Sputnik V COVID-19 vaccine gets approval for emergency use in India

The Drugs Controller General of India (DCGI) will take a final call on the recommendation. Once approved, the vaccine would be imported from Russia for emergency use in the country.

NEW DELHI: The Central Drugs Standard Control Organisation (CDSCO) on Monday (April 12) approved Dr Reddy's application for emergency use authorisation to Russia's Sputnik V vaccine, ANI sources said. It is to be noted that Sputnik V is the third COVID-19 vaccine to have received an official nod after Covishield and Covaxin. The development took place amid the second wave of coronavirus infections across the country. 

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 Organization (CDSCO) on Monday 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, PTI quoted them as saying. 

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 per cent in the interim analysis of phase 3 clinical trial, which included data on 19,866 volunteers in Russia. 

(With PTI inputs)