Indian firms race to sell generic oseltamivir

Home/Policies & Legislation | Posted 29/10/2009 post-comment0 Post your comment

With the Indian government permitting ‘restricted’ sales of oseltamivir, a generic version of Roche's Tamiflu for influenza A H1N1, the domestic market is seeing a flurry of activity as Indian firms move to stock their products at retail pharmacies.

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India's Health Ministry has permitted the retail sale of oseltamivir through chemists who hold a licence to stock and sell drugs specified under schedule X of the Drugs and Cosmetics Rules against medical prescriptions.

Under schedule X, patients will be required to produce two copies of the prescription, one of which will need to be retained by the chemist for about two years. Every distributor, stockist and dealer holding stocks of oseltamivir would also need to submit to the concerned licensing authority in the state or Union territory, a monthly statement, with details on the quantity of such drugs available with them.

Cipla has launched its generic version of oseltamivir (marketed as Antiflu), which is priced at about Rs475 (Euros 6.80) for 10 capsules. Cipla's CEO, Mr Amar Lulla, said that Antiflu is the only WHO-approved generic oseltamivir in India and the company has launched the product across the country. Cipla has already developed a paediatric version of oseltamivir and also markets a generic zanamivir.

Natco Pharma, which has launched its generic version of oseltamivir (marketed as Natflu), said that it expects to release 10 million capsules of the product by October 2009. Natflu has been priced at Rs480 (Euros 6.87) for a bottle of 10 capsules and the company said that it is ready with 125,000 doses of the product.

Mr Kumaraswamy Srivatsava, Natco's National Sales Manager, said that the company was working with low margins for the product in view of the pandemic situation. He said that Natco expects to be ready with a paediatric version of the product in about two months, i.e. by the end of November 2009.

Strides Arcolab's generic oseltamivir (marketed as Starflu), has been priced at Rs460 (Euros 6.58) per strip of 10 capsules, while Hetero Drugs, which had earlier been granted a production sub-license for Tamiflu by Roche, launched its product (Fluvir) at about Rs450 (Euros 6.44) for 10 capsules. Details on Ranbaxy Laboratories' domestic sales plans were not immediately available on 25 September 2009.

About 480 chemists across India currently qualify to stock oseltamivir and industry experts expect this number to increase to about 1,000 as more chemists seek licences under schedule X and state governments consider these applications expeditiously.

Significantly, all five domestic manufacturers are said to be in the fray for a recent government tender to procure about 8.5 million capsules of oseltamivir.

Industry sources said that the tender could be shared by all five producers provided they agree to match the lowest price quoted to the government. Natco is believed to have offered to make supplies at about Rs290 (Euros 4.15) for 10 capsules, though the lowest offered price is said to be in the region of Rs240 (Euros 3.44) for 10 capsules.

Last month India's Health Minister, Ghulam Nabi Azad, said that an additional 20 million capsules of oseltamivir would be procured, given that the Indian government had already distributed a significant portion of the existing stockpile of about 10 million capsules. As of 23 September 2009, India reported 8,696 cases of influenza A H1N1, with 264 deaths across the country.

References:
Scrip News 25 September 2009. Indian firms race to sell generic oseltamivir.

Source: Scrip News

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