Timely resolution of FDA action crucial to Indian pharma's US pipeline

Analysts say overall risks remain high for US generics business

The Indian pharmaceutical industry’s recent tryst with the US drug regulator may impact future pipelines, observe analysts.

Data shows that there were about 60 official action indicated (OAI) citations by the US Food and Drug Administration (USFDA) at Indian sites between November 2019 and November 2022.

For the most part, in the past 12 months, five OAI classifications have been issued, of which two have been escalated to ‘import alert’.

Research analysts at Motilal Oswal revealed in a recent report that in Calendar 2022, around four plants have got import alerts from the FDA and there were at least seven