The General Controller of Medicines of India (Drug Controller General of India) has registered the Russian anti-COVID vaccine Sputnik V, the Russian Direct Investment Fund (RDIF) reports.
India became the 60th country where the use of the drug was approved. Sputnik V is one of three coronavirus vaccines approved for use in this country.
India is also the state with the largest population among the 60 countries, where Sputnik V is registered. The total number of inhabitants of these states now reaches 3 billion people, or 40% of the world’s population.
Registration of the drug was carried out as part of an accelerated procedure (EUA), taking into account the results of clinical studies of the vaccine in Russia, as well as positive phase III data from additional clinical studies in India, which are carried out in partnership with Dr. Reddy’s Laboratories.
India is the leading manufacturing hub for the Russian vaccine. RDIF has entered into agreements with India’s largest pharmaceutical manufacturers (Glass Pharma, Hetero Biopharma, Panacea Biotec, Stelis Biopharma, Virchow Biotech) to produce more than 850 million doses of Sputnik V per year.
“We welcome the decision of the Indian regulators to approve the Sputnik V vaccine. Obtaining permission to use the drug is an important stage for the partnership between Russia and India in the field of clinical research “Sputnik V” and local vaccine production.
The Russian drug has an efficacy of 91.6% and provides full protection against severe cases of coronavirus according to clinical research published in the leading medical journal The Lancet. India is an international vaccine hub and strategic partner for the production of Sputnik V. RDIF has created a number of partnerships with leading pharmaceutical companies in India, due to which Sputnik V will be produced both for vaccination of the country’s population and for ensuring international supplies. In India, more than 850 million doses of the Sputnik V vaccine will be produced annually to vaccinate more than 425 million people around the world, “said Kirill Dmitriev, CEO of the RDIF.
In terms of the number of approvals received by state regulators, Sputnik V ranks second in the world.
Currently, the use of the Satellite V vaccine has also been approved in Russia, Belarus, Argentina, Bolivia, Serbia, Algeria, Palestine, Venezuela, Paraguay, Turkmenistan, Hungary, the UAE, Iran, the 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, Djibouti, Republic of the Congo, Sri Lanka, Laos, Iraq, North Macedonia, Kenya, Morocco, Jordan, Namibia, Azerbaijan, Philippines, Cameroon, Seychelles, Mauritius, Vietnam, Antigua and Barbuda, Mali and Panama.