The Drug Controller General of India (DCGI) has granted permission to Dr Reddy’s Laboratories to import Russia’s Covid-19 vaccine, Sputnik V, into the country for restricted use in emergency situations.
The vaccine utilises two different vectors for the two jabs in a course of vaccination.
In September last year, Dr Reddy’s and the Russian Direct Investment Fund (RDIF) had collaborated to carry out the clinical trials of the vaccine and distribute it in India.
RDIF had conducted trials of the vaccine in Russia while more phase II / III clinical trials of Sputnik V were conducted by Dr Reddy’s in India.
Dr Reddy’s Laboratories co-chairman and managing director GV Prasad said: “We are very pleased to obtain the emergency use authorisation for Sputnik V in India.
“With the rising cases in India, vaccination is the most effective tool in our battle against Covid-19. This will enable us to contribute to our nation’s effort of vaccinating a significant proportion of our population.”
RDIF noted that India is the major production hub for Sputnik V. It has already entered agreements with Indian pharmaceutical firms such as Gland Pharma, Hetero Biopharma, Panacea Biotec, Stelis Biopharma and Virchow Biotech to manufacture over 850 million doses of the vaccine a year.
RDIF CEO Kirill Dmitriev said: “Approval of the vaccine is a major milestone as Russia and India have been developing extensive cooperation on clinical trials of Sputnik V in India and its local production.
“The Russian vaccine has efficacy of 91.6% and provides full protection against severe cases of Covid-19 as demonstrated by the data published in one of the leading medical journals The Lancet.”
Last month, the RDIF and Virchow Biotech signed an agreement to annually produce up to 200 million doses of Sputnik V in India.