DCGI grants emergency use permission to Sputnik Light Covid-19 vaccine
Sputnik Light is the ninth vaccine to be approved in the country
Sputnik Light is the ninth vaccine to be approved in the country
Sputnik Light is the ninth vaccine to be approved in the country
Sputnik Light is the ninth vaccine to be approved in the country
The Drugs Controller General of India (DGCI) on Sunday granted emergency use permission to single-dose Sputnik Light Covid-19 vaccine in India. The approval will further strengthen the nation’s collective fight against the pandemic, Union Health Minister Mansukh Mandaviya said.
Sputnik Light is the ninth Covid-19 vaccine to be approved in the country.
The DGCI approval came two days after an expert panel of the Central Drugs Standard Control Organisation (CDSCO) recommended granting restricted emergency use authorisation (EUA) to Sputnik Light subject to various regulatory provisions.
The panel, which deliberated on the application by Dr Reddy's Laboratories, had noted that the safety and immunogenicity data presented by the firm from the Indian study was comparable with that of the ongoing phase-3 clinical trial interim data from Russia.
Sputnik Light is equivalent to the component-1 of Sputnik V. Dr Reddy's Laboratories had claimed that the vaccine is approved in 29 countries, including Argentina and Russia.
After detailed deliberations, the CDSCO panel had recommended for grant of permission for a restricted use in an emergency situation and had sent its recommendations to the Drugs Controller General of India (DCGI) for the final approval.
According to some of the conditions for granting EUA, the vaccine is indicated for active immunisation to prevent Covid-19 in individuals aged above 18 years and the firm should submit the safety, efficacy and immunogenicity data from the ongoing clinical trials in India and Russia for a review as and when available.
The firm should submit the safety data, including the data on AEFI and AESI, with due analysis every 15 days for the first two months and monthly thereafter till the completion of the ongoing clinical trial in the country. Thereafter, the firm should submit the safety data in accordance with the provisions and standard procedures.
On July 1 last year, India's drug regulator had refused to grant EUA to Sputnik Light.
With PTI inputs