This approval expands the total count of Covid-19 vaccines authorised in the country to five.
Last week, J&J submitted an application seeking Emergency Use Authorization (EUA) for its vaccine to the Indian government.
The company stated it was too early to provide a timeline for the delivery of Covid-19 vaccines, reported Reuters.
J&J plans to make the doses available in the country via a partnership with Indian pharma firm Biological E.
The firm sought EUA in the country based on efficacy and safety results from the Phase III ENSEMBLE clinical trial.
This trial showed that the vaccine had 85% efficiency in preventing severe Covid-19 in all the places analysed.
Commenting on the EUA, J&J stated: “This is an important milestone that paves the way to bringing our single-dose Covid-19 vaccine to the people of India, and the rest of the world, through a collaboration with Biological E.
“Biological E will be an important part of our global supply chain network, helping to supply our Johnson & Johnson Covid-19 vaccine through the extensive collaborations and partnerships we have with governments, health authorities and organisations such as Gavi and the COVAX Facility.”
The single-dose vaccine has shown to provide protection against Covid-19 linked hospitalisation and death, from 28 days after the inoculation.
In July, J&J reported that its single-dose Covid-19 vaccine showed strong, continued neutralising antibody activity against the Delta variant, besides other SARS-CoV-2 viral variants.
India has authorised the use of Covid-19 vaccines developed by AstraZeneca, Bharat Biotech, Russia’s Gamaleya Institute and Moderna.