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India allows retail sale of swine flu drugs oselatamivir and zanamivir

Wednesday, September 16, 2009, 17:09 This news item was posted in Consumer, health category and has 0 Comments so far.

Oseltamivir pills to be available in drug retail stores in India in a week

Swine flu drugs oseltamivir and zanamivir will now be available through retail medical shops in India. Related story: Swine flu drugs only through health centers

Oseltmivir to treat H1N1 swine flu has been restricted through government health centres so far, as a measure to prevent random of the drugs the possibility of developing resistance to these two drugs –one of the two available options to treat swine flu.

Retail sale of oselatamivir phosphate had been banned by the Central government and its distribution was permissible only through public health institutions. On the other hand, there was no restriction on the retail sale of Zanamivir.

However, the ban on retail sales of oseltamivir has been removed by the Ministry of Health & Family Welfare on 15th September, 2009 by issuing notification under Section 26 E of the Drugs and Cosmetic Act, 1940.

As per the current information available with the Government of India oselatamivir phosphate and zanamivir are only available drugs that can be used for the treatment of Influenza ‘A’ (H1N1) in humans. Taking into account the current spread of the influenza ‘A’ (H1N1) in the country, the Ministry of Health & Family Welfare has decided that retail sale of oselatamivir phosphate and Zanamivir should be allowed in the country but in a regulated manner, the notification said.

Oseltamivir pills are likely to be available in the retail shops within the next five to seven days.

Both oseltamivir and zanamivir drugs, however, would be available in the retail market only from  chemists who hold a licence under Schedule X.

Only chemists who have the license to sell, stock or distribute drugs specified under Schedule X to the Drugs and Cosmetic Rules, 1945 would be authorized to sell the above named drugs against proper medical prescriptions, the notification stated.

State governments have also been advised to augment the number of chemists with Schedule X licences by granting these licences expeditiously on application by such chemists who may now seek a licence under Schedule X.

Pharmaceutical companies manufacturing oseltamivir and zanamivir drugs have been kept in a state of readiness to roll out the drugs into the retail market.

The health department, which was maintaining an oseltamivir stockpile of 10 million doses, has already exhausted or decentralized over 7.5 million capsules to distribute them to the H1N1 infected states.

Now the health ministry plans to buy another 20 million doses of oseltamivir soon for its reserve. The government has alerted and asked the domestic companies like Ranbaxy Labs, Cipla, Natco Pharma, Strides Arcolab, Hetero Drugs and Roche India to be ready to supply for an order of 20 million capsules at short notice.

On september 1, Daiichi Ranbaxy Laboratories got orders from the Centre to supply 900,000 doses of oseltamivir- the generic version of Roche’s anti-viral Tamiflu – used to treat the H1N1 flu, a Ranbaxy spokesman said.

Bangalore-based Strides Arcolab also bagged a contract order from the Ministry of Health, Government of India for supply of 7.40 lakh doses of oseltamivir capsules, a day ago to tackle the emergency situation arising out of H1N1 pandemic outbreak in the country, as part of its second round of oseltmavir procurement to bolster the drug stockpile. (See related story)

Earlier, India government had procured around 9 million doses of oseltamivir from Hetero Drugs, the only domestic company that has a manufacturing agreement with Roche to make the low cost version of the patented version.

The health ministry also gave order to Roche for another one million doses of oseltamivir to complete its 10 million doses drug reserve.

The government is procuring oseltamivir at around Rs 280 for a pack of 10 tablets.

The health ministry is also considering to stockpile zanamivir (Relenza) –the alternative therapy available in the market against H1N1 swineflu.

Relenza has been recommended by the World Health Organization (WHO) as the alternative drug for the treatment of swine flu as in some cases the virus has shown resistance to the drug.

The maker of zanamivir, UK-based drug maker GlaxoSmithKline (GSK) is in currently talks with the Indian government for introducing its patented drug, Relenza.

Till now, Relenza has not been recommended for patients in India.GSK is currently not manufacturing the drug in India but it is supplying the drug to many countries across the globe and is also in the process of increasing its manufacturing capacity for the drug. GSK and Biota have the patent over the drug till 2014.

The first case of swine flu in the country was reported in May, and the first death in early August.

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