Russia, who claimed to have made the first coronavirus vaccine in the world and named it Sputnik V, has been receiving much skepticism around the world. Even India, the vaccine is facing setbacks.
In India, an expert panel at the Central Drugs Standard Control Organisation (CDSCO) has asked Dr Reddy’s Laboratories to submit a revised protocol for conducting both phase 2 and phase 3 human clinical trials for the Russian vaccine against Covid-19, Sputnik V.
The Hyderabad-based pharmaceutical company had applied to the Drugs Controller General of India (DCGI) late last week, seeking permission to conduct phase-3 human clinical trials of the Russian vaccine.
According to reports, India’s drug regulator has refused 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 reason for the setback happened after the recommendations by the expert panel of the CDSCO. They 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.
