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<ul><li>Confirmed cases of COVID-19 infection cross 12 lakhs around the globe with the number of deaths reported nearing 70,000. </li><li>The malignant virus invades more than 200 countries and the demand for drugs and medical equipment surge fast. </li><li>The anti-malarial drug <keyword id="4751090" type="PERSON" weightage="20" keywordseo="Hydroxychloroquine">Hydroxychloroquine</keyword> is seen as a game changer in treating COVID-19 infection. Here are the basics of this life-saving drug you must know.</li></ul>In a recent conversation with the Prime Minister of India, Donald Trump, the American President requested India to supply them huge quantities of Hydroxychloroquine. Addressing the press, Trump also warned of retaliation measures if India declined the request as it did to other countries in the face of perceiving a demand for the drug with the cases mounting up in the country too. What is <keyword id="8947192" type="UNKNOWN" weightage="20" keywordseo="Hydroxychloroquine-medicine">Hydroxychloroquine medicine</keyword> Hydroxychloroquine can be described as a racemic mixture comprising of R and S enantiomer. We can compare Hydroxychloroquine with chloroquine, an aminoquinoline. This is a commonly prescribed medicine in treating uncomplicated malaria, rheumatoid arthritis, systemic lupus erythematosus, and chronic discoid lupus erythematosus. Hydroxychloroquine is also used to address the prophylaxis of malaria in places where chloroquine resistance is unlikely. Developed during World War II as a derivative of quinacrine, this drug is said to have much lesser side effects. The FDA approved this drug on 18 April 1955. In the face of COVID-19 pandemic, the FDA has sanctioned an emergency authorization for hydroxychloroquine and chloroquine. This authorization gives room for the unapproved use of these drugs in treating the COVID-19 cases in the light of the critical public emergency seen around. The effectiveness of hydroxychloroquine in remedying the COVID-19 infection is yet to be proved though this drug is administered in the treatment in a large scale as on date. The American experiment Towards the end of March 2020, the US Food and Drug Administration provisionally approved the use of hydroxychloroquine in treating COVID-19 patients. Since then, the medical community in New York has been administering this drug to the novel coronavirus infected patients in combination with some other drugs. This experiment with hydroxychloroquine happening in the epicenter of the US has given a hint to Trump, the American President that this anti-malarial drug could be a game changer in treating COVID-19 infection. He said that this drug was giving successful results and if the trend continued, it would be a gift from heaven. The country had then quickly stocked up about 29 million doses of hydroxychloroquine besides asking India to supply the drug to them. India’s policy on hydroxychloroquine supplies to the world Last month, India had imposed a ban on the export of hydroxychloroquine. However, India is most likely to life the ban and clear the pending international orders for the drug after meeting the local requirements. It is also said that after perceiving the humanitarian situation of the COVID-19 scenario, the Department of Pharmaceuticals and Ministry of External Affairs will decide whether to fulfill the pending international orders for hydroxychloroquine. See Also - <a href="https://www.businessinsider.in/india/news/india-lifts-partial-ban-on-hydroxychloroquine-after-donald-trump-warns-of-retaliation-if-pm-modi-doesnt-help-the-us/articleshow/75022401.cms">India lifts partial ban on hydroxychloroquine medicine</a>

