Indian H1N1 swine flu vaccine at Rs 50-100 per dose by March

India made H1N1 swine flu vaccines at half the price of imported vaccines will hit the markets by March.

Currently, the imported H1N1 swine flu is priced around Rs 300-400. But H1N1 swine flu vaccines produced by Indian companies may have a price of only Rs 50-100, reports said.

Initially, the India made H1N1 swine flu vaccines were expected to be launched in India only by April this year. However, Indian companies have advanced their their schedule to launch the vaccine as early by March, reports said quoting V M Katoch, director-general, Indian Council of Medical Research (ICMR) and secretary to the Government of India, department of health research.

In December, India placed an order with the French drug maker Sanofi Pasteur for supplying 1.5 million doses of H1N1 swine flu vaccine.

Sanofi Pasteur’s 2009 H1N1 swine flu vaccine batches will be available in India in January.

GlaxoSmithKline, which supplies Pandemrix, Baxter (Celvapan) and Novartis (Focetria) are the other multinational vaccine suppliers who have been competing to supply H1N1 swine flu vaccines in India.

India’s health ministry has given approval to French drug maker Sanofi Pasteur for conducting pre-market trials of swine flu vaccine in the country, which is a mandatory condition for selling the vaccine in India.

Initially, India was planning to import four million doses of the vaccine. Indian manufacturers will now supply the remaining doses.

However, the health ministry cut it down to 1.5 million doses, in view of the possibility indigenously produced H1N1 swine flu vaccine to be made available by March.

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.

Drug Control General of India has given approval to Zydus Cadila of Ahmedabad to carry out human studies of its H1N1 vaccine in India.

Zydus Cadila was the first Indian company to file the clinical trial protocol with the DCGI pushing back other domestic rivals who are also in race to launch H1N1 swine flu vaccine in India.

Zydus Cadila would have the vaccine ready by March, so the government would not need to import batches, according to government sources.

Bharat Biotech, Panacea Biotech and Serum Institute of India are the three biotech companies assigned by the Indian government to develop H1N1 swine flu vacccine.

Serum Institute of India has started preclinical animal studies for its indigenous H1N1 swineflu vaccines in India.

Pune, Maharashtra based Serum Institute has begun studies to test the toxicity and safety of its experimental vaccine currently being developed before attempting to study in humans, reports said quoting Serum officials.

Serum also plans to make H1N1 vaccine available to the Indian government by March 2010.

New Delhi-based Panacea’s  egg based H1N1 vaccine is currently going through pre-clinical testing in animals.

Bharat Biotech, Hyderabad, which is currently working on a cell-based vaccine, also expects its animal studies to start human studies by January.

Probably Bharat Biotech would start the human studies of its H1N1 vaccine as early as  January, 2010. The clinical studies are expected to be complted by March, 2010, subject to regulatory approval and  Bharat Bio would launch its own vaccine by April 2010, if everything goes as planned.

Cadila Pharmaceuticals and Biological E Ltd, Hyderabad are also working on H1N1 vaccines.

Cadila Pharmaceuticals, another pharma major from Ahemedabad, is also developing an H1N1 Swine flu vaccine in callaboration with Novavax.

CPL Biologicals Pvt. Ltd, the newly formed joint venture between Cadila Pharmaceuticals in India, expects to start producing H1N1 swin flu vaccine in next four months, Novavax Inc announced in a press release.

GlaxoSmithKline (GSK), Novartis, Baxter International and Sanofi-Aventis are the multinational companies applied for test license to the DCGI for carrying out clinical trials in India for their version of swine flu vaccines.

India has reported 1010 deaths confirmed by lab due to H1N1 as on January 6, 2010, as per the data available with the Union Health Ministry,.

Maharashtra on top of the list with 282 lab confirmed death cases. After Maharashtra, the maximum number of people who have lost their lives due to this pandemic disease is in Rajasthan which has registered 152 cases till January 6, and is followed by its neighbour Gujarat with 134 lab confirmed death cases so far. Gujarat is closely followed by the southern state of Karnataka with 133 death cases.

Delhi reported 73 deaths, Andhra Pradesh 52 , Kerala 34, Punjab 35 and Haryana 33.

The states which were registered comparatively less number of deaths included Uttar Pradesh (16), Uttarakhand (13), Madhya Pradesh (11), Chandigarh (8), Tamil Nadu (7), Himachal Pradesh (7), Puducherry (6), Goa (5), Orissa (3) Chhattisgarh (2), Jammu & Kashmir (2), Mizoram (1) and Assam (1).

However, no deaths were registered in some states like Bihar, Jharkhand, West Bengal, Nagaland, Manipur, Meghalaya, Andaman & Nicobar and Daman & Diu.

World Health Organisation recently reported that there is still intensive virus activity in some countries including India, even though H1N1 swine flu started waning in other parts of the world including US and Europe.