A committee of experts of the Indian government recommended approval of Russian Covid-19 vaccine Sputnik V for emergency use today in the country, which is reeling from an unprecedented surge of daily cases of the virus.
The Subject Expert Committee (SEC) of India's Central Drugs Standard Control Organization (CDSCO) today discussed the application of Indian pharma major Dr Reddy's Laboratories which sought emergency use authorisation for Sputnik V, sources said.
A final call on the recommendation of the SEC will be taken by the Drugs Controller General of India (DCGI).
If approved, Sputnik V will be the third Covid-19 vaccine to be available in India after Covishield by Oxford AstraZeneca and Covaxin, which was developed by the Indian Council of Medical Research.
Sputnik V has demonstrated an efficacy rate of 91.6 percent in the interim analysis of phase three clinical trials, which included data on 19,866 volunteers in Russia.
Sputnik V would be imported from Russia for emergency use in India, the sources said.
In September last year, Dr Reddy's partnered with the Russian Direct Investment Fund (RDIF), to conduct clinical trials of Sputnik V, and for its distribution rights in India.
While Covaxin is being manufactured by Bharat Biotech, Covishield is being produced by Serum Institute of India in Pune.
Along with Dr Reddy's Laboratory, the RDIF partnered with Virchow Biotech Private Limited of India in March this year to produce up to 200 million doses per year of Sputnik V in India.
It has partnered with Stelis Biopharma Pvt Ltd and Panacea Biotec earlier in April to produce 200 million and 100 million doses per year,respectively, of Sputnik V in the country.