DCGI grants emergency use permission for anti-COVID drug developed by DRDO lab

Published : May 08, 2021 21:22 IST

A Covid care hospital built by the Defence Reserch and Development Organisation (DRDO) at Awadh Shilp Gram in Lucknow, on April 28. DRDO has also, in collaboration, developed a drug for moderate to severe COVID patients. Photo: PTI

On May 1, the Drugs Controller General of India (DCGI) granted permission to the Institute of Nuclear Medicine and Allied Sciences (INMAS), a laboratory of the Defence Research and Development Organisation (DRDO), for ‘Emergency Use’ of its drug 2-deoxy-D-glucose (2-DG) as “adjunct therapy in moderate to severe COVID-19 patients”. The drug has been developed in collaboration with Dr Reddy’s Laboratories (DRL), Hyderabad, for use as an anti-COVID-19 therapeutic application.

Announcing the DCGI’s approval, a statement from the DRDO said: “Clinical trial results have shown that this molecule helps in faster recovery of hospitalised patients and reduces supplemental oxygen dependence. A 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. And being a generic molecule and analogue of glucose, it can be easily produced and made available in plenty in the country.”

The drug comes in a sachet, in powder form, and is to be orally consumed after being dissolved in water. Explaining the effectiveness of the drug an official from the DRDO said: “The drug 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. We expect the drug 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.”

The DRDO claimed that patients treated with 2-DG showed faster symptomatic cure on various endpoints compared with those under “Standard of Care (SoC) treatment”. Also, a significantly favourable trend (2.5 days difference) was seen in terms of the median time to achieving normalisation of specific vital signs and parameters as compared to SoC treatment.

The initiative of developing anti-COVID therapeutic application of 2-DG was taken up in April 2020. Scientists at INMAS-DRDO, conducted laboratory experiments with adequate help from their colleagues at the Centre for Cellular and Molecular Biology (CCMB), Hyderabad, and found that “this molecule works effectively against the SARS-CoV-2 virus and inhibits its viral growth”. Based on those results, the DCGI’s Central Drugs Standard Control Organisation (CDSCO) permitted Phase-II clinical trial of 2-DG on COVID-19 patients in May 2020.

Armed with the permission, the DRDO, along with its industry partner DRL, Hyderabad, started clinical trials to test the safety and efficacy of the drug in patients. In the Phase-II trials (including dose ranging) conducted during May to October 2020, the drug was found to be safe in COVID-19 patients and they showed significant improvement in their recovery. Phase IIa was conducted in six hospitals and Phase IIb (dose ranging) clinical trials were conducted in 11 hospitals across the country. Phase-II trials were conducted on 110 patients.

On the basis of the successful results, the DCGI permitted Phase-III clinical trial in November 2020. The Phase-III trial was conducted on 220 patients between December 2020 and March 2021 at 27 COVID hospitals in Delhi, Uttar Pradesh, West Bengal, Gujarat, Rajasthan, Maharashtra, Andhra Pradesh, Telangana, Karnataka and Tamil Nadu. The detailed data of phase-III trial was presented to the DCGI.

A significantly higher proportion of COVID-19 patients treated with the 2-DG arm, improved symptomatically and became free from supplemental oxygen dependence (42 per cent versus 31 per cent) by Day-3 in comparison to standard treatment protocols. This, said officials from the DRDO, indicated an early relief from oxygen therapy and dependence.

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