Since the Covid-19 outbreak began, Indian pharmaceutical firms have taken a two-year break from "warning letters" and other regulatory actions. But recently the US drug authority has decided to increase its inspection activity there and wants to conduct more surprise or "short notice" inspections.

Sarah McMullen, country director - India at US Food and Drug Administration (USFDA) said that the US regulator had restarted surprise inspections in India. Outside of the US, India has the most USFDA-registered medication production facilities.

India used to undergo 200 inspections annually on average before the outbreak. Due to restrictions caused by Covid, this number fell to 80 in 2020 and to just 5 in 2021. Also, a drastic decrease was seen in the Official action indications (OAIs) and warning letters. 25 warning letters were issued in 2020 to several Indian companies. This number dropped to 2 in 2021 and 3 in 2022 till date.

The number of OAIs decreased dramatically from 40 to 50 each year before the pandemic to just 60 OAI, as stated by the Motilal Oswal study from September 2019 to September 22.

The companies′ stock price often declines when they are issued warning letters or violate the OAIs and prevent the concerned plant from selling new generic medications in the US. Inspection delays also result in delays in new product approvals, which disturbs the US business

Due to the Covid pandemic, USFDA was forced to delay international inspections or prioritize them depending on their mission-important status for most of the last two years. The US agency intends to conduct several surprise visits and last-minute inspections as the pandemic winds down.  (ETHealthWorld, September 20, 2022) https://health.economictimes.indiatimes.com/news/pharma/us-drug-regulator-resumes-surprise-inspections-in-india/94313602