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.
“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,” an official source told news agency PTI.
The Pune-based SII worked with Russia’s Gamaleya Research Institute of Epidemiology and Microbiology to build Sputnik V at its licenced Hadapsar facility, according to the article.
On Thursday, the business filed an application with the DCGI in this respect.
According to the DCGI’s four criteria, the SII must present a copy of its agreement with the Gamaleya Research Institute of Epidemiology and Microbiology for the transfer of cell bank and viral stock, as well as a copy of its agreement with Gamaleya for technology transfer.
According to the sources, the SII must also provide 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 for permission to import strains/seed lots and cell banks.and for carrying out research and development.
The RCGM has questions about SII’s application and has requested a copy of the material transfer agreement between the Pune-based company and the Gamaleya Research Institute of Epidemiology and Microbiology.
Dr Reddy’s Laboratories in India is now producing Russia’s Sputnik V vaccine.
According to initial reports, the Russian vaccine would be given in two doses separated by 21 days. The two doses of Sputnik V have a 91 percent efficacy rate, whereas the single dose has a 79.4 percent efficacy rate, according to Gamaleya.
According to Gamaleya, the vaccination has been licenced in over 65 nations thus far.
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.
In India, the Serum Institute intends to apply for a limited emergency use licence for the vaccine.
