Compulsory licenses to hit Indian pharma market

With the first ever compulsory license granted last year to Natco for Nexavar, the Indian government is all set to repeat the same for three more anti cancer drugs


According to a recent report in the Indian Express, the Department of Pharmaceuticals has initiated the proceedings to grant compulsory licenses for three anti- cancer drugs namely, Trastuzumab , Ixabepilone and Dasatinib.

Trastuzumab, an innovator biologic is marketed as Herceptin by Roche for HER2+ breast cancer patients. The drug, a monoclonal antibody, has been hailed as revolutionary, for providing a subsect of people affected breast cancer a chance to fight the disease. Ixabepilone is used for and has been developed by Bristol-Myers Squibb for the treatment of breast cancer in combination with another drug, after the failure of other drugs. Dasatinib is also a BMS drug marketed as Sprycel for the treatment of Chronic Myelogenous Leukemia (CML).

It will be interesting to note, which Indian biotech company will be granted the compulsory license to produce the blockbuster biologic, Herceptin.

BioSpectrum had earlier looked at both the sides of the Compulsory Licensing story here. While its keenest advocates have welcomed the governments' proactive stance for affordable healthcare, prominent members of the MNC pharma lobby have called it a measure to stifle innovation which does not expand access to drugs.

Up until now, a compulsory license has been granted only to Natco Pharma for the anti cancer drug Nexavar, originally marketed by Bayer, in August last year. The license created a storm in the Indian pharma industry with activist groups applauding the decision as it would pave way for similar action with other expensive drugs.

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