Kick starting the process for a possible issuance of compulsory licences for anti-cancer drugs, the Department of Industrial Policy and Promotion (DIPP) has sought details from the Health Ministry regarding three medicines sold by multi-nationals Roche and Bristol-Myers Squibb in India to make them affordable.
The Health Ministry had approached the DIPP last month for issuance of compulsory licences (CLs) for three anti-cancer drugs — trastuzumab, ixabepilone and dasatinib — which are very expensive.
“The DIPP has sent a set of 12-14 questions to the Health Ministry on Wednesday. The department wants more information on things such as the number of cancer patients in India; prices of these three drugs in the domestic and international markets; alternative drugs if available and the name of the manufacturers and the like,” sources told PTI.
The Health Ministry had expressed concerns over the exorbitant prices of the three drugs.
While one vial (of 50 ml) of 40 mg trastuzumab costs Rs.1.24 lakh, 60 tablets of 20mg each of dasatinib priced at Rs.1.17 lakh. Similarly, one vial of 45 mg of ixabepilone costs Rs.66,430.
The sources, however, said a decision on these three drugs, the patent for which are held by Swiss drug major Roche and U.S.-based drug maker Bristol-Myers Squibb, respectively, are unlikely to be taken in a hurry.
Under the Indian Patents Act, a CL 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.
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.