The health ministry has set aside Rs 100 crore as an interim budget to purchase these vaccines from any one of the four international manufacturers — Novartis, GSK, Sanofi Pasteur and Baxter — whose candidates are presently undergoing human trials.
However, India has one clear condition — the vaccine would have to undergo safety and efficacy trials on the Indian population before being used in the country.
According to experts, the vaccine may behave differently in Indians in comparison to people of other nationalities and may cause serious side effects like paralysis, urticaria and toxic reactions. Refusing to accept data from the trials conducted in foreign countries, ICMR director general Dr V M Katoch wrote to all four companies making it clear that even if it was not a largescale trial, the companies would have to atleast undertake a two-month bridge study on around 500 healthy volunteers.
Novartis and GSK have agreed to initiate a bridge study in India while the other two are yet to get back.
The global vaccines are expected to be available by October-end. It will then undergo a two-month bridge study in India. If found to be safe and efficacious in the Indian population, the two-dose vaccine, expected to cost around Rs 500 per dose, will be imported for frontline health workers dealing with H1N1 cases.
India’s indigenous vaccine being developed by Serum Institute, Bharat Biotech and Panacea Biotech is expected to be ready by April. The Indian vaccine will then be picked up by the government at a much cheaper price to vaccinate other high risk groups like children younger than five years old, people suffering from chronic health disorders and pregnant women.
Speaking to TOI, Dr Katoch said, "India can’t use a new vaccine against a completely novel virus without being sure that it is safe and effective for the Indian population. Till now, two of the foreign companies have agreed to carry out bridge studies in India. If all four companies carry out the study and their vaccines prove safe, we will then buy from whoever gives us the cheapest price. To start with, we will use it on healthcare workers for which we would require around 40 lakh doses of the imported vaccine."
According to director general of health services Dr R K Srivastava, countries like UK, France and US have booked vaccines from these international manufacturers under an advance purchase agreement. This is because the candidate vaccines have been tried on their population which isn’t the case with India.
An official said, "Even though these companies knew that most of their vaccines will be purchased by developing countries like India and China, they didn’t conduct trials here."
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