Dr. Reddy's application rejected to perform Sputnik Light Trials in India


Posted on 01 July 2021


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India's top regulatory body has rejected Dr. Reddy's Laboratories permission to perform Phase-3 trials for the Russian-made Sputnik Light Covid-19 vaccine in India, according to news agency ANI on Thursday, citing sources familiar with the matter. According to reports, the Central Drugs Standard Control Organisation (CDSCO) expert council declined to authorise the Hyderabad-based pharmaceutical company to conduct the third phase trials for the one-shot Sputnik Light vaccine because it could not discover "scientific rationale" for it. Sputnik Light is a Covid-19 single-dose vaccination. According to news agency PTI, it is a slimmed-down, one-shot version of Sputnik V that the government had been considering for a quick introduction in India. Dr. Reddy's Laboratories filed an application for regulatory approval in June, and the drug regulatory agency was expected to accept it. It would have been the country's first and only single-dose vaccine if it had been approved. According to a study of data acquired 28 days after the injection was administered as part of Russia's mass vaccination programme between December 2020 and April 2021, Sputnik Light showed 79.4 percent efficiency, according to the vaccine's researchers. The Gamaleya Center also revealed that Sputnik Light was effective against all new coronavirus strains in laboratory experiments, according to the announcement.



Key Points


  • India's top regulatory body has rejected Dr. Reddy's Laboratories permission to perform Phase-3 trials for the Russian-made Sputnik Light Covid-19 vaccine in India, according to news agency ANI on Thursday, citing sources familiar with the matter.

  • The Gamaleya Center also revealed that Sputnik Light was effective against all new coronavirus strains in laboratory experiments, according to the announcement.


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