US Senator Jim Banks has voiced serious concerns over the quality of pharmaceutical imports from India and China, urging the Food and Drug Administration (FDA) to intensify scrutiny of overseas manufacturing sites.

In a letter addressed to FDA Commissioner Martin Makary, the senator stressed that American consumers depend on the agency to safeguard the integrity of the nation’s drug supply chain, warning that insufficient oversight could expose the public to dangerous, substandard products.

Banks highlighted that inspections of foreign drug facilities have not yet returned to pre-pandemic levels, even as the number of overseas manufacturers continues to increase. He cited data from the FDA’s Centre for Drug Evaluation and Research (CDER), which indicate that nearly 39 per cent of all pharmaceutical facilities subject to import alerts are located in China, while 13 per cent are in India.

This contrasts with an average of roughly 10 per cent in other regions, illustrating the disproportionate concentration of compliance issues in these two countries.

The senator noted that in the 2024 fiscal year, the FDA managed to inspect only 28 per cent of Chinese pharmaceutical plants and 33 per cent of Indian ones listed in its Site Catalogue, which identifies facilities known to supply the American market.

He expressed particular concern that Indian manufacturers recorded the highest rate of serious regulatory breaches, with 13 per cent cited for violations of Current Good Manufacturing Practices (CGMP). Despite the FDA’s efforts to prioritise inspections in these regions, Banks argued that the current pace falls short of the risks involved.

While acknowledging the FDA’s initiative to establish a “green list” highlighting compliant manufacturing sites, Banks cautioned that such measures would be effective only if accompanied by more frequent and thorough inspections. He urged the agency to expand its monitoring framework, ensuring that facilities in high-risk jurisdictions are routinely assessed and held to the same standards as domestic plants.

In addition to tougher oversight abroad, the senator advocated for expedited approval and inspection procedures for new pharmaceutical facilities within the United States. He encouraged the FDA to accelerate the implementation of its proposed PreCheck program, intended to support domestic production and reduce reliance on foreign supply chains.

According to Banks, boosting transparency and strengthening home-grown capability are essential to mitigating the vulnerabilities revealed in the current system.

The senator has requested that the FDA provide a comprehensive response by 7 November 2025, detailing ongoing inspection efforts, regional compliance records, and upcoming initiatives to enhance safety in the global drug market.

His appeal reflects a growing legislative push in Washington to reduce dependence on imports from countries frequently linked to quality deficiencies and to prioritise the security of the American pharmaceutical supply chain.

Based On ANI Report