AHMEDABAD: The race amongst Indian swine flu vaccine-makers seems to be moving to the next level with Cadila Healthcare Ltd, the Rs 2,900-crore Zydus Group's listed entity, filing for the next phase of clinical trials after completing the first phase.
Talking to ET, Zydus Cadila CMD, Pankaj Patel said: "We have successfully completed our phase I trials and last week we have filed application with DCGI for phase II & III clinical trials". He said, he was hopeful of getting the requisite permission this month. Zydus conducted the first phase of trials for six weeks within Ahmedabad. "The vaccine was found to be effective, safe and well tolerated," said Mr. Patel.
Last month, Serum Institute of India (SII) become the first Indian company to announce the success of phase–I human clinical trials for its swine flu (H1N1) vaccine. SII too will begin the next phase of clinical trials after obtaining the necessary permission from the DCGI.
Amongst the other players working on the development of indigenous H1N1 vaccines are Bharat Biotech and Panacea Biotech. Cadila Pharmaceuticals Ltd, another Ahmedabad-based pharma major, too is working on developing H1N1 vaccine using Virus Like Particles (VLP) technology.
Zydus now plans to conduct the Phase-II and Phase-III clinical trials in Ahmedabad, Bangalore, Jaipur and Pune. The company will be manufacturing the vaccine at its vaccine manufacturing facility at Moraiya, Gujarat. "We will initially be producing 5-6 lakh doses per month which will be doubled to 10 lakh doses per month in the next 6 months." He said.
The company earlier made an announcement during the third quarter in this fiscal year that it planned to launch the H1N1 vaccine in the Indian market by April 2010.
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