American lawmakers question FDAs drug inspection programme in India, China

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-06-25T12:30:35+05:30 | Updated On 25 Jun 2024 12:30 PM IST

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.

Another inspector found zero compliance issues in 20 out of 23 inspections (85 per cent) in China while finding compliance issues in almost half of domestic inspections during the same period. These are unusual inspection outcomes, the opposite of what would be expected given the widely reported failures in quality control and lack of adherence to current good manufacturing techniques by drug manufacturing facilities in China and India, the lawmakers wrote.

"By contrast, 16 FDA inspectors, with over 325 inspections collectively in India, found compliance issues during every inspection they conducted. As a measure of what a pattern of rigorous inspections should look like, the Committee reviewed the inspection outcomes for 3 FDA inspectors with a professional reputation for thoroughness who also had at least 10 inspections in China or India during the studied period," they wrote.

These expert inspectors reported finding no compliance issues during inspections in China at a rate of only 6.7 to 11.4 per cent and at a rate of zero to 9.5 per cent in India, they said, adding that such large variations in inspection outcomes are troubling, and they merit further investigation. At a minimum, the Committee is concerned that these findings suggest vast differences in the skill, thoroughness, and competence of FDA inspectors.

As such, the lawmakers pressed for more information regarding the agency's foreign drug inspection programme.

Read also: USFDA inspection: Biocon gets 4 observations for Visakhapatnam API facility

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Source : with inputs

Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751