What is Hydroxychloroquine medicine and how it could be a game changer

(Eds: Adding more info) New Delhi, Apr 7 () India is the biggest manufacturer of <keyword id="4751090" type="PERSON" weightage="20" keywordseo="Hydroxychloroquine">hydroxychloroquine</keyword>, the anti-malarial drug that is being touted as 'game-changer' in the fight against COVID-19 and is being aggressively sought by US President Donald Trump. The country has the capacity to quickly ramp up the output of hydroxychloroquine. Days after it added the drug to the list of more than two dozen APIs that cannot be exported while officials get a handle on how much will be needed for COVID-19 outbreak in the country, India on Tuesday agreed to lift the ban after Trump sought supplies for the US. India manufactures 70 per cent of the world's supply of hydroxychloroquine, according to Indian Pharmaceutical Alliance (IPA) secretary-general Sudarshan Jain. The country has a production capacity of 40 tonnes of hydroxychloroquine (HCQ) every month, implying 20 crore tablets of 200 mg each. And since the drug is also used to auto-immune diseases like rheumatoid arthritis and lupus, manufacturers have good production capacities that can also be ramped up. Ipca Laboratories, Zydus Cadila and Wallace Pharmaceuticals are top pharma companies manufacturing HCQ in India. Jain says the production capacity is sufficient to meet the current demand and if the need arises, the companies are committed to ramping up production. Recently, the Ministry of Health and Family Welfare had reportedly placed an order for around 10 crore tables of HCQ with Ipca laboratories and Zydus Cadila. The drug is not manufactured in developed nations such as the US because of non-existent malaria. Hydroxychloroquine is very similar to chloroquine, one of the oldest and best-known anti-malarial drugs, but with lesser side-effects. It can be bought over the counter and fairly inexpensive. But its purchase and use has been severely restricted as it was selectively used in the treatment of coronavirus because of its antiviral properties. India gets the active pharmaceutical ingredient (API) that is used to manufacture HCQ from China and supplies so far have been steady. As much as 70 per cent of all the APIs needed by India to manufacture drugs come from China. After Trump stated that the US could "retaliate" if India does not release stocks of the drug, Indian officials said exports of hydroxychloroquine and paracetamol will be allowed depending on availability of stock after meeting domestic requirements and existing orders. Last month, the US Food and Drug Administration (FDA) partially lifted a three-year-old 'import alert' on Ipca's two plants to import the medicine. Zydus Cadila has also received an order from the US. Pharma industry officials said the country has enough stock of HCQ and companies were ready to ramp up the capacity to meet domestic requirements as well as exports. On March 25, India had banned export of HCQ and added it to a list of more than two dozen APIs that can no longer be exported. India is the largest exporter of the drug. Officials said India would export the drug on a case-by-case basis after meeting all the domestic requirements. "The Government has withdrawn the restrictions on 12 products and its formulations. Various scenarios are being assessed and it will be the endeavour to meet both the domestic demand and export obligation for Paracetamol and hydroxychloroquine," Jain said. The objective is to minimise speculative buying and hoarding in these trying times and ensure balance in the distribution for patients and segments who need them, he added. In a similar vein, Indian Drug Manufacturers' Association (IDMA) Executive Director Ashok Kumar Madan said: "India needs around 24 million tablets per year as on date for the three indications --- malaria, lupus, and rheumatoid arthritis, it was being used". India currently has an annual installed capacity of around 40 metric tonnes of active pharmaceutical ingredients (APIs) of hydroxychloroquine. With this capacity, "we can make around 200 million tablets of 200 mg", he added. So this indicates that India currently has spare available capacity. Now, "we have to see how much would the country's requirements for the drug would grow for both treatment and prevention of COVID-19. The companies have already started ramping the capacity." The major API makers for the drug in the country are Zydus, Ipca and Mangalam Drugs. The major formulation makers of hydroxychloroquine are Ipca, Zydus, Wallace Pharmaceuticals, and Cipla, Madan said. India exported hydroxychloroquine API in April-January 2019-20 period worth USD 1.22 billion. During the same period exports of formulations made from hydroxychloroquine were at USD 5.50 billion. Indian Council of Medical Research (ICMR) recommended HCQ be used as a preventive medication for COVID-19 high-risk group. It has also recommended the use of the drug for those involved in the care of 'suspected or confirmed cases of the coronavirus and for asymptomatic household contacts of laboratory-confirmed patients, apart from healthcare workers who are involved in the treatment of COVID-19'. Ipca is the drug's top manufacturer globally. Each COVID-19 patient reportedly needs 14 tablet course and so the 10 crore pills ordered by the government can potentially treat over 71 lakh people. AKT RR ANZ BAL

India biggest producer of 'game-changer' hydroxychloroquine drug; has enough capacity

