Health Ministry orders Rs 50 Cr worth H1N1 vaccine from Sonafi Pasteur

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Health Ministry orders Rs 50 Cr worth H1N1 vaccine from Sonafi Pasteur

Posted On: 30-Dec-2009 20:08:39 By: Rajib Das


New Delhi: Taking serious note to the ever increasing reports of swine flu deaths across the country the Health Ministry approved French drug maker Sanofi Pasteur for conducting pre-market trials of swine flu vaccine in the country.

An order of 15 lakh vaccine dosages worth Rs 50 crore has been given to the company for starting the vaccine trials.

?Of four international vaccine manufacturers, it has been decided that Sanofi Pasteur?s vaccine will be used here. GSK, Baxter and Novartis also have shown interest in selling H1N1 vaccine in India,? an official in the Ministry of Health and Family Welfare said on Wednesday.

He said, ?Sanofi Pasteur will supply 1.5 million doses of swine flu vaccine at present. An expenditure to the tune of Rs. 50 crore has been incurred for it.?

At present, the company will conduct pre-market human trials of swine flu vaccine to check its efficacy on Indians.

?Since no Indian company is ready yet for the phase IV trial, we are considering the foreign brand as it is already tried, tested and in use in other countries,? Dr. V. M. Katoch, Director General, Indian Council of Medical Research said.

More than 21,000 people have been affected by swine flu virus in India and more than 700 deaths have been reported from different cities here.

Zydus Cadila of Ahmedabad, the Indian swine flu vaccine manufacturing company, has recently got a nod from the Drug Controller General of India to carry out human studies of its vaccine.

http://www.mynews.in/News/Health_Mi..._H1N1_vaccine_from_Sonafi_Pasteur_N34076.html#

 

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Re: Health Ministry orders Rs 50 Cr worth H1N1 vaccine from Sonafi Pasteur

Posted: Wed, Dec 30 2009. 8:46 PM IST

Health minister to import 1.5 millions doses of H1N1 vaccine

New Delhi: The health ministry has placed an order to import 1.5 million doses of the swine flu vaccine into India, which will be available in January.

This is contrary to the government?s earlier claims of importing four million doses of the vaccine. Indian manufacturers will now supply the remaining doses.

?We have placed an order for importing 1.5 million doses already,? said Vineet Chawdhry, joint secretary, health ministry. ?Indigenous production of the vaccine will be ready by March, so we will have that available soon as well.?

The health ministry has been trying to make the vaccine available in India for the last two months and had sped up regulatory approvals for studies to be conducted on the safety of the vaccine.

Chawdhry said India?s Zydus Cadila would have the vaccine ready by March, so the government would not need to import batches, which is why an order for only 1.5 million doses has been placed at the moment.

Cadila is not one of the three Indian drug makers being supported by the government to develop and manufacture the H1N1 flu vaccine. The ones that are supported are Serum Institute of India Ltd, Bharat Biotech International Ltd and Panacea Biotech Ltd. According to ministry officials, who declined to be named, vaccines of these three firms will not be ready before April.

Chawdhry declined to name the overseas company that will supply the vaccine, citing a confidentiality clause. Ministry officials, however, have been in talks with four international vaccine makers?GlaxoSmithKline Plc (GSK), Baxter International Inc., Novartis AG and Sanofi Pasteur SA.

On 1 December, Mint reported that the vaccines could be available in the country by the end of the month following approvals by the Indian regulator for human clinical trials to two multinational drug makers, GSK and Baxter, while among Indian vaccine makers, only Zydus Cadila had submitted the clinical trial protocol to the regulator to conduct trials of its vaccine candidate.

The vaccine, said Chawdhry, would initially be made available to healthcare workers who come in direct contact with the virus and are at greater risk of being infected by it. It would could later be made available to the general public, either through government or private channels, he said.

As on 29 December, India reported 25,572 confirmed cases of swine flu, of which 898 resulted in death. Delhi reported 8,306 cases, the highest among the states.

According to World Health Organisation director general Margaret Chan, while the worst of the swine flu outbreak is over in the US and Canada, there is still intensive virus activity in some countries including India. Chan also warned that the virus could still mutate and countries must ?guard against complacency?.

http://www.livemint.com/2009/12/30204656/Health-ministry-to-import-15.html