US drug regulator resumes surprise inspections in India

The US drug regulator has stepped up its inspection activity in India, and plans to have more surprise or ‘short notice’ inspections, ending the two-year reprieve from ‘warning letters’ and other regulatory measures that Indian drug makers have enjoyed since the onset of the Covid-19 pandemic.

“In terms of (inspection) activity (in India) we are getting closer to pre-pandemic levels,” Sarah McMullen, country director – India at US Food and Drug Administration (USFDA) told ET, at the sidelines of a recent industry event in Mumbai.

McMullen said that the US regulator has resumed surprise inspections in India.

India has the largest number of USFDA-registered drug manufacturing facilities outside of the US. The US accounted for 29% of the total pharma exports of India woth $24.62 billion in FY22.

On an average during the pre-pandemic period, India used to see about 200 inspections annually. This number dropped to 80 in 2020, and to just 5 in 2021 due to Covid related disruptions.

This resulted in official action indications (OAIs) and warning letters falling significantly. In 2020, Indian companies received 25 warning letters. This number dropped to 2 in 2021 and stands at 3 far in 2022.

The OAIs, which ranged anywhere from 40-50 a year in India , too fell steeply in the pandemic period. According to a Motilal Oswal report, Indian manufacturing sites have received 60 OAI citations over Sep’19-Sep’22.

The issue of both warning letters and OAI results in lack of approval for sale of new generic drugs to the US from the concerned plant, often resulting in a fall in the stock price of the impacted company. Postponed inspections also means delay of new product approvals hurting the US business.

USFDA had to postpone foreign inspections or prioritise them based on mission critical status for much of the last two years due to Covid pandemic. With the pandemic receding, the US agency plans to have hundreds of unannounced or short notice inspections.

(With inputs from health)