<ul class="summary-list"><li>President Donald <keyword id="6354862" type="UNKNOWN" weightage="60" keywordseo="trump">Trump</keyword> Monday <a href="https://www.businessinsider.com/president-trump-says-hes-been-taking-hydroxychloroquine-2020-5">said on Monday</a> that he has been taking the experimental drug <keyword id="4751090" type="PERSON" weightage="60" keywordseo="Hydroxychloroquine">hydroxychloroquine</keyword> "every day" for a week and a half.</li><li>However, there is no clinical evidence so far that proves the drug is effective against <keyword id="8763838" type="UNKNOWN" weightage="60" keywordseo="covid-19">COVID-19</keyword>, and there are not yet any approved treatments or vaccines for the disease.</li><li>In April, the US Food and Drug Administration issued a clear-cut warning against the use of chloroquine or the derivative drug hydroxychloroquine to treat COVID-19, stating it posed a risk of heart rhythm problems. </li><li>In its guidance, the <keyword id="6354656" type="ORGANIZATION" weightage="60" keywordseo="fda">FDA</keyword> said that hydroxychloroquine has "not been shown to be safe and effective for treating or preventing COVID-19."</li><li><a href="https://www.businessinsider.com/?hprecirc-bullet">Visit Business Insider's homepage for more stories</a>.</li></ul>President Donald Trump Monday <a href="https://www.businessinsider.com/president-trump-says-hes-been-taking-hydroxychloroquine-2020-5">said on Monday</a> that he has been taking the experimental drug hydroxychloroquine "every day" for a week and a half.<a href="https://www.fda.gov/drugs/drug-safety-and-availability/fda-cautions-against-use-hydroxychloroquine-or-chloroquine-covid-19-outside-hospital-setting-or">In April</a>, the US Food and Drug Administration issued a clear-cut warning against the use of chloroquine or the <a href="https://www.ncbi.nlm.nih.gov/books/NBK537086/">derivative drug</a> hydroxychloroquine to treat COVID-19, stating it posed a risk of heart problems. During a Q&amp;A with reporters, Trump said that he had consulted with the White House doctor, who then administered the medication. He went on to say that he had heard "very good things" about the drug and that every COVID-19 test he has taken has shown up negative.<a href="https://www.businessinsider.com/trump-touts-chloroquine-for-covid-19-but-dismisses-risks-2020-4">Trump has previously touted hydroxychloroquine</a> as a potential treatment for the novel <keyword id="1754604" type="PERSON" weightage="60" keywordseo="coronavirus">coronavirus</keyword>. The drug is often used for the prevention and treatment of certain types of malaria as well as rheumatoid arthritis, lupus, and a few other conditions.While large trials are underway, there is no clinical evidence so far that proves the drug is effective against COVID-19. There are not yet any approved treatments or vaccines for the disease.<h2>The FDA, however, has warned about risks associated with using the drug off label.</h2>"The FDA is aware of reports of serious heart rhythm problems in patients with COVID-19 treated with hydroxychloroquine or chloroquine," the notice said, mentioning that the drug can interact poorly with other medications, including the common antibiotic azithromycin. It continued: "We are also aware of increased use of these medicines through outpatient prescriptions. Therefore, we would like to remind health care professionals and patients of the known risks associated with both hydroxychloroquine and chloroquine. We will continue to investigate risks associated with the use of hydroxychloroquine and chloroquine for COVID-19 and communicate publicly when we have more information." On the effectiveness of the drug to treat COVID-19, the FDA said: "Hydroxychloroquine and chloroquine have not been shown to be safe and effective for treating or preventing COVID-19."According to the FDA, the drug can cause "abnormal heart rhythms" along with "a dangerously rapid heart rate called ventricular tachycardia." These risks may increase when treated alongside other medications, including azithromycin, which the notice said was "being used in some COVID-19 patients without FDA approval." It added that patients with other health conditions like heart and kidney disease "are likely to be at increased risk of these heart problems when receiving these medicines." The FDA said that patients taking the medications to treat malaria or autoimmune conditions "should continue taking their medicine as prescribed," despite the risks associated. "Be aware that there are no proven treatments for COVID-19 and no vaccine," the FDA stresses. "Do not buy these medicines from online pharmacies without a prescription from your health care professional." Read the original article on <a href="https://www.businessinsider.com/fda-guidelines-on-taking-hydroxychloroquine-to-treat-coronavirus-2020-5">Business Insider</a>

Trump says he has started taking hydroxychloroquine. Last month the FDA said the drug has 'not been shown to be safe and effective for treating or preventing COVID-19.'

