DCGI approves emergency use of new anti-Covid drug developed by DRDO

NewsBharati    08-May-2021
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New Delhi, May 08: In the major development, the Drugs Controller General of India (DCGI) has approved the emergency use of an anti-Covid-19 drug developed by the Defence Research and Development Organisation (DRDO) for moderate to severe Covid-19 patients.
 
 
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DRDO has developed the drug in the collaboration with Dr. Reddy’s Laboratories (DRL), Hyderabad. In April 2020, INMAS-DRDO scientists conducted laboratory experiments with the help of the Centre for Cellular and Molecular Biology (CCMB). During which they found that this molecule works effectively against the SARS-CoV-2 virus and inhibits viral growth.
 
 
 
Following this, DCGI's Central Drugs Standard Control Organization (CDSCO) permitted Phase-II clinical trial of 2-DG in Covid-19 patients in May 2020.
 
According to the ministry, clinical trials of the therapy, the drug 2-deoxy-D-glucose (2-DG), have shown that this molecule helps in faster recovery of hospitalized patients and reduces supplemental oxygen dependence. The drug will be of immense benefit to the people suffering from Covid-19.
 
 
 
Phase II was conducted in six hospitals whereas, Phase IIb (dose-ranging) clinical trial was conducted at 11 hospitals all over the country. Phase-II trial was conducted on 110 patients.
 
The press release said that 2-DG arm, a significantly higher proportion of patients improved symptomatically and became free from supplemental oxygen dependence (42 percent vs 31 percent) by Day-3 in comparison to SOC, indicating an early relief from Oxygen therapy/dependence. The similar trend was observed in patients more than 65 years also.
 
 
The drug 2-deoxy-D-glucose prevents virus growth by stopping viral synthesis and energy production. Its selective accumulation in virally infected cells makes this drug unique. It comes in powder form, which is taken orally by dissolving it in water.
 
“In the ongoing second wave of Covid-19 pandemic, a large number of patients are facing severe oxygen dependency and need hospitalisation. The 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 Covid-19 patients and burdens the health infrastructure of the country,’’ DRDO said.
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