Indian pharma really feeling the pain of lagging US generic approvals
- The combination of increased filings for new generic drugs and increased inspections of Indian facilities beset for quality woes has led to a severe slowdown in revenues for Indian pharma.
- Ranbaxy Labs and Dr Reddy's Laboratories both posted lower Q2 earnings because of the slowdown in generic approvals. Sun Pharmaceuticals and Cipla Ltd. are expecting similar results when they report second-quarter earnings.
- The Generic Drug User Fee (GDUFA) program, which was implemented by the FDA in October 2012, is intended to alleviate backlogs, but the program has taken longer than expected to ramp up.
Despite the fact that the GDUFA program is still working on clearing backlogs, India's shortfall is exacerbated by the quality-related challenges in pharma manufacturing facilities. Nonetheless, the FDA maintains that it is keeping pace with historical performance, including 45 generic approvals in August, as well as September, outpacing both 2012 and 2013 performance.
Future goals are even more ambitious. By 2017, the FDA would like to decrease the review time from 30 months to 10 months. In the mean time, India pharma companies are working to comply with quality-related reform requests to facilitate faster approvals.