Industry experts believe that this development could result in stricter regulatory scrutiny of domestic companies in the coming months. They are concerned that increased regulatory pressure may affect the profit margins of domestic companies operating in the US.
The US Congress’ Energy and Commerce Committee highlighted that Chinese and Indian manufacturers have received the most FDA warning letters for manufacturing lapses. They expressed worry about the US’s heavy dependence on foreign manufacturers who repeatedly violate FDA safety regulations. These violations include the presence of carcinogens in medicines, data falsification or destruction, and nonsterile manufacturing processes. The committee conveyed these concerns in a recent letter to FDA Chief Robert Califf.
“The FDA’s recent decision to address drug shortages by allowing the temporary import of unapproved drugs from India and China makes effective foreign inspection programs in those countries crucial,” the letter added. India houses approximately 530 USFDA-approved plants. The letter also mentioned a report by the government accountability office that deemed the FDA’s practice of conducting pre-announced foreign inspections ineffective and raised questions about the equivalence of foreign and domestic inspections.
According to one analysis, out of approximately 2,800 foreign manufacturing facilities, the FDA inspected only 6%, with a mere 3% of Indian manufacturers being inspected.
The letter states that China presents a more dangerous situation than India in many respects. From fiscal years 2020 to 2022, the FDA conducted only 40 inspections in China compared to 131 in FY19 alone.