Drug cos 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, the world’s most lucrative market, and a key driver of Indian pharma’s growth.
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 non-sterile 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 congressional panel is not the only one which is worried. 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”. It also said the USFDA is inadequate at holding foreign manufacturers accountable for repeatedly violating regulations.
In the context of shortages, the committee questioned the FDA on its dependence on Ahmedabad-based Intas Pharmaceuticals for the supply of two chemotherapy drugs carboplatin and cisplatin, despite the regulator being aware of “significant, repeated quality control failures”.
The facility was one of only five manufacturers supplying the US market with chemotherapy drugs, carboplatin and cisplatin.
Intas had voluntarily stopped manufacturing operations in response to quality control failures on June 5. But until a June 9 briefing with congressional staff on cancer drug shortages, the FDA was not aware of the company’s plans to halt operations at Ahmedabad, the letter said.
“This lapse in communication is concerning, as the FDA was ostensibly aware of the ongoing quality issues at the plant…” it said.
Further, the committee questioned why the regulator had discontinued the practice of unannounced inspections, despite a 2014-15 pilot in India proving to be successful at “exposing widespread misconduct”.
Later with the emergence of the coronavirus, and for over two years, it switched to remote inspections. Once these inspections resumed, they did so at a much lower level than before the pandemic. 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.