Regulator Gives Nod To Emergency Use Of DRDO's Anti-Covid Drug That Will Come In Powder Form

·3-min read

The Drugs Controller General of India (DCGI) has approved the emergency use of an anti-Covid drug developed by the Defence Research and Development Organisation (DRDO) to treat moderate to severe Covid-19 patients.

The therapeutic use of the drug, 2-DG (2-deoxy-D-glucose), helps Covid-19 patients recover faster, and also reduces their dependence on medical oxygen (MO). It accumulates in the infected cells and stop the virus from multiplying.

The Institute of Nuclear Medicine and Allied Sciences (INMAS), a lab of DRDO, in collaboration with Dr Reddy’s Laboratories, Hyderabad, has developed the drug.

The anti-Covid drug was cleared after the clinical trial results revealed that a molecule present in the drug helps in faster recovery of hospitalised patients and reduces supplemental oxygen dependence. As per findings, a higher proportion of patients treated with the drug tested negative for Covid in RT-PCR tests.

In the ongoing second Covid-19 wave, 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, according to a government release.

“The drug comes in powder form in sachet, which is taken orally by dissolving it in water. It 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 unique,” the release said.

“Being a generic molecule and analogue of glucose, it can be easily produced and made available in plenty in the country.”

In April 2020, INMAS-DRDO scientists had conducted laboratory experiments with the help of the Centre for Cellular and Molecular Biology (CCMB) and found that this molecule works effectively against SARS-CoV-2 virus and inhibits viral growth.

Based on these findings, DCGI Central Drugs Standard Control Organization (CDSCO) had given permission for the phase-II clinical trial of 2-DG in Covid-19 patients in May 2020.

After conducting the phase 2 trial, it was found that the drug accumulates in the virus-infected cells and prevents virus growth by stopping viral synthesis and energy production. It was also revealed that the drug comes in powder form in a sachet, which is taken orally by dissolving it in water.

“In efficacy trends, the patients treated with 2-DG showed faster symptomatic cure than Standard of Care (SoC) on various endpoints. A significantly favourable trend (2.5 days difference) was seen in terms of the median time to achieving normalisation of specific vital signs parameters when compared to SoC,” the government release said.

Following its success in the phase-II trial, the phase-III clinical trial was conducted on 220 patients from December 2020 to March 2021 at 27 Covid-19 hospitals across the states of Delhi, Uttar Pradesh, West Bengal, Gujarat, Rajasthan, Maharashtra, Andhra Pradesh, Telangana, Karnataka and Tamil Nadu.

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