Drug Regulation Patent

SpicyIP TidBit: NHRC asks Govt for clarification on (anti?)CL stance


The National Human Rights Commission (NHRC) has on April 1, 2016 issued a press release expressing its apprehension over the India’s alleged promise to the US to refrain from issuing compulsory licenses in pharmaceutical drugs for commercial purposes. The Commission is particularly skeptical about the fact that “at least two applications for compulsory licenses to produce, domestically, generic versions of drugs patented in America were rejected last year.” These two applications (concerning ‘Saxagliptin’ and ‘Dasatnib’) have been examined on SpicyIP here and here respectively.

The Economic Times recently reported the Indian Government’s private assurance to the US-India Business Council (USIBC) in this regard. Our SpicyIP Fellowship Applicant Inika Charles has covered this here. Prof. Basheer has critically analyzed this secret handshake here. Subsequently, the Ministry of Commerce released a press note denying the existence of any such assurance. This has been reported on SpicyIP by Balaji Subramanian here.

The NHRC has called for reports within two weeks’ time on this issue from the Union Ministries of Commerce & Industries and Health. It has stated that:

“If the Government, by invoking the provisions of the Indian Patents Act grants compulsory license to manufacture a particular drug, it would increase access to more affordable generic versions of the same bringing much needed solace to the thousands of the people. Providing an affordable healthcare system is a basic bounden duty of any Government…”

The Commission has stressed upon India’s first compulsory license grant in Nexavar, which was granted mainly on commercial grounds. This compulsory license has been covered by Prof. Basheer on here. SpicyIP’s Full Report on the Bayer-NATCO dispute can be found here and its summarized version can be found here.

While the Commerce Ministry has previously attempted to put this allegation to rest, Balaji’s post is testament that this response has not been received well by critics. Therefore it will indeed be interesting to see how the Ministries will respond to this call of duty from the NHRC.

Ritvik M Kulkarni

Ritvik Kulkarni is a final year student at ILS Law College, Pune. He is the Student Coordinator of the ILS Intellectual Property Rights Cell and Student Editor at the ILS Abhivyakti Law Journal since 2014-15. Ritvik first learnt of IP while preparing for his first moot; and has been regularly taking his weekly IP fix ever since. Additionally, he takes interest in learning the law and practice of domestic and international dispute settlement. Speaking of disputes, he's an ardent follower and jabra fan of Game of Thrones. You can get in touch with him at [email protected]; and dont worry he loves F.R.I.E.N.D.S too.

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