Thursday, February 25, 2010

First Trial Over for Indian Made H1N1 Vaccine

Ahmedabad: Zydus Cadila announced completion of the first phase of the H1N1 vaccine trial on Thursday. The Ahmedabad-based drug maker will now commence the phase II and phase III clinical trials in Ahmedabad, Bangalore, Jaipur and Pune.

An Indian made H1N1 vaccine is on the way. The Ahmedabad based drug company Zydus Cedilla who is making the vaccine in India and has announced the completion of the first phase trial on Thursday. The vaccine has to go through the second and third trial in Ahmedabad, Bangalore, Jaipur and Pune now which will take six more months.

The company’s press release said “Multi-centric trials extending for a period of six weeks are currently underway. On successful completion of the trials, the group will submit the results to the Drug Controller General of India (DGCI) for marketing approval.” The vaccine has been developed by a team of experts using conventional technology at the company’s Vaccine Technology Centre here, the statement said.

The Indian made vaccine will be available in market by April 2010. The company is proposing to produce six million doses initially. The H1N1 vaccine is in huge demand in India to the extent of 50 to 60 million dosages initially.

At the same time the vaccinations against H1N1 in India will begin from next week itself, using the 1.5 million doses of vaccine imported from the French drug manufacturer, Sanofi Pasteur that has passed the safety test. The clinical bridge study results conducted on 100 adult subjects in Delhi and Pune were submitted to the Drug Controller General of India on Wednesday by the company. The trials were completed on February 21. The results were then checked thoroughly in Lyon before being submitted to DCGI.

DCGI Dr Surinder Singh told TOI, "The trials of the vaccine have proven its safety profile. By Friday, we will vet the results and give its clearance for use on humans in India. By next week, the vaccination should begin."