Drug companies on toes amid glare on USFDA

MUMBAI: A US congressional panel has voiced concern on the ineffective action on quality lapses taken by its national drug regulator Food and Drug Administration (FDA) particularly in manufacturing facilities in India and China. Together, India and China supply approximately 32% of generic drugs, and nearly half of active pharmaceutical ingredients (APIs) to the US.

Industry experts feel the development could potentially lead to a stricter regulatory scrutiny of domestic companies over the next few months. The increase in regulatory pressure, they fear, could impact profit margins of domestic companies operating in the US.
Highlighting that Chinese and Indian manufacturers “receive the most FDA warning letters” for manufacturing lapses, the US Congress’ Energy and Commerce Committee said “we are worried that the US is overly reliant on sourcing from foreign manufacturers with a demonstrated pattern of repeatedly violating FDA safety regulations” It outlined the violations as “carcinogens in medicines, destroying or falsifying of data, and nonsterile manufacturing processes”, in a recent letter to the regulator’s chief, Robert Califf.

“The FDA’s recent decision to address shortages of critical drugs by allowing the temporary import of otherwise unapproved drugs from India and China makes having effective foreign inspection programs in those countries critical”, it added. India is home to about 530-odd USFDA-approved plants. Meanwhile, the letter cites a government accountability office’s report last year that termed the FDA’s practice of conducting pre-announced foreign inspections as ineffective, and which raises questions about the “equivalence of foreign to domestic inspections”.
One analysis found that of approximately 2,800 foreign manufacturing facilities, the FDA inspected only 6%, with just 3% of Indian manufacturers being inspected.
In many respects, China presents a more dangerous situation than India, the letter says. Between fiscal years 2020 and 2022, the FDA conducted only 40 inspections in China as compared to 131 in FY19 alone.