Friday, May 27, 2022

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

By PTI

Published: Updated On - 12:26 AM, Sun - 9 May 21

The drug has been developed by Institute of Nuclear Medicine and Allied Sciences (INMAS), a leading laboratory of Defence Research and Development Organisation (DRDO).

New Delhi: An anti-Covid oral drug developed by the DRDO has been approved by the Drugs Controller General of India (DCGI) for emergency use as an adjunct therapy in moderate to severe coronavirus patients, the Defence Ministry said on Saturday.

Clinical trials of the drug 2-deoxy-D-glucose (2-DG) showed that it helps in faster recovery of hospitalised patients and reduces supplemental oxygen dependence, it said.

“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 patients,” the Ministry said. It said the anti-Covid therapeutic application of 2-DG drug has been developed by the Institute of Nuclear Medicine and Allied Sciences (INMAS), a leading laboratory of Defence Research and Development Organisation (DRDO), in collaboration with Dr Reddy’s Laboratories (DRL) in Hyderabad. “On May 01, DCGI granted permission for emergency use of this drug as an adjunct therapy in moderate to severe Covid patients. Being a generic molecule and analogue of glucose, it can be easily produced and made available in plenty in the country,” the Ministry said in a statement. Adjunctive therapy is a treatment used together with the primary treatment to assist it.

The drug comes in powder form in a sachet and 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,” the Ministry said.

In terms of efficacy trends, the Ministry said, patients treated with 2-DG showed faster symptomatic cure than the 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,” it said.

“A higher proportion of patients treated with 2-DG showed RT-PCR negative,” it said, adding the drug would be of immense benefit to the people suffering from Covid.

The Ministry said the DRDO started work on the project following Prime Minister Narendra Modi’s call for preparedness against the pandemic early last year. “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, Hyderabad, and found that this molecule works effectively against SARS-CoV-2 virus and inhibits the viral growth,” the Ministry said. Based on these results, the DCGI’s Central Drugs Standard Control Organisation (CDSCO) permitted Phase-II clinical trial of 2-DG in Covid-19 patients in May 2020. The DRDO, along with DRL, started the clinical trials to test the safety and efficacy of the drug in Covid patients. “In Phase-II trials conducted during May to October 2020 on 110 patients, the drug was found to be safe and showed significant improvement in their recovery,” it said. “Phase IIa was conducted in six hospitals and Phase IIb (dose ranging) clinical trial was conducted at 11 hospitals all over the country,” it said. The ministry said based on successful results, DCGI further permitted the Phase-III clinical trial in November 2020. It said the Phase-III clinical trial was conducted on 220 patients between December 2020 and March 2021.