• India's drug regulator gives approval to Russia's Sputnik V COVID-19 vaccine
  • The vaccine will be manufactured in the country by Dr Reddy's Laboratories
  • Some states raised concerns about shortages of Covishield and Covaxin

India's top drug regulatory body has approved Russia's Sputnik V COVID-19 vaccine for emergency use as the country overtook Brazil as the second-worst hit after the United States.

Sputnik V will be the third COVID-19 vaccine to be cleared by India as coronavirus infections surged in a deadlier second wave. It works in similar ways as AstraZeneca's vaccine, which is produced by the Serum Institute of India as Covishield.

India has given more than 100 million doses of Covishield and Covaxin, which was indigenously developed by Hyderabad-based Bharat Biotech. India has put curbs on vaccine imports after several parts of the country experienced severe shortages.

Russia's Sputnik V is the third vaccine to be approved by India after the Oxford-AstraZeneca shot and Covaxin
Russia's Sputnik V is the third vaccine to be approved by India after the Oxford-AstraZeneca shot and Covaxin AFP / Andreas SOLARO

The Russian Direct Investment Fund or RDIF (Russia's sovereign wealth fund) said Monday that India has become the 60th country to have approved of the two-dose Sputnik V.

The sovereign wealth fund said an expert panel of the Drugs Controller General of India (DCGI) recommended emergency license to the vaccine.

Sputnik V has the highest effectiveness, which is 91.6 per cent, after Moderna and Pfizer vaccines.

The RDIF has reached agreements with five pharmaceutical companies in the country aiming to produce more than 850 million doses per year. Limited doses will be manufactured by month-end and the production will ramp up gradually.

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

"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," the RDIF 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 an extensive cooperation on clinical trials of Sputnik V in India and its local production," RDIF CEO Kirill Dmitriev said.

According to the earlier statements released by RDIF, over 200 million doses of Sputnik V are to be supplied to Dr Reddy's for distribution in India which would help immunize nearly 100 million people in the country.

India began its vaccination drive on January 16. As per the Union Health Ministry's Data, on Tuesday, India recorded 161,736 new COVID-19 infections in the last 24 hours taking the total toll to 13,689,453.