Indian firms fared better in USFDA inspections in recent years, says IPA

Revised Schedule M implementation is going to be “instrumental” in elevating quality of pharma manufacturing in India as it tries to meet and exceed international standards, felt leading pharma firms. Meanwhile, there has been a notable improvement in India’s performance when it comes to US FDA inspection outcomes, data shared by the Indian Pharmaceutical Alliance (IPA) suggested. The share of Official Action Indicated (OAI) status issued after an USFDA inspection for Indian sites has fallen from 26 per cent in 2014 to 13 per cent in 2023. In comparison, the share of OAI in total USFDA inspections has risen from 7 per cent in 2014 to 15 per cent in 2023, thereby indicating more stringency.Indian pharma accounts for 20 per cent of the global exports of generics by volume and is thus considered a pharma powerhouse. It supplies 47 per cent of US generic medicines demand. The IPA represents the top 23 research driven pharma companies in India. It also revealed while Indian pharma companies have improved data integrity and observations, gaps between practices and written procedures have increased from 19 per cent to 23 per cent, gaps in facilities and ancillary infrastructure maintenance have risen from 17 per cent to 23 per cent.