US Senator Jim Banks has expressed worry about low-quality medications being imported from nations like China and India and has called on the Food and Drug Administration (FDA) to increase inspections of pharmaceutical production facilities abroad.
The FDA must "do more to protect the US drug supply," Banks wrote in a letter to FDA Commissioner Martin Makary, cautioning that a lack of control could put American consumers at risk. He noted that even though the number of producers is still increasing, inspections of foreign medicine facilities have not yet reached their pre-pandemic levels.
"The FDA is supposed to safeguard the public from tainted medications by spotting them at the source and preventing them from getting into the supply chain. "The scope of the issue is evident from the FDA's import alerts," Banks wrote.
Nearly 39% of all facilities with import alerts were in China, and 13% were in India, according to statistics from the FDA's Center for Drug Evaluation and Research (CDER), the senator said, while the average for other regions was 10%.
According to him, the FDA only visited 28% of Chinese and 33% of Indian facilities in fiscal year 2024 that were identified in its Site Catalog, which is a list of establishments recognized to produce medications for the US.
According to Banks, "Indian manufacturers had the highest rate of serious manufacturing violations, at 13 per cent," according to violations of Current Good Manufacturing Practices (CGMP). Although the FDA has given priority to inspections in China and India, the Indiana Republican stated that "it must do more to keep pace with the risk we are facing."
He praised the agency's "green list" program, which lists establishments that satisfy FDA requirements, but stated that it won't work unless more locations undergo routine inspections.
In order to encourage domestic medication manufacture, banks also demanded that the FDA PreCheck program be expanded and that new pharmaceutical manufacturing facilities located in the US be approved and inspected more quickly.
"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 said in a letter to the Food and Drug Administration.
By November 7, 2025, the senator has requested that the FDA provide comprehensive responses on inspection activities, regional compliance breakdowns, and actions being taken to enhance quality and transparency in the global drug supply chain.
