FDA new drug approval run rate down in FY20 for most Indian pharma majors

According to analysts, companies are skeptical about entering crowded opportunities

Indian drugmakers have been careful in filing new drug applications with the US regulator. New application submissions as well as withdrawal of filed applications continue as companies focus on rationalising their approach to launching drugs in the US market and choose to focus on comparatively high margin products.

A quick look at the number of abbreviated new drug applications (ANDAs) approvals received by key Indian drug makers from the US Food and Drug Administration  (USFDA) shows that in FY20, most companies have seen a decline in the number of approvals compared to the previous year.