INDIA's central drug authority has recommended on Monday (12) granting approval to Russia's Covid-19 vaccine Sputnik V for emergency use in the country with certain conditions.
The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) today took up Dr Reddy's Laboratories’ application 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, it said.
In September last year, Dr Reddy's partnered with the Russian Direct Investment Fund (RDIF) to conduct Sputnik V’s clinical trials 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 per cent in the interim analysis of the phase 3 clinical trial, which included data on 19,866 volunteers in Russia.
Amid Covid-19 surge and vaccine shortage, this could prove vital as India reported a record daily tally of 168,912 infections on Monday (12), the world's highest.
India now accounts for one in every six daily infections worldwide. Monday's new cases carried it past Brazil, for an overall tally of 13.53 million, placing it second after the United States, with 31.2 million.
A full opening of India's economy after last year's strict lockdown - mass religious festivals and political rallies in states holding elections have worsened the second wave of infections, experts claim.
Dr Kalpana Lakhani Garavi Gujarat
