Health ministry seeks compulsory licence for Bristol-Myers' cancer drug

03 Apr 2014


The union health ministry is considering a generic version of Bristol-Myers Squibb's cancer drug Dasatinib, which is sold under the brand name `Sprycel', in a bid to make the medicine more affordable, but the Department of industrial Policy and Promotions (DIPP) is in no mood to support compulsory licensing of the drug without sufficient reason.

SprycelDIPP has sought clarifications from the health ministry on the reasons under which it wants approval for a generic version of the drug.

While the health ministry is constrained by the prohibitive cost of the medicine, the commerce ministry seems to have developed cold feet following US criticism of India's patent regime.

DIPP, which is under the commerce and industry ministry, has told the health ministry to let a domestic firm seek a compulsory licence if the issue was one of ''affordability''.

The commerce ministry has sought details and empirical data from the health ministry to support any claims of non-affordability (which calls for issue of CL under Section 84 of the Patents Act at the instance of a local firm).

If the health ministry can prove there is an emergency or extreme urgency for generic manufacture of the drug, the DIPP can allow its manufacture via a notification.

But, if the health ministry wants compulsory licence on the grounds that the patented version of the leukaemia drug is not affordable by the masses, then the approval of the Indian Patent Office is required.

A month's dosage of Bristol-Myers Squibb's patented drug Dasatinib, which is sold under the brand name `Sprycel', costs around Rs60,000.

The Patent office has so far given compulsory licence to only to generic production of Bayer's anti-cancer drug, Nexavar.

In March 2012 it allowed Hyderabad-based Natco to sell a generic version of Nexavar, on the grounds of non-availability and high price of the patented drug (See: Natco granted compulsory licence for Bayer's Nexavar).

The Patent Office had, in October 2013, rejected the application of Mumbai-based BDR Pharmaceuticals to make a generic version of Dasatinib.

Following this, the health ministry approached the DIPP, asking it to grant a licence by issuing a notification.

The health ministry has to collate data on the number of patients suffering due to unavailability of the patented medicine to convince the government of a crisis situation.

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