July 24, 2021

DCGI permits SII to manufacture Russia’s Sputnik V Covid-19 vaccine in India

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The Drugs Controller General of India (DCGI) on Friday approved the Pune-based Serum Institute of India (SII) to begin manufacturing of Russian Covid-19 vaccine, Sputnik V, days after the application filed by SII.

According to news agency PTI citing official source, “The DCGI has granted permission to the Serum Institute to manufacture the Sputnik Covid-19 vaccine in India for examination, test, and analysis at its licensed Hadapsar facility with certain conditions.”

On April 13, India gave emergency utilization approval to Sputnik V.

SII has collaborated with Gamaleya Research Institute of Epidemiology and Microbiology, Moscow, in Russia for the production of Sputnik V at its licensed Hadapsar facility. SII had earlier made a statement about manufacturing and supply 10 crore doses of Covishield in June and is simultaneously manufacturing Novovax.

The DCGI had presented four conditions, where SII had to submit a copy of agreement with Gamaleya Research Institute of Epidemiology and Microbiology for Transfer of cell bank, an agreement copy of Technology Transfer. SII was also urged to submit a copy of RCGM permission over importing cell bank and virus stock and a permit letter to commence Research and Development of Sputnik V.

Presently, Sputnik V is being supplied in the country by Dr Reddy’s Laboratories, who had formalized a pact with the Russian Direct Investment Fund (RDIF), for the first 250 million doses.

(With agency inputs)

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