In the last 10 years, Indian drugmakers have seen more regulatory inspections from the United States Food and Drug Administration (USFDA), but a halving of OAI (official action indicated) classifications, according to a Mckinsey representative.
OAIs involve regulatory and/or administrative actions recommended by the regulator. And the last decade has seen OAIs fall 50 per cent from 23 pe rcent in 2014 to 11 per cent in 2024, said Sathya Prathipati, senior partner McKinsey & Company. There were 109 USFDA inspections in 2014, and 25 OAIs, while 2024 saw 166 inspections and 19 OAIs, said Prathipati, ahead of the Global Pharmaceutical Quality Summit that Mckinsey partners, now in its 10th year.
The summit is hosted by the Indian Pharmaceutical Alliance, a platform for large domestic drugmakers. Inspections of global pharma decreased from 1849 to 940, in the same period, and OAIs increased from 6 per cent to 14 per cent, he pointed out.
Further, he pointed out that the nature of observations have also evolved from typical data integrity or lab handling issues to observations on aseptic practices or contamination of written procedures; gaps in maintenance of facility to ensure sanitary conditions and failure to review unexplained discrepancies, for example.
The summit that usually sees a representation from several global drug regulators, including the USFDA, will this time not have regulatory representatives from the US regulator, organisers said, due to the transition the agency was witnessing under the new administration under President Trump.
The industry-meet also comes at a time when reports of opioid abuse allegedly fuelled by an Indian company, get reported from West African countries. Industry representatives pointed out that the Indian drug regulator had stopped the manufacture and export of the combination drug, reported to be causing the problem.
Sudarshan Jain of the Indian Pharmaceutical Alliance pointed out that the $58 billion Indian pharma market supplied 70 per cent of the world’s anti-retroviral drugs and 60 pe rcent of the world’s vaccine supplies. There were 2050 WHO-GMP (Good Manufacturing Plants) and 752 USFDA-approved plants. The association was also setting up an institute in Ahmedabad and Hyderabad, he said, adding that 4.5 acres had been finalised, at both locations. It would train graduates and industry employees.
