As US FDA scrutiny intensifies on Indian drug facilities, a tangle of domestic factors deepens the challenge

In a major crackdown, the US Food and Drug Administration (FDA) has been conducting an increased number of inspections of pharmaceutical manufacturing facilities in India.

The trend has picked up pace due to a number of factors, including concerns about the quality and safety of Indian-made drugs, as well as the growing importance of India as a global supplier of pharmaceuticals, reports The Pharma Letter’s India correspondent.

The FDA has found that some companies are not in compliance with cGMP regulations. Some of the violations include failing to properly test drugs, not following correct manufacturing procedures, failing to adequately document manufacturing processes, failing to report problems with drug manufacturing. and in some cases, destroying data.