India’s Government to Create Independent Drug Regulatory Authority

The Indian government has announced that it will create a new independent drug regulatory authority, to be called the Central Drug Administration or the National Drug Authority, which will be structured similarly to the U.S. Food and Drug Administration (FDA). India’s Minister of Health and Family Welfare, Dr. Anbumani Ramadoss, met with the FDA to discuss this issue during a recent visit to the U.S.

The drug regulatory authority will most likely be composed of around 10 departments each overseeing various issues; for example, drug safety, drug law enforcement, cosmetics, and biological products. It is anticipated to be functioning within two years. The government hopes to eventually set up a cooperative agreement with the FDA whereby regulatory approvals granted in the U.S. would be valid in India and vice versa.

The move to a centralized drug control system overseen by a national regulator is a response to recommendations by the Mashelkar Committee, a group of experts convened to examine the drug regulatory system in India. The regulation of drugs is currently decentralized, with individual state drug authorities reporting to the Drug Controller General of India in the Central Drugs Standard Control Organization. However, this system has led to inconsistency in the enforcement of drug laws and the quality of drug testing throughout the country. The creation of an independent drug regulator will hopefully lead to more rigorous and consistent regulation of drugs and higher quality standards overall.