A committee of the US Congress has stated that it was particularly concerned about foreign drug inspections conducted in India and China. The FDA conducted unannounced audits at selected suspicious sites for the pilot programme. It has exposed widespread misconduct and significant violations of its regulations, including falsified quality records.

Letter written asserting the concerns regarding violations of FDA regulations

The chair of the Energy and Commerce committee Cathy McMorris-Rodgers has written a letter to the Food and Drug Administration (FDA) commissioner Robert M Califf and stated some concerns. In this letter, McMorris-Rodgers pointed out the FDA’s decision and stated that addressing shortages of critical drugs by allowing the temporary import of otherwise unapproved drugs from India and China makes having effective foreign inspection programmes in those countries critical.

US dependency on Indo-Chinese drug manufacturers

McMorris-Rodgers further added in the letter that the Chinese and Indian manufacturers receive the most FDA warning letters, and these violations have included carcinogens in medicines, destroying or falsifying of data, and non-sterile manufacturing processes.

“Given that approximately 32% of generic drugs and 45% of active pharmaceutical ingredients (APIs) are from these two countries, we are worried that the US is overly reliant on sourcing from foreign manufacturers with a demonstrated pattern of repeatedly violating FDA safety regulations,” stated the letter.

FDA reviews and exposes the violations

From 2014 to 2015, the FDA conducted a pilot programme in India that eliminated extended advance notice for inspections. Instead, the FDA conducted short notice or unannounced visits and selected sites for the programme that the agency believed had significant issues. The pilot programme appears to have been successful at exposing widespread misconduct and significant violations of FDA regulations, including falsified quality records.

Despite the pilot programme’s success, the FDA elected to discontinue it. The COVID-19 pandemic stopped most in-person inspections of foreign drug manufacturers from Mar 2020 until Apr 2022. In lieu of in-person inspections, the FDA resorted to alternatives and workarounds, such as remote interactive inspections of drug manufacturing facilities voluntarily, the letter added. 

Once FDA inspections resumed, they did so at a much lower level than before the pandemic. One analysis found that out of approximately 2,800 foreign manufacturing facilities, the FDA inspected only 6% of them, with just 3% of Indian manufacturers being inspected, the letter concluded.

(Source: IANS)

Edited for style

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