Panacea Biotec gets DCGI license to manufacture Sputnik V
New Delhi: Panacea Biotec announced receipt of manufacturing license from Drugs Controller General (India) for Sputnik V vaccine against Covid-19 pursuant to its collaboration with Russian Direct Investment Fund (Russia's sovereign wealth fund).
The license is a necessary condition for using Sputnik V produced by Panacea Biotec in India.
"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 said batches have successfully passed all the checks for quality parameters both at the Gamaleya Center in Russia and at the Central Drug Laboratory, Kasauli, Himachal Pradesh in India," the company said.
Sputnik V was registered in India under the emergency use authorization procedure on April 12, 2021 and vaccination against Covid-19 with the Russian vaccine started on May 14, 2021.
Sputnik V has been registered in 67 countries globally with total population of over 3.5 billion people. 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.
Dr. Rajesh Jain, Managing Director, for Panacea Biotec, said: "Panacea Biotec is delighted to announce the obtaining of the manufacturing license to produce Sputnik V vaccine in India. At this occasion, we thank the leadership of our Hon'ble Prime Minister Modi ji and Government of India for timely handholding and expediting clearances to enable 'Make in India' vaccines."
Panacea Biotec is an innovation-led biopharmaceutical group that focuses on discovery, development, and commercialisation of prescription medicines primarily, focusing on Vaccines, Diabetes, Transplant, Gastroenterology, and Oncology.