DCGI Gives Emergency Approval Of DRDO-Developed Anti-Covid Oral Drug

The DCGI had on May 1 granted permission for emergency use of the drug as adjunct therapy in moderate to severe Covid-19 patients.

Anti-Covid oral drug, a drug to treat Covid-19 patients developed by the DRDO (Defence Research and Development Organisation), has been given emergency approval by the country’s developed by the DRDO (Defence Research and Development Organisation top drugs controller amid the battle of India’s second wave of the pandemic that is killing thousands every day.

The drug comes in powder form in a sachet and is taken orally by dissolving it in water.

The Anti-Covid therapeutic application of the drug 2-deoxy-D-glucose (2-DG) has been developed by a DRDO lab and Hyderabad-based Dr Reddy’s Laboratories.

The drug clearance was approved by the Drugs Controller General of India (DCGI), after the clinical trial results showed that a molecule present in the drug helps in faster recovery of hospitalised patients and reduces supplemental oxygen dependency.

According to reports, a major proportion of patients treated with the drug tested negative for Covid in RT-PCR tests.

The DRDO took the initiative of developing anti-Covid therapeutic application of 2-DG to respond to Prime Minister Narendra Modi’s call for preparedness against the pandemic.

In April 2020, when the first wave of pandemic struck India, experiments were conducted by the scientists at DRDO’s laboratory Inmas along with the help of Hyderabad-based Centre for Cellular and Molecular Biology (CCMB) and found that this molecule works effectively against SARS-CoV-2 virus and constrains the viral growth.

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

Therefore, the clinical trails to test the safety and efficacy of the drug in Covid-19 patients was started by DRDO along with its industry partner Dr Reddy’s Laboratories.

“In Phase-II trials (including dose ranging) conducted between May and 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 6 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,” a top DRDO official said on Saturday.

The DCGI then permitted the phase III of clinical trials in November 2020 based on the successful results, the official further said.

Between December 2020 and March 2021, it was conducted on 220 patients at 27 Covid-19 hospitals across 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% vs 31%) 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 DRDO official said.

The DCGI had on May 1 granted permission for emergency use of the 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, the DRDO said.

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