India developing indigenous swine flu vaccine

"We are not bothered about what is happening abroad. Our government has a plan to have indigenous vaccine by the end of this year and we will be among the first few countries to have such a vaccine to tackle the H1N1 virus," V.M. Katoch, secretary in the department of health research, said.

"India started working on a vaccine from April soon after the pandemic broke out abroad. At least three companies are working on the vaccine. One company has made real progress and we believe by November, we will have something in hand," he added.
Katoch said the vaccine will be available in the market in an injectable format by the year-end.

Over the last couple of months, India has reported over 700 cases of swine flu, with Delhi and Maharashtra being the worst hit. Both the states have reported over 50 percent of the total cases in the country.

"The WHO has made available four strains and the drug controller (of India) has approved them all. Based on this, the vaccine is being developed at three places across the country.

"Three pharma companies - Serum Institute of India (Pune), Bharat Biotech (Hyderabad)  and Panacea Biotech (New Delhi) - are working on developing the vaccine. The Pune company has made some real progress," he said.

While  the Serum Institute is developing an "egg-based" vaccine, the other two are developing "cell line vaccines". "But all of them will be available as injections," Katoch added.

When asked about human trials, he said the health ministry has already notified health centres about this and all interested parties were welcome.

"After the animal trials at the above three companies, the vaccine will go for human trials. May be by November we will do some human trials."

"Before allowing any one we will verify his clinical trial credentials, past history and efficiency. There is a modern guideline for this and clinical trial centres have to follow the official protocol," the secretary said.

He also said human trials will be conducted in multiple centres. "Some may be outside India too."

Katoch, a leading health scientist, said interested parties need to give a brief description of interest, experience, expertise and infrastructure available for conducting Phase-I and or Phase II multi-centre clinical trials.

He said India is ready for "fast track approval" of the vaccine as it generally takes a lot of time to develop a medicine or vaccine. He also clarified that quality shall not be compromised and all "safety measures" shall be taken care of.

The country has reported four H1N1 deaths so far. As on July 31, the World Health Organization has reported 162,380 laboratory confirmed cases of influenza A (H1N1) and 1,154 deaths in over 150 countries.