DCGI tells Dr Reddy’s to submit Russian efficacy data on Sputnik Light vaccine, says no need to conduct separate trial

Earlier the DCGI refused to grant emergency-use authorisation to single-dose Covid vaccine Sputnik Light.

The Drugs Controller General of India (DCGI) told Dr Reddy’s to submit efficacy data from the Phase III clinical trial of Sputnik V in Russia to the Subject Expert Committee (SEC) for marketing authorisation, the Hyderabad-based pharmaceutical company said in a statement.

A view shows vials with the one-dose Sputnik Light vaccine against the coronavirus disease (COVID-19) in a vaccination centre at a city market in Moscow, Russia. (REUTERS)

“Dr Reddy’s should submit safety, immunogenicity and efficacy data from the phase III clinical trial of Sputnik V in Russia to the SEC for its consideration of Marketing Authorisation of Sputnik Light in India,” the statement said.

Earlier the DCGI refused to grant emergency-use authorisation to single-dose Covid vaccine Sputnik Light. The Subject Expert Committee (SEC) after holding a meeting on July 30 observed that Sputnik-Light is the same as the component-1 of Sputnik V. It said that the safety, efficacy and immunogenicity data in the Indian population is already generated in a trial here.

Dr Reddy's Laboratories submitted a proposal to the drugs regulator seeking market authorisation of Sputnik-Light, along with the interim safety and efficacy data generated from the phase 1 and phase 2 clinical trials in Russia, according to the recommendations made by the SEC which were uploaded on the Central Drugs Standard Control Organisation (CDSCO) website on Thursday. The pharma company also presented the protocol for conducting the phase-3 clinical trial of the vaccine in India before the committee.

The SEC pointed out that Sputnik-Light is the same as the component-1 of Sputnik V and said the firm has already generated the safety and immunogenicity data of component 1 in India. It said that the Phase III trials which are ongoing in Russia and efficacy data is yet to be generated.

“The SEC also observed that in view of the safety and immunogenicity data already generated by Dr. Reddy’s in India on the first dose component of Sputnik V (in other words, Sputnik Light), there was no need for a separate Phase III trial of Sputnik Light in India,” the statement further said.