Aurobindo to Jubilant Life Sciences, drug makers face USFDA heat

Some of the inspections have not yet received a final classification, which raises the potential for OAIs

Major Indian drug makers, who have scored on compliance with the US Food and Drug Administration (USFDA) in recent years, are now facing the heat of regulatory action.

Of 174 USFDA inspections in India in 2018, only seven were classified as official action indicated (OAI), according to a study by the Indian Pharmaceutical Alliance (IPA) and consultancy firm McKinsey. This was a significant improvement over the previous year when 22 inspection outcomes were classified as OAI. 

This year, however, started on a tense note for drug makers with at least eight OAI inspections in the past six months. The list of these