Obamacare, buyouts boost India's tally of ANDAs

Nov 25 2013, 08:53 IST
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ANDA pertains to a generic drug that is therapeutically equivalent to an already approved innovator drug but is exempt from the requirements of clinical trials data for regulatory validation. ANDA pertains to a generic drug that is therapeutically equivalent to an already approved innovator drug but is exempt from the requirements of clinical trials data for regulatory validation.
SummaryOne in four abbreviated new drug applications approved by regulator in 2012 belonged to Indian company.

A fiscally stressed Washington’s policy support to low-priced alternatives to innovator drugs and a flurry of recent acquisitions have helped Indian drug companies outdo their American counterparts in the latter’s home turf in securing approvals for generic medicines.

According to the US Food and Drug Administration (FDA) data reviewed by FE, one in four abbreviated new drug applications (ANDAs) approved by the regulator in 2012 belonged to an Indian company, a shade better than the performance by the US generic drug companies led by Mylan and Watson Labs. Available data for this year (till October-end) have only cemented India’s lead.

An ANDA pertains to a generic drug that is therapeutically equivalent (bio-equivalent) to an already approved innovator drug but is exempt from the requirements of generating pre-clinical and clinical trials data for regulatory validation. The exemption reduces drug development costs and allows companies to sell their drugs at a fraction of the branded drug’s price.

Indian drug companies have long been the most aggressive foreign players in the big and fast-growing US generic drug industry, accounting for a third of ANDA approvals and second only to the US’ own generics industry, with a 40% share in these approvals. Together, Indian and US firms bagged three-fourths of ANDAs approved over the last seven years (see table). Five out of the 10 top ANDA filers since January 2007 have been Indian firms, with Sun Pharma in the second slot after Mylan.

According to analysts, Indian firms have gone one better than the US in the approved ANDA kitty over the last couple of years primarily because of Sun Pharma’s acquisition of US-based Caraco and Taro Pharmaceutical Industries in 2010 and Mutual Pharma in 2012. These takeovers enabled the Indian firm to add ANDAs held by these companies to its kitty. Other factors that have buttressed India’s ANDA performance are the focus of US President Barack Obama’s healthcare plan on low-cost drugs and dismal growth in the alternative (European) markets, hit by the economic slump.

It is, however, pertinent to note that India’s share (13%) in the $30-billion US generic drugs market does not reflect its top slot on the ANDA table. This is because the country, credited with over 150 pharmaceutical manufacturing plants approved by the USFDA (the highest outside the US) focuses on high-volume generics and is yet to build competitive strength in the high-value specialty generics that offer attractive margins. India exported

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