Pharmaceutical/Drug Registration in India

The Indian pharmaceutical/drug market is about $22 billion. The Indian regulator of pharmaceuticals is the Central Drug Standards Control Organization (CDSCO). CDSCO is also commonly referred to as the DCGI, which stands for Drug Controller General India.

All pharmaceuticals imported into India must have prior approval from the DCGI. The principal legislation for drug products in India is the Drugs and Cosmetics Act of 1940 (DCA). Both state and national authorities share the work of pharmaceutical/drug regulation.

Depending on the type of pharmaceutical, drugs will first go through a new drug approval to get a drug registration. For drugs that have never been marketed in India before, the DCGI typically requires phase III trials to be perfomed in India. Then an import registration certificate can be received from the DCGI. Finally, the importing party uses the import registration certificate to obtain an import license from the DCGI.

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

India Pharmaceutical Regulatory Report 2011 (publication for sale)
India Medical Devices Manufacturers, Distributors, Exporters Directory 2011 (First of its kind!)
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