Most FDA warnings to Indian, Chinese pharma companies

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 programme 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.