<ul class="summary-list"><li>Taking the malaria pills <keyword id="4751090" type="PERSON" weightage="60" keywordseo="Hydroxychloroquine">hydroxychloroquine</keyword> failed to help newly infected <keyword id="1754604" type="PERSON" weightage="60" keywordseo="coronavirus">coronavirus</keyword> patients, trial results published Thursday found.</li><li>The study conducted by researchers at the University of Minnesota enrolled 491 people with mild cases of <keyword id="8763838" type="UNKNOWN" weightage="60" keywordseo="covid-19">COVID-19</keyword>, the disease caused by the coronavirus. The volunteers were randomized to receive either hydroxychloroquine or placebo.</li><li>The group receiving the experimental pills did not do better and suffered more side effects, according to results <a href="https://www.acpjournals.org/doi/10.7326/M20-4207">published in the Annals of Internal Medicine</a>.</li><li>It's the latest in a long string of evidence against hydroxychloroquine's use against this <keyword id="43587" type="ORGANIZATION" weightage="60" keywordseo="pandemic">pandemic</keyword>. </li></ul>Once again, hydroxychloroquine has flunked as a potential coronavirus treatment. Researchers at the University of Minnesota found it didn't help patients with newly diagnosed and mild cases of COVID-19. <a href="https://www.businessinsider.com/malaria-pill-chloroquine-tested-as-coronavirus-treatment-2020-3">The generic medication</a>, commonly taken to treat malaria, arthritis, and lupus, <a href="https://www.businessinsider.com/malaria-pill-chloroquine-tested-as-coronavirus-treatment-2020-3">became an obsession of President Donald Trump</a>, who has touted its ability to be a game-changer against the pandemic.Read more: <a href="https://www.businessinsider.com/list-coronavirus-treatments-tested-in-clinical-trials-2020-4">Drugmakers are racing to use existing medicines to fight the coronavirus. Here's what you need to know about the 14 most promising medications being put to the test.</a>Even as <a href="https://www.recoverytrial.net/news/statement-from-the-chief-investigators-of-the-randomised-evaluation-of-covid-19-therapy-recovery-trial-on-hydroxychloroquine-5-june-2020-no-clinical-benefit-from-use-of-hydroxychloroquine-in-hospitalised-patients-with-covid-19">other studies have showed the drug fail to help hospitalized patients</a>, some hydroxychloroquine supporters have latched onto its prospects as treatment to given early on in the course of infection. The University of Minnesota study, <a href="https://www.acpjournals.org/doi/10.7326/M20-4207">published Thursday in the Annals of Internal Medicine</a>, suggests there's no benefit when given earlier.The study enrolled 491 adults across the US and Canada. The volunteers enrolled within four days of developing symptoms, with a majority joining the trial within a day after observing symptoms. This group did not require hospitalization and had relatively mild cases of COVID-19, the disease caused by the coronavirus pandemic. After randomizing the group to receive either hydroxychloroquine or placebo, researchers tracked the participants to see if the malaria pills could decrease the severity of symptoms more than a placebo over the next two weeks.Read more: <a href="https://www.businessinsider.com/coronavirus-antibody-treatments-eli-lilly-regeneron-gsk-amgen-2020-4">Customized drugs designed to prevent and treat the coronavirus are storming into the clinic. Here are the top drugmakers crafting antibody treatments, which are set to play a key role in halting the pandemic.</a>The results found no benefit to taking hydroxychloroquine instead of placebo. The researchers also noted there was no benefit among volunteers who also took zinc or vitamin C.Forty-three percent of people taking hydroxychloroquine reported side effects compared to 22% of the placebo group. About one-quarter of the group on hydroxychloroquine still had symptoms after two weeks compared to 30% on placebo — a difference that was not statistically meaningful.Read more: <a href="https://www.businessinsider.com/power-players-leading-the-race-for-coronavirus-drugs-and-vaccines">Meet the 14 top drug industry leaders who are leading the sprint to develop coronavirus treatments and vaccines in record time</a>It's the second major finding to come from Dr. David Boulware, an infectious disease physician at the University of Minnesota. Last month, another one of his studies found hydroxychloroquine <a href="https://www.businessinsider.com/hydroxychloroquine-fails-to-prevent-coronavirus-study-in-nejm-2020-6">failed to prevent infections in people recently exposed to the virus</a>."Taken together, there is no convincing evidence that hydroxychloroquine can either prevent COVID-19 after exposure or reduce illness severity after developing early symptoms," Dr. Caleb Skipper, an infectious diseases fellow studying under Boulware, said in a statement.Read more: <a href="https://www.businessinsider.com/hydroxychloroquine-fails-to-prevent-coronavirus-study-in-nejm-2020-6">The first high-quality study of malaria pill hydroxychloroquine just found it doesn't help prevent coronavirus infections</a>

Yet another study of hydroxychloroquine just found that it doesn't work to treat the coronavirus

Port Louis, Apr 15 () In a humanitarian gesture, India on Wednesday gifted life-saving drugs, including Hydroxychloroquine tablets, to Mauritius and Seychelles to help them deal with the coronavirus pandemic that has infected 2 million people worldwide.Mauritius Vice Prime Minister Leela Devi Luchoomun Dookun received the consignment of half a million Hydroxychloroquine tablets that arrived here on Wednesday evening through a special Air India cargo flight from Delhi, the Indian High Commission in Port Louis said in a statement."The shipment was made possible as a special gesture although a restriction on its export from India continues to be in force in view of the unprecedented prevailing difficult situation because of COVID-19 global pandemic," it said.Mauritius is one of the first countries to receive supplies of this medicine after a special exemption was granted for a few countries. "This demonstrates the unique ties between our two countries," the statement said.It said the consignment was part of the 13 tonnes of essential lifesaving medicines that have been sent for Mauritius. This is the first such consignment of essential medicines and a second consignment will follow in coming weeks."India is a proud partner of Mauritius and remains committed to contributing to the public health and welfare of all people of Mauritius," it said, adding that India will continue to work closely with Mauritius in these difficult times. India also gifted the first consignment of four tonnes of essential lifesaving medicines to Seychelles, in view of the ongoing COVID-19 crisis. "These medicines were procured basis the request from the Government of Seychelles. The consignment was brought to Seychelles by an Air India Special Charter Boeing 787 flight from New Delhi," said a statement issued by the High Commission of India in Seychelles.This is a special arrangement made in view of the special relations with Seychelles in order to enable the supply of these medicines despite the restrictions in place due to the lockdown, it said."Despite its own domestic challenges and constraints, India has always believed in sharing its resources and expertise with its friends and partners," the statement said.This airlift also strengthens the spirit of cooperation between the two sides based on India's Neighbourhood First Policy and Seychelles' India First Policy, it added.As part of this consignment, India swiftly decided to send the supplies of Hydroxychloroquine to Seychelles. The anti-malarial drug is now used to treat COVID-19 patients with effective outcomes. Health authorities worldwide have recommended Hydroxychloroquine for COVID-19 patients with positive outcomes. ZHZH

