According to a press release issued by the city-based drug maker, Dr. Reddy's will supply the drug 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 the country.
2-DG manufactured by Dr. Reddy's has a purity of 99.5 per cent and is being sold commercially under the brand name 2DG.
The maximum retail price (MRP) of each sachet has been fixed at Rs 990, with a subsidized rate offered to Government institutions, it said.
2-DG, a oral drug was developed by the Institute of Nuclear Medicine and Allied Sciences (INMAS), a laboratory of the Defence Research and Development Organisation (DRDO), in collaboration with Dr. Reddy's.
Dr. G Satheesh Reddy, Secretary, Department of Defence (R&D) and Chairman, DRDO said "We are pleased to have worked closely with our long-term industry partner Dr. Reddy's Laboratories, Hyderabad, for testing 2-DG as therapeutic application in treatment of COVID-19 patients. DRDO has been contributing in the fight against COVID-19 pandemic with its spin off technologies."
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.
Emergency use approval for anti-COVID-19 therapeutic application of the drug was granted on May 1, 2021.
Satish Reddy, Chairman, Dr. Reddy's, said "2-DG is yet another addition to our COVID-19 portfolio that already covers the full spectrum of mild to moderate and severe conditions and includes a vaccine. We are extremely pleased to have partnered with DRDO in our collective fight against the COVID-19 pandemic."
Domestic pharma firm Glenmark Pharmaceuticals had on Saturday launched antiviral drug Favipiravir, under the brand name FabiFlu, for the treatment of patients with mild to moderate COVID-19 at a price of about Rs 103 per tablet
Hetero has received the manufacturing and marketing approval for Remdesivir from the Drug Controller General of India (DCGI) for the treatment of COVID-19, it said in a statement.
Hetero's generic version of Remdesivir will be marketed under the brand name 'Covifor' in India.
The drug will be available in 100 mg vial (injectable) which has to be administered intravenously in a hospital setting under the supervision of a healthcare practitioner, it said.
Asked about the price of the drug, Hetero Group of Companies MD Vamsi Krishna Bandi told PTI it will be in the range of Rs 5,000-6,000 per dose.
Currently, the drug is being manufactured at the company's formulation facility in Hyderabad. The active pharmaceutical ingredient (API) is being made in the firm's Visakhapatnam facility, he added.
The drug will be available only through hospitals and government, and not the retail channel, Vamsi said
The company is focused on providing one lakh doses in the next few weeks, and the production can be ramped up based on demand, he added.
The drug has been granted approval by DCGI for the treatment of suspected or laboratory-confirmed cases of COVID-19 in adults and children, hospitalised with severe symptoms of the disease, the company said.
"In the light of increasing COVID-19 cases in India, the approval of 'Covifor' (Remdesivir) can prove to be a game-changer given its positive clinical outcomes.
"Backed by strong backward integration capabilities, we can ensure that the product is immediately made available to patients across the country," Hetero Group of Companies Chairman B ParthaSaradhi Reddy said.
The company is prepared for ensuring enough stocks to cater to the present needs, he added.
The product is being launched under a licensing agreement with Gilead Sciences Inc to expand access to COVID-19 treatment in low and middle-income countries, Hetero said.
In May, domestic pharma firms Hetero, Cipla and Jubilant Life Sciences had entered into non-exclusive licensing agreements with drug major Gilead Sciences Inc for manufacturing and distribution of Remdesivir.
The medicine has been issued an Emergency Use Authorization (EUA) by the United States Food and Drug Administration (USFDA) to treat COVID-19 patients.
(PTI)
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The complaint was filed at Jyoti Nagar police station in Jaipur on Friday.
Avnish Parashar, Additional Deputy Commissioner of Police (DCP), south, Jaipur, said: "Ramdev, Acharya Balkrishna, Balbir Singh Tomar, Anurag Tomar and Anurag Varshney, were booked under Section 420 (cheating) of the Indian Penal Code and relevant sections of the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, as per the FIR lodged by an advocate Balbir Jakhar."
