Panacea Bio gets DCGI nod to make Sputnik V
The Drugs Controller General of India has granted Panacea Biotec the licence to manufacture the Russian-made Covid vaccine Sputnik V in India, the company announced on Sunday, making it the first firm that will manufacturing the vaccine locally.
Panacea Biotec is one of six companies to have entered into partnerships with the Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund that is marketing the vaccine globally.
“Panacea Biotec… (is in) receipt of manufacturing licence from Drugs Controller General (India) for Sputnik V vaccine against Covid-19 pursuant to its collaboration with Russian Direct Investment Fund. The licence is a necessary condition for using Sputnik V produced by Panacea Biotec in India,” the pharma company said in a statement.
The two-dose vaccine has 91.6% efficacy in preventing serious illness.
The initial test batches produced at Panacea Biotec’s facilities at Baddi in 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 statement read.
Even though the company did not respond to further queries on when the vaccine will be available, people familiar with the matter, on condition of anonymity, said that under its terms with RDIF, Panacea is likely to produce 100 million doses per year. Dr Reddy’s Laboratories that has tied up with RDIF to market the first 250 million doses of the Russian vaccine, is also likely to market the doses produced by Panacea. Sputnik V was registered in India under the emergency use authorisation procedure on April 12 and vaccination against Covid-19 with the Russian vaccine started on May 14.
As part of the soft launch, the vaccine has been administered in several Indian cities so far, including Visakhapatnam, Bengaluru, Mumbai, Kolkata, Delhi, Baddi, Chennai, Miryalaguda, and Kolhapur. Sputnik V has been registered in 67 countries globally with total population of over 3.5 billion people.