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Wednesday, December 2, 2009

Generic Drug to treat the H1N1 influenza

Posted on 10:11 PM by Anonymous

Indian drug major Cipla has launched generic versions of anti-flu drugs oseltamivir and zanamivir in the local market to treat the H1N1 influenza.Cipla will brand oseltamivir in the local market as Antiflu and zanamivir as Virenza. Antiflu will cost Rs 475 for 10 capsules, in line with the price of competing products in the market. Virenza — an inhaled drug — will cost Rs 800, which includes the price for an inhalation device.


Dr Y K Hamied, chairman and managing director of Cipla, said his company was equipped to make 2 million doses of oseltamivir a month, in case of any eventuality. Already 450 people have died of H1N1 in India and the winter season may cause further spread of the virus, he said.Cipla’s Antiflu is a copycat version of Swiss multi-national Hoffmann-La Roche’s Tamiflu and Virenza is the copy of GlaxoSmithKline’s Relenza. Both drugs, used globally to treat the ongoing H1N1 pandemic, lack patent protection in India as these are pre-1995 innovations.

On August 28, the Indian government had allowed restricted retail sale of the drug under Schedules X category of the Drugs and Cosmetics Act, similar to the sale of narcotics drugs. Six Indian companies — Ranbaxy, Cipla, Strides Acrolab, Hetero, Hetco and Roche — were allowed to manufacture and sell the drug. The government has also stockpiled the drug from these manufacturers for supply through government channels.

“Now the US is facing a shortage of oseltamivir and we have informed our readiness to supply the drug if needed. We make about 20 drugs in the anti-viral segment and are among the global leaders in this category,” said the Cipla chief, who revolutionised HIV/AIDS treatment globally by selling generic drug cocktails at less than a $1 per day.Both drugs have patent protection in many developed countries, including the US and Europe. Hyderabad-based Hetero is the only supplier licensed by Roche to market oseltamivir in India under the brand name Fluvir.

Cipla has so far exported about $10 million worth of Antiflu to countries in Latin America, Africa, South-East Asia and West Asia, where the drug lacks patent protection.In 2005, we had stockpiled about 2.5 tonnes of oseltamivir but there was no demand and about $15-20 million worth products had just piled up as inventory,” said Hamied.

Countries with patent protection for these drugs can also allow generic players to manufacture and market it, invoking compulsory licence provisions of the patent rules, which allow breaking of patent rules during emergency, said Hamied.Hamied has suggested that governments should encourage stockpiling of shikimic acid, which is extracted from the ‘Chinese Star Anise’ and is used as a base material for production of oseltamivir through a 14-step chemical process, instead of stockpiling the finished drug.

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