Shock: No approval for Phase III trial of Sputnik Light, DCGI rejects Dr Reddy’s Lab’s application

In the war against the corona virus in the country, the hopes of the immediate arrival of Russia’s single-dose vaccine Sputnik Light have suffered a major setback. Russia’s Sputnik Light vaccine did not get approval for Phase III trials. Sources gave this information on Thursday.

According to sources, the Indian drug regulatory body has refused permission to Dr. Reddy’s Lab to conduct Phase III trials of Sputnik Lite in India. Let us inform that at present vaccination is being done in India with the Sputnik-V vaccine.

It was believed that if the trial of Sputnik Light was approved and then it was also allowed for emergency use, it would become the first single-dose vaccine to be found in India. However, on what grounds its trial has not been approved, its information is not yet available.

Sputnik Light has been approved in Russia
Russia has already approved this vaccine regarding Sputnik Light and its trial is going on in many other countries. Sources with knowledge of the matter said that with the introduction of a single dose of Sputnik Lite, the issue of importance of the recombinant adenovirus type-5 (RAD-5) component, used in the second dose of the existing two-dose Sputnik-V vaccine, also remains unanswered. becomes necessary.

Sources said, “The Subject Expert Committee (CEC) prepared on Kovid-19 of the Central Drugs Standard Control Organization (CDSCO) deliberated on the application. After that, the approval for the third phase was refused.