The Department of Industrial Policy and Promotion (DIPP) last week once again approached the health ministry with the request to grant a compulsory license (CL) for the cancer drug, Dasatinib, on the ground that it is unaffordable to several thousands of cancer patients in the country. DIPP had already rejected the health ministry’s request to grant CL for Dasatinib, a patented drug of US based Bristol Myers Squibb, in March last on technical grounds. The health ministry wanted the government to issue a CL under Section 92 of the Indian Patents Act which allows issue of licences in a situation of national emergency or for a public non-commercial use. DIPP’s stand is that if the health ministry wanted a CL to be issued for a drug on the affordability ground, application should be made under Section 84 of the Patent Act and generic drug firms have to first seek a compulsory licence for the same. The government then starts a process of calling for applications from these companies. But the generic companies have not yet applied for a CL for the manufacture of generic versions of this cancer drug from DIPP. India's first CL was granted in 2012 under Section 84 to Hyderabad-based Natco Pharma to manufacture a generic version of another cancer drug, Nexavar, belonging to German multinational, Bayer.
Health ministry’s concern and initiative in this regard is understandable considering the high price at which this patented cancer drug is being marketed in the country by Bristol Myers Squibb. A month’s dose of Dasatinib, sold as Sprycel in India, costs around Rs.1.6 lakh which is beyond the reach of most cancer patients in the country. Granting a CL for the drug can certainly bring down its price in the country. BMS which sells Dasatinib under brand Sprycel, has already blocked the launch of generic versions planned by Hetero Pharma, Natco and BDR Pharma by taking legal recourse. The TRIPS agreement on intellectual property allows national governments to issue compulsory licences for production of generic versions of patented products to meet public health concerns or in a situation of national emergency or for a public non-commercial use. The Health Ministry, however, has taken a stand that the prohibitively high price of the patented version of the leukaemia drug kept it out of reach of a large number of patients in the country and this can ultimately lead to a grave public health issue in the country. High prices of essential drugs have been a serious public issue in India for some years now with the outbreak of life style diseases among all classes of Indian population. In a situation like this DIPP should n’t take a rigid stand on this matter and delay issue of CL for such a critical drug.