More generic drugs from India clearing FDA approval: report
- The Food and Drug Administration approved 84% more generic drugs from Indian companies over the last fiscal year, compared to a year prior, reports The Economic Times.
- Under the Generic Drug User Fee Act, the FDA has worked to accelerate its approval process for generics and clear a backlog of applications.
- The hastened pace sets up an interesting contrast as the FDA has also ramped up its oversight efforts, citing a number of major Indian manufacturers for compliance violations.
Generics are already big business for India, as the country’s pharmaceutical industry supplies much of the world’s off-brand drugs.
But this recent surge in FDA approvals was headlined by more activity from smaller companies.
Overall, 201 drugs were approved in the April 2015 to March 2016 fiscal year, compared to 109 drugs in the same period a year prior, according to The Economic Times. Aurobindo Pharma topped the list with 50 approvals, outpacing Sun Pharma and Dr. Reddy’s.
One of the driving forces behind the increased approval of Indian generics was the Generic Drug User Fee Act, according to comments by D.G. Shah, secretary general of the Indian Pharmaceutical Alliance. The legislation provided increased funding for the FDA, expedited its review process, and increased inspection frequency for companies to comply with good manufacturing practice standards.
But Indian drugmakers have also complained of heavy-handed oversight from the FDA. Satish Reddy, chairman of Dr. Reddy’s, recently pointed to FDA enforcement as a factor checking growth for the industry.
- Economic Times of India USFDA nods to Indian drugs up 84% in 1 year