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

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

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

DCGI sets four conditions for SII

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

The SII on May 18 had also applied to the 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, the official sources said. The RCGM has raised some queries over SII's application and has sought a copy of the material transfer agreement between the Pune-based firm and the 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 The Lancet, Sputnik V has shown a 91.6 per cent efficacy against COVID-19 in its phase 3 trials. A trial run of administering Sputnik V has already begun in Hyderabad. The DCGI had granted permission for restricted emergency use of Sputnik V with certain conditions - making it the third vaccine to receive a nod in India. 

Sputnik V’s 3 Mn Doses Arrive In Hyderabad

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

Moreover, Panacea Biotec has collaborated with the Russian Direct Investment Fund (RDIF) for the production of 100 million doses of Sputnik V vaccine. Headquartered in Delhi, Panacea Biotec along with RDIF announced the launch of the production of Sputnik V on Monday. On Friday, the 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 the Centre to bring Sputnik Light to the country and an application seeking regulatory approval is likely to be filed soon. Developed by the Gamaleya Research Institute of Epidemiology and Microbiology and financed by the Russian Direct Investment Fund, Sputnik Light has demonstrated the efficacy of 79.4% as compared to 91.4% for the two-shot Sputnik V.

(With PTI Inputs)