WTO Reviews India's Trade Policies, Including Drug Patents, Compulsory Licensing

Posted 03 June 2015 | By Michael Mezher 

WTO Reviews India's Trade Policies, Including Drug Patents, Compulsory Licensing

The World Trade Organization (WTO) is conducting its sixth review of India's trade policies this week.

To coincide with the review, the WTO Secretariat has released a report on India's trade and related policies, which highlights areas of many areas of progress, while noting some areas of concern related to India's policies on drug patents.


The WTO routinely reviews its members' trade-related policies in order to track developments that may affect global trade.

India's patent system has long been a source of controversy for western drugmakers, many of whom have been denied patents under Section 3(d) of The Patents Act.

In 2012, India exercised its right, under Article 31 of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, to issue a compulsory license for Bayer's cancer drug Nexavar, citing concerns that the drug was not accessible to patients in the country. While drugmakers feared India might expand the practice, the compulsory license issued to Natco Pharma to produce a generic version of Nexavar remains the country's first and only compulsory license.

WTO Report

It its report, the WTO Secretariat notes several areas of concern related to India's policies on intellectual property and drug trade.

While the report acknowledges India has updated The Patents Act, in part to incorporate its duties under TRIPS, it points out that the act has not been updated in the past decade.

The report also mentions that India fell 10 spots in its rank on the Global Innovation Index 2014, despite only issuing a single compulsory license, and has stated it would only do so "within the provisions of … TRIPS."

Regulatory data protection is also raised as an issue, as it is not specifically provided under The Drugs and Cosmetics Act of 1940. While the report notes that regulatory data protection "is said to be protected under the Official Secrets Act," but notes that it is not clear to what extent protections are enforced.

The review of India's trade policies will conclude after a second session on 4 June 2015, after which the WTO will publish any revisions to the report as well as the chairperson's remarks and minutes from the review.

WTO Trade Policy Review

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