New Delhi | Jagran News Desk: India's drug regulatory authority Central Drugs Standard Control Organisation (CDSCO) has rejected a proposal from Dr Reddy's Laboratories Ltd to conduct a large study in the country to evaluate Russia’s Sputnik-V COVID-19 vaccine and has asked it to first test the vaccine in a smaller trial. 

The recommendations by an expert panel of the CDSCO noted that safety and immunogenicity data from early-stage studies being conducted overseas is small, with no inputs available on Indian participants.

India’s move comes as a setback for Russia’s plan to roll-out the vaccine even before full trials show how well it works, while pushing back its efforts to win approval for the vaccine in the country that leads the world on average number of new infections.

The past few days have seen a flattening curve of cases in India with the country recording continious dip in number of active cases and deaths. The number of infections in India have crossed 68 lakh, of which over 58 lakh have recuperated from the disease. 

India's COVID-19 tally had crossed the 20-lakh mark on August 7, 30 lakh on August 23 and 40 lakh on September 5. It went past 50 lakh on September 16 and crossed 60 lakh on September 28.

The Russian Direct Investment Fund (RDIF), which is marketing the Sputnik V, and Dr. Reddy's Laboratories last month announced their partnership to run clinical trials and distribute the vaccine in India.

Russia was the first country to grant regulatory approval for a novel coronavirus vaccine, and did so before large-scale trials were complete, stirring concerns among scientists and doctors about the safety and efficacy of the shot.

(With inputs from agencies)

Posted By: Abhinav Gupta