COVID-19: India provides life-saving drugs to Mauritius and Seychelles

<ul><li>India has decided to partially lift the ban on the export of the ‘wonder drug’ <keyword id="4751090" type="PERSON" weightage="20" keywordseo="Hydroxychloroquine">Hydroxychloroquine</keyword>, an anti-malaria drug that is used to treat <keyword id="1754604" type="PERSON" weightage="20" keywordseo="coronavirus">Coronavirus</keyword>. </li><li>The move comes as the US President Donald Trump appealed to the Indian government for an urgent supply of the drugs. </li><li>Trump said that he was unaware of the development and didn’t “like that decision.” </li><li>Scientists and experts are still uncertain of its impact in controlling Coronavirus in particular, though it is effective against viral infections in general. </li><li><a href="https://www.businessinsider.in/searchresult.cms?query=coronavirus&amp;sortorder=effectivedate">Follow the comprehensive coverage of the coronavirus pandemic and its impact, and other useful resources that can help you in the fight on Business Insider India.</a></li></ul>India has decided to partially lift the ban on the export of the ‘wonder drug’ Hydroxychloroquine, an anti-malaria drug that is used to treat Coronavirus. <a href="https://theprint.in/diplomacy/india-partially-lifts-ban-on-export-of-hydroxychloroquine-hours-after-trumps-threat/396792/">According to</a> a report by ThePrint, both paracetamol and hydroxychloroquine will be supplied to ‘clear the existing orders’. While all other medicines under the ‘free’ category will also be shipped now. The move comes after the US President Donald Trump appealed to the Indian government for an urgent supply of those two drugs and even warned of a retaliation. India had banned the export of hydroxychloroquine recently after its own cases rose. However, Trump said that he was unaware of the development and didn’t “like that decision.” Trump believes that the combination of two drugs — antibiotic azithromycin and hydroxychloroquine — a ‘game changer’ for treating Coronavirus. It works for virals but can it cure Covid-19? Though Trump has called this drug ‘a gift from heaven’, most scientists and experts have their doubts of its impact in controlling Coronavirus in particular. It is however effective against viral infections in general. <div type="image" title="corona2" msid="74809541" hostid="261"></div> India too seems to be banking on the drug. "Hydroxy-chloroquine is found to be effective against Coronavirus in laboratory studies and in-vivo studies. Its use in prophylaxis is derived from the available evidence of benefit as treatment and supported by preclinical data," IANS reported citing the advisory by the Ministry of Commerce and Industry. International experts however are divided. David Sullivan, professor of microbiology at the Johns Hopkins Bloomberg School of Public Health and an infectious disease physician<a href="https://time.com/5808894/hydroxychloroquine-coronavirus/"> believes that if the drug genuinely worked for Coronavirus infection</a>, the healthcare professionals would know it by now. “Right now we have no clinical evidence that it works,” he said. Yet, Covid-19 is a fairly new infection and there are few studies on its workings and hence the drugs that can contain it. Clinical trials can help extract critical information on its use and dosage, <a href="https://time.com/5808894/hydroxychloroquine-coronavirus/">said</a> Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and member of the White House Coronavirus Task Force. French and Chinese studies support US’ claims Right now, the only evidence medical professionals around the world have are a few random studies. A French study which examined infected patients showed that the level of virus in blood <a href="https://time.com/5808894/hydroxychloroquine-coronavirus/">dropped after medication</a>. <div type="image" title="close-up-1853400_1920" msid="74809570" hostid="261"></div> Another Chinese study reiterated the same results. Approximately 100 patients were tested in China, where the disease first started, and the combination of the two drugs — antibiotic azithromycin and hydroxychloroquine — was found to reduce viral infection. However, as far as the lab studies of Hydroxychloroquine are concerned, the researchers found that it could stop viruses like influenza and SARS-CoV-2 from infecting human cells. But, there is still a lag. “The problem is that what happens in the lab often doesn’t predict what happens in a patient,” Dr Otto Yang of the University of California, Los Angeles <a href="http://v">told</a> the TIME. <div type="image" title="laboratory-3827745_1920" msid="74809614" hostid="261"></div> Side effects of hydroxychloroquine The drug however is strictly prohibited for those below 15 years and above 60 years due to possible side-effects on kidney and heart. In spite of stamping on the drug, Indian Council for Medical Research (ICMR) scientist Raman Gangakhedkar warned against self-medication. "Do not go for the COVID-19 test just on suspicion or consume hydroxychloroquine without a doctor's prescription because the medicine has its side effects,” he told IANS. See also: <a href="https://www.businessinsider.in/india/news/those-who-violate-coronavirus-lockdown-could-be-jailed-for-2-years-and-fined/articleshow/74807160.cms">Those who violate Coronavirus lockdown could be jailed for 2 years and fined</a> <a href="https://www.businessinsider.in/india/news/coronavirus-death-cases-in-india-all-those-who-died-of-coronavirus-their-age-medical-and-travel-history/articleshow/74787832.cms">All those who died of Coronavirus in India, their age, medical and travel history</a> <a href="https://www.businessinsider.in/india/news/heres-how-a-21-day-lockdown-might-help-break-the-covid-19-chain/articleshow/74802999.cms">Here's how a 21-day lockdown might help break the Covid-19 chain</a>

