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The government has waived the requirement for clinical trials of certain categories of drugs in <keyword id="19895063" type="General" weightage="20" keywordseo="India" source="keywords">India</keyword> if they are approved in the <keyword id="19899478" type="General" weightage="20" keywordseo="US" source="keywords">US</keyword>, the <keyword id="19922618" type="General" weightage="20" keywordseo="UK" source="keywords">UK</keyword>, Japan, Australia, Canada and the European Union. The waiver only covers five categories -- orphan drugs for rare diseases, gene and cellular therapy products, <keyword id="22559447" type="General" weightage="20" keywordseo="new-drugs" source="keywords">new drugs</keyword> used in pandemic situations, new drugs used for special defence purposes and new drugs having significant therapeutic advances over the current standard care. This waiver would ensure expeditious availability of the latest medicines for treating diseases like cancers, rare diseases like Spinal Muscular Atrophy (SMA) and Duchenne Muscular Dystrophy (DMA), and autoimmune conditions in India. "As per Rule 101 of New Drugs and Clinical Trials Rules, 2019, the Central Licensing Authority, with the approval of the Central Government, may specify, by an order, the name of the countries, from time to time, for considering waiver of local clinical trial for approval of new drugs under Chapter X and for grant of permission for conduct of clinical trial under Chapter V of the said rules," the Drugs Controller General of India (<keyword id="20559042" type="General" weightage="20" keywordseo="DGCI" source="keywords">DGCI</keyword>) said in an order issued on August 7. "In exercise of the powers conferred under Rule 101 of the said rules with the approval of the Central Government, the countries namely USA, UK, Japan, Australia, Canada and EU are hereby specified for following categories of new drugs," it said. Presently, several medicines already approved by other regulatory authorities in the US, the UK and the EU are not immediately available for Indian patients because of certain regulatory requirements under the Drugs and Cosmetics Act and rules made thereunder. These include the requirement of conducting a local clinical trial and generating safety and efficacy data before marketing authorisation in India, an official explained. However, Rule 101 of the New Drugs and Clinical Trials, 2019, allows the DCGI to specify certain countries for considering waiver of local clinical trials for approval of new drugs. "The advantages of operationalising this rule are that the latest medicines to treat diseases like cancers, rare diseases like SMA and DMA, and autoimmune conditions will become available expeditiously in India. "Presently, the delay in launching a new or novel medicine in India is anywhere between 5-20 years when compared to western markets. With the waiver of Rule 101, the scope of parallel launches of medicines in India along with the West will be opened up," the official explained. Besides, there will be a considerable reduction in the cost of various advanced medicines. Also, there will be a substantial reduction in the public procurement costs of the central and state governments under various schemes like the Central Government Health Scheme (CGHS) and Ayushman Bharat. Another advantage is that the resources which would have gone into approving the Indian clinical trials could now be utilised productively elsewhere, the official said. The costs of conducting local clinical trials will be reduced for pharmaceutical firms, therefore passing on these savings to patients. This is especially true for cases of rare diseases where firms have logistical difficulties in finding participants. The change will promote further research in these areas as there will be access to patient data in the Indian context much earlier, ultimately promoting indigenous innovation and shift from volume to value, the government's mission for the pharmaceutical industry, the official said. SEE ALSO:<a href="https://www.businessinsider.in/business/news/ola-wants-to-re-enter-the-quick-commerce-business-to-take-on-blinkit-and-swiggy-instamart/articleshow/112364583.cms" target="_blank"></a> <a href="https://www.businessinsider.in/business/news/ola-wants-to-re-enter-the-quick-commerce-business-to-take-on-blinkit-and-swiggy-instamart/articleshow/112364583.cms" target="_blank">Ola wants to re-enter the quick commerce business to take on Blinkit and Swiggy Instamart</a><a href="https://www.businessinsider.in/finance/banks/news/rbi-mpc-meet-cheque-clearing-time-reduced-upi-limit-increased-for-tax-payment/articleshow/112366099.cms" target="_blank"></a> <a href="https://www.businessinsider.in/finance/banks/news/rbi-mpc-meet-cheque-clearing-time-reduced-upi-limit-increased-for-tax-payment/articleshow/112366099.cms" target="_blank">RBI MPC meet – Cheque clearing time reduced, UPI limit increased for tax payment</a><a href="https://www.businessinsider.in/business/auto/news/tata-curvv-ev-with-up-to-585-km-range-launched-starting-at-17-49-lakh/slidelist/112342769.cms" target="_blank"></a> <a href="https://www.businessinsider.in/business/auto/news/tata-curvv-ev-with-up-to-585-km-range-launched-starting-at-17-49-lakh/slidelist/112342769.cms" target="_blank">Tata Curvv EV with up to 585 km range launched starting at ₹17.49 lakh</a>

Govt waives clinical trial requirement for several drugs approved in select countries

