India Drug Approval Strategy

The pharmaceutical market in India is about $22 billion and growing quickly. Developing the right India drug regulation strategy is key.

India's Drugs and Cosmetics Act (DCA) governs the registration, import, manufacture, testing, and sale of drugs and cosmetics. The India drug administration agency is the Central Drugs Standard Control Organization (CDSCO).

Getting approval for the import of drugs into India consists of three main phases: 1) new drug approval (not necessarily for new drugs only); 2) an import drug registration certificate; and 3) an import license. Getting these three things done in India's bureaucratic government can be challenging.

Indian law fixes prices for a wide range of drugs. The National Pharmaceutical Pricing Agency (NPPA) implements these price controls.

For more information on India drug registration issues, please see the following PBM publications and/or contact us to discuss your specific needs.

India Pharmaceutical Regulatory Report 2010 (publication for sale)
Doing Business in India (webcast for sale)
Pharmaceuticals in India: A Business and Regulatory Outlook
Strategies for Success in China, Japan and India (webcast for sale)
India's Pharmaceutical Markets (webcast for sale)
India's Medical Markets Webcast (webcast for sale)
Indian Pharmaceutical Industry: Market, Regulatory, Import and Investment Regime