Panacea Biotec has announced it has received manufacturing licence from Drugs Controller General India for Covid-19 vaccine - Sputnik V.
The company, a vaccine and pharmaceutical producer, has a collaboration with Russian Direct Investment Fund and the licence 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. These 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.
Sputnik V was registered in India under the emergency use authorisation procedure on April 12 and for vaccination against Covid-19 that started on May 14. Sputnik V has been registered in 67 countries.
The vaccine is based on human adenoviral vectors and uses two different vectors for the two shots in a course of vaccination, providing immunity with a longer duration.
Dr Rajesh Jain, Managing Director, Panacea Biotec, in a regulatory filing with BSE said, “Panacea Biotec has obtained the manufacturing licence to produce Sputnik V vaccine in India. We thank Prime Minister Narendra Modi and the government of India for timely handholding and expediting clearances to enable ‘Make in India’ vaccines.”
The safety, efficacy and lack of negative long-term effects of adenoviral vaccines have been proven by more than 250 clinical studies over two decades.
SputnikV can be stored at +2° to +8°C, means it can be stored in a conventional refrigerator and does not need additional cold-chain infrastructure. The vaccine is priced at about $10 per shot.