(Reuters) – India’s drug regulator has knocked back a proposal from Dr Reddy’s Laboratories Ltd <REDY.NS> 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 its efforts to win approval for the vaccine in the country that leads the world on average number of new infections.
India is expected to overtake the United States over the next several weeks as the country with the world’s largest number of cases.
The Russian Direct