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Centre approves anti-Covid drug (powder) developed by DRDO for emergency use

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DCGI approves anti-Covid drug developed by DRDO for emergency use. The drug comes in powder form in sachet, which is taken orally by dissolving it in water.

The Centre has approved an anti-Covid drug developed by DRDO for emergency use, the Union Defence Ministry Saturday said. The drug, 2-deoxy-D-glucose (2-DG), has been developed in collaboration with Dr Reddy’s Laboratories.

The Drugs Controller General of India (DCGI) has approved the emergency use of drug 2-deoxy-D-glucose (2-DG) as an adjunct therapy in moderate to severe Covid-19 patients.

The Institute of Nuclear Medicine and Allied Sciences (INMAS), a lab of Defence Research and Development Organisation (DRDO), has developed the drug, in collaboration with Dr Reddy’s Laboratories, Hyderabad.

“Clinical trial results have shown that this molecule helps in faster recovery of hospitalized patients and reduces supplemental oxygen dependence. Being a generic molecule and analogue of glucose, it can be easily produced and made available in plenty. Higher proportion of patients treated with 2-DG showed RT-PCR negative conversion in Covid patients,” DRDO said in an official statement on Saturday.

In April 2020, during the first wave of Covid-19, INMAS-DRDO scientists had 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, DCGI Central Drugs Standard Control Organization (CDSCO) gave permission for phase-II clinical trial of 2-DG in Covid-19 patients in May 2020.

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 6 hospitals and phase-IIb (dose ranging) clinical trial was conducted at 11 hospitals all over the country.

“In efficacy trends, the patients treated with 2-DG showed faster symptomatic cure than Standard of Care (SoC) on various endpoints. The drug comes in powder form in sachet, which 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,” the statement added.

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 December 2020 to March 2021 at 27 Covid-1 hospitals situated in states of Delhi, UP, West Bengal, Gujrat, Rajasthan, Maharashtra, Andhra Pradesh, Telangana, Karnataka and Tamil Nadu.

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 statement said.

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Deal Lieutenant Deal Lieutenant
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Wow, Let’s see how will it work! smiling_imp smiling_imp

Deal Lieutenant Deal Lieutenant
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Hoping the situation may normalize after it comes in Market.

Pro Analyst Pro Analyst
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@justforcoupon bro, it may be helpful for you.

Deal Subedar Deal Subedar
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Phase-III clinical trial was conducted on 220 patients cry
Critic Critic
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Probably because it is based on a compound known for many years & has been researched since 2006 for cancer related treatments. Also it is practically useless for severe cases while in case of mild cases it can at best save some oxygen(not an issue if adequate oxygen supply is available in the first place). In short this is not some miracle drug which will significantly help in current corona situation but rather more of an “effort” to show govt is doing something.

Deal Captain Deal Captain
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smile
Entertainer Entertainer
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@vijkap201

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Super Stud Super Stud
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Hope this help drug help, to fight india against covid
But producing it at such a large scale is again a problem just like vaccine

Finance Ninja Finance Ninja
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India has capacity to produce 2 to 4 billion vaccine in a month.

now your next question will be then why India is not producing vaccine at a large scale ?

answer is ‘vaccine patent’.

out of 3000 Indian vaccine producing companies, only 2 companies have license to produce covid vaccine. confused

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Finance Mentor Finance Mentor
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Looks promising.. Lets hope for good

Critic Critic
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hm

Critic Critic
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Let’s see how this works though every little bit helps.

I’m not aware of any miracle drug which can stop Covid anywhere in the world. If there’s is, please post here for benefit of others.

Budding Star Budding Star
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First batch of DRDO’s anti-Covid drug to be released on Monday, May 17

The first batch of anti-COVID drug 2-DG, developed by the DRDO, will be released on Monday, May 17 by defence minister Rajnath Singh and health minister Harsh Vardhan, officials said.

The Drugs Controller General of India (DGCI) has approved the oral drug for emergency use as an adjunct therapy in moderate to severe coronavirus patients, the defence ministry said earlier this month.

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Defence minister Rajnath Singh and Union health minister Dr Harsh Vardhan release first batch of anti-Covid drug 2DG developed by DRDO

Deal Major Deal Major
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Govt releases atmanirbhar anti-Covid drug 2DG

Defence Minister Rajnath Singh and Union Health Minister Dr Harsh Vardhan release first batch of anti-COVID drug 2DG developed by DRDO.

“With the support of DRDO and in the leadership of Union Defence Minister Rajnath Singh, this (Anti-COVID drug 2DG) may be our first indigenous research-based outcome to fight against COVID-19. It will reduce recovery time and oxygen dependency,” Vardhan said.

“Not just for India but I hope it serves in the fight against COVID, globally in the coming days. I thank and congratulate DRDO and its scientists,” the minister said.

