New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has turned down the proposal of Dr Reddy’s Laboratories Ltd to conduct a large study in India to evaluate Russia’s Sputnik-V COVID-19 vaccine and has asked it to first test the vaccine in a smaller trial.
An expert panel of the CDSCO stated that since safety and immunogenicity data from early-stage studies conducted overseas is small with no inputs on Indian participants, the vaccine’s large scale test cannot be allowed.
It will be a setback for Russia’s plan to market the vaccine even before full trials. 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 the vaccine even before large scale trials were complete, leading to concerns among scientists and doctors about the safety and efficacy of the shot.
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