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US Senator Jim Banks has urged the Food and Drug Administration (FDA) to step up inspections of overseas pharmaceutical manufacturing facilities, expressing concern over poor-quality drugs being imported from countries like India and China.
In a letter to FDA Commissioner Martin Makary, Banks said the agency must "do more to protect the US drug supply," warning that lax oversight could endanger American consumers. He pointed out that inspections of foreign drug plants have not yet returned to pre-pandemic levels, even as the number of manufacturers continues to grow. "The public expects the FDA to protect them from impure drugs by identifying them at the source and blocking them from entering the supply chain. The FDA's import alerts demonstrate the extent of the problem", Banks wrote. According to the senator, data from the FDA's Center for Drug Evaluation and Research (CDER) shows that nearly 39 per cent of all facilities facing import alerts were located in China, and 13 per cent were in India, compared to an average of 10 per cent for other regions. He added that in fiscal year 2024, the FDA inspected only 28 per cent of Chinese facilities and 33 per cent of Indian facilities listed in its Site Catalog, a record of facilities known to manufacture pharmaceuticals for the US. "Indian manufacturers had the highest rate of serious manufacturing violations, at 13 per cent," Banks said, citing Current Good Manufacturing Practice (CGMP) breaches. The Indiana Republican said that while the FDA has prioritized inspections in China and India, "it must do more to keep pace with the risk we are facing." He welcomed the agency's "green list" initiative , which publishes facilities meeting FDA standards , but said it can only be effective if more sites are inspected regularly. Banks also called for faster approval and inspection of new US-based pharmaceutical manufacturing facilities, urging expansion of the proposed FDA PreCheck program to support domestic drug production. "The public expects the FDA to protect them from impure drugs by identifying them at the source and blocking them from entering the supply chain," Banks wrote in a letter to FDA. The senator has asked the FDA to respond by November 7, 2025, with detailed answers on inspection efforts, regional compliance breakdowns, and steps being taken to improve transparency and quality in the global drug supply chain. (ANI)
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