The Indian pharmaceutical regulator has refused to conduct a large study to evaluate Russia’s CoV vaccine – Sputnik V in their home country.
Before that, the Indian pharmaceutical company named Dr. Reddy’s Laboratories proposed to the Drug Administration to research and evaluate the “candidate” of the Russian Covid-19 vaccine, but it was rejected. The Indian Drug Administration suggests that some additional clinical trials should be performed.
A panel of experts under the Central Pharmaceutical Standards Control Organization (CDSCO) has made recommendations, noting that Sputnik V’s safety and immunogenicity data are from phase studies. The head being made abroad is very small. Not even any of the volunteers in India ever participated in the experiment.
The move by India serves as a “step backwards” to Russia’s plan to deploy vaccine Covid-19. Even earlier Sputnik V tests have shown how well it works. At the same time, this rejection also pushed back efforts to gain approval to use Sputnik V in the world’s leading country for the average number of new infections. According to recorded data, India is likely to overtake the US in the next few weeks, becoming the country with the highest number of Covid-19 infections in the world.
Last month, the Russian Direct Investment Fund (RDIF) completed a contract with Indian pharmaceutical firms to produce multiple doses of Sputnik V vaccine in the country. RDIF and Dr. Reddy’s Laboratories have announced their partnership with the aim of soon conducting clinical trials and distributing vaccines in the country. The two sides also reached an agreement that Russia will supply 100 million doses of its vaccine to the Indian market.
However, with the Drug Administration rejected the proposal of Dr. Reddy’s Laboratories, this deal may be delayed. Both the pharmaceutical company and the RDIF side have not yet released any statements about the incident.
Currently, Russia is the first country to provide regulatory licensing for a new Covid-19 (Sputnik V). This decision, made before the completion of large-scale clinical trials, raised a lot of concerns for scientists and medical experts about the safety and effectiveness of this “candidate”.