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Tag: 2 DG drug

  • BDR Pharma inks license agreement with DRDO to produce COVID-19 drug 2-DG

    By PTI
    NEW DELHI: BDR Pharma on Monday said it has inked a licensing pact with the Defence Research and Development Organisation (DRDO) to manufacture, distribute, and market COVID-19 drug 2-Deoxy-D-Glucose (2-DG) in the country.

    BDR Pharma has inked a pact with the Defence Research and Development Establishment (DRDE) and the Institute of Nuclear Medicine and Allied Sciences (INMAS) of the DRDO for manufacturing, distribution, and marketing of 2-DG in the country.

    Last month, the Drugs Controller General of India (DCGI) had approved the oral medication for emergency usage as adjuvant therapy in mild to severe COVID-19 patients.

    “We are pleased to secure a license from the DRDO and add 2-Deoxy-D-Glucose to our COVID product offering. This arrangement aims to ensure that this drug reaches as many eligible Indian patients as possible who are suffering from the devastating pandemic.

    “Our aim is to ramp up the availability of successful treatment and coordinate manufacturing so that there is no scarcity of drugs to give to people fighting the disease,” BDR Pharmaceuticals CMD Dharmesh Shah said in a statement.

    The company thinks that by widening and deepening the identification and development of COVID-19 therapy options, this collaboration can address more unmet medical needs, he added.

    The product would be priced competitively and will be available in powder form in a sachet that can be consumed orally after being dissolved in water, the drug maker noted.

    The Mumbai-based company noted that it has already applied to the Drug Controller General of India (DCGI) for restricted emergency use authorisation to manufacture Drug 2-DG to treat COVID-19 patients in India.

    For the development of 2-DG drugs, the DRDO has recently signed agreements with four major Indian generic medicine producers.

    The DRDE had produced 2-DG and the clinical trials were carried out in collaboration with Dr Reddy’s Laboratories by the INMAS, a DRDO lab.

    After receiving positive responses in Phase-II and Phase-IIb trials, DCGI permitted 2-DG phase-III trials in November 2020.

    The Phase-II trial, which lasted from December 2020 to March 2021, enrolled 220 patients.

    The medicine was discovered to speed up the recovery of COVID-19 patients in hospitals and to lessen the need for supplementary oxygen in COVID-19 patients.

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  • After DRDO’s 2-DG drug, 1.50 lakh units from PM CARES fund approved purchase of Oxycare system

    The drug 2-deoxy-D-glucose (2-DG) formulated by DRDO has been approved by the Drug Controller General of India amidst the havoc of Corona across the country. Along with this, DRDO is building hospitals in the most corona infected parts of the country. At the same time, DRDO teams are constantly making all efforts to save the lives of the countrymen in this era of epidemics. Amidst all this, DRDO has designed OxyCare system to eliminate the lack of oxygen in the country. An excellent decision has been taken by the Central Government to take this step further by DRDO.

    After the anti-covid drug, now the Defense Research and Development Organization has fully prepared to solve the oxygen problem of the patients. After this DRDO’s Oxycare System Discovery has been approved for purchase through PM Care Fund. DRDO may soon start its supply process. This information has been provided by DRDO.

    According to the news, to overcome the oxygen shortage, the purchase of 1 lakh 50 thousand units of Oxycare system prepared by the DRDO has been approved from the PM Cares Fund. The price of this oxycare system is being said to be Rs 322.5 crores. It is a SpO2-based oxygen supply system, which regulates oxygen, delivering oxygen to the patient based on the SpO2 level.

  • DRDO’s anti-COVID drug reducing oxygen dependence approved for emergency use

    By Express News Service
    NEW DELHI: The Drugs Controller General of India (DGCI) has granted emergency use approval to an anti-Covid drug 2-deoxy-D-glucose (2-DG) developed by the Defence Research and Development Organisation(DRDO) lab. This after a three-phase clinical trial of the drug had shown a faster recovery of hospitalised patients. 

    The Ministry of Defence on Saturday informed that “Clinical trial results have shown that this molecule helps in faster recovery of hospitalised patients and reduces supplemental oxygen dependence. A 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.”

    The anti-COVID-19 therapeutic application of the drug 2-DG has been developed by the Institute of Nuclear Medicine and Allied Sciences (INMAS), a lab of the Defence Research and Development Organisation (DRDO), in collaboration with Dr Reddy’s Laboratories (DRL), Hyderabad.

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     The work on the drug began in April 2020, during the first wave of the pandemic. INMAS-DRDO scientists conducted laboratory experiments with the help of the Centre for Cellular and Molecular Biology (CCMB), Hyderabad. The final phase III trial of the drug was conducted from December 2020 to March this year and it was found that this molecule works effectively against SARS-CoV-2 virus and inhibits its growth.

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

    The DRDO, along with its industry partner DRL, Hyderabad, started clinical trials to test the safety and efficacy of the drug in COVID-19 patients. In Phase-II trials (including dose-ranging) conducted from 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 trials was conducted across 11 hospitals all over the country. Phase-II trial was conducted on 110 patients.

    In efficacy trends, the MoD said 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 normalisation 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 between December 2020 to March 2021 at 27 COVID hospitals in Delhi, Uttar Pradesh, West Bengal, Gujarat, Rajasthan, Maharashtra, Andhra Pradesh, Telangana, Karnataka and Tamil Nadu.

    The detailed data of phase-III clinical trials was presented to the DCGI. It was found that a significantly higher proportion of patients given the drug improved symptomatically and became free from supplemental oxygen dependence (42% vs 31%) by Day 3, indicating an early relief from oxygen therapy/dependence.

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

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    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.

    The drug comes in powder form in a sachet, which is taken orally by dissolving it in water. It accumulates in the virus-infected cells and prevents the growth of the virus by stopping viral synthesis and energy production. Its selective accumulation in virally infected cells makes this drug unique.

    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. ALSO WATCH: