The vaccine 'Rotovac' is the outcome of public-private partnership between the Indian government's Department of Biotechnology (DBT) and pharma company Bharat Biotech.
Once licensed by the Drugs Controller General of India (DCGI), the vaccine will cost around Rs.54 per dose compared to the currently available vaccine which costs Rs.2,250 per dose. Each child needs to take three doses as part of vaccination.
"This is an important scientific breakthrough against rotavirus infections, the most severe and lethal cause of childhood diarrhoea, responsible for approximately 100,000 deaths of small children in India each year and rotavirus vaccine can save 60,000 deaths," said DBT Secretary K. Vijay Raghavan.
"The clinical results indicate that the vaccine, if licensed, could save the lives of thousands of Indian children who get rotavirus diarrhoea every year," he said.
As part of clinical trials, 7,000 infants from low income families in Delhi, Pune and Vellore were administered the vaccine.
"The clinical trials show that the vaccine is efficacious in reducing severe rotavirus diarrhoea by 56 percent during the first year of life, with protection continuing into the second year of life while it reduces the deaths by over 75 percent," said M.K. Bhan, former DBT secretary and currently advisor to the Indian Academy of Paediatrics.
The vaccine originated from an attenuated (weakened) strain of rotavirus that was isolated from an Indian child at the All India Institute of Medical Sciences in New Delhi in 1985-86.
"This is the first time that India has developed a vaccine and it is totally indigenous as strain was taken from an Indian infant, the vaccine was manufactures in India and clinical trials were also done in India," said Bhan.
"With its low price and strong efficacy, the vaccine has the potential to significantly reduce the incidence of severe diarrhoea due to rotavirus among children in India. It can also help in reducing infant deaths in other developing countries," he added.
The oral vaccine can be given alongside routine immunization vaccines like polio vaccine and others.
"It represents the successful research and development of a novel vaccine from the developing world with global standards," said Krishna M. Ella, chairman and managing director of Bharat Biotech.