Fewer Indian pharma plants get US FDA action notice in 2023, so far

6 per cent of inspections in first 6 months of CY23 resulted in OAI status

Indian pharmaceutical manufacturing units have received only three official action indicated (OAI) status from the US Food and Drug Administration (US FDA) in the first six months of 2023, against 16 in the previous two years, even as they face increased scrutiny from the American drug regulator. 

An OAI status means that objectionable conditions had been found during the inspection by the FDA and regulatory action is recommended.

An analysis of data by the Indian Pharmaceutical Alliance (IPA), which represents the top 24 drug firms in India, shows that of 52 inspections during 2023, so far, 49 resulted in either