The Drug regulator of India has declined the 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.
This move by India 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 the 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 corona virus cases.
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 a novel corona virus vaccine; and did so before large-scale trials were complete; stirring concerns among scientists and doctors about the safety; and efficacy of the shot. RDIF and Dr. Reddy did not immediately reply to Reuters’ request; for comment outside business hours.
