India Approves Russia’s Covid-19 Vaccine Sputnik V For Emergency Use

Dr Reddy's had applied for emergency use of Sputnik-V, which is in Phase 3 of clinical trials in India, the UAE, Venezuela and Belarus.

Outlook Web Bureau

Updated on: 12 April 2021 4:22 pm

Russia's Covid vaccine Sputnik V has been recommended for use in India by a committee of experts as the country battles a record spike in virus cases in the country. If approved by regulator DCGI, this will be the third vaccine to be used in India after Serum Institute of India's Covishield - developed by Oxford-AstraZeneca - and Bharat Biotech's Covaxin.

The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) went through an application turned in by Dr Reddy's Laboratories which sought 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 per cent in the interim analysis of the phase 3 clinical trial, which included data on 19,866 volunteers in Russia.

(With PTI Inputs)