Dr. Reddy’s Laboratories has been denied permission by India’s top regulatory body to conduct the Phase-3 trials for the Russian-made Sputnik Light coronavirus disease (Covid-19) vaccine in India, reported press agency ANI on Thursday, citing people conversant in the event . consistent with reports, the expert committee of the Central Drugs Standard Control Organisation (CDSCO) refused to permit the Hyderabad-based drug company to conduct the third phase trials for the one-shot Sputnik Light vaccine because it didn’t find the “scientific rationale” behind an equivalent .
Dr. Reddy’s Laboratories had partnered with the Russian Direct Investment Fund (RDIF) last year in September to conduct the Phase-3 trials of the Russian-made Sputnik V Covid-19 vaccine in India, and distribute up to 100 million doses of it in India. The vaccine was approved for emergency use within the country in April this year.
Sputnik Light may be a single-dose Covid-19 vaccine. it’s a slimmed-down, one-shot version of Sputnik V that the govt was earlier watching for a speedy launch in India, press agency PTI reported in late May. An application seeking regulatory approval for it had been filed in June and Dr. Reddy’s Laboratories was expecting it to be approved by the drug regulatory body. If approved, it might are the primary and only single-dose vaccine within the country.
Sputnik Light demonstrated 79.4% efficacy, consistent with an analysis of knowledge gathered 28 days after the shot was administered as a part of Russia’s mass vaccination programme between December 2020 and April 2021, the vaccine’s developers said during a statement. Gamaleya Center also demonstrated during laboratory tests that Sputnik Light had proven effective against all new strains of the coronavirus, the statement said.