The US is banking on India’s Hydroxychloroquine medicine — yet experts have their doubts

New York, Apr 7 () A New Jersey-based generic pharmaceutical company, co-founded by two Indian-Americans has donated millions of hydroxychloroquine sulfate tablets to Louisiana, New York and Texas to help COVID19 patients.Amneal Pharmaceuticals has pledged to donate 400,000 hydroxychloroquine sulfate tablets to the State of Louisiana to help respond to the COVID-19 health emergency, according to a press release dated March 30 from Louisiana Attorney General Jeff Landry.However, the US government's top infectious disease specialist Anthony Fauci has been vocal about his concern that there is not enough evidence to suggest that Hydroxychloroquine is the drug that cures COVID19.The release said that the large donation will go toward clinical trials and patient treatment in Louisiana.Hydroxychloroquine, an old and inexpensive drug used to treat malaria, is seen as a viable therapeutic solution by President Trump to coronavirus that has so far killed more than 10,000 Americans and infected over 3.6 lakh within weeks. Bridgewater, New Jersey-headquartered Amneal was founded in 2002 by Chirag Patel and Chintu Patel, who are also the Co-CEOs. "Amneal has donated millions of hydroxychloroquine sulfate tablets in total to states other than Louisiana, including New York and Texas, and stated they will provide more as needed. The company also announced donations of products directly to hospitals across the country," the release added.The press release from the Louisiana Attorney General quoted Chirag and Chintu Patel as saying that "all of us at Amneal are committed to supporting our communities in the global fight against COVID-19. We are working with urgency to assist the hardest hit states and hospitals around the country to benefit as many patients as possible during this critical time."Amneal's hydroxychloroquine sulfate tablets are approved by the United States Food and Drug Administration (FDA) to treat malaria, rheumatoid arthritis, lupus, childhood arthritis, and other autoimmune diseases. Hydroxychloroquine is not FDA-approved for the treatment of COVID-19; but it has been identified as a possible treatment for COVID-19, and the US Government has requested its immediate availability, the release said.Landry thanked Amneal for the donation and said "it is important we all work together to help solve the COVID-19 crisis." The Louisiana State University School of Medicine is working to launch two different clinical trials using hydroxychloroquine in relation to COVID-19. One trial will utilise hydroxychloroquine on those who have significant COVID-19 disease.The other trial protocol will use and test the drug as a preventative measure for those healthcare workers on the front lines battling the epidemic. Trials will be conducted at the University Medical Center in New Orleans and at the LSU Medical School locations in Baton Rouge and Lafayette.Dean of LSUHSC School of Medicine Steve Nelson said the donation will allow them to conduct clinical trials examining how hydroxychloroquine may help clear the virus from the lungs of infected patients and to potentially help shield healthcare workers who are on the front lines treating patients."The hydroxychloroquine donation by Amneal comes at an important time. The Louisiana Board of Pharmacy has noted serious concerns over the availability of this drug and has issued specific guidance on the dispensing of the drug, including its March 25th guidance noting that it should be dispensed for COVID-19 when the prescription bears a COVID-19 diagnosis," the release said. YAS PMSPMS

Pharma company founded by Indian-Americans donates hydroxychloroquine tablets in US

