The Serum Institute of India has been granted approval by the Drug Controller General of India to manufacture the Sputnik V coronavirus jab for examination, test, and analysis, just days after applying to the DCGI.
“We have got preliminary approval for Sputnik V. But actual manufacturing will take several months. In the meantime, our focus remains Covishield and Covovax,” Serum Institute of India’s (SII)
On Thursday, the company filed a request with the DCGI. According to the DCGI’s four requirements, the Serum Institute must present a copy of its cell bank and virus stock transfer agreement with the Gamaleya Research Institute of Epidemiology and Microbiology, as well as a copy of its technology transfer agreement with Gamaleya. According to the sources, the SII must also submit a copy of the RCGM authorization to import a cell bank and virus stock, as well as a copy of the RCGM authorization to begin research and development of a viral vector vaccine called Sputnik V.
Drug Controller General of India grants Serum Institute of India the permission to manufacture SPUTNIK V for examination test and analysis at its licensed facility at Hadapsar: Sources pic.twitter.com/S2lVY2cFl7— ANI (@ANI) June 4, 2021
According to the sources, the SII must also submit a copy of the RCGM authorization to import cell bank and virus stock, as well as a copy of the RCGM authorization to begin research and development of the viral vector vaccine Sputnik V.
Last month, the SII applied to the Department of Biotechnology’s Review Committee on Genetic Manipulation (RCGM) for permission to import strains/seed lots and cell banks, as well as to conduct research and development.
The Russian vaccine has been approved for use in more than 65 nations, but the EU and US health authorities have yet to authorize it.
Sputnik V has better efficacy than the two vaccines now being used in India: Oxford-Covishield, AstraZeneca’s made by the SII, and Bharat Biotech’s Covaxin, both of which have the efficacy of 91.6 percent.
Sputnik V, which was developed in May by DRL, was the second most costly vaccine at the time, costing $948 per dose, which rises to $995.40 after adding the 5% GST slab. Sputnik V, which was released in May by DRL, was the second most costly vaccine at the time, costing $948 per dose, which rises to $995.40 after adding the 5% GST slab.