USFDA warnings: Concerns remain even as India fares better than US

According to the USFDA, India accounted for nearly 18 per cent of the active pharmaceutical ingredients (APIs) sourced by the US, while China accounted for 13 per cent

Heightened regulatory scrutiny by the US drug regulator for Indian pharma is a concern for the industry. However, long-term data shows that Indian sites have received fewer warning letters from the US regulator, compared to China and the US itself.

Between 2014-15 and 2018-19 (FY19), sites in India received 66 warning letters from the US Food and Drug Administration (USFDA), while those in China received 73 warning letters, and plants in the US received 97 warning letters.

The data shared by Francis Godwin, director, office of manufacturing quality, office of compliance, USFDA, at an event here showed that India fared