<ul><li>Zydus Cadila, on August 13, launched Remdesivir under the brand name Remdac, used to treat patients suffering from severe symptoms of COVID-19. </li><li>Priced at ₹2,800 per 100 mg vial, it is the cheapest <keyword id="9013152" type="UNKNOWN" weightage="20" keywordseo="remdesivir-drug">Remdesivir drug</keyword> available in India </li><li>Apart from Cipla and Hetero Labs, Jubilant Lifesciences, and Mylan are working to manufacture the drug in India. </li></ul>Zydus Cadila has launched Remdesivir under the brand name Remdac, used to treat patients suffering from severe symptoms of COVID-19, in the Indian market. Remdac is priced at ₹2,800 per 100 mg vial, making it the cheapest version of the drug so far. Zydus Cadila is the fifth company to make this antiviral drug in India. They have said that 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. <table style="border-width: initial; border-style: none; width: 468pt; table-layout: fixed;"></colgroup><tbody><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Company </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Brand </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Remdesivir Price </td></tr><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Zydus Cadila </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Remdac </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">₹2800 </td></tr><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Hetero Labs </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Covifor </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">₹5000-₹6000 </td></tr><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Cipla </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Cipremi </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Not disclosed yet </td></tr></tbody></table> 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. Previously, pharmaceutical giants Cipla and Hetero introduced generic versions Remdesivir — an antiviral drug first used to treat Ebola — to fight coronavirus. India’s Health Ministry approved use of the drug to treat mild cases of coronavirus. However, the drug is not recommended to treat those who have several renal impairment, pregnant and lactating women, children below 12 years age. Hetero said it will make its version of Remdesivir — Covifor — available between ₹5,000 to ₹6,000 for a vial. Whereas, Cipla is yet to decide the cost of Cipremi. Cipla’s Cipremi is available for only those patients who are on oxygen support. Apart from Cipla and Hetero Labs, Jubilant Lifesciences and Mylan are also working to manufacture the drug in India. Dr Reddy’s Laboratories, Biocon firm Syngene and has also received voluntary permission from Gilead Sciences to produce Remdesivir in India. (With inputs from PTI) SEE ALSO: <a href="https://www.businessinsider.in/politics/world/news/trump-was-rushed-from-the-briefing-room-by-secret-service-after-a-shooting-outside-of-the-white-house/articleshow/77474005.cms">Trump was rushed from the briefing room by Secret Service after a shooting outside the White House</a> <a href="https://www.businessinsider.in/careers/news/mckinsey-facebook-amazon-nokia-and-some-other-companies-looking-for-a-product-manager-right-now/slidelist/77464438.cms">McKinsey, Facebook, Amazon, Nokia — and some other companies looking for a product manager right now</a> <a href="https://www.businessinsider.in/business/startups/news/how-karan-bajaj-sold-his-less-than-18-month-old-startup-white-hat-jr-to-byjus/articleshow/77415329.cms">A WhatsApp message, six weeks of talks and a $300 million deal – how Karan Bajaj sold his less than 18-month old startup White Hat Jr to Byju’s</a>

These are the companies that are making Remdesivir in India

New York, Amid news that the US has bought up virtually the entire global supply of <keyword id="8775508" type="UNKNOWN" weightage="20" keywordseo="remdesivir">remdesivir</keyword>, a new study outlines how the drug could save lives in countries with a lower hospital capacity, such as South Africa, where Covid-19 is beginning to overwhelm intensive care units (ICUs). The study, published in the journal Clinical Infectious Diseases, estimated that remdesivir's ability to shorten ICU stays could increase the number of patients treated in South Africa's ICUs by more than 50 per cent. "There are many countries with limited ICU capacity that could benefit from this double impact on mortality," says study lead author Dr Brooke Nichols, Assistant Professor at <keyword id="9539346" type="COMPANY" weightage="20" keywordseo="the-boston-university">the Boston University</keyword>. For the remdesivir study, the research team used their South African National Covid-19 Epidemiology model to look at the estimated three to six months when severe cases will exceed the country's 3,450 available ICU beds. If every one of South Africa's ICU patients with Covid-19 received remdesivir, reducing the average ICU stay, the researchers estimated that the number of patients treated in ICUs from June to December would increase from between 23,443 and 32,284 patients to between 36,383 and 47,820. The findings showed that the increased capacity of remdesivir could save as many as 6,862 lives per month as the country's cases peak and the drug could prevent the deaths of as many as 13,647 South Africans by December. The mortality rate for Covid-19 in ICUs varies from country to country and hospital to hospital, so the number of lives saved from increased ICU capacity would also vary, the study said. The research team has been modelling South Africa's Covid epidemic to help the country's government make informed decisions, and previously predicted that the country's ICU capacity could be overwhelmed as early as this month. "The hardest-hit province, the Western Cape, exceeded ICU capacity in June," the study authors informed. Earlier this month, the European Commission had authorised anti-viral drug remdesivir for the treatment against coronavirus, making it the first drug authorised at the European Union level for the treatment of Covid-19.

