Defence Minister Rajnath Singh and Health Minister Harsh Vardhan released the first batch of anti-COVID-19 drug 2-DG, developed by the Defence Research and Development Organisation (DRDO) in New Delhi On May 17.
The Drugs Controller General of India (DCGI) has granted permission for the emergency use of the drug, 2-deoxy-D-glucose (2-DG), as an adjunct therapy in moderate to severe coronavirus patients, the defence ministry said earlier in May. The ministry said that the clinical trials of the drug showed that it helps in a faster recovery of hospitalised patients and reduces supplemental oxygen dependence.
On the launch of the first batch of the drug, Vardhan said, “With the support of DRDO and in the leadership of Defence Minister Rajnath Singh, this drug may be our first indigenous research-based outcome to fight against COVID-19. It will reduce recovery time and oxygen dependency.”
The health minister congratulated the scientists at DRDO and hoped that the drug will serve in the battle against novel coronavirus infection in the coming days. “I thank and congratulate DRDO and its scientists. We have seen under the leadership of Prime Minister Narendra Modi, DRDO has played an important role in the fight against COVID-19. I hope the drug serves in the fight against COVID-19 not just in India but globally in the coming days,” Vardhan said.
The drug has been released at a time when India is grappling with a record-breaking wave of the coronavirus pandemic that has stretched the country's healthcare infrastructure to its limit.
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Development of 2-DG drug
The anti-COVID therapeutic application of the drug has been developed by the Institute of Nuclear Medicine and Allied Sciences (INMAS), a leading laboratory of the DRDO, in collaboration with Dr Reddy's Laboratories (DRL) in Hyderabad.
“In April 2020, during the first wave of the pandemic, 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,” the Ministry of Defence said in a statement.
Efficacy of 2-DG drug in clinical trials
The drug regulatory authority had granted permission for phase-II clinical trials of the drug in May 2020 based on the results of INMAS-DRDO scientists' laboratory experiments.
In Phase-II trials conducted from May to October 2020 on 110 patients, the drug was found to be safe in COVID-19 patients and showed significant improvement in their recovery, the statement said.
Phase IIa was conducted in six hospitals and Phase IIb (dose ranging) clinical trial was conducted at 11 hospitals all over the country.
"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 statement added.
Considering the successful results, the DCGI further permitted the Phase-III clinical trials in November 2020. It 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.
"In 2-DG arm, 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," said the Ministry of Defence.
This similar trend of recovery was observed in patients aged more than 65 years who were administered with the drug, it added.
Benefits of 2-DG drug
Clinical trial results have shown that the drug helps in faster recovery of hospitalised patients and reduces supplemental oxygen dependence.
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 defence ministry claimed.
Higher proportion of patients treated with 2-DG showed RT-PCR negative conversion in COVID patients.
How to take 2-DG drug?
The DRDO’s anti-COVID-19 drug 2-DG comes in a powder form in a sachet and is taken orally by dissolving it in water. It need to be taken twice during the day for 5-7 days, said DRDO Project Director and Scientist of 2-DG, Dr Sudhir Chandana.
How 2-DG drug works in treating COVID-19 infection
The 2-DG 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," the defence ministry explained in a statement.
Will 2-DG drug work on variants of the coronavirus?
Director of the Institute of Nuclear Medicine and Allied Sciences, Dr Anil Mishra, has explained in an interview to All India Radio this drug is effective against all variants of coronavirus.
Availability and price
The medicine 2 DG will be available at retail shops within a week, said Dr Mishra.
The final price of 2-DG will be determined by the DRDO partner Dr Reddy's, which is manufacturing the medicine. It will be priced by keeping affordability in mind.
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