Two of the accused including Balbir Singh Tomar and Anurag Tomar, are the chairman and the director of the Jaipur-based NIMS University. The fifth accused, Varshney, is a scientist at Patanjali Ayurved.
Jakhar said the accused have endangered the common people's lives by making false claims of finding a COVID-19 vaccine as they neither informed the Rajasthan government nor the Centre about the clinical trials of Coronil.
Patanjali Ayurved, on Tuesday launched Coronil tablet and Swasari vati medicine claiming that they can cure COVID-19 within seven days.
However, the AYUSH ministry expressed unawareness about the development and Patanjali was stopped from advertising the medicine within a few hours after its launch.
Patanjali earlier also claimed that the two Ayurveda-based medicines have shown 100 per cent favourable results during clinical trials on COVID-19 patients except those on a life support system.
The clinical trials were reportedly held in NIMS Jaipur.
While Ramdev claimed making a thorough clinical case study on patients admitted at NIMS, its Chairman, B.S. Tomar on the other hand said, "No clinical trial in our hospital was made for the drug as there was no serious case of patients admitted. Only 100 asymptomatic patients in our hospital were given a few ayurvedic medicines under the Patanjali banner. We did not ask for medicine to cure coronavirus but had only these ayurvedic immunity boosters who helped recovery of asymptomatic cases faster by 35 per cent."
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Glenmark Pharmaceuticals had launched FabiFlu last month at a price of Rs 103 per tablet.
In a regulatory filing Glenmark announced a price reduction of 27 per cent for FabiFlu. The new maximum retail price (MRP) is Rs 75 per tab, it said.
“The price reduction has been made possible through benefits gained from higher yields and better scale, as both the active pharmaceutical ingredient (API) and formulations are made at Glenmark’s facilities in India, the benefits of which are being passed on to patients in the country,” the filing said.
“Our internal research shows us that we launched FabiFlu in India at the lowest market cost as compared to the cost of Favipiravir in other countries where it is approved. And now we hope that this further price reduction will make it even more accessible for patients across the country,” Glenmark Pharmaceuticals Senior Vice President and Head India business Alok Malik said.
Further, the company has commenced a post marketing surveillance (PMS) study on FabiFlu to closely monitor the efficacy and safety of the drug in 1,000 patients that are prescribed with the oral antiviral, as part of an open label, multicenter, single arm study, the filing added.
“We expect this post marketing surveillance study to shed more light on the drug’s clinical effectiveness and safety in a large cohort of patients prescribed FabiFlu,” Malik added.
On June 20, Glenmark announced that it received manufacturing and marketing approval from India’s drug regulator for FabiFlu, making it the first oral Favipiravir-approved medication in India for the treatment of mild to moderate COVID-19.
Glenmark has also completed the phase 3 clinical trial with Favipiravir (FabiFlu) in mild to moderate COVID-19 patients in India. The trial results will be available shortly, the company said.
Glenmark is also conducting another phase 3 clinical trial to evaluate the efficacy of two antivirals drugs Favipiravir and Umifenovir as a combination therapy in moderate hospitalised adult COVID-19 patients in India.
Shares of Glenmark Pharma were trading 1.34 per cent lower at Rs 421.00 apiece on BSE.
(PTI)
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In a reply to V.G. Somani, Directorate General of Health Services, Central Drugs Standard Control Organisation, Glenmark has responded to allegations made in the representation by an unnamed Member of Parliament.
Glenmark said it is "dismayed" by the allegations as it brought an oral anti-viral agent in less than 3 months, being the first and only company to conduct a robust 150-patient randomized controlled trial and launching the drug at an affordable price.
"Glenmark has been at the receiving end of such careless, unsubstantiated allegations that are devoid of merits whatsoever as amply demonstrated above," it said.
