The new rotavirus vaccine is expected to be made available at a cost of around $1 per dose, allowing poor countries to easily vaccinate their children against the deadly infection that is spread through contaminated hands and surfaces.
The Department of Biotechnology secretary Dr. K. Vijay Raghavan said, "The clinical results indicate that the vaccine, if licensed, could save the lives of thousands of children each year in India."
Safety and efficacy profile of Rotavac, developed from a weakened strain of the virus, is established in Phase III trials.
A total of 6,799 infants received Rotavac and the UIP vaccines, including the oral polio vaccine (OPV), in the randomised, placebo-controlled phase-III trial conducted at three sites in India.
Results supported the simultaneous adminstration of OPV and Rotavac for the improved immune response.
The vaccine can be dristributed in India upon gaining license and the World Health Organization approval is required to distribute it globally.
Two other vaccines, which also demonstrated the efficacy, were found to be more expensive.
The development was the result of a global partnership that includes the government, Bharat Biotech, the Bill and Melinda Gates Foundation and the US Centers for Disease Control and Prevention, and several others.