Panacea Biotec on Monday said it had received the manufacturing license from Drugs Controller General India to produce the Sputnik V vaccine in the country.
The license is a necessary condition for using Sputnik V produced by Panacea Biotec in India.
“Panacea Biotec is delighted to announce the obtaining of the manufacturing license to produce Sputnik V vaccine in India. We thank the leadership of Prime Minister Modi and the Government of India for timely handholding and expediting clearances to enable ‘Make in India’ vaccines,” Rajesh Jain, Managing Director, Panacea Biotec said.
The batches produced at Panacea Biotec’s facilities at Baddi, Himachal Pradesh were earlier shipped to the Gamaleya Center in Russia for quality control.
The batches have successfully passed all the checks for quality parameters both at the Gamaleya Center and at the Central Drug Laboratory, Kasauli.
Sputnik V was registered in India under the emergency use authorization procedure on April 12, this year and vaccination against Covid-19 with the Russian vaccine started on May 14, 2021.
The vaccine is based on a proven and well-studied platform of human adenoviral vectors and uses two different vectors for the two shots in a course of vaccination, providing immunity with a longer duration than vaccines using the same delivery mechanism for both shots.
The Sputnik V vaccine is based on a proven and well-studied platform of human adenoviral vectors, which cause the common cold and have been around for thousands of years.
It uses two different vectors for the two shots in a course of vaccination, providing immunity with a longer duration than vaccines using the same delivery mechanism for both shots.
The storage temperature of Sputnik V at +2+8 deg C means it can be stored in a conventional refrigerator without any need to invest in additional cold-chain infrastructure.