According to Dr Reddy’s, a government expert panel has said that Phase 3 trial data from Russia for the single-dose Sputnik Light vaccine can be submitted in India.

The company released a statement which said that the Subject Expert Committee (SEC) looked into its submission for Marketing Authorization of Sputnik Light in India. The company presented interim safety and efficacy results from Phase I/II clinical trial of the vaccine in Russia, and a clinical trial protocol for Phase III trial in India. Considering the fact that Sputnik Light is the first dose component of Sputnik V vaccine, and the company has already obtained safety and immunogenicity data on this first dose component in the country through clinical trial; and a phase III efficacy trial is ongoing in Russia on Sputnik Light, the SEC opined that the safety, immunogenicity and efficacy data can be submitted by the company from the phase III clinical trial of Sputnik V in Russia for consideration of Marketing Authorization of Sputnik Light in India, said the company.

The expert committee of the CDSCO denied permission to the company to conduct Phase III trials for the single dose vaccine as there was no "scientific rationale" for it… (NDTV, July 1, 2021)