Concerns raised by US Congress panel over effectiveness of FDA inspections in India

New Delhi: A US Congress committee expressed special worry over foreign drug inspections carried out in China and India.

Cathy McMorris-Rodgers, chair of the Energy and Commerce Committee, wrote a letter to Food and Drug Administration (FDA) Commissioner Robert M. Califf in which she emphasised the importance of having effective foreign inspection programmes in China and India given the FDA's recent decision to temporarily permit the import of otherwise unapproved medicines from those nations in order to address critical drug shortages.

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

“Given that approximately 32 per cent of generic drugs and 45 per cent 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.

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

Despite the pilot program’s success, the FDA elected to discontinue it.

The Covid-19 pandemic stopped most in-person inspections of foreign drug manufacturers from March 2020 until April 2022. In lieu of in-person inspections, the FDA resorted to alternatives and workarounds, such as remote interactive inspections of drug manufacturing facilities on a voluntary basis, 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 per cent of them, with just 3 per cent of Indian manufacturers being inspected, the letter concluded.

With inputs from IANS