India’s drug regulatory authority Central Drugs Standard Control Organisation (CDSCO) has rejected a proposal from Dr Reddy’s Laboratories Ltd to conduct the next-level study in the country for evaluating Russia’s Sputnik-V COVID-19 vaccine and recommended to test it first in a smaller trial manner.
The expert panel of CDSCO has observed that enough data was not available on the safety and immunogenicity of the vaccine from the initial-stage trials abroad. The panel also notified that no inputs were available about Indian participants.
India’s move comes as a major setback for Russia’s plan to roll-out the vaccine before full trials and analyzing its effects. In the past few days, India has observed a flattening curve of cases with the country recording continuous dip in the number of active cases and deaths. Till now, the number of cases in India have reached around 68 lakh, of which over 58 lakh have recovered from the disease.
The Russian Direct Investment Fund (RDIF) is marketing the Sputnik V and Dr. Reddy’s Laboratories had announced their partnership last month to run clinical trials and avail the vaccine in India.
Worldwide, Russia became the first country to grant regulatory approval for COVID-19 vaccine, and did so before large-scale trials were complete. On October 4, the Union Health Minister Harsh Vardhan had also said that no definitive decision had been made on the Russian vaccine. Narendra Modi government will take a decision which is in the best interest of the people of India. The Centre has repeatedly said that India may get its coronavirus vaccine by early 2021.
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