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Friday, Nov 11, 2005


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Ministry permits generic cos to make bird flu drug

Nithya Subramanian

New Delhi , Nov. 10

THE Industry Ministry has given a green signal for allowing domestic pharmaceutical companies to manufacture generic versions of Tamiflu (oseltamivir), considered the most effective drug to treat avian influenza, commonly called bird flu.

Clearing the air surrounding the patents for the drug filed by Swiss drug major Roche and the innovator company, Gilead Sciences, the Ministry has said that under the present policy a compulsory license is not necessary, as a product patent has not yet been granted for the molecule. In fact, the nearly half-a-dozen patents pending in the Mail Box do not cover the molecule, but are for some of its intermediate compounds, said top Government officials.

"So far, only a process patent has been granted for Tamiflu and not a product patent. Therefore, generic companies who want to follow the same process to manufacture the drug would have to seek permission from the innovator," added officials.

According to Government sources, the Industry Ministry conveyed this to representatives of an inter-Ministerial Committee set up to tackle the bird flu outbreak at a meeting held earlier in the week.

"Also, Roche has been granted marketing rights for Tamiflu in India," they said.

At present, three Indian companies, Cipla, Ranbaxy and Hetero, have stated that they are ready to manufacture the drugs. Mr Malvinder Mohan Singh, President - Pharmaceuticals, Ranbaxy, today reiterated that the company is capable of manufacturing the drug in lab scale. "We are now preparing for commercial production. We have had discussions with Roche and are expecting a decision soon," he said.

Roche has indicated that it has received about 150 requests for licenses to manufacture the drug, and has already held discussions with eight possible partners.

It expects to shortlist the candidates later this month.

Meanwhile, domestic industry is of the view that just like other South-East Asian countries, Government must be ready with a concrete plan to tackle the spread of bird flu. Officials said that companies have asked the Government to give it some indication of the size of the order, so that it could make investments in sourcing raw materials and manufacturing the drugs.

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