How remdesivir drug can save lives in nations with lower hospital capacity

<ul><li>Cipla will launch its version of Remdesivir in the next 1-2 days under the brand name 'Cipremi'.</li><li>The drug will be sold at an approximate price of ₹4,000 per vial.</li><li>Remdesivir is considered a key drug in the fight against Covid-19 as a randomised clinical trial conducted with the drug demonstrated faster clinical recovery in hospitalised patients.</li><li>The Union Health Ministry has asked all the states to strengthen their vigil, so that black marketing of Covid-19 drug Remdesivir is prevented.</li></ul>As India faces a shortage of Covid-19 drug Remdesivir, the pharmaceutical company Cipla said it will launch its version of Remdesivir in the next 1-2 days. <a href="https://www.cnbctv18.com/healthcare/exclusive-as-india-faces-shortage-of-remdesivir-cipla-says-its-supplies-will-hit-market-in-next-1-2-days-6281911.htm">In an interview with CNBC TV18</a>, Kedar Upadhyay, Cipla’s CFO said that the Daman-based Sovereign Pharma had released the first batch of the drug from its manufacturing plant and Cipla will be selling it under the brand name 'Cipremi'. While Mumbai-based BDR Pharma holds the contract for manufacturing of Cipla’s Remdesivir, the company has further sub-contracted the manufacturing of the finished dosage and packaging to Daman-based Sovereign Pharma. <div type="Article" hostid="261" msid="76747405" title="These are the companies manufacturing COVID-19 drug Remdesivir in India" mstype="2" mssubtype="0"></div> "We are attempting to launch Remdesivir in the next 1-2 days. We cannot comment on the volumes just as yet, but there is a huge demand-supply gap in the market," Upadhyay told CNBC TV18. However, <a href="https://www.cnbctv18.com/healthcare/exclusive-as-india-faces-shortage-of-remdesivir-cipla-says-its-supplies-will-hit-market-in-next-1-2-days-6281911.htm">reports</a> say that Sovereign Pharma has the capacity to scale up production to 95,000 vials per month. Sovereign Pharma got all necessary approvals for manufacturing the drug within a week, after an inspection by the Central Drugs Standard Control Organisation. The drug will be sold at an approximate price of ₹4,000 per vial. Upadhyay told CNBC that the company is also preparing to set up a Remdesivir manufacturing facility in-house. Remdesivir is considered a key drug in the fight against Covid-19. The drug’s popularity grew after a randomised clinical trial used the drug on 1,063 patients over 60 centres across US, Europe and Asia and saw faster clinical recovery in hospitalised patients. To expand the supply of Remdesivir, US-based Gilead earlier announced non-exclusive voluntary licensing agreements with generic pharmaceutical manufacturers based in India, Egypt and Pakistan. The agreements allow Cipla and other companies including Dr. Reddy's Laboratories Ltd.; Hetero Labs Ltd.; Syngene, a Biocon company; and Zydus Cadila Healthcare Ltd. to manufacture Remdesivir for distribution in 127 countries. Government cracks down on Remdesivir black market The Union Health Ministry has asked all the states to take all measures to ensure that Remdesivir is not sold in the black market. The ministry acted upon it after t<a href="https://www.outlookindia.com/newsscroll/health-ministry-steps-in-to-curb-black-marketing-of-covid-drug/1888995">he Directorate General of Health Services said that it has received </a>a letter from LocalCircles routed through the Health Ministry, raising concerns over black marketing and overpricing of Remdesivir in certain markets. "In view of the above, you are requested to instruct your enforcement officials to keep strict vigil on the matter to prevent black marketing and sale of Remdesivir injection above the MRP," the DGHS said in the letter to the states. SEE ALSO: <a href="https://www.businessinsider.in/science/news/the-us-bought-up-90-of-the-worlds-supply-of-remdesivir-for-the-next-3-months-and-patents-mean-many-countries-wont-be-able-to-get-any/articleshow/76729248.cms" data-type="tilCustomLink">The US bought up 90% of the world's supply of remdesivir for the next 3 months, and patents mean many countries won't be able to get any</a> <a href="https://www.businessinsider.in/stock-market/news/gilead-rises-after-pricing-its-coronavirus-fighting-drug-remdesivir/articleshow/76692239.cms" data-type="tilCustomLink">Gilead rises after pricing its coronavirus-fighting drug remdesivir</a>

