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India declines proposal to test Sputnik-V Covid-19 vaccine in large study

India's drug regulator has knocked back 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 Central Drugs Standard Control Organisation (CDSCO) noted that safety and immunogenicity data from early-stage studies being conducted overseas is small, with no inputs available on Indian participants.

News source ~ Business Standard