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This is an archive article published on September 18, 2009

Flu: Tests on animals by month-end

Four institutes are working to make indigenous raw material for manufacturing Oseltamivir or Tamiflu....

While H1N1 vaccine has got regulatory approval abroad,Indian vaccine manufacturers are likely to start animal testing by the end of this month.

Dates were finalised after government gave Rs 10 crore each to three vaccine manufacturers Serum Institute of India ,Bharat Biotech and Panacea Biotech as part of the Advance Purchase Agreement.

Sources in Serum Institute confirmed that testing would start within seven to 10 days. Tests are likely to be carried on rats and mice,the model considered closest to human bodies.

As the vaccine manufacturers have the flu vaccine technology ready,India may also get seasonal flu vaccines which are not available in the country.

The H1N1 vaccine research in the country can lead to the production of an all-round vaccine for seasonal flu. The platform is ready. The manufacturers will have to just replace the H1N1 virus with the seasonal flu virus, said Dr V M Katoch,director general,Indian Council of Medical Research,and secretary health research,Ministry of Health.

Whether there is a market for flu vaccines in the country needs to be seen. We have no data for seasonal flu and deaths due to it. We are going to get the data from the network of viral diagnostic labs that we are setting up across the country, said Katoch.

However,an official from Serum Institute said,We have some data from market research which shows there is a growing need for flu vaccines among those below five years of age and the elderly. So if we get a market we will manufacture the seasonal flu vaccine as well.

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Meanwhile,four educational institutions Delhi University,NIPPER in Mohali,and IITs in Delhi and Mumbai are working to make indigenous raw material for manufacturing Oseltamivir or Tamiflu.

Though Indian generic drug manufacturers have been making generic version of Tamiflu,the expensive raw material for the drug,Shikimic acid,still has to be imported from the west.

The government of India has decided to explore the possibility of indigenous production of the Shikimic acid, said Dr Katoch. An expert group was constituted at ICMR and proposals from various Indian institutions were invited. The government has now approved the proposals of the four institutes and approved grants for the research.

If the institutes succed in their endevours, cost of the drug can be effectively reduced. The government is buying a pack of 10 tablets of Tamiflu for Rs 280. It has stockpiled 40 million capsules and 4.5 lakh bottles of paediatric Tamiflu syrup. The material for another six million capsules is being kept in banking arrangements with the pharma companies. The Department of Health Research had also constituted a committee at ICMR to explore the possibility of developing indigenous reagents for testing H1N1 virus. Each positive test costs the government Rs 10,000 and each negative test costs Rs 5,000. The reagents are imported from a Germany.

 

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