India-based Zydus Cadila has received an approval from the Drug Controller General of India (DCGI) to conduct clinical trials for the H1N1 (swine flu) vaccine. The egg based, inactivated vaccine, based on conventional technology, has been developed at its Vaccine Technology Centre in Ahmedabad.
The company claims that, with this approval, it has become the first Indian pharma company to commence multicentric clinical trials of its vaccine.
Pankaj Patel, chairman and managing director of 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 H1N1 free 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 infectious disease.”
The indigeneous H1N1 vaccine is expected to hit the markets by April 2010.
Zydus Cadila had earlier received the WHO prequalification accreditation for its rabies vaccine, Lyssavac N – the Purified Duck Embryo Rabies Vaccine (PDEV). The group has also recently set up a Vaccine Technology centre near its manufacturing facility at Moraiya, Ahmedabad, India.