Data on US FDA observations on Indian firms disturbing: Edelweiss
MUMBAI: Data on US FDA inspections in past 8 years and warning letters (WL) issued and their resolutions in recent years paints a disturbing picture, says a recent Edelweiss report.
Since the Generic Drug User Fee Amendments (GDUFA’s) implementation in Oct 2012, FDA inspections have doubled in India and China (20% versus 11% of total inspections earlier), which led to considerable increase in issuance of WLs (55% versus 33% of total earlier). WL resolutions have become longer and rarer - only 9 out of 108 WLs have been sorted out taking an average of ~500 days. Data for India and China is even bleaker with just one resolution out of the 64 WLs issued in past 52 months.
Cadila Healthcare’s Moraiya unit (474 days) looks poised to be resolved soon post its recent re-audit that had no FDA observations. While data suggests that Sun Pharma’s Halol unit (454 days) and Dr Reddy’s (349 days) are closer to resolution timeframe, the concern is that the WLs are not easy to resolve.
Inspections in India and China rise post-GDUFA, the report says.
GDUFA was implemented with the twin goals of faster generic approvals and eliminating the disparity in inspections of domestic and foreign manufacturing facilities. Faster approvals and decline in US FDA’s backlog are well publicised, but the second goal of bringing the foreign manufacturing facilities at par with US facilities in terms of surveillance inspections and its impact is not very well analysed.
Back in 2012, ~11% of inspections were conducted in India/China, while today it has shot up to ~20% whereas overall inspections globally remained at similar level (refer Table 1) against 22% of the manufacturing plants are situated here, the report said.
Since the Generic Drug User Fee Amendments (GDUFA’s) implementation in Oct 2012, FDA inspections have doubled in India and China (20% versus 11% of total inspections earlier), which led to considerable increase in issuance of WLs (55% versus 33% of total earlier). WL resolutions have become longer and rarer - only 9 out of 108 WLs have been sorted out taking an average of ~500 days. Data for India and China is even bleaker with just one resolution out of the 64 WLs issued in past 52 months.
Cadila Healthcare’s Moraiya unit (474 days) looks poised to be resolved soon post its recent re-audit that had no FDA observations. While data suggests that Sun Pharma’s Halol unit (454 days) and Dr Reddy’s (349 days) are closer to resolution timeframe, the concern is that the WLs are not easy to resolve.
Inspections in India and China rise post-GDUFA, the report says.
GDUFA was implemented with the twin goals of faster generic approvals and eliminating the disparity in inspections of domestic and foreign manufacturing facilities. Faster approvals and decline in US FDA’s backlog are well publicised, but the second goal of bringing the foreign manufacturing facilities at par with US facilities in terms of surveillance inspections and its impact is not very well analysed.
Back in 2012, ~11% of inspections were conducted in India/China, while today it has shot up to ~20% whereas overall inspections globally remained at similar level (refer Table 1) against 22% of the manufacturing plants are situated here, the report said.