Cipla says COVID-19 drug Remdesivir will hit market this week

<ul><li>Remdesivir has little or no effect on hospitalised COVID-19 patients, according to a new study by the World Health Organisation (WHO).</li><li>When coronavirus pandemic initially broke, it emerged as one of the most preferred treatments for the disease around the world.</li><li>In July, Gilead released further data suggesting that Remdesivir <a href="https://www.ft.com/content/978b4f8a-62b5-43a0-ad32-dda1930ec47c">may improve chances of survival among COVID-19 patients.</a> However, these findings were not confirmed by a randomised controlled trial until now. </li><li>Even before WHO’s study, a Lancet report <a href="https://www.businessinsider.in/science/health/news/remdesivir-the-coronavirus-miracle-drug-may-be-overhyped-suggests-lancet-study/articleshow/75470476.cms">contradicted </a>Gilead’s claims indicating that the drug may not be the most ‘promising’ treatment for coronavirus.</li><li>Not just Remdesivir, no repurposed drug or combination including Hydroxychloroquine <a href="https://www.nytimes.com/2020/10/15/health/coronavirus-remdesivir-who.html">reduced </a>chances of death of a COVID-19 patient, according to the <keyword id="808941" type="PERSON" weightage="20" keywordseo="WHO-study">WHO study</keyword>. </li></ul>Remdesivir, one of the earliest touted treatments for COVID-19 in the world, is not effective in preventing deaths of coronavirus patients, according to a study sponsored by the World Health Organisation study. The results of the study — <a href="https://www.ft.com/content/ee9b611f-2b4b-4572-afe1-b0b804d17a94">covering</a> over 2,700 people for Remdesivir across 30 countries — were posted online on October 15 and are not peer-reviewed yet. The researchers tried to treat a patient with Remdesivir for 10 days, where each patient received a 200 milligrams (mg) dose on the first day and 100 mg doses on subsequent days. “These Remdesivir, Hydroxychloroquine, Lopinavir and Interferon regimens appeared to have little or no effect on hospitalized COVID-19, as indicated by overall mortality, initiation of ventilation and duration of hospital stay,” noted the findings of the WHO’s Solidarity trial that was released on medRxiv. Gildead disagrees with WHO study Remdesivir was originally developed by Gilead Sciences to treat the Ebola virus and Hepatitis C. The company has so far <a href="https://www.nytimes.com/2020/10/15/health/coronavirus-remdesivir-who.html">refuted</a> all the claims made by the WHO study. It asserts that more rigorous studies have found Remdesivir beneficial. “The emerging data appear inconsistent with more robust evidence from multiple randomised, controlled studies validating the clinical benefit of (Remdesivir),” Gilead <a href="https://www.ft.com/content/ee9b611f-2b4b-4572-afe1-b0b804d17a94">said </a>in a comment. WHO has not made in public comment since the study is not public yet. Not just Remdesivir, no repurposed drug or combination including Hydroxychloroquine <a href="https://www.nytimes.com/2020/10/15/health/coronavirus-remdesivir-who.html">reduced </a>chances of death of a COVID-19 patient, according to the WHO study. WHO study brings bad tidings for Remdesivir producers Remdesivir is currently the only antiviral drug <a href="https://www.nytimes.com/2020/10/15/health/coronavirus-remdesivir-who.html">authorised </a>for treating COVID-19 in the US. It was taken by <a href="https://www.businessinsider.in/politics/world/news/trump-baselessly-says-he-may-be-immune-to-covid-19-after-being-hospitalized-and-treated-with-a-steroid-used-for-severe-cases/articleshow/78505594.cms">US President Donald Trump </a>when he was admitted to the hospital after testing positive for the virus. India’s Health Ministry too approved the use of the drug to treat mild cases of coronavirus. However, the drug is not recommended to treat those who have several renal impairments, pregnant and lactating women, children below 12 years age. <table style="border-width: initial; border-style: none; width: 468pt; table-layout: fixed;"></colgroup><tbody><tr><td colspan="3" style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Cost of Remdesivir treatment in India </td></tr><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Company </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Brand </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Cost of Therapy </td></tr><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Hetero </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Covifor </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">₹32,400 </td></tr><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Cipla </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Cipremi </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">₹24,000 </td></tr><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Jubilant Lifesciences </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">JUBI-R </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">₹28,200 </td></tr><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Cadila Healthcare </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Remdac </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">₹16,800 </td></tr><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Mylan </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Desrem </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">₹28,800 </td></tr><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Dr Reddy’s </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Redyx </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">₹32,400 </td></tr></tbody></table>Source:Nomura report dated October, 2020. There are six pharmaceutical giants in India — including Hetero Labs, Jubilant Lifesciences, Dr. Reddy’s Laboratories, Biocon firm Syngene and Zydus Cadila Healthcare — who have signed a non-exclusive agreement with Gilead to produce Remdesivir. The WHO study is likely to be a setback for all the pharmaceutical companies producing Remdesivir. The increasing number of cases in India drove the demand for Remdesivir. According to industry experts, Remdesivir was bringing in at least ₹6.5 million to ₹13 million in revenues per day at the current caseload. “Assuming 5% to 10% market share, we estimate current demand at 1,200 to 2,400 vials per day, which translates to ₹6.5 million to ₹ 13 million in revenues per day at the current caseload. We factor in ₹1.2 billion and ₹0.9 billion in sales from Remdesivir in FY21F and FY22F respectively,” a Nomura report dated October 2020 said. WHO isn’t alone in its skepticism of Gilead’s Remdesivir Remdesivir emerged as one of the most preferred treatments for COVID-19 — this new found disease that was threatening the world — largely driven by Gilead’s narrative. Even before WHO’s study, a Lancet report <a href="https://www.businessinsider.in/science/health/news/remdesivir-the-coronavirus-miracle-drug-may-be-overhyped-suggests-lancet-study/articleshow/75470476.cms">contradicted</a> the pharmaceutical giant’s claims indicating that Remedesivir may not be the most ‘promising’ treatment for coronavirus. It warned that Remdesivir provided no clinical benefits to patients who have tested for coronavirus. Despite the warnings, Gilead Sciences continue to claim Remdesivir as a plausible treatment for COVID-19. In July, Gilead released further data suggesting that it <a href="https://www.ft.com/content/978b4f8a-62b5-43a0-ad32-dda1930ec47c">may improve chances of survival. </a>However, these findings have not been confirmed by a randomised controlled trial until now. “What all of us would like to see is what is frequently called a ‘magic bullet’; a drug that’s already in existence, that is safe and works effectively in patients. Unfortunately, in this case, this trial at least suggests the benefits of Remdesivir weren’t there at all,” Julie Fischer, an associate research professor in the Department of Microbiology and Immunology at Georgetown University <a href="https://www.aljazeera.com/news/2020/10/16/who-trial-finds-repurposed-drugs-have-little-effect-on-covid-19">told Al Jazeera</a>. SEE ALSO: <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/science/health/news/chinas-covid-19-coronavirus-is-safe-prompts-antibody-response-says-a-lancet-study/articleshow/78696495.cms">China's COVID-19 coronavirus is safe, prompts antibody response, says Lancet </a>

