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.
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