New Delhi: The Drug Controller General of India (DCGI), Dr VG Somani, on Friday granted the Serum Institute of India (SII) to manufacture the Russian-made Sputnik V vaccine against the coronavirus disease (Covid-19), days after the Pune-based vaccine manufacturer had applied for the same. "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," news agency PTI reported, citing official sources.
India granted emergency use authorisation to Sputnik V on April 13. A test license, according to the Central Drugs Standards Control Organisation (CDSCO) website, is granted for the import of small quantities of drugs for purposes of examination, testing, or analysis. This license, unless suspended or revoked, will be enforced for a period of three years from the date of its issuance on June 4.
The Pune-based SII has collaborated with Gamaleya Research Institute of Epidemiology and Microbiology, Moscow, in Russia for developing Sputnik V at its licensed Hadapsar facility. The SII has already told the government that it will be able to manufacture and supply 10 crore Covishield doses in June, while it is also manufacturing the Novavax vaccine, the regulatory clearance for which is awaited from the United States.
Earlier on Thursday, the Serum Institute of India had sought out the much-coveted DCGI nod to manufacture the Russian vaccine. 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 transfer of cell bank and virus stock and a copy of the agreement for technology transfer with Gamaleya.
The Pune-based SII was also asked to submit a copy of the RCGM permission to import cell bank and virus stock and a copy of the RCGM permission to initiate research and development of viral vector vaccine Sputnik V, an official source told PTI.
Sputnik V is currently being distributed in India by Dr Reddy’s Laboratories, which signed a pact with the Russian Direct Investment Fund (RDIF) that globally markets the Covid-19 vaccine developed by Russia’s Gamaleya Institute. As part of the deal, Dr Reddy’s will distribute the first 250 million doses of Sputnik V.
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