Govt allows export of Russian Covid-19 vaccine Sputnik Light manufactured in India by Hetero Biopharma

The government has permitted the export of Russias singledose Covid19 vaccine Sputnik Light domestically produced here as the jab has not yet been approved for emergency use in India sources said on SundayIndian drug firm Hetero Biopharma Limited has been allowed to export 40 lakh doses of Sputnik Light to Russia sources in the know of the developments told PTISputnik Light is the same as component1 of the Russian vaccine Sputnik V which is being used in Indias antiCovid inoculation programme after getting emergency use authorisation from Indias Drug Regulator in AprilThe Russian ambassador had 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 to his country till the vaccine gets emergency use authorisation from Indias drug regulatorIn a communication to the Centre Russian Ambassador Nicholay Kudashev had stated that Hetero Biopharma Limited already has manufactured one million doses of Component 1 of the Sputnik V and two million doses of the Sputnik Light but the sixmonth shelf life of the vaccine may expire before its registration which will result in the wastage of vaccine doses sources saidAlso read Sputniks singledose vax gets DCGI nod for PhaseIII trials in IndiaThe government has permitted Indian drug firm Hetero Biopharma to export 40 lakh doses of Sputnik Light to Russia The decision was taken this week following detailed deliberations a source saidOver the past months the RDIF has been working closely with Indian pharmaceutical companies to ramp up the production of Sputnik vaccine in India that could be used in the local and global markets the ambassador had stated in his communication last monthAt the moment RDIF together with Dr Reddys Laboratories is working with authorities concerned on the registration of the Sputnik Light in IndiaWe would like to note that Indian manufacturers of the Russian vaccine are discouraged by the current ban that prevents the use of the produced Sputnik Light vaccine in India and its export to other countries stated the communication from the ambassador to V K Paul chair of the National Expert Group on Vaccine Administration for Covid19 NEGVACIf permanent or timetotime permission could be granted to Hetero Biophar Limited to export the produced Sputnik Light vaccine by selling it to RDIF until its registration in India this could encourage the company to scale up the production of the vaccine and provide the Indian market with more supplies of the Sputnik Light by the moment of its regulatory approval it saidThe Drugs Controller General of India DCGI had in September given permission to Dr Reddys Laboratory Limited to conduct phase3 bridging trials of Sputnik Light in IndiaThe DCGIs permission was based on the recommendations by the Subject Expert Committee on Covid19 of the Central Drugs Standard Control OrganisationCDSCO which held its meeting on August 5According to the recommendations of the SEC meeting held last month Dr Reddys which has tied up with the RDIF to market the jab in India presented updated safety immunogenicity and efficacy data of Phase III clinical trial of Sputnik Light vaccine conducted in Russia along with the proposal to conduct the clinical trial in India After detailed deliberation the committee recommended for grant of permission for conduct of Phase III immunebridging clinical trial in Indian population subject to the condition the SEC recommendation had saidThe Committee noted that the firm has now presented the safety and immunogenicity along with the longevity of the antibodies which gives a measure of the persistence of antibodies in the participantsIn July the subject expert committee of the Central Drugs Standard Control Organisation had refused to grant emergencyuse authorisation for Sputnik LightThe singledose Sputnik Light vaccine demonstrated 794 percent efficacy according to analysed data taken from 28 days after the injection was administered as part of Russias mass vaccination program between December 5 2020 and April 15 2021 An efficacy level of almost 80 percent is higher than that of many twodose vaccinesSputnik Light has proven effective against all new strains of coronavirus as demonstrated by the Gamaleya Center during laboratory tests a press release from RDIF had said on May 6This story has been sourced from a third party syndicated feed agencies Midday accepts no responsibility or liability for its dependability trustworthiness reliability and data of the text Midday managementmiddaycom reserves the sole right to alter delete or remove without notice the content in its absolute discretion for any reason whatsoever