DCGI nods anti-Covid-19 drug developed by DRDO for emergency use

The Drugs Controller General of India has approved an antiCovid19 drug developed by the Institute of Nuclear Medicine and Allied Sciences INMAS for emergency use the Defence Ministry has saidAn antiCovid19 therapeutic application of the drug 2deoxyDglucose 2DG has been developed by INMAS a lab of the Defence Research and Development Organisation DRDO in collaboration with Dr Reddys Laboratories DRL HyderabadClinical trial results have shown that this molecule helps in faster recovery of hospitalised patients and reduces supplemental oxygen dependenceA higher proportion of patients treated with 2DG showed RTPCR negative conversion in Covid19 patients The drug will be of immense benefit to the people suffering from Covid19Pursuing Prime Minister Narendra Modis call for preparedness against the pandemic DRDO took the initiative of developing antiCovid19 therapeutic application of 2DG the ministry said in a statement on FridayIn April 2020 during the first wave of the pandemic INMASDRDO scientists conducted laboratory experiments with the help of the Centre for Cellular and Molecular Biology CCMB Hyderabad and found that this molecule works effectively against the SARSCoV2 virus and inhibits the viral growthBased on these results the Drugs Controller General of Indias DCGI Central Drugs Standard Control Organization CDSCO permitted the PhaseII clinical trial of 2DG in Covid19 patients in May 2020The DRDO along with its industry partner DRL Hyderabad started the clinical trials to test the safety and efficacy of the drug in Covid19 patientsIn PhaseII trials including dose ranging conducted during May to October 2020 the drug was found to be safe in Covid19 patients and showed significant improvement in their recoveryPhaseIIa was conducted in six hospitals and Phase IIb dose ranging clinical trial was conducted at 11 hospitals all over the country The PhaseII trial was conducted on 110 patientsIn efficacy trends the patients treated with 2DG showed faster symptomatic cure than Standard of Care SoC on various endpointsA significantly favourable trend 25 days difference was seen in terms of the median time to achieving normalisation of specific vital signs parameters when compared to SoC the ministry saidBased on successful results the DCGI further permitted the PhaseIII clinical trials in November 2020The PhaseIII clinical trial was conducted on 220 patients between December 2020 to March 2021 at 27 Covid19 hospitals in Delhi Uttar Pradesh West Bengal Gujarat Rajasthan Maharashtra Andhra Pradesh Telangana Karnataka and Tamil Nadu The detailed data of the PhaseIII clinical trial was presented to the DCGIIn 2DG arm significantly higher proportion of patients improved symptomatically and became free from supplemental oxygen dependence 4237 vs 3137 by Day3 in comparison to SoC indicating an early relief from Oxygen therapydependence the ministry statedA similar trend was observed in patients aged more than 65 yearsOn May 1 2021 the DCGI granted permission for Emergency Use of this drug as adjunct therapy in moderate to severe Covid19 patientsBeing a generic molecule and analogue of glucose it can be easily produced and made available in plenty in the countryThe drug comes in powder form in a sachet which is taken orally by dissolving it in waterIt accumulates in the virus infected cells and prevents virus growth by stopping viral synthesis and energy production Its selective accumulation in virally infected cells makes this drug uniqueIn the ongoing second Covid19 wave a large number of patients are facing severe oxygen dependency and need hospitalisationThe drug is expected to save precious lives due to the mechanism of operation of the drug in infected cells This also reduces the hospital stay of Covid19 patients the ministry addedThis 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