Remdesivir drug fails to reduce mortality or hospital stay of COVID-19 patients, says WHO study

Drug maker Cipla Limited on Sunday announced the launch of experimental anti-viral drug remdesivir under its <keyword id="9441113" type="UNKNOWN" weightage="20" keywordseo="brand-name-cipremi">brand name Cipremi</keyword>. Remdesivir is the only US FDA approved Emergency Use Authorisation (EUA) treatment for adult and paediatric patients hospitalized with suspected or laboratory confirmed COVID-19 infection. In May, US drug maker Gilead Sciences extended a voluntary non-exclusive license to Cipla to manufacture and market Cipla's generic version of remedisvir called Cipremi. The Drug Controller General of India (DCGI) has granted Cipla regulatory approval for restricted emergency use in the country as part of the accelerated approval process considering the urgent and unmet medical need, the company said in a statement. As part of a risk management plan, Cipla will provide training on use of the drug, inform patient consent documents, conduct post marketing surveillance as well as conduct a Phase IV <keyword id="122283" type="PERSON" weightage="20" keywordseo="Clinical-trial">clinical trial</keyword> on Indian patients. "Cipla appreciates the strong partnership with Gilead to bring remdesivir to patients in India. We have been deeply invested in exploring all possible avenues to save millions of lives impacted by Covid-19 pandemic, and this launch is a significant milestone in that direction," said Umang Vohra MD and Global CEO, Cipla. According to a preliminary report from the ACTT-1 (Adaptive COVID-19 Treatment Trial 1) study, a randomized clinical trial conducted with remdesivir on 1,063 patients over 60 centres across US, Europe and Asia demonstrated a faster time to clinical recovery in hospitalised patients as compared to placebo. Most of these patients were on oxygen therapy of which some were receiving high flow oxygen or non-invasive ventilation, and some were on a mechanical ventilator. The mortality rates in the study were 7.1 per cent in those given remdesivir and 11.9 per cent in those who were given placebo. In May, Gilead Sciences signed non-exclusive voluntary licensing agreements with six Indian pharmaceutical companies to boost the supply of remdesivir, the experimental antiviral drug that has shown promise in Covid-19 treatment. These companies were -- Dr. Reddy's Laboratories Ltd., <keyword id="9441116" type="COMPANY" weightage="20" keywordseo="zydus-cadila-healthcare-ltd-">Zydus Cadila Healthcare Ltd.</keyword>, Biocon company Syngene, Hetero Labs Ltd.; Jubilant Lifesciences; and Cipla Ltd. Media reports said that Hetero Labs Ltd has also received regulatory approval from DCGI but the drug maker was yet to make it official. Cipla said it will be commercialising remdesivir through its own facilities and partnered sites. The drug will be supplied through government and open market channels, to ensure equitable distribution. SEE ALSO: <a href="https://www.businessinsider.in/india/news/water-sold-in-aluminum-cans-to-avoid-plastic-use-is-the-latest-trend-in-india/articleshow/76490551.cms" data-type="tilCustomLink">Water sold in aluminum cans to avoid plastic use is the latest trend in India – but costs six times than that of a mineral water bottle</a> <a href="https://www.businessinsider.in/tech/news/can-non-chinese-mobile-brands-leverage-current-consumer-sentiment-in-india/articleshow/76490835.cms" data-type="tilCustomLink">Can non-Chinese mobile brands leverage current consumer sentiment in India?</a>

