2. 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.
4. 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.
Proposed New Drug Regulatory System
(Central Drug Standard Control
(State Drug Regulatory Agency)
Central independent body
under Ministry of Health &
7. Regulatory Reforms
Creation of new
Capability & skill
of current staff.
Expansion of zonal &
sub zonal offices.
central & state drug
Expansion of current
INSPECTIONS CDA grants Mfg.
Strict adherence to
8. Regulatory Reforms
to CDA INDEPENDENT
REGULATOR Efficient, strong
& effective CDA.
under DCGI.TRANSPARENCY & 3RD
Awareness program to
Drug information on
Press release against
ADE reporting through