<ul class="summary-list"><li>House Speaker <keyword id="128640" type="PERSON" weightage="60" keywordseo="Nancy-Pelosi">Nancy Pelosi</keyword> on Wendesday said that she gave President <keyword id="6354484" type="PERSON" weightage="60" keywordseo="Donald-Trump">Donald Trump</keyword> a "dose of his own medicine" when she called him "morbidly obese" earlier in the week. </li><li>"I gave him a dose of his own medicine. He's called women one thing or another over time," Pelosi said.</li><li>Pelosi's comments on Trump's weight came in reference to the president's announcement he's taking a controversial drug, <keyword id="4751090" type="PERSON" weightage="60" keywordseo="Hydroxychloroquine">hydroxychloroquine</keyword>, in an effort to prevent <keyword id="8763838" type="UNKNOWN" weightage="60" keywordseo="covid-19">COVID-19</keyword>.</li><li>Hydroxychloroquine is an anti-malarial drug, and the FDA says it has not been shown to be "safe and effective for treating or preventing COVID-19."</li><li>The FDA last month issued a warning that the drug can cause heart problems.</li></ul>House Speaker Nancy Pelosi on Wednesday defended referring to President Donald Trump as "morbidly obese," stating that she delivered him a "dose of his own medicine" in terms of the president's prior disparaging remarks toward women. "I gave him a dose of his own medicine. He's called women one thing or another over time," Pelosi said. "I was only quoting what doctors had said about him so I was being factual in a very sympathetic way."Trump has frequently made negative comments about the appearances of women, attacking an array of public figures ranging from former Secretary of State Hillary Clinton to comedian and actress Rosie O'Donnell."She's a slob. How does she even get on television? If I were running The View, I'd fire Rosie. I'd look her right in that fat, ugly face of hers and say, 'Rosie, you're fired,'" <a href="https://www.bbc.com/news/world-us-canada-50563106">Trump once said</a> of O'Donnell, for example. The House Speaker earlier this week referred to Trump as "morbidly obese" after the president told reporters he'd begun taking the hydroxychloroquine, an anti-malarial drug, in an effort to stave off the novel <keyword id="1754604" type="PERSON" weightage="60" keywordseo="coronavirus">coronavirus</keyword>. The president has controversially promoted the drug as a treatment for the novel coronavirus, which causes the disease COVID-19, even though scientists are highly skeptical of its benefits in this regard. The Food and Drug Administration (FDA) in late April issued a warning on the use of hydroxychloroquine for COVID-19. "The FDA is aware of reports of serious heart rhythm problems in patients with COVID-19 treated with hydroxychloroquine or chloroquine," the warning stated. "Therefore, we would like to remind health care professionals and patients of the known risks associated with both hydroxychloroquine and chloroquine."The FDA said the drug has not been shown to be "safe and effective for treating or preventing COVID-19."Pelosi raised concerns about Trump's health (and weight) after the president announced he's taking the drug. "He's our president, and I would rather he not be taking something that has not been approved by the scientists, especially in his age group and his, shall we say, weight group," <a href="https://www.businessinsider.com/pelosi-trump-is-morbidly-obese-hydroxychloroquine-2020-5">Pelosi said</a> during an interview with the CNN host Anderson Cooper on Monday."I think it's not a good idea," she added.Pelosi went on to describe the 73-year-old Trump as "morbidly obese," citing his prior White House physicals that placed him slightly above the <a href="https://www.cdc.gov/obesity/adult/defining.html">Centers for Disease Control and Prevention's</a> criteria for being "obese."Trump stood 6-foot-3 and weighed in at 243 pounds in 2019 — 4 pounds greater than in the previous year. His body mass index based on those numbers would be 30.4, slightly above the CDC's cutoff, 30.0, between overweight and obese.David Choi contributed reporting. Read the original article on <a href="https://www.businessinsider.com/pelosi-calling-trump-morbidly-obese-dose-of-his-own-medicine-2020-5">Business Insider</a>

Pelosi said calling Trump 'morbidly obese' was a 'dose of his own medicine' given his past comments about women

