India Drafts New Law to Speed Drug Approvals, Sharpen Recalls

India’s health ministry has put together a proposal to overhaul the country’s pharmaceutical rulebook, much of which has been in place since 1940. The draft Drugs, Medical Devices and Cosmetics Bill 2026 will reshape how the country brings new drugs and devices to market and manages the ones already sold to the public.

One of the draft’s central aims is speed. The national regulator would be able to fast-track approvals for new medicines and devices, and could waive some clinical evidence requirements when public health is at stake. Quality enforcement will also get sharper: any medical products deemed unsafe will be pulled from shelves immediately, and officials would gain broader power to approve, freeze, or revoke licenses, or order non-compliant stock destroyed.

The bill also reshapes the chain of command between Indian national and state authorities. India’s top drug regulator will also gain more power to direct state agencies and step in if a state fails to act appropriately. Each state will need to appoint an official dedicated to local enforcement, and a new advisory board for medical devices will join the existing panel that advises on drug policy.


Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.