Cipla to sell anti-viral drug remdesivir as Cipremi in India

<ul><li><keyword id="8775508" type="COMPANY" weightage="20" keywordseo="remdesivir">Remdesivir</keyword>, steroids, plasma, <keyword id="6284162" type="LOCATION" weightage="20" keywordseo="tocilizumab">Tocilizumab</keyword>, and Favipiravir are some of the most widely used treatments for COVID-19.</li><li>According to <keyword id="40458" type="COMPANY" weightage="20" keywordseo="AIIMS">AIIMS</keyword>’ director Randeep Guleria, the timing of using these drugs — depending on the condition of a COVID-19 patient — is critical in their effectiveness.</li><li>Using them too early or too late could result in harmful side-effects.</li><li>Here are the answers to some of the most frequently asked questions (FAQs) about COVID-19 drugs.</li></ul>(Disclaimer: This should not be considered medical advice. The views and opinions expressed belong to Dr.Randeep Guleria, the director of AIIMS. Please check with your doctor before taking treatment.) It’s been more than a year since the COVID-19 pandemic has been ravaging humanity. Despite predictions that the world would be out of the woods by now, the second wave of the virus is wreaking havoc in countries everywhere, including India. As the number of cases has increased, so has the demand for the drugs that offer potential treatment. This includes everything from the overhyped Remdesivir to less known drugs like Tocilizumab and Favipiravir. These drugs, however, are in short supply. Pharmacies across the country are reporting shortages. Moreover, this has led to a boom in <a href="https://www.businessinsider.in/science/health/news/remdesivir-injection-price-jumps-five-times-as-covid-19-cases-rise/articleshow/82083414.cms">blackmarket sales</a> of these drugs. According to Randeep Guleria, director of All India Institute of Medical Science (AIIMS), these drugs aren’t just something that you can take at home. And the timing of when they should be administered is critical in ensuring that a bad situation isn’t made worse. In a press conference on April 19, Guleria answered some of the most frequently asked questions (FAQs) around COVID-19 and the drugs that fight it. <cmsannotation type="cmsannotation" annotationid="Here’s a quick look at his responses:" comment="subhead" text="Here’s a quick look at his responses:">Here’s a quick look at his responses:</cmsannotation> <ol><li>Is Remdesivir effective in the treatment of COVID-19? No study has conclusively been able to prove that Remdesivir is beneficial in the treatment of COVID-19. “It’s important to understand that Remdesivir is not a magic bullet and it’s not a drug that is reducing mortality,” said Guleria.</li><li>If there is not enough evidence to support the use of Remdesivir to treat COVID 19, why are doctors still prescribing it? “It [Remdesivir] does have a role,” Guleria explained. While everyone has been focused on coming up with a vaccine to fight off the pandemic, the same push has not been seen in the development of antivirals. So, in absence of a good drug that can treat COVID-19, doctors and patients are turning to Remdesivir in hopes of relief.</li><li>When should a patient of COVID 19 take Remdesivir? More important than the drug itself, is the timing of when it is administered. Taking it too early or too late, could do more harm than good.“Remdesivir has been shown to be useful only in those patients who were hospitalised, who showed oxygen saturation and had infiltrates on their chest X-ray or CT scan,” said Guleria. According to him, the optimal timing for Remdesivir is usually after five to seven days of having the virus. “It is of no use if given early to mild or asymptomatic patients,” he told the press. “It is of no use if it’s given very late because it would create a cytokine storm.” A cytokine storm is when the immune system goes into overdrive. The body starts to attack its own cells and tissues instead of just the virus.</li><li>Is Remdesivir something you can take at home? Remdesivir isn’t just a pill that you can down with a glass of water. It comes in a vial and has to be injected into the body. So, ideally, one should not be taking it at home.“It is for patients who are hospitalised and severe. Therefore it should not be given at home. It is for patients who need to be admitted and need hospital care,” said Guleria. </li><li>Are steroids effective in the treatment of COVID 19? Unlike Remdesivir, there is evidence to support the use of steroids in the treatment of COVID-19. The <keyword id="6356311" type="COMPANY" weightage="20" keywordseo="World-Health-Organisation">World Health Organisation</keyword>’s (WHO) recovery trial showed that steroids do have a beneficial effect. “But again, the timing is critical. The recovery trial clearly showed that if we give steroids too early, before oxygen saturation, it showed a harmful effect. Those who got it early had higher mortality than those who did not,” warned Guleria.According to him, steroids are most effective during the later part of the disease, when there is more inflammation and oxygen saturation is falling. “Steroids are only useful for moderate or severe cases,” he said.</li><li>Is plasma a good way to fight off COVID-19? Plasma was popular when COVID-19 initially came around but studies in India, and around the world, have determined that it is not effective in the treatment. “Subsequently, other studies have been done and a large meta analysis as well which combines results of all the studies, have shown that plasma is not effective in treating COVID-19,” said Guleria.</li><li>Should a person with COVID-19 take Tocilizumab? Tocilizumab is a drug of last resort. According to Guleria, it should only be used when a COVID-19 infection in a patient is worsening despite steroids, Remdesivir, and other treatments like anticoagulants. “Tocilizumab is required in less than 2% of COVID 19 patients. Very few patients need this drug because it's only for treating a cytokine storm… And, therefore, it has a limited role,” he explained.</li><li>Is Favipiravir effective in treating COVID-19? Favipiravir is another antiviral that is being promoted for the treatment of COVID 19. It was initially doled out as a treatment of influenza after the H1N1 pandemic.“There is not enough evidence in robust studies to show that it is a good drug. In most countries, it is not being used. They’re not finding higher mortality,” said Guleria. And, since it’s not a proven treatment, India’s national guidelines also don’t recommend its use. </li><li>Is it possible to treat COVID-19 without any of the drugs mentioned above? According to Guleria, people with mild COVID-19 or those who are asymptomatic will improve with just symptomatic treatment.“Outside [in other countries] they treat COVID-19 with paracetamol, good hydration and multivitamins — all of them have recovered without any treatment,” he told reporters. “Giving treatment when it is not required, you may be doing more harm than good.”</li></ol>SEE ALSO: <a href="https://www.businessinsider.in/careers/news/for-saas-y-salaries-indian-engineers-are-skipping-the-traditional-it-services-queue/articleshow/82157280.cms">SaaS-y salaries are 30% more than traditional IT services — and they’re making it tougher for traditional IT service firms to find the right talent</a> <a href="https://www.businessinsider.in/business/startups/news/tiger-global-invests-in-healthcare-startup-pristyn-care-valuation-more-than-doubles-in-six-months/articleshow/82158467.cms">Tiger Global invests in healthcare startup Pristyn Care, valuation more than doubles in six months</a> <a href="https://www.businessinsider.in/india/news/india-has-the-142nd-rank-of-the-180-countries-in-the-world-press-freedom-index-falls-behind-myanmar-sri-lanka-and-nepal/articleshow/82158331.cms">India still has the ‘bad’ classification in the World Press Freedom Index, falls behind Myanmar, Sri Lanka and Nepal</a>

