India Gives FDC Makers 90 Days to Justify Products Lacking Safety, Efficacy Evidence

India is giving makers of unapproved fixed-dose combination drug products more time to justify the manufacturing and marketing of their drugs.

The Drugs Controller General of India said manufacturers of FDC products now have 90 days after receipt of a show-cause notice to provide evidence that their product is safe and effective. Previously, they were given just 30 days to respond.

India has been working to remove unlicensed products from the market for nearly a decade. Its latest move is part of an effort that began in January 2013, when manufacturers were first required to demonstrate the safety and efficacy of their unapproved FDC products.