Written By: Satata Karmakar | Updated : February 7, 2022 11:03 AM IST
One-Shot Sputnik Light COVID-19 Vaccine Gets DGCI Nod For Emergency Use Approval In India
At a time when India is battling the third wave of coronavirus, primarily triggered by the highly transmissible Omircon variant of COVID-19, the Drugs Controller General of India (DGCI) has granted emergency use permission to single-dose Sputnik Light COVID-19 vaccine in the country.
Taking to Twitter, Union Health Minister Mansukh Mandaviya wrote: "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."
DCGI has granted emergency use permission to Single-dose Sputnik Light COVID-19 vaccine in India.
This is the 9th #COVID19 vaccine in the country. This will further strengthen the nation's collective fight against the pandemic. Dr Mansukh Mandaviya (@mansukhmandviya) February 6, 2022
This comes following recommendations of an expert panel of India's central drug authority to grant restricted emergency use authorisation to Sputnik Light subject to various regulatory provisions.
Sputnik-Light is the same as component-1 of Sputnik V. Hyderabad-based Dr Reddy's Laboratories is the Indian partner of the Russian Direct Investment Fund (RDIF), which had sought approval from the drug regulator for use of single-dose Russia's Sputnik Light one shot.
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.
Speaking to the media, a source said, "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 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)
