The drug controller has allowed SII to manufacture Sputnik-V jabs jab for examination, test and analysis.
New Delhi: Drugs Controller General of India (DCGI) on Friday approved the approval of the Serum Institute of India (SII) to develop the Russian vaccine Covid-19 – Sputnik V in India.
The drug controller has allowed SII to manufacture Sputnik-V jabs jab for examination, test and analysis.
“DCGI has given the Serum Institute permission to manufacture the Sputnik COVID-19 vaccine in India for examination, test and analysis at its Hadapsar licensed facility with certain conditions,” an official source told PTI.
ALSO READ: UK Authorizes Pfizer-BioNTech Covid-19 Vaccine For Children Between 12 and 15-Year-Olds
According to reports, the Pune-based company has partnered with the Gamaleya Research Institute of Epidemiology and Microbiology, Moscow in Russia to develop Sputnik V at its licensed Hadapsar facility.
The DCGI approval came a day after the Serum Institute filed a similar application on Thursday.
However, prior to the introduction of vaccines, DCGI has set four conditions for Serum in this regard. The pharma giant will need to submit a copy of the agreement between it and the Gamaleya Research Institute of Epidemiology and Microbiology for cell bank transfer and virus stock as well as a copy of the technology transfer agreement with Galeleya.
In addition, SII will also be required to submit a copy of the RCGM permit for importing bank stock and viral stock and a copy of the RCGM approval to initiate research and the development of a vector vaccine Sputnik V.
