The company, which is listed on the bourses as Cadila Healthcare Ltd, boasts of an annual turnover of Rs3,000 crore.
The Ahmedabad-based pharmaceutical company, Zydus Cadila, could be the first Indian company to develop a vaccine for swine flu. The flu, which is caused by the deadly H1N1 virus, has already killed more than 900 people in the country. The company, which is listed on the bourses as Cadila Healthcare Ltd, boasts of an annual turnover of Rs3,000 crore.
It expects to make the vaccine available in the market by April this year. On Monday, the company started clinical trials of the vaccine to test its effectiveness, after it received the go-ahead from the Drug Controller General of India (DCGI).
The egg-based, inactivated vaccine has been developed by the company’s team of experts using conventional technology at the company’s Vaccine Technology Centre in Ahmedabad.
With this development, Zydus Cadila has surged ahead of other pharmaceutical and biotech companies in India in developing a vaccine for the H1N1 virus. Despite their best efforts, no other company has been able to get an approval from the DCGI for clinical trials of their vaccine.
Commenting on the development, the CMD of Zydus Cadila, Pankaj Patel, said on Monday that it was a significant achievement for his company.
“We have started multi-centric clinical trials of the vaccine from today,” he said. “We plan to conduct trials at 10 different centres in four cities — Ahmedabad, Bangalore, Pune and Jaipur.”
He further said that the company expected to finish clinical trials by the end of March. “After that, a study of the results will be sent to the DCGI for approval,” Patel said. “If things go as planned, the DCGI’s approval may come by April 2010. We will be ready to launch the vaccine in the market at around the same time.”
Patel declined to comment on the sample size of the trials but he said that the trials would be conducted in accordance with WHO guidelines. The vaccine will be prepared at the Vaccine Technology Centre set up near Zydus Cadila’s manufacturing facility at Moraiya in Ahmedabad. “To begin with, we will produce around 6 million dosages,” Patel said. “By the end of the current fiscal, we plan to produce double this number. The demand for H1N1 vaccine from within India is expected to be around 50 to 60 million dosages initially.
There are two types of H1N1 vaccines available in the market — the intramuscular vaccines and the intranasal vaccines. Manufacturers have the option to choose either egg-based technology or cell-based method of production. The market for the swine flu vaccine is estimated to be around US $676 million and it is expected to cross US $7 billion by 2011.
Cadila Healthcare has been making big strides in vaccine development. The company had earlier received the WHO pre-qualification accreditation for its rabies vaccine, Lyssavac N (the Purified Duck Embryo Rabies Vaccine, or ‘PDEV’).
“We are working on other vaccines as well,” Patel said.
Cadila Pharmaceutical Ltd, another Gujarat-based company, is also confident of getting DCGI approval soon for clinical trials of its swine flu vaccine.
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