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.
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...
Key expert panel go-ahead with a trial waiver put’s Eisai's Alzheimer's therapy on track for a debut in India where tailored pricing will be pivotal. Lilly’s Kisunla is also under regulatory review.
As the US FDA expands unannounced foreign inspections building on pilots in India and China, experts expect higher scrutiny of overseas sites and perhaps even an industry shakeout in the longer term, though staffing and enforcement challenges could slow things down.
India is pressing ahead with “big shifts” in its regulatory approach for cell and gene therapies. Reduced “layers of review”, tighter internal timelines, upcoming guidelines to facilitate CGT development and reforms in the constitution of expert committees are some of the key changes.
US-based Colossal Labs has claimed to bring back the dire wolf from extinction. While the science is not as dramatic in India yet, cell and gene therapies are making progress as treatments for cancer and other diseases. Pink Sheet takes a look at what is driving CGT success and growth.
