New Delhi: Defence Minister Rajnath Singh and Union Health Minister Dr Harsh Vardhan on Monday released the first batch of the 2-Deoxy-D-glucose (2-DG) drug developed by the Defence Research and Development Organisation (DRDO) for the treatment of Covid-19 patients.
Defence Minister Rajnath Singh handed over the Anti-COVID drug 2DG to Union Health Minister Dr Harsh Vardhan.
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In his brief remarks, Rajnath Singh said the drug has brought a new ray of hope for the treatment of COVID-19 patients.
"This is a great example of the scientific prowess of our country. We do not need to be relaxed, nor should we get tired. Because this wave has come for the second time, and there is nothing definite about this. We have to take steps with full caution. I am happy to say that the Medical Corps has also decided to take back its retired doctors so that our health system can be strengthened further. I heartily commend such physicians who are joining this campaign even after their service," he said, at the event in DRDO headquarters, adding that it is not the time to relax and get tired as there is nothing definitive about the course of the pandemic.
Singh said the government has taken the overall situation seriously, whether it is the matter of oxygen supply or ensuring ICU beds or the arrangement of cryogenic tankers for transportation of liquid oxygen.
The defence minister also listed efforts of the armed forces in helping civilian authorities deal with the situation across the country. However, he asserted that deployment of the armed forces for Covid-relief measures has not impacted their operational preparedness at the borders.
"Even after going through all these difficulties, we have ensured that our preparedness at the border does not have any impact. There is no shortage of enthusiasm and enthusiasm of our forces anywhere. We know this very well, no matter how big the difficulty is, we will overcome it," he 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.
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Pursuing Prime Minister Narendra Modi's call for preparedness against the pandemic, DRDO took the initiative of developing an anti-COVID therapeutic application of 2-DG. In April 2020, during the first wave of the pandemic, INMAS-DRDO 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 SARS-CoV-2 virus and inhibits viral growth.
Based on these results, the Drugs Controller General of India's (DCGI) Central Drugs Standard Control Organization (CDSCO) permitted a Phase-II clinical trial of 2-DG in COVID-19 patients in May 2020. The DRDO, along with its industry partner DRL, Hyderabad, started clinical trials to test the safety and efficacy of the drug in COVID-19 patients.
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In Phase-II trials (including dose-ranging) conducted from May to October 2020, the drug was found to be safe in COVID-19 patients and showed significant improvement in their recovery. Phase II (A) was conducted in six hospitals and Phase II (B) (dose-ranging) clinical trial was conducted at 11 hospitals all over the country.
Phase-II trial was conducted on 110 patients. 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.
Based on successful results, DCGI further permitted the Phase-III clinical trials in November 2020. The Phase-III clinical trial was conducted on 220 patients between December 2020 to March 2021 at 27 COVID hospitals in Delhi, Uttar Pradesh, West Bengal, Gujarat, Rajasthan, Maharashtra, Andhra Pradesh, Telangana, Karnataka and Tamil Nadu.
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The detailed data of the phase-III clinical trial was presented to DCGI. In the 2-DG arm, a significantly higher proportion of patients improved symptomatically and became free from supplemental oxygen dependence (42 per cent vs 31 per cent) by Day-3 in comparison to SoC, indicating an early relief from Oxygen therapy/dependence.
A similar trend was observed in patients aged more than 65 years. On May 01, 2021, DCGI granted permission for the 'Emergency Use' of this drug as an adjunct therapy in moderate to severe COVID-19 patients. 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 powder form in a 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. 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.
The approval of the drug has come at a time India has been grappling with a record-breaking wave of coronavirus pandemic that has stretched the country's healthcare infrastructure to its limit.
(With agency inputs)
