NEW DELHI: With an aim to launch vaccine for Influenza H1N1 A Virus (swine flu) in India, Cadila Pharmaceutical will seek the government’s nod in two days for initiating clinical trials in this regard.
Cadila Pharmaceutical Ltd (CPL) had set up a joint venture ‘CPL Biologicals Pvt Ltd’ with the US-based vaccine maker Novavax for manufacturing and developing a host of vaccines, including for swine flu, in India.
“The joint venture is going to file the application with the Drug Controller General of India (DCGI) in the next two days for phase-I clinical trials for swine flu vaccine,” CPL Chairman and Managing Director I A Modi said.
Modi expressed confidence that Cadila would be the first Indian pharma company to launch the swine flu vaccine in India by December.
“If we get the permission of DCGI soon, then with the advanced technology available from our partner, (we) would be able to launch it in India by December this year,” Modi said.
With its existing facility, Cipla can produce up to one million doses of the vaccine per month, which can be scaled up to two million doses, Modi said.
“Novavax has already received permission for clinical trials from the US Federal Drug Administration and if we get it soon, we can simultaneously start the trials,” he added.
The government has already indicated that swine flu related applications it would clear on a fast track basis and the company is hopeful of getting instant approval for it, Modi added.
He said to protect from swine flu pandemic, two dosages of the vaccine are required over two weeks.
The JV has already started building a facility with an estimated investment of Rs 100 crore. In the joint venture Cadila has 80 per cent stake and the remaining 20 per cent is held by Novavax.
Besides this, Cadila Pharma also holds 5.75 per cent stake in Novavax Inc US and has a position on the board of directors of the US-based company.