Indian regulator grants emergency use permission to Sputnik Light Covid vaccine

The Drugs Controller General of India (DCGI) on Sunday granted emergency use permission to Sputnik Light Covid vaccine. Announcement about the single-dose vaccine was made by Mansukh Mandaviya, India's Health Minister.

"DCGI has granted emergency use permission to single-dose Sputnik Light COVID-19 vaccine in India. This is the ninth COVID-19 vaccine in the country. This will further strengthen the nation's collective fight against the pandemic," Mandaviya tweeted.

The go-ahead came after recommendations of an expert panel  of India's central drug authority 

Sputnik-Light is the same as component-1 of Sputnik V.

An official source said in light of recommendations of Subject Expert Committee (SEC) following a meeting on January 31, Dr Reddy's Laboratories presented its proposal for grant of permission to import Sputnik Light for restricted emergency use and booster dose vaccination along with analysis of safety and efficacy data including its benefit against Omicron.

The firm presented that Sputnik Light vaccine is approved in 29 countries, including Russia and Argentina.

"The SEC on COVID-19 of the CDSCO, which deliberated on the application by Dr Reddy's Laboratories, noted the safety and immunogenicity data presented by the firm from the Indian study is comparable with that of the ongoing Phase-3 clinical trial interim data from Russia," the source said.

The interim data of efficacy trial from Russia has shown 65.4 per cent efficacy, 21 days after immunization.

"After detailed deliberation, the SEC had recommended grant of permission for restricted use in emergency situation subject to various regulatory provisions including," the source said. 

(With inputs from agencies)