When to use Remdesivir, Favipiravir, Steroids and Tocilizumab drugs for covid 19 treatment: AIIMS doctor explains

<ul class="summary-list"><li>Colombia's plan to transport 70 "cocaine hippos" to Mexico and India will cost an estimated $3.5m.</li><li>It will be expensive because of how hard and costly it is to anesthetize hippos.</li></ul>Moving 70 so-called "cocaine hippos" from near Pablo Escobar's former ranch in Colombia to sanctuaries abroad is set to cost the country millions of dollars.In fact, the whole operation should cost around $3.5 million, according to Ernesto Zazueta, owner of the Ostok Sanctuary in northern Mexico where 10 of the hippos will be sent, <a href="https://www.france24.com/en/live-news/20230330-removing-colombian-druglord-s-hippos-to-cost-3-5-mn" target="_blank" rel="noopener">Agence France-Presse reported.</a>Another 60 hippos are set to be transferred to a yet-to-be-named facility in India in the coming months, according to AFP.The current plan is to lure the animals with bait into pens where they will remain confined before being transported in special crates on planes to their new homes, Zazueta said, per AFP. But this is not an easy task, and it doesn't come cheap.Hippos tend to be extremely difficult to catch and dangerous to confront, according to a 2020 study by the <a href="https://biology.ucsd.edu/about/news/article_012920.html" target="_blank" rel="noopener">University of California, San Diego.</a>And the animals would need to be professionally anesthetized."Everything with hippos is risky, as well as complex, costly, and time-consuming," said David Echeverri López, who works for Cornare, the Colombia government agency handling the hippo relocation, in an interview with <a href="https://www.businessinsider.com/how-columbia-plans-to-fly-hippos-out-of-the-country-2023-3?inline-endstory-related-recommendations=&amp;_gl=1*8qgiw3*_ga*NTM2ODc2OTc5LjE2MTA3OTk1ODk.*_ga_E21CV80ZCZ*MTY4MDE2Nzk4NC4xMDE5LjEuMTY4MDE2ODI0Mi42MC4wLjA.&amp;r=US&amp;IR=T">Insider's Crystal Raypole </a>earlier this month.Professionally anesthetizing hippos is tricky because of the thickness of their skin and the density of their subcutaneous tissue, according to a<a href="https://www.sciencedaily.com/releases/2012/07/120703120622.htm"> 2012 study in the Journal of the American Veterinary Medical Association.</a>It's also costly, because the drugs required to anesthetize such large animals are expensive.López told Insider that knocking out 70 hippos with these drugs could cause some financial difficulties for Colombian authorities.Around 130 hippos are now living in and around Hacienda Nápoles, Pablo Escobar's former ranch. The animals are descended from the four that were illegally imported by Escobar and then left there after the drug lord was fatally shot in 1993.Since then, the group has rapidly reproduced, with <a href="https://affiliate.insider.com/?postID=6401e9d8d0139654fb0b03b2&amp;site=in&amp;u=https%3A%2F%2Fwww.nationalgeographic.com%2Fanimals%2F2018%2F09%2Fcolombia-cocaine-hippos-rewilding-experiment-news%2F&amp;amazonTrackingID=null&amp;platform=browser&amp;sc=false&amp;disabled=false">some experts predicting that there could be thousands of them</a> in the area within the next couple of decades if nothing is done.Last year, Colombia declared the animals – which are referred to as "cocaine hippos" because of Escobar's role in the cocaine trade and the Medellín drug cartel – an invasive species, one that could <a href="https://www.insider.com/pablo-escobars-pet-hippos-have-multiplied-for-better-or-worse-2020-2" rel="">displace some native animals</a>.In the past, the country has <a href="https://www.insider.com/colombia-sterilizing-drug-lord-pablo-escobars-cocaine-hippos-2021-10" rel="">sterilized some of the hippos</a>, but it hasn't done much to stunt population growth.Colombia is hoping this more extreme measure will have more of an impact.

