India Sets Out Revised GMP Rules: Can It Weed Out Dodgy Players?

India’s revised GMP rules up the bar and lay out specifics for pharmaceutical quality systems, handling of product complaints and supplier audits, among other areas. While risk-based inspections are already being deployed, it will take unflinching enforcement to separate the wheat from the chaff across 10,000 manufacturing sites in the country.

New GMP requirements to be enforced in India • Source: Shutterstock

India has notified revised good manufacturing practice (GMP) norms, marking a fundamental shift in efforts to address quality concerns for pharmaceuticals made in the country and to weed out unscrupulous players who flout the standards (see side box).

The updated norms under Schedule M of India’s Drugs and Cosmetics Rules come against the backdrop of exports of contaminated...