USFDA nods slip for Indian firms in first half of 2018

Indian pharma companies saw the rate of final product approvals from the US Food and Drug Administration (USFDA) slip in the first half of calendar year 2018 — at 101 final approvals, down from 126 during the same period last year. SOHINI DAS writes

The number of approvals in the US of products of Indian pharmaceutical companies has declined to 101 in the first half of 2018 from 126 in the corresponding period last year.

The 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 per cent 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 five 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 filings. "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 per cent 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. Mumbaiheadquartered Lupin got around 8 final approvals, followed by Dr. Reddy's Laboratories at seven.

Last year record number of novel drugs got 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. This implies that the FDA has to act on 90 per cent of the ANDA submissions within 10 months.