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Indian Pharma Firms See Fall in Rate of Final Product Approvals From USFDA

Indian pharmaceutical firms are seeing a slight dip in the rate of final product approvals from the US drug regulator in the first half of 2018 calendar year. Around 101 final approvals were received till date this year, down from 126 during the same period last year. Indian pharma companies, however, had a great 2017 in terms of approvals from the US Food and Drug Administration (USFDA). They received final approvals for 304 abbreviated new drug applications (ANDAs) out of the total 846 given globally — accounting for almost 36 percent of the overall approvals. Though the Indian count has slipped, the number of USFDA approvals has increased globally during the first half of 2018 — from 286 final approvals in January to June, 2017, it rose to 386 in the same period this year. The total number of tentative approvals, too, has increased from 58 to 83. Analysts are optimistic that the sanction rate is likely to witness a pickup in the second half of the year. Cadila Healthcare, for example, received eight final approvals in July alone. Again, Sun Pharmaceuticals received its first product approval for the Halol site (in Gujarat) in July, after 5 years.

Deepak Malik, associate director at Edelweiss Securities, said the second half would present a positive picture as most companies were ready with a robust pipeline of drug fillings. “The slight dip in the approvals is not any sign of concern, it should pick up in the second half,” he added. Aurobindo Pharma received around 22 approvals between January and June 2018. The Hyderabad-based company has been doing consistently well for over a year now — since April 2017 it got 66 USFDA approvals for its ANDAs (including tentative approvals). The company spent 4 percent of its revenues on research and development during 2017-18 at ₹6.6 billion. Cadila Healthcare’s US subsidiary, too, received final approvals for over 16 products during the first half of the calendar year. Mumbai headquartered Lupin got around 8 final approvals, followed by Dr Reddy’s Laboratories at seven. Last year had a seen a record high in terms of novel drugs getting the US regulator’s nod. The USFDA gave its nod to 46 novel medicines in 2017, a 21-year high. Indian players, however, file for generic medicines that have expired patent. The rate of product approvals from the USFDA has improved in the past few years. Around 2012, the Generic Drug User Fee Amendments (GDUFAs) were implemented to expedite the process of drug approvals, and in 2016 the GDUFA entered its cohort-five phase. – Business Standard

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