Approval for the Central Drugs Authority of India

The Government of India’s Union Cabinet has approved the establishment of the Central Drugs Authority of India. This Authority would be an autonomous organization under the Ministry of Health & Family Welfare. Currently, the Central Drug Standards Control Organization works with the State-level Food and Drug Administrations (35 total) to regulate medical products. By establishing this new Central Drugs Authority, the government hopes to make licensing and enforcement of medical products more uniform and centralized while improving the quality and safety of drugs.

This Central Drugs Authority would be similar to the US FDA, with a completely centralized licensing system under the Union Government. Currently, the State Food and Drug Administrations have various responsibilities such as issuing manufacturing licenses for medical licenses, conducting standards and quality monitoring, and enforcing licenses. However, manufacturing licenses will eventually be issued from the Union government as opposed to the State. To accommodate this change, the Cabinet has also approved a phased five-year transition period. The new Central Drugs Authority will be located at the Food and Drug Bhawan, New Delhi.

Other changes include upgrading the position of Drug Controller General India from Joint Secretary to Additional Secretary. In addition, the Cabinet also approved the revival of Additional Drugs Controller India at the level of Joint Secretary to the Government of India.