India's drug regulator approves DRDO's anti-Covid drug for emergency use

The Defence Research and Development Organisation (DRDO), in collaboration with Dr Reddy’s Laboratories (DRL), Hyderabad, has announced the development of an anti-Covid-19 drug that speeds up recovery of hospitalised patients and reduces supplemental oxygen dependence – the big killer in the current phase of the pandemic.

“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,” stated the Ministry of Defence (MoD) on Saturday.

The new treatment consists of a therapeutic application of the drug 2-deoxy-D-glucose (2-DG), developed by the Institute of Nuclear Medicine and Allied Sciences (INMAS), a DRDO laboratory based in Delhi.

It does not function like a vaccination, which is a preventive measure against catching the illness. Instead, the 2-DG molecule hastens the recovery of patients who are already suffering from the disease.

“Phase-III clinical trials of the drug were 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,” stated the MoD.

The detailed data that emerged from Phase-III clinical trials was presented to the Drugs Controller General of India (DCGI). It was observed that patients who were administered the new 2-DG drug in addition to the standard Indian Council of Medical Research treatment, recovered more quickly than patients who were given only the standard treatment.

The DRDO found that 42 per cent of the patients administered 2-DG could be taken off supplemental oxygen dependence by Day-3 of the treatment. In comparison, only 31 per cent of patients who were administered the standard treatment, but not 2-DG, could be taken off oxygen therapy/dependence.

A similar trend was observed in patients aged more than 65 years.

“On May 1, 2021, DCGI granted permission for emergency use of this drug as 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,” said the MoD. 

The drug will be manufactured by Dr Reddy’s Laboratory (DRL), which worked alongside the DRDO as its industry partner during the year-long trials. The drug will be dispensed in powder form in a sachet, and taken orally after 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,” said the MoD.

The DRDO’s success in developing this drug lies in having made an early start. Early last year, when the first wave of the pandemic was still gathering momentum, INMAS took the decision to develop 2-DG into an anti-Covid-19 therapeutic drug. 

In April 2020, INMAS-DRDO scientists conducted laboratory experiments with the help of Centre for Cellular and Molecular Biology (CCMB), Hyderabad and established conclusively that 2-DG inhibits growth of the SARS-CoV-2 virus. Based on this, the Central Drugs Standard Control Organization (CDSCO), which works under the DCGI, gave the green signal in May 2020 for Phase-II clinical trials of 2-DG to be carried out in Covid-19 patients.

In Phase-II trials that were conducted during May to October 2020 on 110 patients in six hospitals, the drug was found to be safe for Covid-19 patients and showed significant acceleration in their recovery. 

Based on these successful results, DCGI further permitted the DRDO to carry out Phase-III clinical trials from November 2020. 

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