DCGI permits restricted emergency use of Russia’s Sputnik Light vaccine

Sputnik Light Vaccine becomes the ninth vaccine against COVID-19 in India with DCGI approval

The Drugs Controller General of India (DCGI) has approved emergency use of single-dose Sputnik Light Covid-19 vaccine in the county, as per an announcement made by the Union Health Minister Mansukh Mandaviya.

The approval comes after an expert panel of the country’s central drug authority recommended the approval of restricted EUA (emergency use authorization) to Sputnik Light vaccine in compliance with several regulatory provisions.

Mr. Mandaviya’s recent tweet reads – DCGI has granted permission on emergency single-dose use of the Russian vaccine in India, making it the ninth Covid-19 vaccine in the country, which will support India’s battle against the pandemic.

According to an official source, the recommendations of the Subject Expert Committee (SEC) boosted multiple initiatives like the proposal for permit by Dr Reddy’s Laboratories seeking approval for importing Sputnik Light for restricted emergency situations.

The permit also pursued booster dose vaccinations in addition to safety analysis and efficacy data showcasing benefits of booster shots against Omicron.

As of now, Sputnik Light Covid-19 vaccine has been granted permission by altogether 29 countries including Argentina, and Russia.

The Central Drugs Standard Control Organization (CDSCO) houses a Covid-19-specific SEC, which contemplated the proposal presented by Dr Reddy’s Laboratories regarding import and use of the Russian antidote.

The CDSCO SEC on Covid-19 observed homogeneity in the safety & immunogenicity data supported by the firm in an Indian study with Russia’s ongoing Phase-3 clinical trial’s interim data.

Imperative to note that the interim data presented by Russia showcasing efficacy of trial has reflected 65.4% efficacy after 21 days of immunization.

With a detailed deliberation, the Covid-19 specific SEC moved forward with the recommendation to grant permission of restricted use of the novel vaccine candidate, notably in emergency situations with regulatory provisions in mind.

Source Credit: https://www.thehindu.com/news/national/dcgi-grants-emergency-use-permission-to-single-dose-sputnik-light-covid-vaccine/article38389136.ece