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
THANK YOU