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Will DRDO’s 2DG medicine work against COVID variants?

10,000 doses of an anti-COVID-19 therapeutic application of the drug 2-deoxy-D-glucose (2-DG), developed by the Defence Research and Development Organisation (DRDO) for treatment of Covid-19 released by Defence Minister Rajnath Singh.

The first batch of the drug released by Rajnath Singh and Dr Harsh Vardhan at an event at the headquarters of the Defence Research and Development Organisation (DRDO).

The Drugs Controller General of India (DGCI) has approved the oral drug for emergency use as an adjunct therapy in moderate to severe coronavirus patients, the defence ministry said earlier this month.

The approval of the drug has come at a time when India is grappling with a record-breaking wave of the coronavirus pandemic that has stretched the country’s healthcare infrastructure to its limit.

DRDO’s 2-DG manufacturer

The oral drug has been developed by Institute of Nuclear Medicine and Allied Sciences (INMAS), a lab of Defence Research and Development Organisation (DRDO), in collaboration with Dr Reddy’s Laboratories (DRL), Hyderabad.

DRDO anti-covid drug: Dosage and how it works

The drug comes in a powder form in a sachet and is taken orally by dissolving it in water. The drug accumulates in the virus-infected cells and prevents virus growth by stopping viral synthesis and energy production. The drug will stop the virus from multiplying.

DRDO anti-covid drug price

The pricing will be determined by Dr Reddy’s laboratories, which is manufacturing the doses.

Will DRDO’s 2DG medicine work against COVID variants?

According to the clinical trials, the drug is supposed to arrest any variant as a multiplying virus, irrespective of variant, will need food and thus will get trapped by the drug.

Will DRDO’s 2-DG drug be a game changer?

DRDO’s anti-covid drug is seen as a game changer as it helps in faster recovery of hospitalised patients and reduces supplemental oxygen dependence.

“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 aged more than 65 years,” the DRDO said.

This comes as a boon amid the devastating second COVID-19 wave, where a large number of patients are facing severe oxygen dependency and need hospitalisation.

A higher proportion of patients treated with 2-DG showed RT-PCR negative conversion in COVID patients. In efficacy trends, the patients treated with 2-DG showed faster symptomatic cure than Standard of Care (SoC) on various endpoints, the DRDO said.

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Registry data suggests phase-3 clinical trials for 2-DG at over 12 locations may continue till Aug

With the government presenting DRDO-developed drug 2-DG as a potential game-changer in the fight against COVID-19, the clinical trial registry data suggests that the phase-3 trials for the medicine at over two dozen government and private hospitals and involving 220 patients may continue till August.

The third-phase trials began in January, while the phase-2 trials were conducted over a three-month period between June and September last year and involved 110 patients. (PTI)

Benevolent Benevolent
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Any way I can view the clinical trials report please? Is it made available to public?

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Budding Star Budding Star
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DRDO responds to questions on 2-DG’s efficacy; Also launches Antibody Detection Kit for COVID-19

Sharing details of the clinical trials, the DRDO said that the trials for this drug started last year in April during the first wave of the pandemic, in which the scientists from INMAS carried out experiments with the help of Centre for Cellular and Molecular Biology (CCMB), Hyderabad.

Amidst debate over the efficacy of the recently launched drug 2-deoxy-D-glucose (2-DG), Defence Research and Development Organization (DRDO) says that Dr Reddy’s Lab were joint development partners in the study on COVID patients. Responding to queries from the Financial Express Online, DRDO officials say, “Dr Reddy’s Lab was the development partner in this clinical study on COVID patients, as long-standing industry partners of DRDO for 2-DG clinical applications since 2004. Earlier they have successfully completed phase-3 clinical trials of 2-DG for radiotherapy of brain tumor patients.”

“Other organisations might have worked on the drug in different ways however DRDO work is based on the scientifically well-established principle that 2-DG suppresses energy generation in our cells that are infected by virus, and thereby stops viral growth in body,” DRDO official said in response to Patanjali claims.

Adding, “DRDO and Dr Reddy’s lab presented the work to DCGI and got emergency use approval as per procedure.”

What does DRL say?

According to the official spokesperson: “There is sufficient literature available in the public domain on 2-DG in the area of immunology/cancer therapy as it is not a new drug. In India, 2-DG has been a DRDO drug from the start. No other institute was involved in its development. The trials to test its use against COVID-19 were a collaboration between the DRDO and Dr. Reddy’s; no other institute was involved.”

The story so far …

According to an official statement issued by the Ministry of Defence (May 8, 2021), this drug has been jointly developed and produced by DRDO and Dr Reddy’s Laboratories (DRL), Hyderabad. The statement said that the drug has undergone clinical trials and it has shown that there is a faster recovery of hospitalized patients. During the trials, according to the statement, this drug helped in reducing supplemental oxygen dependence.

