H1N1 swine flu market in India is expected to see heightened action in the coming months as more and more companies join the fray to launch own versions of the vaccine in the country.
India’s top drug regulator, Drug Controller General of India has said it will permit Panacea Biotec to conduct clinical trials for its swine flu vaccines in the country.
“We will give permission to Delhi-based Pancea Biotec to conduct clinical trials for their Influenza A HINI (swine flu) vaccine in India,” the Drug Controller-General of India Surinder Singh was quoted as saying.
DCGI has already given permission to a few other vaccine makers in the country to conduct necessary clinical trials before launching thier versions of H1N1 swine flu vaccines 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.
New Delhi-based Panacea’s egg based H1N1 vaccine was completing 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.
Most 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.
VaxInnate is a privately-held biotechnology company based in USA and is focused on developing proprietary vaccines, including those for both pandemic and seasonal influenza.
Biological E plans to manufacture H1N1 pandemic swine flu vaccine under a technology licence from VaxInnate.
VaxInnate recombinant H1N1 vaccine is based on the novel Toll-Like Receptor (TLR) technology platform, which dramatically improves vaccine immunogenicity and efficacy.
Biological E would produce vaccine for India and other South Asian countries, including Bangladesh, Bhutan, the Maldives, Nepal, Pakistan and Sri Lanka.
The H1N1 pandemic swine flu vaccine is projected to enter clinical development in India in early 2010. And the vaccine could become available for emergency use in India by mid 2010.
TLR technology enables Biological E to produce more than 300 million vaccine doses every month and is a practical indigenous solution to meet the needs of India’s 1.2 billion population, making the country self sufficient in the event of an emergency, the release said.
Biological E., Ltd is a biopharmaceutical company based in Based in Hyderabad, India.
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.
Sanofi Pasteur’s 2009 H1N1 swine flu vaccine batches will be available in India in January.
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 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.