Last Updated on December 31, 2023 by The Health Master
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 C-19 pandemic.
“In terms of (inspection) activity (in India), we are getting closer to pre-pandemic levels,” Sarah McMullen, country director-India at the US Food and Drug Administration (USFDA), said on the sidelines of a recent industry event in Mumbai.
McMullen said that the US regulator has resumed surprise inspections of pharma units 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, worth $24.62 billion in FY22.
On 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 C-19-related disruptions.
This resulted in official action indications (OAIs) and warning letters falling significantly. In 2020, Indian pharma companies received 25 warning letters. This number dropped to 2 in 2021 and stood at 3 in 2022.
The OAIs, which ranged anywhere from 40-50 a year in India, also fell steeply during the pandemic period. According to a Motilal Oswal report, Indian manufacturing sites have received 60 OAI citations from Sep 19-Sep to Sep 22.
The issue of both warning letters and OAI results in a lack of approval for the 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 mean delays in new product approvals, hurting US businesses.
USFDA had to postpone foreign inspections or prioritize them based on mission-critical status. With the pandemic receding, the US agency plans to have hundreds of unannounced or short-notice inspections.
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