OVERVIEW OF

REGULATORY SETUP IN
INDIA
Ketan Mehta
INDIA MDO GPS
21st Nov 2012

Agenda
(1)
(2)
(3)

Governmental Regulatory Structure

Drug & Cosmetic Regulatory Bodies
Other Important Regulatory Bodies
(1)
(2)

(4)

Bureau of Indian Standard

Legal Metrology Department

Industry Associations/Bodies
(1)
(2)
(3)
(4)

ISTMA
CII
FICCI
ASCI

(1)
GOVERNMENTAL
REGULATORY
STRUCTURE

Governmental Regulatory Structure

India is unique
FMCG / Pharma
Industry

Ministry of
Chemicals &
Fertilizers

Ministry of Health
& Family
Welfare

Ministry of
Commerce &
Industry

Ministry of
Science &
Technology

Patent office

Dept. of Science &

Technology

Ministry of
Finance

Ministry of
Consumer Affairs

DGHS
Dept. of
Pharmaceuticals
CDSCO

Pharma Policy

NPPA
Pricing

DTAB

Legal metrology
BIS

DCGI
IPR
Drugs & Cosmetics
Act
Drugs & Magic
Remedies Act
Marketing Approval
Clinical Trials

Patents Act

R&D

FDI

Biotech Policy

Tax & Duty

Transfer
Pricing

Labeling and
Weight errors
National standards

Functions of governments: Central Vs

Functions of central
StateFunctions of state
government

Statutory Functions:

To lay down regulatory measures, amendments to

Acts and Rules.

To lay down standards of drugs, cosmetics,

diagnostics and devices.

To lay down regulation for clinical research &

consumer studies

To form regulation related to import & export of the

product

Work relating to the Drugs Technical Advisory Board

(DTAB) and Drugs Consultative Committee (DCC).

Publication of Indian Pharmacopoeia.

Other Functions

Coordinating with State Drugs Control Organizations

to achieve uniform administration of the Act; and
policy guidance.

Guidance on technical matters.

Pots market surveillance

Statutory
Functions:
government

(1) To exercise licensing of

manufacturing and sales
establishments & Licensing of drug
testing laboratories. (2) To set up work
processes and guidance for the
exercise of regulations.

To exercise compliance to the

standards

To exercise regulation related to clinical

research & consumer studies.

Other Functions:

Investigation and prosecution in

respect of contravention of legal
provisions.

Administrative actions.

Pre- and post- licensing inspection.

Recall of sub-standard drugs &

cosmetics.

(2) DRUG &

COSMETIC
REGULATORY
BODIES

Cosmetic regulatory framework in

India
Registration of
locally
manufactured
cosmetics

NOC for specific

purposes

BIS

Registration of
imported
cosmetics
Individual
government body
issuing standards
( FP, RM)

Zon
al
FDA

DCGI
(Delhi)

List & Contact of FDA

http://www.cdsco.nic.in/forms
/list.aspx?lid=1370&Id=0

Regulatory Authorities for product approval

Regulatory Authorities for product approval

Govt

Ministries

Departments

Responsibility

Central
Governmen
t
Ministry of Health &
Family Welfare
Directorate of Drugs
Control Administration
(DCGI)
Dept of AYUSH

-New drug approval

-Cosmetic imports,
- NOCs for dual use
- Policy decisions
- Advisory role over state
FDAs

State
Governmen
t
State department for
Health

Food and Drug

Administration
State Dept of AYUSH

- Manufacturing units approval

- Sale & Distribution licenses
- FDA licenses for cosmetics and
OTC
- Autonomous nature for many
activities

(3) OTHER
REGULATORY
BODIES

BUREAU OF INDIAN STANDARDS( BIS) was set up on Jan-1947 as a statutory

body under BIS ACT, as NATIONAL STANDARDS BODY of INDIA
OBJECTIVES

Harmonious, development of standardization and quality control in national

and international arena

Certification schemes for products and systems

Growth and development of Indian industry, commerce and exports

Consumer protection
WHAT IS IT FOR US?

Issues national standards, few of them are made mandatory e.g Schedule S

Main body to influence standards. DCGI consults BIS for guidance on cosmetic
standards.

Mandatory to put artwork declarations provided by BIS standards

 Production and General

Engineering (PGD)
Civil Engineering(CED)
Chemical(CHD)
Electro technical(ETD)
Food andAgriculture(FAD)
Electronics and Information
Technology
Mechanical
Engineering(MED)
Management and
Systems(MSD)
Metallurgical
Engineering(MTD)
Petroleum, Coal and Related
Products (PCD)
Transport Engineering (TED)
Textile(TXD)
Water Resources(WRD)
Medical Equipment and
Hospital Planning( MHD)

subcommittee: CHD &

PCD

BIS Committees

Structure of BIS and its committees

CHD 1 Inorganic chemicals

CHD 6 Natural gases
CHD 25 Soaps & other
surface active agents.
___________________________
PCD 7 Solid Mineral Fuels
PCD 9 Organic Chemicals
Alcohols & Allied Products
and Dye Intermediates
PCD 12 Plastics
PCD 13 Rubber and Rubber
Products
PCD 18 Natural and Synthetic
Fragrance Materials
PCD 19 Cosmetics
PCD 21 Plastics Containers

There are mainly

4 type of
standards in
PCD.
1.

