DIPP seeks details on 3 cancer drugs for compulsory licencing

New Delhi: Kick starting the process for a possible issuance of compulsory licences for anti-cancer drugs, the DIPP has sought details from the Health Ministry regarding three medicines sold by multinationals Roche and Bristol-Myers Squibb in India to make them affordable.

The Health Ministry had approached the Department of Industrial Policy and Promotion (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 yesterday. The department wants more information on things like number of cancer patients in India; prices of these three drugs in domestic and international market; alternative drugs if available and name of manufacturers etc," 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 1,24,000, 60 tablets of 20mg each of dasatinib priced at Rs 1,17,220. Similarly, one vial of 45 mg of ixabepilone costs Rs 66,430.

The sources, however, said a decision on the drugs -- trastuzumab, ixabepilone and dasatinib -- the patent for which are held by Swiss drug major Roche and US-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 WTO agreement also, 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 government had issued the first such licence in March last year. India`s patent office had granted a licence to Hyderabad-based drug maker Natco Pharma to make and sell a copy of Bayer Corporation`s patented cancer drug Nexavar by invoking the compulsory licensing provision of the country`s patent law.

Natco was allowed to sell the drug at a price not exceeding Rs 8,880 for a pack of 120 tablets required for a month`s treatment, as compared to a whopping Rs 2.80 lakh per month charged by Bayer for its patented Nexavar drug.


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