Ahmedabad-based Cadila Healthcare Ltd could well be the first Indian company to launch the H1N1 vaccine in India. It expects to bring its vaccine in the market by April 2010.
The Rs 3,000 crore turnover company commenced the clinical trials of its vaccine from Monday after a go-ahead signal from Drug Controller General of India (DCGI) for conducting clinical trials on humans.
With this development, Cadila Healthcare has outpaced many other pharma and biotech companies including Cadila Pharma, Serum Institute, Panacea Biotech and Bharat Biotech in getting approvals for conducting clinical trials.
Cadila Pharma, another Gujarat-based company, is also confident of getting DCGI approval for clinical trials soon.The egg based, inactivated vaccine based on conventional technology, has been developed by the group’s experts at its Vaccine Technology Centre in Ahmedabad.
Pankaj Patel, CMD, Cadila Healthcare, said, “The company plans to conduct the clinical trials in 10 centres in Ahmedabad, Bangalore, Pune and Jaipur. We expect to complete the trials by end of March 2010, after which we will send the study results to DCGI for approval. We expect DCGI approval by April 2010 and will ready to launch the vaccine in the same month.”
Patel didn’t comment on the sample size for the trials, but said, “We will do as per World Health Organisation’s (WHO) guidelines. The first swine flu vaccine will be ready from the Vaccine Technology Centre near the manufacturing facility at Moraiya, Ahmedabad. To begin with, we will be ready with the infrastructure to produce 6 million dosages which we plan to double by the end of the current fiscal.”
The demand for H1N1 vaccine in India is estimated to touch 50 to 60 million doses in the initial phase.
The group had earlier received the WHO prequalification accreditation for its rabies vaccine, Lyssavac N – the Purified Duck Embryo Rabies Vaccine (PDEV). “We are also working on vaccines for malaria and Human Papillomavirus – HPV and progress is satisfactory,” Patel said.
There are two types of H1N1 flu vaccines available in the market — the intramuscular vaccines and intranasal vaccines. H1N1 flu vaccine market is estimated to be $676 million with the first lot of doses being commercialised in September 2009.
The market is expected to cross $7 billion by 2011.