India's Health Ministry moots state or center-led drug regulation

In a change of stance from its earlier proposal, India's Health Ministry has proposed that either the state or central authorities be empowered to regulate drugs and cosmetic manufacture, instead of only the Central Drugs Standard Control Organization (CDSCO).

India's New Drugs, Medical Devices and Cosmetics Bill, 2023, is likely to be introduced in Parliament this week in the monsoon session. The new bill will replace the existing 82-year-old Drugs and Cosmetics Act of 1940 with updated laws and stricter regulatory standards for the pharmaceutical industry.

This bill aims to regulate the import, manufacture, distribution, sale and testing of drugs, medical devices, and cosmetics, as well as their quality, safety, efficacy, performance and clinical trials of new drugs and investigational medical devices.