Therapy Areas: Vaccines
Russia's Sputnik V COVID--19 vaccine approved for use in India
13 April 2021 -

The Drugs Controller General of India in India has approved the Russia's COVID--19 vaccine Sputnik V, CNN news website revealed on Tuesday.

India is currently fighting a second wave of the virus and has given emergency use approval to Sputnik V, the third coronavirus vaccine to be approved after Covishield, developed by Oxford-AstraZeneca and manufactured by the Serum Institute of India, along with Covaxin, made by Indian firm Bharat Biotech.

India's Ministry of Health stated that the decision was made by the Drugs Controller General of India after a Subject Expert Committee of the Central Drugs Standard Control Organization "deliberated on various critical areas for consideration including safety, immunogenicity, efficacy data from overseas clinical studies, indication, age group, dosing schedule, precautions, storage, warnings, adverse effects of special interest, risk benefit evaluation."

Sputnik V has been approved for use in 60 countries across the world and is manufactured in India by pharmaceutical firm Dr. Reddy's Laboratories, which partnered with the Russian Direct Investment Fund (RDIF) in September 2020 to conduct clinical trials of Sputnik V and distribute the vaccine in India.