DCGI allows Serum Institute to manufacture Sputnik V vaccine in India

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Pune-based SII has collaborated with the Gamaleya Research Institute of Epidemiology and Microbiology, Moscow, in Russia to develop sputnik v in a licensed facility.

A health worker prepares a dose of the Sputnik V vaccine against Covid-19
A health worker prepares a dose of the Sputnik V vaccine against Covid-19

Medication Controller of India (DCGI), Dr. VG Somani, on Friday gave the Indian Serum Institute (SII) to produce Sputnik V vaccines made by Russia against Coronavirus (Covid-19), days after Pune-based vaccine manufacturers have been applied to the same thing. “DCGI has gave permission to the Serum Institute to produce Covid-19 Sputnik Vaccines in India for examination, tests, and analysis in their licensed facility with certain conditions,” said the PTI news agency, citing official resources.

India provided authorization of emergency use to Sputnik V on April 13. The testing license, according to the Standards Central Website Standards Control Organization (CDSCO), is given to import small amounts of drugs for inspection, testing, or analysis. This license, unless deferred or revoked, will be enforced for a period of three years from the date of issuance on June 4.

Pune-based SII has collaborated with the Gamaleya Research Institute of Epidemiology and Microbiology, Moscow, in Russia to develop sputnik v in a licensed facility. SII has told the government that it would be able to produce and supply 10 doses of Crore Covishield in June, while it also produces Novavax vaccines, regulatory permits that are awaited from the United States.

Previously on Thursday, the Serum Indian Institute had been looking for a dcgi nod that was very coveted to produce Russian vaccines. According to the four conditions set by the drug regulator, the Serum Institute was asked to submit a copy of the agreement between it and the Gamaleya Research Institute of Epidemiology and Microbiology for bank cell transfers and stock of viruses and copies of the agreement for transfer technology with Gamaleya.

SII-based Pune was also asked to submit a copy of the RCGM permit to import cell banks and viruses and a copy of the RCGM permit to begin the Research and Development of Vector Viral Vector Sputnik V, the official source of PTI said.

Sputnik V is currently distributed in India by the Dr. Reddy Laboratory, which signed a Pact with Russian Direct Investment Fund (RDIF) which globally marketed the Covid-19 vaccine developed by Russia’s Gamaleya Institute. As part of an agreement, Dr. Reddy will distribute 250 million first doses of Sputnik V.

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