Sputnik V vaccine authorized in India

New Delhi: The Drug Controller General of India (DCGI) has approved the use of the Russian Sputnik V vaccine against coronavirus in the country. India has become the 60th country to approve Sputnik V.

Sputnik V is one of only three coronavirus vaccines registered by India’s regulatory authorities.

India is the most populated country to register the Russian vaccine. The total population of 60 countries where Sputnik V is approved for use is 3 billion people or about 40% of the global population.

The vaccine has been registered in India under the emergency use authorization procedure based on results of clinical trials in Russia as well as positive data of additional Phase III local clinical trials in India conducted in partnership with Dr. Reddy’s Laboratories.

India is the leading production hub for Sputnik V. The Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund) has reached agreements with the leading pharmaceutical companies in the country (Gland Pharma, Hetero Biopharma, Panacea Biotec, Stelis Biopharma, Virchow Biotech) aimed at the production of more than 850 million doses per year.

Sputnik V ranks second among coronavirus vaccines globally in terms of the number of approvals issued by government regulators.

Sputnik V has also been approved in Russia, Belarus, Argentina, Bolivia, Serbia, Algeria, Palestine, Venezuela, Paraguay, Turkmenistan, Hungary, UAE, Iran, Republic of Guinea, Tunisia, Armenia, Mexico, Nicaragua, Republika Srpska (entity of Bosnia and Herzegovina), Lebanon, Myanmar, Pakistan, Mongolia, Bahrain, Montenegro, Saint Vincent and the Grenadines, Kazakhstan, Uzbekistan, Gabon, San-Marino, Ghana, Syria, Kyrgyzstan, Guyana, Egypt, Honduras, Guatemala, Moldova, Slovakia, Angola, Republic of the Congo, Djibouti, Sri Lanka, Laos, Iraq, North Macedonia, Kenya, Morocco, Jordan, Namibia, Azerbaijan, Philippines, Cameroon, Seychelles, Mauritius, Vietnam, Antigua and Barbuda, Mali and Panama.

Kirill Dmitriev, CEO of the Russian Direct Investment Fund, said: “We appreciate the decision of India’s regulatory bodies to grant authorization for Sputnik V. 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 an 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.”

“India is a vaccine-manufacturing hub and our strategic partner for the production of Sputnik V. RDIF has created partnerships with a number of India’s leading pharmaceutical companies for the production of Sputnik V which will provide for both vaccination of the population in India and global distribution of the Russian vaccine. Over 850 million doses of Sputnik V are going to be produced in India annually sufficient to vaccinate more than 425 million people around the world,” added Dmitriev.