India overtook Brazil to become the country with the second-highest number of COVID-19 cases worldwide after the United States, as it battles a second wave and only has given around 105 million doses to a population of 1.4 billion.
The RDIF, responsible for marketing Sputnik abroad, said the Drug Controller General of India (DCGI) formally approved Sputnik V's use in the country.
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A post on the Sputnik V official Twitter account said that “India, the world’s 2nd most populous nation, became the 60th country to register #SputnikV after positive results of local Phase 3 clinical study. Sputnik V is now authorized in 60 countries with a population of over three bln people."
On Monday, two people familiar with the matter said the panel of India's Central Drugs Standard Control Organisation (CDSCO) had already recommended the authorization.
To date, the RDIF has signed deals to produce more than 750 million doses of Sputnik V in India with six different domestic firms.
To date, India has been using two vaccines, one developed by AstraZeneca and Oxford University, and the other by the domestic firm Bharat Biotech.
Developed by Moscow’s Gamaleya Institute, Sputnik V has proved 91.6% effective against COVID-19 and is already approved for use in more than 50 countries worldwide.
The firm marketing the vaccine in India, Dr. Reddy’s, said it was awaiting formal word from the authorities.
“Dr. Reddy’s and RDIF are working diligently with the Indian regulatory authorities to obtain the approval for Sputnik V. We are fully committed to playing our part in India’s fight against COVID,” the company said Monday.