Industry

Indian, Chinese Pharma Companies getting most FDA warnings

“Given that approximately 32 per cent of generic drugs and 45 per cent of active pharmaceutical ingredients (APIs) are from these two countries."

The Health Master

July 23, 2023

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Warning Letter Sign FDA USFDA — Warning Letter

Last Updated on October 11, 2024 by The Health Master

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

In a letter to U.S. Food and Drug Administration (USFDA) Commissioner Robert M Califf, Chair of the Energy and Commerce Committee Cathy McMorris-Rodgers said the USFDA’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.

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Chinese and Indian manufacturers receive the most USFDA warning letters, McMorris-Rodgers said, adding that these violations have included:

Carcinogens in medicines,
Destroying or falsifying of data,
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.”

“From 2014 to 2015, the USFDA conducted a pilot program in India that eliminated extended advance notice for inspections.”

“Instead, the USFDA 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 USFDA regulations, including falsified quality records,” the letter added.

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