Panacea Biotec has entered into an advance marketing agreement with Ministry of Health and Family Welfare (MoHWF) for supplying its H1N1 swine flu vaccine Pandyflu.
Panacea Biotec, which is based in New Delhi, northern India, is currently doing clinical studies on Pandyflu vaccine. Pandyflu is an inactivated split version vaccine using egg- based technology.
India’s ministry of health and family welfare was holding discussions with indigenous vaccine manufacturers to assess their capacity to develop, manufacture and supply H1N1 swineflu vaccine for national programme.
Panacea Biotec has set up a BSL2 level manufacturing unit (high-containment facility) with BSL3 practices at Lalru, Punjab for manufacturing Pandyflu vaccine.
The company has developed a unique virus purification strategy that has yielded satisfactory results in trial runs.
Panacea used the seed virus to produce three consecutive batches of the vaccine using embryonated chicken eggs.
To develop this technology, Panacea had procured a classical reassortant virus from CDC, Atlanta in June 2009.
Panacea’s facility has an annual capacity to manufacture 45 million doses of the vaccine, the company said.
The company expects that Phase I studies on Pandyflu would be completed by March 2010. It plans Phase II and III studies in adult and pediatric population, soon after.
The ministry has entered into this Advance Market Commitment (AMC) Agreement with Panacea Biotec, the company said in a statement.
Already, several Indian companies including Zydus Cadila, Serum Institute of India, Bharat Biotech have started clinical trials of their own versions of H1N1 swine flu vaccines in India.
Recently, India’s Biological E Limited has entered into an agreement with USA’s VaxInnate Corporation to license its recombinant H1N1 pandemic swine flu vaccine.
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 by February.
Last year, four companies had approached the government to provide assistance in locally developing the vaccines for HINI.
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.
India has reported 1376 deaths from H1N1 swine flu infection in the country as of 2nd March 2010, according to an official communique from the ministry of health and family welfare issued by Press Information Bureau.
India has tested samples from 128944 persons for Influenza A H1N1 in government laboratories and a few private laboratories across the country till date and 29710 or 23.04% of them have been reported positive.
The western state of Maharashtra comes first with 369 deaths among the total 5577 lab confirmed cases of H1N1 swine flu deaths.
Maharashtra is followed by other states – Gujarat and Rajasthan -in the western region with 289 and 194 deaths respectively.
Gujarat and Rajathan have 1214 and 2192 each.
Delhi has the highest number of lab confirmed cases of H1n1 infection: 9687. However, India’s capital city registered only 95 cumulative number of deaths from swine flu.
Among the southern states, Karnataka accounted for the highest casualties with 148 deaths and 2138 cases of lab confirmed infections.
Andhra Pradesh reported 52 deaths and 782 infections while the states of Tamil Nadu and Kerala registered 7 deaths 2084 confirmed infections and 37 deaths and 1468 infections respectively.
The north-eastern states of West Bengal, Manipur, Meghalaya, Nagaland and nothern states of Bihar, Jharkhand as well as union territories Daman Diu, Andaman Nicobar reported zero deaths from swine flu.
It was reported earlier that H1N1 influenza or swine flu infections could continue in India for one more year.
Even though the trend in H1N1 swine flu infection is on the decline globally, it has now started showing up in places which are new. So, naturally India may have to face another year of swine flu infection, according to V M Katoch, Director General, Indian Council of Medical Research (ICMR).
“In places where swine flu cases were already reported, it has been contained. But we found that it is spreading to new pockets and hence we face the challenge for one more year. It is like a flood and will take some time to recede,” V M Katoch stated.
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.
India was to begin vaccination against H1N1 swine flu in the country by March this year as the first batches of imported vaccine from Sanofi-Pasteur will arrive India by the end of February.