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According to an analysis done by India-based Economic Times, FDA approvals for generic drug applications from India-based firms nearly doubled from the year April 2014 to March 2015 (109 approvals) to the following year ending March 2016 (201 approvals). Participating in the upswing of approvals were lesser known firms such as MSN Lab, Shasun Pharma, Granules India, Ajanta Pharma and Gland Pharma, the ET report notes. It points out that the growth came during the period when large players like Sun Pharma and Dr. Reddy’s had reduced filings from their plants due to compliance issues, “dispelling the long-held view that regulatory agencies, particularly USFDA, harboured a vendetta against the domestic industry.” According to the ET analysis, Aurobindo, Lupin and Glenmark led with 50, 27 and 18 approvals respectively in the year ending March 2016, as against Sun Pharma (14), Lupin (10) and Jubilant, Hetero Labs and Macleods (8 each) the previous year. ET reported that India accounts for around 30% (by volume) and about 10% (value) of the $70-80 billion US generics market.
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