An expert panel of India’s Central drug authority has recommended granting approval to Russian COVID-19 vaccine Sputnik V for emergency use in the country with certain conditions, sources said.
The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) on April 12 took up the application of Dr Reddy’s Laboratories seeking emergency use authorisation for Sputnik V.
The Drugs Controller General of India (DCGI) will take a final call on the recommendation. If approved, it will be the third COVID-19 vaccine to be available in India.
The vaccine would be imported from Russia for emergency use in the country, they 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.
The Drugs Controller General of India (DCGI) has already given the emergency use authorisation for two COVID-19 vaccines — Covaxin of Bharat Biotech and Covishield of Oxford-AstraZeneca, being manufactured by Serum Institute of India in Pune.
Sputnik V has demonstrated an efficacy rate of 91.6% in the interim analysis of Phase III clinical trial, which included data on 19,866 volunteers in Russia.