India scores better than US in regulatory action by USFDA in 2019

From FY15 to FY19, Indian manufacturers received fewer warning letters than Chinese counterparts

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 better than