The document provides an overview of the Indian pharmaceutical industry and proposed regulatory reforms. It discusses that the Indian pharmaceutical sector consists of about 300 organized companies and 20,000 total businesses, producing over 400 bulk drugs and supplying 20% of the global generic drug market. The regulatory framework is currently based on the 1940 Drugs and Cosmetic Act. Proposed reforms include forming a Central Drug Authority similar to the US FDA to facilitate licensing uniformity and drug regulation improvements, as well as increasing manpower training, infrastructure expansion, stricter inspections, and ensuring financial and operational independence of the regulatory body.

1. Indian Pharmaceutical Regulations
A current regulatory overview
Prepared by: Sambhujyoti Das

2. Indian Pharmaceutical Sector – An Overview
2
One of the high performing knowledge based segments of the manufacturing sector.
• The ‘organised’ sector of India’s pharmaceutical industry consists of about 300 companies.
• The total sector is estimated at nearly 20,000 businesses.
• 400 + bulk drugs are produced.
• Producing high quality generic medicines that are sold around the world.
• Supplying 20% (value wise) of the global market for generic medicines.
• Exporting medicine to over 200 countries.
• Total review around US$ 20 bn +.
• Compound annual growth rate of 20 percent.

3. 3
+
Regulatory Framework
As per Drugs & Cosmetic Act 1940.

4. Proposed New Drug Regulatory System
4
• Formation of Central Drug Authority (CDA) in January 2007.
• The organisational structure of CDA would be similar to US FDA.
• It would be strong, well equipped, empowered, independent and professionally managed.
• It would facilitate upgradation of the national drugs regulator, uniformity of licencing and
improvement in drug regulations.
• Strict enforcement of GMP standards to builds up trust of its clients and the obligation on
the regulatory bodies.
• Training and technical capacity building and provide necessary know how to help
manufacturer with GMP compliance.
• Focus on inspection, pharmacovigilance and drug enforcement activities.

5. 5
Proposed New Drug Regulatory System
CDA
(Central Drug
Administration)
CDSCO
(Central Drug Standard Control
Organization)
SDRA
(State Drug Regulatory Agency)
Central independent body
under Ministry of Health &
Family Welfare
Central body
State entity

6. Roles and Responsibilities
6

7. Regulatory Reforms
7
MANPOWER
 Creation of new
posts.
 Capability & skill
development through
trainings.
 Optimum utilization
of current staff.
INFRASTRUCTURE
 Expansion of zonal &
sub zonal offices.
 Strengthening of
central & state drug
testing labs.
 Expansion of current
pharmacovigilance
programmes.
INSPECTIONS  CDA grants Mfg.
license.
 Establish
surveillance against
suspected persons.
 Strict adherence to
scheduled
standards.

8. Regulatory Reforms
8
FINANCE
 Additional fund
to CDA INDEPENDENT
REGULATOR  Efficient, strong
& effective CDA.
 Autonomous
organization
under DCGI.TRANSPARENCY & 3RD
PARTY OVERSIGHT
 Traceable distribution
channel.
 Awareness program to
customers.
 Drug information on
internet.
 Press release against
noncomplying products
and organizations.
 ADE reporting through
internet.

9. Questions and discussion
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