Pharmaceuticals manufacturer Dr. Reddy’s Laboratories Ltd said it received permission from India’s drug regulator to import and supply the Sputnik V COVID-19 vaccine in India.
Like the other two vaccines approved in India, the nod for Sputnik V is also an ’emergency use authorization’, meaning that it cannot be sold to anyone and everyone, but only to those classes of persons for which it has been approved by the government.
Currently, all COVID-19 vaccines are approved for everyone above 60, and for people with comorbidities such as diabetes and high blood pressure above 45 years of age.
The move will help ease the shortage of vaccine supplies in the country.
Yesterday, India’s Drug Controller General of India (DCGI) had taken a decision to allow companies to supply the Sputnik V vaccine in India, making it the third one to get EUA from the body.
“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 signficant proportion of our population,” said DRL co-chairman and managing director, GV Prasad.
Several drug makers had earlier tied up with Russian authorities to manufacture the vaccine in India. However, they are yet to start making the vaccine in large quantities and were waiting for the EUA.
The vaccine uses two different vectors for the two shots in a course of vaccination.
The efficacy of Sputnik V was determined to be 91.6% as per a published article in the Lancet, one of the world’s oldest and most respected medical journals.
In September 2020, Dr. Reddy’s had partnered with the Russian Direct Investment Fund (RDIF) to conduct the clinical trials of Sputnik V and distribute the vaccine in India. In addition to the trials conducted in Russia by RDIF.
Phase II / III clinical trials of the vaccine were carried out by Dr. Reddy’s in India.
Sputnik V is now approved for use in 60 countries around the world.
It ranks second among coronavirus vaccines globally in terms of the number of approvals issued by government regulators.
Besides the Russian vaccine, two others — the Oxford-Astrazeneca vaccine and Bharat Biotech’s Covaxin — are also approved for controlled use in India.
The country has managed to inoculate around 5% of its population, which is well below the 25% or so penetration achieved by the US so far.
India is undergoing its second wave of COVID-19 infections, with daily cases nearing the 2 lakh mark — compared to a peak of around 1 lakh seen in the first wave.
The actual number of infections are likely to be several times higher, given that most people infected with the virus do not get themselves tested, and it’s mostly the critical cases that come on the record.