Sharing details of the clinical trials, the DRDO said that the trials for this drug started last year in April during the first wave of the pandemic, in which the scientists from INMAS carried out experiments with the help of Centre for Cellular and Molecular Biology (CCMB), Hyderabad.

It went on to state the molecule was working effectively against SARS-CoV-2 virus, and inhibited the viral growth. Last May, Drugs Controller General of India’s (DCGI) and Central Drugs Standard Control Organization (CDSCO) had approved the Phase-II clinical trial of 2-DG in COVID-19 patients. This Phase II was done between May-October.

The approval for the Phase III trial was given last November. And it is expected to go on until August 2021 in over 200 hospitals. Globally this drug has been tested for treating various cancers. But it is only in India that it has been tested for COVID-19 pandemic. However, the DRDO statement indicates that the Phase III trials are over and the DCGI approval has been given based on the findings.

Meanwhile, Patanjali Research Institute claims it made a strong case for its therapeutic use against COVID-19 last year.

Covid-19 Antibody Detection Kit “DIPCOVAN”

On Friday (May 21, 2021) the Defence Institute of Physiology and Allied Sciences (DIPAS), under DRDO, developed an antibody detection-based kit “DIPCOVAN”.

More about the kit

This kit can detect both spike as well as nucleocapsid (S&N) proteins of SARS-CoV-2 virus with a high sensitivity of 97% and specificity of 99%.

It has been developed in association with New Delhi based development and manufacturing diagnostics company — Vanguard Diagnostics Pvt Ltd.

This kit according to the Ministry of Defence (May 21, 2021) has been developed indigenously by the scientists and has been tested 1000 patients at various COVID designated hospitals in Delhi.

According to the note, three batches of the product were validated during the last one year and in April this year the ICMR gave its approval.

And, earlier this month the regulatory approval from the Drugs Controller General of India (DCGI), CDSCO, Ministry of Health and Family Welfare, was given to the manufacture for sale and distribution.

This kit is intended for the qualitative detection of IgG antibodies in human serum or plasma, targeting SARS-CoV-2 related antigens.

And, with a shelf life of 18 months, this kit requires just 75 minutes to conduct the test without any cross reactivity with other diseases.

When will it be available in the market?

Industry partner Vanguard Diagnostics Pvt. Ltd is expected to commercially launch the product next month. And at the time of its launch in the first week, there will be a ready stock of 100 kits (Approx 10,000 tests). The company has a production capacity of 500 kits/month soon after the launch.

And will be Rs 75 per test.

With this kit there will be a better understanding of COVID‐19 epidemiology. And will also help in assessing an individual’s previous SARS‐CoV‐2 exposure.

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Zydus Cadila seeks human trial approval from Modi govt

Zydus Cadila has sought regulatory approval for clinical trials of its antibody cocktail to treat mild COVID-19, as the country grapples with a shortage of medicines and vaccines needed to effectively tackle a devastating second wave of the pandemic.

The treatment candidate, ZRC-3308, was earlier shown to reduce lung damage during animal trials, the drugmaker said, adding it was found to be safe and well-tolerated.

The therapy is a cocktail of two monoclonal antibodies, which mimic natural antibodies that the body generates to fight infection. ’

At this juncture, there is a critical need to explore safer and more efficacious treatments to combat COVID,’ Zydus Cadila’s managing director, Sharvil Patel, said in a stock exchange filing. – Reuters

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2-DG: DRDO’s Covid-19 drug to be available for Rs 990, commercial launch in mid-June.

The price of DRDO’s 2DG anti-COVID 19 drug has been fixed at Rs 990 per sachet by Dr Reddy’s lab.

The price of DRDO’s 2DG anti-COVID 19 drug has been fixed at Rs 990 per sachet by pharma major Dr Reddy’s Laboratories , news agency ANI reported. However, the drug will be provided by government hospitals at a discounted price, officials told ANI.

2-deoxy-D-glucose (2DG) is an oral anti-viral drug for Covid-19 patients. The drug has generated a lot of curiosity after it was launched on May 17 by the Ministry of Defence. It has been developed by the Institute of Nuclear Medicine and Allied Sciences (INMAS), a leading laboratory of the DRDO, in collaboration with Dr Reddy’s Laboratories (DRL) in Hyderabad.

According to Dr Reddy’s Laboratories, the drug will be commercially launched in mid-June.

Meanwhile, Dr Reddy’s Laboratories on Thursday released the second batch of 2-DG. The mass production is expected to begin in the first week of June.

Earlier this month, the Drugs Controller General of India (DGCI) had approved the oral drug for emergency use as an adjunct therapy to treat severe Covid patients.

According to the Ministry of Defence, the drug during clinical trials showed that it facilitates faster recovery of hospitalised Covid patients and reduces dependence on supplemental oxygen. Higher proportion of patients treated with 2-DG showed RT-PCR negative conversion in COVID patients.

