New Delhi: The Drugs Controller General of India (DCGI) refused to give emergency-use authorisation to the Russian Covid-19 vaccine Sputnik-Light.
The Subject Expert Committee noted that Dr Reddy's Laboratories has already generated data of component-1 in India. It also pointed out that the Phase-3 trial is underway in Russia, and efficacy data is yet to be generated, reported The News Minute.
The SEC recommended that Dr Reddy's Laboratories should present the safety, immunogenicity, and efficacy data of the Phase 3 trial that is taking place in Russia to receive marketing authorisation.
The Subject Expert Committee said that Sputnik-Light is the same as the component-1 of Sputnik V. The meeting on June 30, the safety and immunogenicity data in the Indian population has already been generated in a trial here. The DCGI has ruled out the requirement of another trial (Phase-3 trial) due to a lack of data and reasons.
Dr Reddy's Laboratories has sought a market authorisation for Sputnik-Light along with the interim safety and efficacy data generated from the Phase 1/2 clinical trials in Russia. The SEC website showed that the manufacturing company presented the protocol for conducting the Phase-3 clinical trial of the vaccine in India, said The News Minute Report.
A spokesperson of Dr Reddy's Laboratories said that the SEC has observed that there is no need for another clinical trial of Sputnik-Light in India because the company has already generated the safety and immunogenicity data on the first-dose component. The first-dose component of Sputnik V is Sputnik-Light.