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The Commerce and Industry Ministry has initiated the process to find merit over issuing compulsory licences for blood cancer drug ‘Dasatinib’ that could ensure availability of the life saving medicine at affordable rates.
The ministry has sought details from the Health Ministry, which had approached the Department of Industrial Policy and Promotion for issuance of compulsory licences (CLs) for the drug sold by US-based firm Bristol-Myers Squibb in India.
Dasatinib is used in treatment of Chronic Myeloid Leukemia (CML) and costs around Rs 1.17 lakh for sixty tablets of 20mg each.
“The DIPP has sent a set of nine questions to the Health Ministry seeking details on Dasatinib and prevalence of CML in India, and whether the situation could be termed national emergency or extreme urgency as its occurrence is very rare just 0.001 per cent,” a source said.
These include information such as if the drug is used as the first line of treatment of the disease, how many patients in India suffer from it and if Dasatinib is considered as a complete cure for it.
Also, DIPP has sought details about the government’s procurement policy for the medicine.
“DIPP is waiting for the reply and after that it will take action on the matter,” a source added.
The Health Ministry had expressed serious concerns over the exorbitant price of the drug.
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.
In March 2012, Hyderabad—based Natco Pharma was allowed to manufacture and sell cancer—treatment drug Nexavar at a price over 30 times lower than charged by patent—holder Bayer Corporation, under CL.
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.
The development assumes significance as the US had raised concerns over issuance of the licence by India earlier. New Delhi had so far issued only one such licence.
The US has also raised concerns over intellectual property regime of India, which is compliant to international legal framework.
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