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. Two vaccines - the Serum Institute of India's Covishield and Bharat Biotech's Covaxin - were cleared in January.
India is the most populated country to register the Russian vaccine. 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. RDIF has reached agreements with the leading pharmaceutical companies in the country (Gland Pharma, Hetero Biopharma, Panacea Biotec, Stelis Biopharma, Virchow Biotech) aimed at 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.
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.
India is a vaccine-manufacturing hub and our strategic partner for production of Sputnik V. RDIF has created partnerships with a number of India’s leading pharmaceutical companies for 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.
