons per 100,000 populations were reported to have
suffered from malaria. People of rural area suffer twice than that of urban area and it is slightly
high for males than for females. All these diseases however vary and differ from state to state
depending on the climate and geographical locations of the areas.
IV] Disability:
A survey by the National Sample Survey Organization 1991 estimates that around 1.9 percent of
population are disabled in India. Other estimates suggest that between 6 and 10 percent of the
population in any developing country is affected by disability, which means 60-100 million
Indians are affected by disability. Four to 14 million people are blind, 3.2 million people with
hearing impairment, over 16 million people are affected by locomotor disabilities and 3 percent
of India's children are mentally retarded. The government of India has policies related for the
disabled, rehabilitation schemes, grant-in-aid schemes and schemes run through NGOs.
According to ICMR (Indian council of Medical Research), cataract is the main cause of 55
percent of blindness. The major causes of blindness as seen in the survey conducted by the
National Programme for Control of Blindness (NCB), included cataract , refractive errors, corneal
opacities, glaucoma, trachoma and vitamin A deficiency. 41
3. Violation of Human Rights and National Human Rights Commission's view:
Human Rights aren't just about violence and terrorism. Unsafe drugs too fall into the category.
The National Human Rights Commission (NHRC) has described the manufacture, distribution
and sale of unsafe drugs and medical devices as a violation of human rights.42

41

http://searo.who.int/EN/Section313/Section1519_10855.htm

42

http://www.drugscontrol.org/default.asp

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4. Differences between on paper and real:

The past century has seen an overall decrease in infant and child mortality, increased longevity,
the global eradication of smallpox, and the control of major infectious diseases, particularly in
some parts of the world and in certain social classes. Improved socio-economic conditions and
living standards, including better housing and nutrition; public health measures; education; and
increased access to medical and health care, are the major causal factors. Developments in
medical science and technology and important societal shifts underlie some of the changes. The
latter includes participatory democracy, which has increased opportunities for previously
powerless sections of society, and recognition of the basic human right to health and health care
based on social justice, among others.
However at the start of the new millennium, long-standing and yet unresolved challenges remain.
They include the continuing health divide between the rich and poor; between and within
countries; the gap between expected outcomes and reality; implementation gaps in health
programmes; and disparities in control over decision making concerning health, between the
powerful and powerless.43

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HealthCooperationPapers,Vol.17_http://www.aifo.it/english/resources/online/books/other/poverty%26health/37po

rest-thelma.pdf

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CHAPTER X
CONCLUSION:
The Indian pharmaceutical and life sciences sector is growing at very rapid pace. Many foreign
companies are looking at India as one of their main areas of operation. Similarly, domestic
companies have started spreading their wings globally.
Present drugs (pharmaceuticals) administration and regulation is taking its move to attain set
standards. Public health forces run by Government are overburdened and so are struggling to
give their best. Large geographical size, high population density, lack of infrastructure, lack of
preservation facilities ,lack of transport, inaccessibility, illiteracy, poverty, poor nutritional
status, ignorance about health ,diversity in food habit and life style are various failings.
Government precessions to supply safe and economic pharmaceutical products are yet to be
actioned. Low finance for health, lack of funds are some of the reasons behind. Medical sciences
are fast developing and information technology resources are almost everywhere , its need of an
hour to create awareness, and significance by following national and international authorities that
will help in deciding correct and fair services of pharmaceuticals towards the society. This will
help health Government /companies /personnel to deliver high quality services and raise up their
standards. These regulations are not only mandatory but helpful in health sector both in
Government and Private Companies.
It is required for industry players to aware of existing legal framework which regulates the
pharmaceutical and life sciences industry in India. Many new legislations and guidelines have
been introduced and it has become imperative for everyone to be aware of them including the
existing legal regulatory regime which governs all the facets of pharmaceutical and life science
industry including manufacturing, marketing and distribution, research and development and
clinical trials. It includes history, structure and functions of each of the regulatory and
administrative authorities.
Thus it is of paramount importance that regulatory and administrative authority that are required
to be followed and their functions in industry practices like contract manufacturing, clinical
trials, import and manufacture of medical devices, stem cell research, and regulations and
guidelines which govern these practices helps in good Governance.
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It also applies to all the pharmaceuticals and life sciences companies which are looking at setting
up operations in India.

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BIBLIOGRAPHY
NATIONAL AUTHORITIES:
ICMR (Indian Council of Medical Research)
CDSCO (Central Drugs Standard Control Organization)
DCGI (Drug Controller General of India)
INTERNATIONAL AUTHORITIES:
WHO (World Health Organization)
ICH (International Conference on Harmonization)
CFR (Code for Federal Regulation)
ACTS:
Drugs and Cosmetics Act, 1940
Drugs and Cosmetics Rules, 1945
Pharmacy Act, 1948
Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954
Narcotic Drugs and Psychotropic Substances Act, 1985
Medicinal and Toilet Preparations (Excise Duties) Act, 1955
Drugs (Price Control) order, 1955 (under the Essential Commodities Act.)
Industries (Development and Regulation) Act, 1951
Trade and Merchandise Marks Act, 1958
Indian Patents and Designs Act, 1970
Factories Act, 1948
BOOKS:
Nishith Desai Associates - Indian Pharma and Life Science Industry-Legal and Tax Framework
J.L.Valverde - Key Issues in Pharmaceutical Law Pharmaceuticals policy and law
Vijay Malik - Law relating to Drugs and Cosmetics
NATIONAL HUMAN RIGHTS COMMISSION:
Report, 1996
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