Moving Pablo Escobar's 'cocaine hippos' to Mexico and India will cost Colombia an estimated $3.5 million

Beijing, A chemotherapy medication originally developed to treat <keyword id="63672" type="PERSON" weightage="20" keywordseo="Lymphoma">lymphoma</keyword> has outperformed the popular remdesivir drug against SARS-CoV-2 in lab settings, and could potentially be repurposed to treat <keyword id="8763838" type="UNKNOWN" weightage="20" keywordseo="covid-19">Covid-19</keyword>, say researchers. A novel computational drug screening strategy combined with <keyword id="10531201" type="UNKNOWN" weightage="20" keywordseo="lab-experiments">lab experiments</keyword> suggest that pralatrexate drug is a promising candidate for Covid-19 patients. The novel screening approach identified four promising <keyword id="14721" type="COMPANY" weightage="20" keywordseo="Drugs">drugs</keyword>, which were then tested against SARS-CoV-2 in lab experiments. Two of the drugs, pralatrexate and azithromycin, successfully inhibited replication of the virus. Further lab experiments showed that pralatrexate more strongly inhibited viral replication than did remdesivir, a drug that is currently used to treat some Covid-19 patients, said Haiping Zhang of the <keyword id="10531200" type="UNKNOWN" weightage="20" keywordseo="shenzhen-institutes">Shenzhen Institutes</keyword> of Advanced Technology in <keyword id="95282" type="LOCATION" weightage="20" keywordseo="Shenzhen">Shenzhen</keyword>, China. Zhanh and team screened 1,906 existing drugs for their potential ability to inhibit replication of SARS-CoV-2 by targeting a viral protein called RNA-dependent RNA polymerase (RdRP). The findings, published in open-access journal <keyword id="1318021" type="COMPANY" weightage="20" keywordseo="PLoS-Computational-Biology">PLOS Computational Biology</keyword>, suggest that pralatrexate could potentially be repurposed to treat Covid-19. "However, this chemotherapy drug can prompt significant side effects and is used for people with terminal lymphoma, so immediate use for Covid-19 patients is not guaranteed. Still, the findings support the use of the new screening strategy to identify drugs that could be repurposed," the researchers noted. With the Covid-19 pandemic causing illness and death worldwide, better treatments are urgently needed. One shortcut could be to repurpose existing drugs that were originally developed to treat other conditions. "We have demonstrated the value of our novel hybrid approach that combines deep-learning technologies with more traditional simulations of molecular dynamics," Zhang said. He and his colleagues are now developing additional computational methods for generating novel molecular structures that could be developed into new drugs to treat Covid-19. SEE ALSO: <a href="https://www.businessinsider.in/business/auto/news/kia-motors-11-electric-vehicles-in-2021-but-india-may-have-to-wait-longer-to-buy/articleshow/80056447.cms">INTERVIEW: Kia Motors’ 2021 plan includes 11 electric vehicle launches ⁠— but India may have to wait longer</a> <a href="https://www.businessinsider.in/business/startups/news/india-edtech-in-charts-how-the-shi[%E2%80%A6]es-of-byjus-unacademy-and-others/articleshow/80040270.cms">India’s edtech in charts – How the shift to online learning meant money, valuation and users for the likes of BYJU’S, Unacademy, and others</a> <a href="https://www.businessinsider.in/business/telecom/news/jio-announces-free-domestic-voice-calls-from-january-1/articleshow/80044256.cms">Jio announces free domestic voice calls from January 1</a>

You Searched For "remdesivir drug cost in india" and got 9 results

Govt waives clinical trial requirement for several drugs approved in select countries

PTI

These are the companies that are making Remdesivir in India

BI India Bureau

How remdesivir drug can save lives in nations with lower hospital capacity

BI India Bureau

Cipla says COVID-19 drug Remdesivir will hit market this week

Navdeep Yadav

Remdesivir drug fails to reduce mortality or hospital stay of COVID-19 patients, says WHO study

Preeti Soni

Cipla to sell anti-viral drug remdesivir as Cipremi in India

IANS

When to use Remdesivir, Favipiravir, Steroids and Tocilizumab drugs for covid 19 treatment: AIIMS doctor explains

BI India Bureau

Moving Pablo Escobar's 'cocaine hippos' to Mexico and India will cost Colombia an estimated $3.5 million

Joshua Zitser

Lymphoma drug outperforms Remdesivir against COVID-19 virus

IANS

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