The Indian pharmaceutical companies have received 19 warning letters, out of the 41 (46 per cent) issued by the Office of Manufacturing Quality of the US Food and Drug Administration (USFDA) in 2019, the most in four years. This reversed the recent trend wherein Indian companies had been increasingly complying with the standards and resolving their manufacturing quality issues quickly that had cropped up over the last four-five years.

If the Indian drug manufacturers accounted for nearly 50 per cent of the current good manufacturing practices (cGMP)-related warning letters in 2015, it reduced to less than 30 per cent in 2016. This number further reduced to 24 per cent in 2017. In 2018, none of the top ten domestic firms were in the cGMP warning letter list, though many firms were struggling to get out of the trouble.

Out of 68 warning letters issued by the USFDA in 2018, 10 were related to India. In 2017, India's share of warning letters was 17 out of 79. According to a study by the Indian Pharmaceutical Alliance (IPA) and consultancy firm McKinsey, a couple of years ago, the number of FDA inspections in India declined from 272 in 2017 to 192 in 2015, but the share of plants receiving a clearance without adverse observations increased from 32 per cent to 51 per cent.