DCGI approves anti-COVID drug developed by DRDO for emergency use

The oral drug comes in powder form

DRDO-Oxygen-sanjay-ahlawat Final touches being made to the DRDO's oxygen plant at RML hospital, Delhi | Sanjay Ahlawat

After setting up make-shift hospitals and medical oxygen plants to combat catastrophic second wave of COVID-19, the Defence Research and Development Organisation (DRDO), has developed an anti-Covid drug for emergency use.

An anti-Covid therapeutic application of the drug 2-deoxy-D-glucose (2-DG), is developed by the Institute of Nuclear Medicine and Allied Sciences (INMAS), DRDO's Delhi based laboratories in collaboration with Dr Reddy’s Laboratories Hyderabad.

DRDO officials claim that the clinical trial results have shown that this molecule helps in faster recovery of hospitalised patients and reduces supplemental oxygen dependence.

The Drugs Controller General of India’s (DCGI) has granted permission for emergency use of this drug as adjunct therapy in moderate to severe COVID-19 patients. And, being a generic molecule and analogue of glucose, it can be easily produced and made available in plenty in the country, according to DRDO official. 
The drug which comes in powder form in a sachet, 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.

"Higher proportion of patients treated with 2-DG showed RT-PCR negative conversion in COVID-19 patients. The drug will be of immense benefit to the people suffering from COVID-19," a DRDO official said.

As per updated data by the union health ministry, India saw a record 4,187 fatalities due to COVID-19 in a single day, taking the country's death toll to 2,38,270, while 4,01,078 new infections were reported in a day, pushing the tally to 2,18,92,676. Registering a steady increase, the active cases have increased to 37,23,446, comprising 17.01 per cent of the total infections, while the national COVID-19 recovery rate has dropped to 81.90 per cent.

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.

DRDO, has constructed four COVID-19 hospitals in Ahmedabad, Varanasi, Lucknow and Delhi.

In April 2020, during the first wave of the pandemic, scientists with the INMAS 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), the Central drugs standard control organization 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.

DRDO official added that 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. "Clinical trial under Phase II was conducted at 11 hospitals all over the country and was done on 110 patients," an official further said while adding that in efficacy trends, the patients treated with 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," DRDO claimed.
And, based on successful results, DCGI further permitted the Phase-III clinical trials in November 2020. And the clinical trial was conducted on 220 patients between December 2020 to March 2021 at 27 COVID-19 hospitals in Delhi, Uttar Pradesh, West Bengal, Gujarat, Rajasthan, Maharashtra, Andhra Pradesh, Telangana, Karnataka and Tamil Nadu. The detailed data of phase-III clinical trial was presented to DCGI.
"In 2-DG arm, 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," official added. DRDO also claims that the similar trend was observed in patients aged more than 65 years.