Drugs Controller General of India (DCGI) approves DRDO's anti-COVID drug for emergency use

Drugs Controller General of India (DCGI) approves DRDOs anti-Covid drug for emergency use

The Defence Research and Development Organisation (DRDO) in association with Dr Reddy’s Laboratories Ltd has announced development of an anti Covid-19 drug that helps the COVID patients to speed up recovery and reduces supplemental oxygen dependence.

The anti-Covid-19 therapeutic application of the drug 2-deoxy-D-glucose (2-DG) has been developed by Institute of Nuclear Medicine and Allied Sciences (INMAS), a lab of DRDO, in collaboration with Dr Reddy’s Laboratories, Hyderabad.

“Clinical trial results have shown that this molecule helps in faster recovery of hospitalised patients and reduces supplemental oxygen dependence. 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 in the ongoing pandemic,” DRDO said in a release.

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

“In the ongoing second wave of Covid-19 pandemic, a large number of patients are facing severe oxygen dependency and need hospitalization. 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 and burdens the health infrastructure of the country,’’ DRDO said.

Trials data

DRDO took the initiative of developing anti-COVID therapeutic application of 2-DG. In April 2020, during the first wave of 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.

Based on these results, Drugs Controller General of India’s (DCGI) Central Drugs Standard Control Organization (CDSCO) permitted Phase-II clinical trial of 2-DG in Covid-19 patients in May 2020.

DRDO along with its industry partner Dr Reddy’s Laboratories (DRL, Hyderabad) started the clinical trials to test the safety and efficacy of the drug in COVID-19 patients.

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. Phase IIa was conducted in six hospitals and Phase IIb (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 normalization 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 during Dec 2020 to March 2021 on a large number of patients at 27 Covid hospitals situated in states of Delhi, UP, West Bengal, Gujrat, Rajasthan, Maharashtra, Andhra Pradesh, Telangana, Karnataka and Tamil Nadu. The detailed data of phase-III clinical trials was presented to DCGI.

“In 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. The similar trend was observed in patients more than 65 years also,” the release said.