Russia's Sputnik V vaccine to seek India approval by March
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A source close to the drug regulator said the application could come within days and when approved, bolster India's 18-day-old immunisation campaign which has covered more than 4 million people with two other shots.
Russia's Sputnik V vaccine will seek emergency-use authorisation by next month, a company official said on Wednesday.
A source close to the drug regulator said the application could come within days and when approved, bolster India's 18-day-old immunisation campaign which has covered more than 4 million people with two other shots.
India's Dr. Reddy's Laboratories Ltd has been working with the Russian Direct Investment Fund (RDIF) to hold small clinical trials of Sputnik V in India. On Tuesday, RDIF told Indian news agency ANI that it expected to get approval for the vaccine this month or the next.
The company had partnered with RDIF to distribute 250 million doses.
Indian regulator the Central Drugs Standard Control Organisation (CDSCO) had no immediate comment on a potential application.
The vaccine has proved 91.6 per cent effective against COVID-19, based on late-stage trials in Russia, results published in the Lancet medical journal showed on Tuesday.
More than a million people in Russia have received Sputnik V, which is marketed abroad by the RDIF and has been approved for emergency use in Algeria, Argentina, Bolivia, Mexico and Serbia.
RDIF expects India to produce about 300 million doses of Sputnik V this year. Hetero Biopharma is making more than 100 million doses.
India's regulator has approved for emergency use the AstraZeneca vaccine and another developed at home by Bharat Biotech and the state-run Indian Council of Medical Research. A similar request from Pfizer and partner BioNTech for their vaccine is pending with the regulator.
India has so far registered 10.78 million coronavirus cases. Deaths stand at 154,596.