NEW DELHI: The DCGI has given consent to the Serum Institute of India (SII) to make the Sputnik Covid-19 vaccine in India for evaluation, evaluation and analysis using specific states, official sources said on Friday.
The Pune-based company has collaborated with all Gamaleya Research Institute of Epidemiology and Microbiology, Moscow in Russia for growing Sputnik V in its accredited Hadapsar centre.
“The DCGI has given consent to the Serum Institute to fabricate the Sputnik Covid-19 vaccine in India for evaluation, evaluation and investigation in its accredited Hadapsar centre with particular states,” an official source said.
The organization had filed an application to the DCGI inside this respect on Thursday.
In accordance with the four requirements determined by the DCGI, the Serum Institute might need to submit a copy of the arrangement between the Gamaleya Research Institute of Epidemiology and Microbiology for transport of mobile virus and bank inventory and submit the duplicate of arrangement for tech transfer together with Gamaleya.
Further, the SII must submit a duplicate of this RCGM consent to import mobile virus and bank inventory and a replica of the RCGM consent to initiate study and development of viral vector vaccine Sputnik Vthe sources stated.
The SII on May 18 had applied to the Review Committee on Genetic Manipulation (RCGM), Department of Biotechnology trying to clearance for export of strains/seed cell banks, and also for executing research and development, ” the official sources said.
The RCGM has increased some questions over SII’s application, and it has sought a duplicate of material transport agreement between the Pune-based company along with also the Gamaleya Research Institute of Epidemiology and Microbiology.
Russia’s Sputnik V vaccine is now being fabricated by Dr Reddy’s Laboratories at India.
The SII intends to find limited emergency use consent of this vaccine in India.