Volunteers in India will be immunised with a new locally made coronavirus vaccine in July.
An unspecified number of people will have the vaccine, as part of a trial by Hyderabad-based firm Bharat Biotech.
Tests in animals suggest the vaccine is safe and triggers an effective immune response.
The trials are among many across the world – there are around 120 vaccine programmes under way. Half a dozen Indian firms are developing vaccines.
This is the first India-made vaccine and developed from a strain of the virus that was isolated locally and weakened under laboratory conditions.
India’s drug control authorities have allowed Bharat Biotech to hold Phase 1 and 2 of clinical human trials after “company submitted results generated from preclinical studies, demonstrating safety and immune response”, a statement issued by the firm added.
The two trials are designed to test whether the vaccine is safe, rather than whether it is effective.
The locally obtained strain of the virus was instrumental in developing the vaccine quickly, the firm said.
“The difference between the strains present globally is something still being researched,” a spokesperson for the vaccine maker told the BBC.
The vaccine is called Covaxin and has been locally developed in collaboration with India’s National Institute of Virology and Indian Council of Medical Research, according to Dr Krishna Ella, chairman of Bharat Biotech.
The firm, which has delivered more than 4 billion doses of vaccines worldwide, has developed vaccines for H1N1 and rotavirus, among other diseases.
Apart from Bharat Biotech, Zydus Cadilla is working on two vaccines, while Biological E, Indian Immunologicals, and Mynvax are developing a vaccine each. Another four or five home-grown vaccines are in early stages of development.
Pune-based Serum Institute of India, the world’s largest vaccine maker by number of doses produced and sold globally, has also partnered to mass produce a vaccine being developed by the University of Oxford and backed by the UK government.
India is among the largest manufacturer of generic drugs and vaccines in the world.
It is home to half a dozen major vaccine makers and a host of smaller ones, making doses against polio, meningitis, pneumonia, rotavirus, BCG, measles, mumps and rubella, among other diseases.
Correspondents say a vaccine would normally take years, if not decades, to develop.
Most experts think a coronavirus vaccine is likely to become available by mid-2021, about 12-18 months after the new virus, known officially as Sars-CoV-2, first emerged.
That would be a huge scientific feat and there are no guarantees it will work, correspondents say.