The manufacturing of Russia’s Sputnik V Covid-19 vaccine will begin in India soon, officials said.
India has already accomplished technology-transfer to Indian companies.
Dr Vinod K. Paul, chairman of the National Expert Group on Vaccine Administration for Covid-19 (NEGVAC) on Thursday said the Central government has proactively eased entry of vaccines approved by the US FDA, EMA, UK’s MHRA and Japan’s PMDA, and WHO’s Emergency Use Listing into India in April.
He said these vaccines will not need to undergo prior bridging trials as the provision has now been further amended to waive off the trial requirement altogether for the well-established vaccines manufactured in other countries.
“No application of any foreign manufacturer for approval is pending with the drugs controller,” Paul, Member (Health) in NITI Aayog, further said.
Paul said that Sputnik vaccine trials got accelerated and with timely approval, Russia has already sent two tranches of vaccines and “accomplished tech-transfer to our companies that would start manufacturing very soon”.
The declaration comes after the developers of Russia’s Sputnik V Covid-19 vaccine and Panacea Biotech on Monday announced that full-scale production of the doses in India will start this summer.
The Russian Direct Investment Fund (RDIF), or Russia’s sovereign wealth fund, has tied up with Indian pharmaceutical firms such as Gland Pharma, Hetero Biopharma, Panacea Biotec, Stelis Biopharma and Virchow Biotech to make more than 850 million doses a year.
Sputnik V has been granted approval for emergency use by India’s drug controller.
The Russian vaccine was registered in India under the emergency use authorisation procedure on April 12 and use of the Russian vaccine started on May 14.
RDIF and Panacea Biotec have agreed to produce 100 million doses a year of Sputnik V.
Sputnik V has so far been registered in 66 countries with a total population of more than 3.2 billion.
RDIF and Gamaleya Center have said the efficacy of Sputnik V is 97.6 per cent, based on analysis of data on coronavirus infection rate among those vaccinated in Russia with both doses of Sputnik V from December 5 last year to March 31 this year.
Paul elaborated that the Central government has continuously remained engaged with all the major international vaccine manufacturers right from mid-2020 and multiple rounds of discussions have taken place with Pfizer, Johnson & Johnson and Moderna.