American lawmakers question FDAs drug inspection programme in India, China

Washington: Three prominent American lawmakers have questioned the Food and Drug Administration's foreign drug inspection program in India and China. In a letter addressed to FDA Commissioner Robert Califf, the lawmakers highlighted discrepancies in inspection results, suggesting these reflect broader institutional shortcomings and dysfunction within the FDA's foreign drug inspection programme.

According to PTI, the letter dated June 21 was written by House Energy and Commerce Committee Chair Cathy McMorris Rodgers, Subcommittee on Health Chair Brett Guthrie, and Subcommittee on Oversight and Investigations Chair Morgan Griffith following the analysis of the outcomes of FDA inspections in India and China from January 2014 to April 2024. "The results of this analysis were surprising, revealing tremendous variation in inspection outcomes. Some FDA inspectors found compliance issues during all or almost all of their inspections. Other inspectors rarely reported finding a single compliance issue. Two inspectors never found a single compliance issue throughout a combined 24 inspections in India," they wrote.