On the concern raised by the MP on unaffordability due to high price, Glenmark said "Compared to other therapies approved for emergency use in COVID-19, FabiFlu is much more economical and an effective treatment option."
Further, given that Favipiravir is an oral therapy, patients can be treated on an out-patient basis without incurring additional hospitalization expenses, unlike other approved drugs which are injectable and hence require administration at hospitals.
Favipiravir in India, when launched, was at the lowest market cost (Rs 103/tab) as compared to the cost of Favipiravir in other countries where it was approved.
Despite investing significantly throughout the process of manufacturing, Glenmark has managed to keep the pricing of Favipiravir lower as compared to price of Favipiravir in other countries.
Subsequently, on July 13, Glenmark reduced price of FabiFlu to Rs 75 per tablet. The price reduction was made possible through our efforts to obtain better yield and better scale, and with both API and formulations manufactured at Glenmark's own facilities in India.
Today, Favipiravir is a part of several state government protocols and thousands of COVID-19 patients have benefited from the prescription of the product, the company said.
There is an allegation of misleading/false claim that Favipiravir is effective in COVID-19 patients with comorbidities like diabetes, hypertension as Phase 3 clinical trial was designed to evaluate the efficacy in these co-morbidities.
In its response, Glenmark said the alleged statement pertaining to co-morbidity in the press release dated June 20 was not derived from or alluded to Glenmark's ongoing Phase 3 clinical trial. On the contrary, the reference to comorbidity was clearly based on data from Japanese registry -- the largest collection of real-world evidence on clinical use of Favipiravir in COVID-19.
"In fact what is surprising is that the allegation of false claim is being made that when Glenmark, being a responsible corporate citizen, explicitly referenced upfront the Japanese registry, and at no point linked it to our India Phase 3 clinical trial," it said.
"In view of the above, it is clear that Glenmark's communication at the launch of the said Product has been completely misread and/or quoted out of context which is harming our reputation," Glenmark said.
There is also an allegation that Favipiravir is not tested as monotherapy in Phase 3 clinical trial in India. "At the outset, Glenmark denies having made any such claim at any point in time that "Favipiravir alone" is effective in treatment of Covid-19 patients with mild to moderate disease," it said.
In the light of the pandemic, in all COVID-19 trials being proposed/conducted across India, all patients receive standard supportive care as per the guidance of Health Ministry as giving the patients placebo alone in such a situation would be unethical as it would deprive the patients of any care at all.
Globally, similar approach, including standard supportive care is adopted in clinical trials that are being conducted to consider treatment options for COVID-19 patients.
Similarly, in the Glenmark Study, as per the guidelines issued by ICMR and Health Ministry, patients with mild to moderate COVID 19 symptoms were treated with Favipiravir plus recommended standard supportive care versus standard supportive care alone.
"It is pertinent to note that the standard supportive care in Glenmark Study did not include HCQ or any other anti-viral drug. Consequently, since both arms of the Glenmark Study received standard supportive care under this design, any advantage observed in the treatment arm can solely be attributed to the administration of Favipiravir," Glenmark rebutted.
(IANS)
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Priced at Rs 2,800 per 100 mg vial, Remdac is the most economical Remdesivir brand in India, Zydus Cadila said in a regulatory filing.
The company said the drug will be made available across India through the group's strong distribution chain reaching out to government and private hospitals treating COVID-19 patients.
Remdac is the most affordable drug as we would like to enable patients to have access to this critical drug in the treatment of COVID-19, Cadila Healthcare Managing Director Dr Sharvil Patel said.
Through the course of this pandemic, the company's efforts have been focused on supporting people in this healthcare crisis, whether it is through developing vaccines, ramping up production and distribution of critical drugs and therapies, making diagnostic tests available or exploring new treatment options, Patel added.
In June this year, Zydus had entered into a non-exclusive agreement with Gilead Sciences Inc to manufacture and sell Remdesivir, the investigational drug, which has been issued an emergency use authorisation by the US Food and Drug Administration (USFDA) to treat patients suffering from severe symptoms of COVID-19.