2.

3.

4.

Raw Material
standard
Finished
product
standard
Common
standards
Other
standards

SharePoint Link:
http://vcs.pg.com/sites/CF/gpsra/Beauty%20Care/Forms/AllItems.aspx?RootFolder=%2fsites%2fCF%2fgpsra%2fBeauty%20Care%2fIndia%20BIS
%20Compliance%20Work&FolderCTID=&View=%7b4D86F06D%2d0555%2d43B4%2d9372%2d410030BAF813%7d

Legal Metrology Department

Goal: to establish the standards of Weights & Measures based on SI
units and regulate trade & commerce of packed commodities across
India.
Functions:
to regulate use of correct weighing and measuring instruments
to ensure mandatory declarations on package
to carry out regular/surprise inspections in markets
to take regulatory action for not complying with regulations
What is it for us?
Main body to influence legal metrology related regulation.
Mandatory to put artwork declarations provided by package
commodity rules
Mandatory to follow standard pack sizes for few categories e.g.
Laundry

(4) INDUSTRY
BODIES

Now called IBHA (Indian Beauty & Hygiene Association)

Indian Soap & Toiletries Makers Association (ISTMA) is an

organization representing manufacturers such as Hindustan Lever
Limited, Procter & Gamble Hygiene and Health Care Limited,
Colgate-Palmolive (India) Limited, Godrej Consumers Products
Limited, Wipro Limited, Reckitt Benckiser Limited, J.L. Morison
(India) Limited, Henkel SPIC (India) Limited, etc.

The Confederation of Indian Industry(CII) is a non-government, not-for-profit,

industry-led and industry-managed organisation, seeking to play a proactive role in
Indias development process. The organisation works to create and sustain an
environment conducive to the growth of industry inIndia, partnering industry and
government alike through advisory and consultative processes. The confederation is
headquartered inNew Delhi.
Functions

CII aims to usher change by working closely with government on policy issues,
enhancing efficiency, competitiveness and expanding business opportunities for
industry through a range of specialised services and global linkages. It also provides
a platform for sectoral consensus building and networking. Major emphasis is laid
on projecting a positive image of business, assisting industry identify and execute
corporate citizenship programmes. CII undertakes research, interacts with key
government officials and disseminates information through publications, seminars
and events.

With 64 offices in India, 9 overseas inAustralia,Austria,China,France,Germany,

Japan,Singapore,UK,USAand institutional partnerships with 223 counterpart
organisations in 100 countries, CII aims to serve as a reference point for Indian
industry and the international business community.

TheFederation of Indian Chambers of Commerce and

Industry(FICCI) is an association of business organizations
inIndia, headquartered in the national capitalNew Delhi.
FICCI is one of the main organizations to fund and support
many governmental and non-governmental educational
institutes. It was founded byGD Birlaand Purushottam
Takkur in 1927, on the advice ofMahatma Gandhi.

Industry
Associations
IBHA/ISTMA

CII

(Scientific
Association)

Across Industry
Association)

1. Operated by industry
members
2. Influencing cosmetic
regulations
3. Influencing legal
metrology regulations
4. Protect Industry from
common issues

1. Self operated body

2. Biggest industry
organization partnering
with 223 counter part in
100 countries
3. Influencing aid for
across industry issues

FICCI
Across industry
association

1. Self operated body

2. Mainly to protect
commercial interest of
industries
3. Similar purpose as
like CII

Goal: to achieve its own overarching goal: to maintain and enhance the
public's confidence in advertising.

ASCI is a self regulatory voluntary organization of the advertising industry.

ASCI was established in 1985 for Self-Regulation in Advertising, ensuring

the protection of the interests of consumers.

The ASCI was formed with the support of all four sectors connected with
Advertising, viz. Advertisers, Ad Agencies, Media (including Broadcasters
and the Press) and others like PR Agencies, Market Research Companies
etc. Its main objective is to promote responsible advertising thus
enhancing the public's confidence in Advertising.

ASCIs Code for Self-Regulation in Advertising is now part of ad code under

Cable TV Acts Rules. Violation of ASCIs Code is now violation of Govt.
rules.

ASCI is member of The European Advertising Standards Alliance (EASA)

Thank You!

References

http://www.cdsco.nic.in/

http://www.ipapharma.org/Regulations.aspx

http://www.bis.org.in/

http://www.cii.in/

http://www.ficci.com/

http://consumeraffairs.nic.in/consumer/?q=node/44

http://www.ascionline.org/