India’s drug regulator has granted permission for restricted emergency use of the Russian COVID-19 vaccine Sputnik V with certain conditions, the Union Health Ministry announced on Tuesday, while stating that Dr Reddy’s Laboratories will import the vaccine to be used within the country.
The approval by the Drugs Controller General of India (DCGI) paves the way for a 3rd vaccine to be available within the country.
The approval came after the topic Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organization (CDSCO) on Monday recommended granting approval to Sputnik V for restricted emergency use subject to certain regulatory conditions.
The DCGI in January had already given the emergency use authorisation for 2 COVID-19 vaccines — Covaxin of the Bharat Biotech and Covishield of Oxford-AstraZeneca, being manufactured by the Serum Institute of India in Pune.
Dr Reddy’s Laboratories Ltd (DRL) had applied for the grant of permission to import and market Gam-COVID-Vac combined vector vaccine, popularly called Sputnik-V, developed by M/s Gamaleya Institute, Russia for Emergency Use Authorization, the ministry said during a statement.
The Gam-COVID-Vac combined vector vaccine (Component I & Component II) has been developed by the National research facility for Epidemiology and Microbiology of the Ministry of Health of the Russia , Moscow, Russia and is approved in 30 countries across the planet .
DRL has collaborated with the National research facility for Epidemiology and Microbiology of the Ministry of Health of the Russia for obtaining regulatory approval for import for marketing in India.