NEW DELHI: The government has allowed the export of Russia’s single-dose COVID-19 vaccine Sputnik Lite here domestically as the jab is not yet approved for emergency use in India, sources said on Sunday.
Sources close to the development told PTI that Indian pharmaceutical company Hetero Biopharma Ltd has been given permission to export 4 million doses of Sputnik Lite to Russia.
Sputnik Lite is similar to component-1 of the Russian vaccine Sputnik V which is being used in India’s anti-Covid inoculation program after receiving emergency use authorization from India’s drug regulator in April.
The Russian Ambassador urged the Indian government to allow the export of Sputnik Light produced by Hetero Biopharma, one of the partners of the Russian Direct Investment Fund (RDIF) in the production of the jab, until the vaccine receives emergency use authorization. . From the drug regulator of India.
In a communication to the Centre, Russian Ambassador Nikolay Kudashev said that Hetero Biopharma Ltd has already manufactured one million doses of component 1 of Sputnik V and two million doses of Sputnik Lite, but the six-month shelf life of the vaccine has expired. Might be possible. Prior to its registration, which would result in wastage of vaccine doses, the sources said.
“The government has allowed Indian pharmaceutical company Hetero Biopharma to export 4 million doses of Sputnik Lite to Russia. The decision was taken this week after detailed deliberations,” a source said.
Over the past months, RDIF has been working closely with Indian pharmaceutical companies to accelerate production of the Sputnik vaccine in India, which can be used in local and global markets, the ambassador said in his communication last month.
Presently RDIF is working with the concerned authorities on the registration of Sputnik Light in India along with Dr Reddy’s Laboratories.
“We would like to note that the Indian manufacturers of the Russian vaccine are discouraged by the current ban that prevents the use of the Sputnik Lite vaccine produced in India and its export to other countries,” VK Paul said in a communication to the ambassador. The National Expert Group on Vaccine Administration for COVID-19 (NEGVAC).
If Hetero Biofer Limited can be permitted permanently or periodically to export the Sputnik Lite vaccine produced by selling it to RDIF until registration in India, this may encourage the company to increase production and provide the vaccine. Is. With excess supply of Sputnik Lite in the Indian market till the moment of its regulatory approval, it said.
The Drugs Controller General of India (DCGI) in September had given permission to Dr Reddy’s Laboratory Ltd to conduct Phase-3 bridging trials of Sputnik Lite in India.
The DCGI permission was based on the recommendations of the Subject Expert Committee on COVID-19 of the Central Drugs Standard Control Organization (CDSCO), which met on August 5.
In line with the recommendations of the SEC meeting held last month, Dr Reddy’s, which has tied up with RDIF to market the jab in India, updated the safety, immunogenicity and efficacy of the Phase III clinical trial of the Sputnik Lite vaccine conducted in Russia. data presented. Along with this, a proposal has also been made to conduct clinical trials in India.
“After detailed deliberation, the Committee recommended allowing for the conduct of Phase III immune-bridging clinical trials in the Indian population”, the SEC’s recommendation said.
The Committee noted that the firm has now introduced the longevity of antibodies as well as safety and immunogenicity, which give a measure of antibody persistence in participants.
In July, the subject expert committee of the Central Drugs Standard Control Organization refused to grant emergency use authorization for Sputnik Lite.
The single-dose Sputnik Lite vaccine demonstrated 79.4 percent efficacy, according to data analyzed 28 days after injection as part of Russia’s mass vaccination program between December 5, 2020 and April 15, 2021 .
The efficacy level of about 80 percent is higher than that of many two-dose vaccines.
Sputnik Lite has been proven to be effective against all new strains of coronavirus, as demonstrated by the Gamleya Center during laboratory tests, a press release from the RDIF said on May 6.