US Congress Panel Expresses Concern over Effectiveness of FDA Inspections in India

A committee of the US Congress said that it was particularly concerned about foreign drug inspections conducted in India and China.

In a letter to Food and Drug Administration (FDA) Commissioner Robert M. Califf, Chair of the Energy and Commerce Committee Cathy McMorris-Rodgers said the FDA’s recent decision to address shortages of critical drugs by allowing the temporary import of otherwise unapproved drugs from India and China makes having effective foreign inspection programs in those countries critical.

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 of 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.