Serum Institute gets nod to manufacture Russia's Sputnik V in Pune; DCGI sets 4 conditions

In yet anor boost to India's COVID-19 vaccination drive, Drug Controller General of India (DCGI) on Friday granted permission to Serum Institute of India (SII) to manufacture Russia's 'Sputnik V' vaccine in India. While Pune-based makers have received DCGI nod to manufacture Sputnik V, Indian regulatory body has set 4 conditions for same. 

PTI sources have reported that DCGI has given its nod to SII to manufacture Russian-me vaccine at SII's Hapsar facility in Pune for examination, test and analysis with certain conditions. Serum Institute has collaborated with Gamaleya Research Institute of Epidemiology and Microbiology, Moscow in Russia for developing Sputnik V in India. It h submitted an application to DCGI in this regard on Thursday. 

DCGI sets four conditions for SII

According to four conditions set by DCGI, Serum Institute will have to submit a copy of agreement between it and Gamaleya Research Institute of Epidemiology and Microbiology for transfer of cell bank and virus stock and submit copy of agreement for technology transfer with Gamaleya. Furr, SII has to submit a copy of 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, PTI sources said. SII continues to manufacture Oxford-AstraZeneca COVID-19 vaccine - COVISHIELD - in India, which was also one of first vaccines to get DCGI approval in India. 

SII on May 18 h also applied to Review Committee on Genetic Manipulation (RCGM), Department of Biotechnology seeking clearance for import of strains/seed lots and cell banks, and for carrying out research and development, official sources said. RCGM has raised some queries over SII's application and has sought a copy of material transfer agreement between Pune-based firm and Gamaleya Research Institute of Epidemiology and Microbiology.   

Meanwhile, Russia's Sputnik V vaccine is currently being manufactured by Dr Reddy's Laboratories in India. As per a peer-reviewed article published in Lancet, Sputnik V has shown a 91.6 per cent efficacy against COVID-19 in its phase 3 trials. A trial run of ministering Sputnik V has alrey begun in Hyderab. DCGI h granted permission for restricted emergency use of Sputnik V with certain conditions - making it third vaccine to receive a nod in India. 

Sputnik V’s 3 Mn Doses Arrive In Hyderab

biggest commercial consignment of Sputnik-V vaccines arrived in Hyderab on Tuesday early morning at 3:40 am with three million doses delivered to Dr. Reddy's Laboratories. vaccines are being sent to different parts of country as per demands raised by state governments. first batch of Sputnik V h landed in Hyderab on May 1 and it contained 1,50,000 doses of Russian COVID-19 vaccine whereas second batch came in on May 16. 

Moreover, Panacea Biotec has collaborated with Russian Direct Investment Fund (RDIF) for production of 100 million doses of Sputnik V vaccine. Hequartered in Delhi, Panacea Biotec along with RDIF announced launch of production of Sputnik V on Monday. On Friday, Delhi HC also directed Centre to release Rs 14 crore with interest to Panacea Biotec for manufacturing of Sputnik V.

Sputnik V Light in India?

As per ANI sources, Dr Reddy's is in talks with Centre to bring Sputnik Light to country and an application seeking regulatory approval is likely to be filed soon. Developed by Gamaleya Research Institute of Epidemiology and Microbiology and financed by Russian Direct Investment Fund, Sputnik Light has demonstrated efficacy of 79.4% as compared to 91.4% for two-shot Sputnik V.

(With PTI Inputs)