DCGI Approves Anti-COVID Drug Developed By DRDO For Emergency Use
The Drugs Controller General of India (DCGI) has approved an anti-Covid drug for emergency use. The drug has been developed by the Institute of Nuclear Medicine and Allied Sciences (INMAS), a lab of Defence Research and Development Organisation.
According to clinical trial results, anti-Covid therapeutic application of 2-deoxy-D-glucose (2-DG) helped in faster recovery of hospitalised patients and reduced supplemental oxygen dependence.
Higher proportion of patients treated with 2-DG showed RT-PCR negative conversion in Covid patients. The drug will be of immense benefit to the people suffering from Covid-19, a statement released by DRDO said.
In April last year, INMAS-DRDO scientists conducted laboratory experiments with the help of Centre for Cellular and Molecular Biology (CCMB), Hyderabad and found that this molecule works effectively against SARS-CoV-2 virus and inhibits the viral growth.
Based on these results, Drugs Controller General of India’s (DCGI) Central Drugs Standard Control Organization (CDSCO) permitted Phase-II clinical trial of 2-DG in Covid-19 patients in May 2020.
The DRDO, along with its industry partner DRL, Hyderabad, started the clinical trials to test the safety and efficacy of the drug in Covid-19 patients. In Phase-II trials (including dose ranging) conducted during May to October 2020, the drug was found to be safe in Covid-19 patients and showed significant improvement in their recovery. Phase-IIA was conducted in six hospitals and Phase IIb (dose ranging) clinical trial was conducted at 11 hospitals all over the country. Phase-II trial was conducted on 110 patients.
Based on these results, DCGI- CDSCO permitted Phase-II clinical trial of 2-DG in Covid-19 patients in May 2020.
Later, the DCGI further permitted the Phase-III clinical trials in November 2020. The Phase-III clinical trial was conducted on 220 patients during Dec 2020 to March 2021 at 27 Covid hospitals situated in states of Delhi, UP, West Bengal, Gujrat, Rajasthan, Maharashtra, Andhra Pradesh, Telangana, Karnataka and Tamil Nadu.
