India's drug regulator gives clearance for restricted emergency use of Russia's Sputnik V
India's drug regulator has given the clearance for restricted emergency use of Russian Covid-19 vaccine "Sputnik V", paving the way for a third vaccine against novel coronavirus as the country tries to check a surging second wave of the virus.
The approval by the Drugs Controller General of India (DCGI) came hours after the Subject Expert Committee (SEC) on Covid-19 of the Central Drugs Standard Control Organization (CDSCO) on Monday recommended granting approval to Sputnik V for its restricted emergency use subject to certain regulatory conditions, sources said today.
The SEC at its meeting in New Delhi on Monday discussed the application of Indian pharma major Dr Reddy's Laboratories which had sought emergency use authorisation for Sputnik V.
The DCGI had in January given the emergency use authorisation for two vaccines Covaxin produced by Bharat Biotech and Covishield of Oxford-AstraZeneca manufactured by Serum Institute of India in Pune.
The sources said nearly ten crore doses of the Sputnik V vaccine are likely to be imported from Russia in the next six to seven months, our New Delhi correspondent reports.
Russia's sovereign wealth fund the Russian Development Investment Fund (RDIF), which has partnered with Dr Reddy's Laboratories, said more than 850 million doses of the Sputnik V vaccine are going to be produced annually in India to cater to over 425 million people across the world.
The RDIF said in a statement that Sputnik V has a number of advantages, including that there are no strong allergies caused by it.
The price of the vaccine is less than USD 10 per dose and it uses two different vectors for the two shots in a course of vaccination, providing immunity with a longer duration than vaccines using the same delivery mechanism for both the doses, it added.
The vaccine is indicated for active immunisation to prevent Covid-19 in individuals aged 18 years and above and is to be administered intramuscularly in two doses of 0.5 ml each with an interval of 21 days.
The injection has to be stored at -18 degrees Celsius.
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