Lessons Learnt

The Indian pharmaceutical industry, earlier reeling under the regulatory scanner of the USFDA, is learning from its mistakes. Of the 192 inspections held by the USFDA in 2017, only eight were reported as Official Action Indicated (OAI). These were 10 a year ago (271 inspections), 11 in 2015 out of 272 inspections and 21 out 173 inspections in 2014.

In the case of USFDA warning letters for non-US sites, India had only 29 per cent letters of the 49 issued in 2017, a drop from the 39 per cent of 18 letters issued in 2014. While Indian companies were responsible for 30 per cent of import alerts in 2017, Chinese companies were responsible for 50 per cent, said a McKinsey-Indian Pharmaceutical Alliance (IPA) data analysis.

- P.B. Jayakumar