With this approval "Zydus Cadila becomes the first Indian pharma company to commence multicentric clinical trials of its vaccine," the Ahmedabad-based firm said in a statement to the Bombay Stock Exchange.
In recent times, the pandemic H1N1 Influenza has claimed thousands of lives across the globe.
"With the vaccine in the market soon, we should be able to prevent further loss of lives to this infectious disease," Zydus Cadila CMD Pankaj R Patel said.
With the speedy completion of trials and the fast track approvals, the indigenous H1N1 vaccine is expected to hit the markets by April this year, the company said.According to the company, the demand for H1N1 vaccine in India is estimated to touch 50 to 60 million doses in initial phase.
Zydus Cadila's egg-based inactivated vaccine has been developed by the group's experts at its Vaccine Technology Centre in Ahmedabad.
Currently, the H1N1 vaccine market is estimated to be USD 676 million. The market is expected to cross USD 7 billion by 2011.