The Serum Institute of India (SSI) has sought emergency use authorisation from the Drugs Controller General of India (DCGI) for Oxford Covid-19 vaccine in the country.
SII applied to DCGI, citing unmet medical needs due to the pandemic and in the interest of the public at large.
The Indian arm of US pharmaceutical giant Pfizer became the first to seek a similar approval from India's drug regulator for its own Covid vaccine in the country.
The phase 3 clinical trial of Oxford vaccine, Covishield, is being conducted by Pune-based SII.
The clinical trial is being co-sponsored by ICMR in various parts of the country.
In addition, clinical studies are being carried out by Oxford-AstraZeneca in the UK and Brazil.
Based on phase 2 and 3 clinical trial results, SII will pursue early availability of vaccine.
According to the ICMR, the SII has already manufactured 40 million doses of the vaccine under the at-risk manufacturing and stockpiling license it obtained from the DCGI.