The active pharmaceutical ingredient (API) for the drug has been developed and manufactured at the group's API manufacturing facilities in Gujarat.
Zydus Cadila's vaccine candidate ZyCov-D is now in phase II of the clinical trials.
Shares of Cadila Healthcare, the listed entity of the group, were trading at Rs 387 apiece on BSE, 0.44 per cent higher against their previous close.
(PTI)
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For the study, published in the journal Science Advances, the research team from the University of Chicago in the US first focused on finding a weakness in the Covid-19 virus to target.
They chose its main protease: Mpro. Mpro is a key coronavirus enzyme that plays a central role in the virus' life cycle. It facilitates the virus' ability to transcribe its RNA and replicate its genome within the host cell.
The researchers found that the pharmaceutical drug that shows promise as a weapon against Mpro is Ebselen -- a chemical compound with anti-viral, anti-inflammatory, anti-oxidative, bactericidal, and cell-protective properties.
Ebselen is used to treat multiple diseases, including bipolar disorders and hearing loss.
Several clinical trials have proven its safety for use in humans.
According to the study, the research team set out to develop detailed models of the enzyme and the drug.
Using those models and sophisticated supercomputer simulations, they discovered that the small Ebselen molecule is able to decrease Mpro's activity in two different ways.
"In addition to binding at the catalytic site of the enzyme, Ebselen also binds strongly to a distant site, which interferes with the enzyme's catalytic function by relying on a mechanism in which information is carried from one region of a large molecule to another region far away from it through subtle structural reorganisations," said study author Juan de Pablo.
The finding was particularly important because it helped explain Ebselen's potential efficacy as a repurposed drug, and it revealed a new vulnerability in the virus that was previously not known.
The research team's discovery of two binding sites looks promising for Ebselen to be a new drug lead for the design and development of new Mpro inhibitors and Covid-19 treatment.
The team also noted that much work is yet to be done.
"The main protease is one of many proteins in the virus that could be targeted with existing, repurposed drugs, and there are thousands of compounds to be considered," de Pablo said.
"We are systematically investigating each of the proteins involved in the virus function and investigating their vulnerabilities and their responses to a wide range of drugs," de Pablo noted.
(IANS)
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Preliminary results of the study conducted on animal models showed that the drug 4-Phenylbutiric acid (4-PBA) fully curbs mortality caused by respiratory failure derived from cellular stress, showed the research published in the journal Cytokine and Growth Factors Review.
The inflammatory process identified in severe cases of coronavirus causes an uncontrolled and excessive release of cytokines -- molecules in charge of organising the body's defences- which could even trigger vascular hyperpermeability and multi-organ failure.
Controlling such cytokine "storm", through those controlling them, that is, the infected cells, is precisely what these researchers proposed.
"When cells are stressed by infection, they call the cytokines, and the more stressed they are, the more persistent they become, provoking this uncontrolled inflammation. Hence, one possible treatment for Covid-19 is to reduce cellular stress," explained one of the lead researchers Ivan Duran, Professor at University of Malaga in Spain.
According to the researcher, repurposing the 4-PBA anti-stress drug could modulate such cellular stress, which is also present in pathologies like diabetes, ageing or carcinogenesis, which, in turn, are classified as risk factors for Covid-19.
The drug has already been approved for clinical use against other diseases and, hence, easy to apply clinically.
The study also identified the endoplasmic reticulum resident protein "BiP" (Binding Immunoglobulin Protein) - a stress blood marker -- as indicator of cellular stress situations, likely to be explored and measured in affected patients.
This way, BiP levels, apart from determining the efficacy of 4-PBA treatment, could serve as early indicators of Covid-19 risk groups, establishing a correlation between high levels and the inflammatory severity after the viral infection, Duran pointed out.
(IANS)
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