Indian Pharmaceutical RegulationsA current regulatory overview

Prepared by: Sambhujyoti Das

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Indian Pharmaceutical Sector – An Overview

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.

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+

Regulatory Framework

As per Drugs & Cosmetic Act 1940.

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Proposed New Drug Regulatory System

• 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.

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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

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Roles and Responsibilities

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Regulatory Reforms

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.

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Regulatory Reforms

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.

Questions and discussion

THANK YOU