Flu drug plans take a hit

Govt indecision on compulsory licensing route upsets pharma firms' strategy.

Pharmaceutical majors Ranbaxy, Cipla, Nicholas Piramal and Hetero plans to manufacture avian flu drugs are in a limbo following the government's indecision on letting them manufacture the drugs under the compulsory licensing route.

The Union health ministry is yet to intimate the Patent Control Office about notifying domestic companies to produce the generic version of Oseltamivir (marketed by Roche as Tamiflu) and Zanamivir (marketed by GSK as Relenza) in India using the provision of compulsory licensing.

Indian companies, which are in the process of trial-based production of the generic versions of these drugs under the Indian Patents Act, had approached the original patent holder Roche-Gilead seeking permission to manufacture and market the drug in India.

Roche has, however, not responded. But the company's patent application is reportedly pending with the Indian Patent Office. It means, manufacturing a copy of the drug in India for commercial purpose might amount to infringement of the rules.

D G Shah, secretary general, Indian Pharmaceutical Alliance (IPA) and co-chairman, pharmaceutical committee of FICCI, said the government should make its stand clear now whether the country is under the threat of the disease or not. "If there is a risk, it should come out with a statement of the health emergency and should act accordingly to take care of the crisis," he added.

Cipla chairman Yusuf Hamied said, "Cipla has taken up the challenge of the bird flu by providing this drug in India and those third world countries that can legally avail of this offer at humanitarian price." However, with no clear statement coming from the government the company cannot proceed with its plan.

Cipla is said to be in trials to develop the active ingredient, zanamavir for Glaxo SmithKline's flu medicine, which is sold under the name Relenza. This brand, perhaps, does not fall under the purview of the patent guidelines of the country.

Ranbaxy and Hetero had announced that they will be in a position to manufacture a copy version of Tamiflu by mid-2006. The recent entrant to the field has been Nicholas Piramal, which announced that it had approached Roche regarding toll manufacture of Tamiflu.

However, Nicholas Piramal had stated that it would not be interested in making generic copies of the drug and would only manufacture under license from Roche.