Washington DC [US], October 17 (HBTV): US Senator Jim Banks has urged the Food and Drug Administration (FDA) to strengthen inspections of overseas pharmaceutical manufacturing facilities, raising concerns over poor-quality drugs being imported from 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 weak oversight could endanger American consumers. He noted that inspections of foreign drug plants have yet to return to pre-pandemic levels, even as the number of manufacturers continues to increase.
‘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 data from the FDA’s Center for Drug Evaluation and Research (CDER), 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.
The senator 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, which records 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 breaches of Current Good Manufacturing Practice (CGMP) standards. He acknowledged that while the FDA has prioritised inspections in China and India, ‘it must do more to keep pace with the risk we are facing.’
Banks welcomed the agency’s green list initiative, which publicly identifies facilities meeting FDA standards, but said it would only be effective if more sites were inspected regularly.
He also called for expedited approval and inspection of new US-based pharmaceutical manufacturing facilities, urging expansion of the proposed FDA PreCheck programme to strengthen 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 reiterated in his letter.
The senator has asked the FDA to respond by November 7, 2025, with detailed updates on inspection activities, regional compliance data, and measures being taken to enhance transparency and quality in the global drug supply chain.
(ANI)