The race among Indian pharma companies engaged in swine flu vaccine development may soon throw up a winner just when the pandemic enters a critical stage with the onset of winter.

ImageDrug Controller General (India) Dr Surindra Singh told pharmaquest.biz that, the Rs 3,000-crore pharma major Zydus Group has become the first domestic company to file for clinical trial protocol for H1N1 vaccine with the DCGI. With this filing, the Ahmedabad-based major leads other Indian pharma majors including Bharat Biotech, Panacea Biotech and Serum Institute of India, the three entities mandated by the Indian government to develop the vaccine.

Interestingly, another pharma major Cadila Pharmaceuticals which too is developing a swine flu vaccine with US collaboration using an advanced technology belongs to Gujarat, whose chief minister Narendra Modi is still recovering from Swine Flu.

According to DCGI Dr Singh: "Zydus is the first and the only Indian company to file for swine flu vaccine's trial." Among the multinationals, GlaxoSmithKline (GSK), Novartis, Baxter International and Sanofi-Aventis had applied for test license to the DCGI for carrying out clinical trials in India for their version of swine flu vaccines. "Although, it's a long process, amongst the MNCs, GSK is comparatively ahead," says Mr Singh.

When contacted, Zydus did not confirm the development, but top level sources close to the company said Zydus would be the first Indian company to hit the market with the vaccine. The Gujarat pharma company is learnt to have entered into collaboration with European biotech company BioCryst Pharmaceuticals for the development of the H1N1 vaccine.

It may be mentioned here that earlier this year, swine flu has been declared as a global pandemic by the World Health Organisation (WHO) which feared around 2 billion population might get affected. In India, the influenza virus has so far claimed 484 lives and affected 14,406 people.

Globally, the H1N1 vaccine market is forecast to grow beyond $7 billion in next two years from $676 million as of now.

The Indian government, earlier this year, mandated three Indian vaccine makers – Serum Institute of India Ltd, Bharat Biotech and Panacea Biotec — to develop swine flu vaccine on a war footing. However, their research is yet to reach any significant stage.

In reply to an earlier query, the executive director of Serum Institute of India Dr Suresh Jadhav said: "We are developing two types of vaccine – one is injectable (inactivated) and other is intranasal route (live attenuated). Both these vaccines have nearly completed the optimization process of manufacture and are in pre-clinical studies. Immunogenicity trials are nearly over and both the vaccines will come into toxological studies by 2nd week of November 2009. The vaccine would be be made available to the Indian government by March 2010."

Interestingly, Gujarat is the only state that has two pharma giants in advanced stages of the vaccine development. Earlier this year, Cadila Pharmaceuticals Ltd, another Ahmedabad-based pharma major, joined hands with with US-based Novavax Inc. to develop and manufacture seasonal as well as swine flu vaccines using the latest technology – Virus Like Particle technology.