A US house panel looking into the Food and Drug Administration’s foreign inspections has expressed concern on action taken by the regulator on manufacturing facilities in India and China, and the over-reliance on foreign drugmakers.
The development comes against the backdrop of drug shortages in the US, and an incident involving Intas Pharma is mentioned, while referring to shortages in chemotherapy drugs. India is home to about 530 pure-play USFDA-approved plants.
In its letter to the FDA Chief, the US Congress’ Energy and Commerce Committee said it was particularly concerned about foreign drug inspections conducted in India and China.
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“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 programmes in those countries critical. Chinese and Indian manufacturers receive the most FDA warning letters,” it said, outlining violations that included “carcinogens in medicines, destroying or falsifying of data, and non-sterile manufacturing processes.”
The committee was overseeing the FDA’s foreign drug inspections programme. “Given that approximately 32 per cent of generic drugs and 45 per cent of active pharmaceutical ingredients (APIs) are from these two countries, we are worried that the US is overly reliant on sourcing from foreign manufacturers with a demonstrated pattern of repeatedly violating FDA safety regulations,” the letter said.
The letter cited the Government Accountability Office (GAO)’s report last year, that expressed concern on the FDA’s practice of conducting pre-announced foreign inspections, its effectiveness and the question it brings up on the “equivalence of foreign to domestic inspections.”
Pilot programme
From 2014 to 2015, the FDA conducted a pilot programme in India that eliminated extended advance notice for inspections. “The pilot programme appears to have been successful at exposing widespread misconduct and significant violations of FDA regulations, including falsified quality records. Despite the pilot programme’s success, the FDA elected to discontinue it,” it said.
Pharma industry watchers point out the letter appeared to be more concerned about China (where FDA inspectors could be arrested due to a new interpretation of a law), than India. The USFDA Chief’s reply will be closely read in India, in case it signals a tightening of the regulatory framework, an analyst said.
Intas incident
Mentioning the incident involving Gujarat-based Intas, the letter said, in November 2022, “the FDA was aware of significant, repeated quality control failures at Intas’ Ahmedabad manufacturing facility.” The facility was one of only five finished product manufacturers supplying the US market with chemotherapy drugs carboplatin and cisplatin.
Intas had voluntarily stopped operations at its Ahmedabad plant in response to quality control failures on June 5, 2023. But in 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. “This lapse in communication is concerning, as the FDA was ostensibly aware of the ongoing quality issues at the plant, as well as Intas’ significant US market share for cisplatin and carboplatin and the disruption a plant closure would cause in the supply of these drugs,” it said.
China concern
The letter further pointed out, that China presented “a more dangerous situation” than India. Post-pandemic, the FDA began in-person inspections in China in April 2023, it said, adding that there were “troubling political developments in China” that may jeopardize the viability of the FDA’s in-person inspections there.
“Last month, the ruling Communist Party of China announced a reinterpretation of its already sweeping National Security Law to expand the scope of the law beyond state secrets to cover “data, materials or items related to … national interests.”. The law’s new interpretation is so broad that it would allow officials to arrest FDA inspectors or block access to manufacturers’ records if officials deem it in the national interest, the letter said.