DIPP examining proposal to issue CL for 3 anti-cancer drugs
New Delhi: The Commerce and Industry Ministry is examining a proposal from its health counterpart to issue compulsory licences (CL) for three anti-cancer drugs as part of the government`s move to make such medicines affordable.
"The Department of Industrial Policy and Promotion (DIPP) has received the proposal from the Health Ministry. It is being examined in great details," a source said.
The source, however, said a decision on the three patented anti-cancer 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.
"The process of issuance of CL is long. The DIPP has to collect all the relevant data including number of cancer patients in India and pricing of already existed alternative cancer drugs," another source said.
Currently, a month`s dose of each of the three drugs costs more than Rs 1 lakh.
"The DIPP is expected to ask for some more details from different ministries, including the Health Ministry," the source added.
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.
Under the Indian Patents Act, a CL can be issued for a drug if the medicine is deemed unaffordable. Generic drug manufacturers can then bypass the patent.
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.