New Delhi: Serum Institute of India (SII) has obtained approval to manufacture COVID-19 vaccine Sputnik V from Drug Controller General of India (DCGI).
The regulatory physique granted SII permission to manufacture take a look at and evaluation with sure circumstances, PTI mentioned quoting official sources on Friday (June 4).
The improvement comes a day after the Pune-based agency submitted an software looking for DCGI’s nod.
SII has collaborated with Gamaleya Research Institute of Epidemiology and Microbiology, Moscow in Russia for growing Sputnik V at its licensed Hadapsar facility.
“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 supply was quoted as saying.
According to the 4 circumstances set by the DCGI, SII could have to submit a replica of the settlement between it and the Gamaleya Research Institute of Epidemiology and Microbiology for switch of cell financial institution and virus inventory and submit the copy of settlement for expertise switch with Gamaleya.
Further, the SII has to submit a replica of the RCGM permission to import cell financial institution and virus inventory and a replica of the RCGM permission to provoke analysis and improvement of viral vector vaccine Sputnik V, the report mentioned.
Russia’s Sputnik V vaccine is at present being manufactured by Dr Reddy’s Laboratories in India.
Meanwhile, SII CEO Adar Poonawalla has hailed the efforts of India’s Ministry of External Affairs S Jaishankar and the US for lifting restrictions on the manufacturing of COVID-19 vaccine saying that the transfer will increase the nation’s vaccine manufacturing.
Taking to Twitter, Poonawalla thanked US President Joe Biden and MEA saying, “…this coverage change will hopefully enhance the availability of uncooked supplies globally and to India; boosting our vaccine manufacturing capability and strengthening our united combat in opposition to this pandemic.”
