The Ahmedabad-based pharma major, Zydus Cadila has received approval from the Drug Controller General of India (DCGI) to conduct clinical trials for the H1N1 (swine flu) vaccine. With this Zydus Cadila becomes the first Indian pharma company to commence multi-centric clinical trials of its vaccine. The egg-based, inactivated vaccine based on conventional technology has been developed by the group's experts at its Vaccine Technology Centre in Ahmedabad.
Speaking on the development Pankaj R Patel, chairman and managing director, Zydus Cadila said, “India's readiness with a vaccine that is safe and effective in Indian conditions is critical as we go all out to create an H1N1free zone. Our researchers and vaccine experts have worked round-the-clock to strengthen our armoury in this fight against the H1N1 virus. With the vaccine in the market soon, we should be able to prevent further loss of lives to this infections disease.”
H1N1 Influenza A (2009) is the first pandemic influenza of 21st century accounting for more than 12,000 lives in more than 200 countries across the globe. Recent updates indicate that India has recorded over 21,000 confirmed cases since the virus fist struck in May 2009 and has accounted for over 900 lives so far.
With speedy completion of trial and fast track approvals, the indigeneous H1N1 vaccine is expected to hit the markets by April 2010. The demand for H1N1 vaccine in India is estimated to touch 50 to 60 million doses in the initial phase.
There are two types of H1N1 swine flu vaccines available in the market – the intramuscular vaccines and intranasal vaccines, with manufacturers opting for either egg based or cell based manufacturing. Intramuscular H1N1 swine flu vaccine will cater to 80 to 85 per cent of market revenues. Currently, the H1N1 swine flu vaccine market, is estimated to be US$ 676 million with the first lost of doses being commercialised in September 2009. The market is expected to cross US$ 7 billion by 2011.
Backed by a strong technological support and robust infrastructure, Zydus Cadila has been making significant progress in its vaccine technology. The group has earlier received the WHO pre-qualification accreditation for its rabies vaccine, Lyssavac N – the Purified Duck Embryo Rabies Vaccine (PDEV). The group has also recently set up a state-of-the-art Vaccine Technology Centre near its manufacturing facility at Moraiya, Ahemdabad.