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DCGI Gives Serum Institute Permission To Make Sputnik V Vaccine

DCGI Gives Serum Institute Permission To Make Sputnik V Vaccine

Vaccine production is going on in full swing in the country for the prevention of corona pandemic. Meanwhile, Serum Institute of India (SII), the country’s largest pharmaceutical company based in Pune, which is making Covishield vaccine in the country in collaboration with Astragenica, has got permission to make Russia’s Sputnik-V vaccine. News agency PTI quoted official sources as saying that the Drug Controller General of India (DCGI) has approved the Serum Institute of India (SII) to produce anti-Covid-19 vaccine Sputnik V in India for study, testing and analysis with certain conditions. has approved.

The Pune-based company has partnered with Russia’s Gemalia Research Institute of Epidemiology and Microbiology to produce Sputnik V at its licensed Hadapsar centre. “DCGI has given approval to Serum Institute for production of Sputnik V COVID-19 vaccine for study, testing and analysis at its licensed Hadapsar center in India subject to certain conditions,” an official source said.

The company had applied in this regard to DCGI . Serum Institute has to submit a copy of the agreement between it and the Moscow Institute as per the terms and conditions decided by DCGI. The RCGM has raised some questions regarding the application of SII and has sought a copy of the material transfer agreement between the Pune-based company and the Gamleya Research Institute of Epidemiology and Microbiology.

At present, Dr. Reddy’s Laboratories is producing Russia’s Sputnik-V vaccine in India. After getting these approvals, SII plans to seek permission for restricted emergency use of vaccines in India. SII has already informed the government that it will produce and supply 10 crore COVID-19 doses in June. It is also making the Novavax vaccine. Regulatory approval from the US for Novavax is yet to be received. DCGI had approved its emergency use in April. A consignment of 30 lakh doses of Sputnik V reached Hyderabad on Tuesday.

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