Commerce and Industry Ministry considering proposal for compulsory license to anti-cancer drug

NEW DELHI: Commerce and Industry Ministry is considering a proposal of the health ministry for grant of compulsory license (CL) to an anti-cancer drug - Dasatinib, Parliament was informed today.The ministry has received a proposal from the Ministry of Health and Family Welfare for grant of CL in respect of the drug.

Under the Indian Patents Act, a compulsory License can be issued for a drug if the medicine is deemed unaffordable by the government and grants permission to qualified generic drug makers to manufacture it.

Commerce and Industry Minister Nirmala Sitharaman said the matter was examined and accordingly the Health Ministry was requested to furnish full particulars in respect of existence of circumstances of - national emergency; or extreme urgency; or a case of public non-commercial use, as required under Section 92 of the Patents Act 1970.

"The reply by the Department of Health and Family Welfare is under active consideration of this department," Sitharaman said in a written reply to the Lok Sabha.

Dasatinib is used in treatment of Chronic Myeloid Leukemia and costs around Rs 1.17 lakh for sixty tablets of 20mg each.

"No Compulsory License has been granted by the government," she said while replying to a question about the patented drugs for which Compulsory License has been granted by the government so far in the country.

In March 2012, however, a government agency - Controller General of Patents, Designs and Trademarks - had allowed Hyderabad-based Natco Pharma to manufacture and sell cancer- treatment drug Nexavar at a price over 30 times lower than charged by patent-holder Bayer Corporation, under CL.

As per the WTO agreement, a CL can be invoked by a national government allowing a company to produce a patented product without the consent of the patent owner in public interest.

The proposal assumes significance as the US had raised concerns over issuance of the licence by India earlier.