The government has signaled its hard stance on invoking more compulsory licenses, this with the department of industrial policy and promotion (DIPP) listing three anti-cancer drugs as next compulsory licensing candidates. The industry has mixed views on it, reports CNBC-TV18’s Archana Shukla.
The issue relating to saving and securing intellectual property rights (IPR) by the multi-nationals is one critical concern, but experts and industry views are also questioning the provisions under which compulsory licensing would be given especially for complex biotech drugs.
Three drugs are part of this list right now - Roche's breast cancer drug, Herceptin, which is a biotech drug. Bristol-Myers Squibb's (BMS’s) Leukemia drug Sprycel and BMS’s other breast cancer drug Ixempra.
Herceptin is a difficult biotech drug and industry views suggest that it would be very difficult for a generic company to manufacture a generic version of Herceptin in less than two-three years time because lot of bio-equivalent studies have to be done to make the drug look like the original patented drug. Besides that, in India we do not have a clear protocol of how to approve a generic biotech drug. That is where this entire process will get stalled is what the industry says.
Secondly, Natco has already launched almost 94 percent cheaper version in the market for Dasatinib, so affordability has been taken care when it comes to the Leukemia drug Sprycel. Roche last year had launched an almost 33 percent cheaper version of Herceptin in the market.
They were pre-empting that possibly a compulsory licence could be issued on Herceptin because it is an important drug. It treats Breast Cancer so they had brought down the prices and that is where some critics say that Roche will have a stronger case when it comes to compulsory licence.
The provision under which government is planning to give compulsory licence is section 92 of the Indian Patent Act, which allows them to unilaterally grant a compulsory licence if they find that a drug is unaffordable, unaccessible or is not supplied enough.
The other section of the industry is pushing for a compulsory license. They are saying that this will be dealt with; we need more data to see if these are the correct candidates, but we have to make a beginning somewhere and when it comes to affordability, compulsory license will be one key element to be used.