New Delhi: Serum Institute of India (SII) has got the go-ahead from Drugs Controller General of India (DCGI) to manufacture Russian-developed Sputnik vaccine in India.
“The DCGI has granted permission to Serum Institute to manufacture the Sputnik vaccine in India for examination, test and analysis at its licensed Hadapsar facility with certain conditions,” PTI reported quoting a company source.
It took DCGI just one day to give permission after SII submitted an application on Thursday.
It was learnt that among the conditions set by DCGI, SII will have to submit a copy of agreement between the Pune-based company and Russia’s Gamaleya Research Institute of Epidemiology and Microbiology for transfer of cell bank and virus stock as well as a copy of agreement for technology transfer with Gamaleya.
SII will also have to submit a copy of Review Committee on Genetic Manipulation (RCGM) permission to import cell bank and virus stock and a copy of RCGM permission to initiate research and development of viral vector vaccine Sputnik V, sources said.
The licence will be valid for three years from date of issuance (June 4), unless it’s suspended or revoked for some reason.