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DRDO invites EoI to transfer technology of 2-DG drug for bulk production

The Defence Research and Development Organisation (DRDO), which developed 2-Deoxy-D-Glucose (2-DG), a drug used for treatment of COVID-19 patients, has called for Expression of Interest (EoI) to transfer the technology to Indian pharmaceutical industries for production.

According to the EoI document, applications should be submitted before June 17 through email. “The EoI submitted by industries will be scrutinised by a Technical Assessment Committee (TAC). Only up to 15 industries will be given ToT on their capabilities, technical hand holding capability of DRDO and on First Come First Served Basis,” it said.

The bidders should have a Drug license to manufacture Active Pharmaceutical Ingredient (API) from Drug Licensing Authorities and WHO GMP (Good manufacturing Practices) certification among others. Laboratory synthesis process for 2-DG has been developed using D-Glucose as starting material. The synthesis process consists of conversion of D-Glucose to 2-DG through five chemical reaction steps followed by purification.

The process has been established at batch scale (100g) and pilot plant scale (500g) and necessary patents have been filed by DRDO in this regard, the Defence body said. (PTI)

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CSIR-IICT, Bengaluru pharma firm join hands to make Covid drug 2-DG

The CSIR-Indian Institute of Chemical Technology (IICT) here and Bengaluru-based Anthem Biosciences Pvt Ltd have entered into an agreement for technology transfer and manufacture of anti- Covid drug 2-DG.

Studies have shown that 2-DG demonstrated quick recovery and reduction in oxygen dependence among moderate and severely affected Covid patients.

This drug, in the form of powder formulation, was earlier launched by Dr Reddy’s Laboratories in India, IICT said in a release.

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2-DG effective against all virus variants, says study

Glycolytic inhibitor 2-DG attenuates SARS-CoV-2 multiplication in host cells and weakens the infective potential of progeny virions (virus), concludes the study by researchers from Centre for Cellular and Molecular Biology (CCMB), Hyderabad, Institute of Nuclear Medicine and Allied Sciences, Delhi, and Academy for Scientific and Innovative Research, Ghaziabad.

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Dr. Reddy’s Labs announces commercial launch of 2-DG used in treatment of Covid-19

Dr. Reddy’s Laboratories today announced the commercial launch of 2-deoxy-D-glucose(2-DG), a medicine developed by the Defence Research and Development Organisation(DRDO) for the treatment of Covid-19 patients.

Dr. Reddy’s will supply to major Government as well as private hospitals across India. In the initial weeks, the Company will make the drug available in hospitals across metros and Tier 1 cities, and subsequently expand coverage to the rest of India.

2-DG manufactured by Dr. Reddy’s has a purity of 99.5% and is being sold commercially under the brand name 2DGTM. The maximum retail price (MRP) of each sachet has been fixed at Rs. 990, with a subsidized rate offered to Government institutions.

2-DG was developed by the Institute of Nuclear Medicine & Allied Sciences (INMAS), a laboratory of the Defence Research and Development Organisation (DRDO), in collaboration with Dr. Reddy’s. 2-DG is an oral drug.

It can be administered only upon prescription and under the supervision of a qualified physician to hospitalised moderate to severe COVID-19 patients as an adjunct therapy to the existing standard of care.

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Laurus Labs receives licence from DRDO to manufacture Covid drug 2-DG

Drug firm Laurus Labs on Friday said it has received the licence from Defence Research and Development Organisation to manufacture and market Covid-19 treatment drug 2-Deoxy-D-Glucose (2DG).

2DG has been given emergency approval by the Drugs Controller General of India (DCGI) for use on Covid-19 patients in the country, Laurus Labs said in a regulatory filing.

“Laurus Labs has already applied with the Central Drugs Standard Control Organisation (CDSCO) for emergency use authorization (EUA) for 2DG,” it added

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Mankind Pharma gets DRDO nod to manufacture, market COVID drug 2-DG

Drug firm Mankind Pharma on Thursday said it has received licence from the Defence Research and Development Organisation (DRDO) to manufacture and market oral 2-deoxy-D-glucose (2-DG), used for the treatment of COVID-19. 2-DG was developed by the Defence Research and Development Establishment (DRDE), Gwalior.

The clinical trials were conducted by the Institute of Nuclear Medicine and Allied Sciences (INMAS), a lab of DRDO, in association with Dr Reddy’s Laboratories, Mankind Pharma said in a statement. The company will manufacture the product at its facilities in Visakhapatnam and Himachal Pradesh, it added.

The office of the Drugs Controller General of India (DCGI) on May 1 had permitted the emergency use of 2-DG as an adjunct treatment for moderate to severe COVID-19 patients, Mankind Pharma said. (PTI)

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