Indian Pharma firms adjusting to new FDA regulatory norms

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After a year filled with FDA problems, pricing pressures and poor financial results, you would be forgiven for thinking 2016 was a disaster for the Indian generic pharmaceutical industry. However, according to the people in the know, there are mitigating circumstances, and regulations are now starting to be met. 2017 is poised to be a bumper year.

Two of the generic pharmaceutical industry’s foremost commentators gave an interview to CNBC TV18, where they outlined the reasoning behind this optimism. They were Binish Chudgar, Vice Chairman and Managing Director or Intas Pharmaceuticals, and Abhishek Sharma, Pharma analyst at the Indian financial service company, IIFL. Intas have recently acquired the UK and Ireland assets of Teva Pharmaceuticals for around USD 764 million, so they have every reason to feel buoyant.

During the interview, Chudgar was keen to stress that in reality, 2016 was not as bad as people thought. Around 30 percent of generic Pharma producing facilities belong to India and its firms. That is a huge amount of the market. So when something goes wrong, such as a violation of FDA regulations, however slight, it is going to get attention from the media.

Sharma also pointed out that many of India’s most prominent generic pharmaceutical companies have overcome regulatory issues to win approval from the FDA. Lupin and Alkem Laboratories have received Establishment Inspection Reports (EIRs) from the FDA and Sun Pharmaceuticals were acknowledged for making progress in fixing violations reported in 2014.

Divis Laboratories and Dr Reddys Laboratories are also working to fix problems, and there is every reason to believe progress will be made in 2017. Indian generic pharmaceutical factories are also working at high capacity and technology is advancing at a faster rate. Now that factories are being upgraded regularly, changes in FDA regulations can also be incorporated.

As we move into 2017, the Pharma industry in India hopes that these issues will become a thing of the past, and they can get back to growth. However, only time will tell if this line of thinking is correct.





Wilson Sonsini Goodrich & Rosati is the premier legal advisor to technology, life sciences, and other growth enterprises worldwide. In today’s fast-growing, highly regulated generic pharmaceutical market, companies require specialized legal guidance beyond the scope of general corporate and securities counsel. WSGR has an experienced team of experts in key practice areas, including intellectual property, litigation, antitrust, FDA/regulatory, technology transactions, exports and FCPA, trade secret, and trademark and copyrights. Learn more at www.wsgr.

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