By Lalit K Jha Washington, Apr 22 () The plan to use hydroxychloroquine for treating the COVID-19 patients in the US has received a setback with more deaths being reported among those who were given the much-touted anti-malarial drug, according to a report.Another report, however, suggested that there was insufficient clinical data to either recommend or oppose the use of hydroxychloroquine for treating those infected with the deadly coronavirus.US President Donald Trump, who has been aggressively promoting the use of hydroxychloroquine in the treatment of COVID-19 patients, said that he would look into the reports.His administration has stockpiled more than 30 million doses of hydroxychloroquine, a large chunk of which has been imported from India."I don't know of the report. Obviously, there have been some very good reports and perhaps this one's not a good report. But we'll be looking at it. We'll have a comment on it at some point," Trump told reporters during his daily White House news conference on coronavirus on Tuesday.Trump was responding to a question on a study released by a group of scientists on use of hydroxychloroquine with or without antibiotic azithromycin for 368 COVID-19 patients. The unreviewed study submitted to New England Journal of Medicine for publication and posted online found no evidence that the use of hydroxychloroquine, either with or without azithromycin, reduced the risk of mechanical ventilation in patients hospitalised with COVID-19."An association of increased overall mortality was identified in patients treated with hydroxychloroquine alone," said the study that was funded by the National Institute of Health (NIH).The NIH in its report 'Therapeutic Options for COVID-19 Currently Under Investigation' said that there are insufficient clinical data to either recommend or oppose using chloroquine or hydroxychloroquine for treatment of COVID-19.If chloroquine or hydroxychloroquine is used, clinicians should monitor the patient for adverse effects, especially prolonged QTc interval, it said. The panel of the NIH experts recommended against the use of the combination of hydroxychloroquine and azithromycin because of the potential for toxicities. US Food and Drug Administration Commissioner Stephen M Hahn said that no final decision has been taken as yet."I've mentioned from this podium and in other venues before, what FDA is going to require is data from clinical trials, randomised clinical trials, hydroxychloroquine/placebo, to actually make a definitive decision around safety and efficacy," he told reporters.The first one is a small retrospective study at the Veteran's Affairs (VA) hospital."And similar to the data we talked about before with the French study, this is something that a doctorate would need to consider as part of a decision in writing a prescription for hydroxychloroquine," he said. "But the preliminary data are helpful to providers. I want to ask them (doctors) to incorporate the data as we have it come forward. It's not definitive data. It doesn't help us make a decision from a regulatory review.""But doctors should incorporate that in the decision-making they make on a one-on-one basis," Hahn said in response to a question. Congressman Bill Pascrell said the report analysing hydroxychloroquine as a potential COVID-19 treatment at veterans hospitals is a bombshell indictment of the damage Trump and his administration does to Americans by putting politics before science. "The world class medicine and doctors we enjoy today are the fruit of generations of painstaking work by our ancestors. Evidence-based science is the only way out of this crisis, not unproven miracle therapies personally favored by Donald Trump."Trump's frequent touting of this treatment was deeply irresponsible, and may have heaped unnecessary pain and suffering, not to mention false hope, upon Americans struck by this terrible illness," he said. "I have repeatedly warned the FDA about the danger of prizing Trump's political pressure over scientific process. Unless we are guided by science and science alone, we will have more unnecessary deaths on our hands," Pascrell said. LKJ RHL MR MRJ

Use of hydroxychloroquine shows no benefit for treating COVID-19 patients: report

By Lalit K Jha Washington, Apr 22 () The plan to use much touted anti-malarial drug hydroxychloroquine for treating COVID-19 patients has received a setback with more deaths being reported among those who were given the drug, according to a report. While another report suggested that there was insufficient clinical data to either recommend or oppose the use of hydroxychloroquine for treating those infected with the deadly virus. President Donald Trump, who has been aggressively promoting the use of hydroxychloroquine in the treatment of COVID-19 patients, said that he would look into the reports. His administration has stockpiled more than 30 million doses of hydroxychloroquine, a large chunk of which has been imported from India. "I don't know of the report. Obviously, there have been some very good reports and perhaps this one's not a good report. But we'll be looking at it. We'll have a comment on it at some point," Trump told reporters during his daily White House news conference on coronavirus. Trump was responding to a question on a study released by a group of scientists on use of hydroxychloroquine with or without antibiotic azithromycin for 368 COVID-19 patients. The unreviewed study submitted to New England Journal of Medicine for publication and posted online found no evidence that use of hydroxychloroquine, either with or without azithromycin, reduced the risk of mechanical ventilation in patients hospitalised with COVID-19. "An association of increased overall mortality was identified in patients treated with hydroxychloroquine alone," said the study that was funded by the National Institute of Health or NIH. NIH in its report 'Therapeutic Options for COVID-19 Currently Under Investigation' said that there are insufficient clinical data to either recommend or oppose using chloroquine or hydroxychloroquine for treatment of COVID-19.If chloroquine or hydroxychloroquine is used, clinicians should monitor the patient for adverse effects, especially prolonged QTc interval, it said. The panel of NIH experts recommended against the use of the combination of hydroxychloroquine and azithromycin because of the potential for toxicities. US Food and Drug Administration Commissioner Stephen M Hahn said that no final decision has been taken as yet."I've mentioned from this podium and in other venues before, what FDA is going to require is data from clinical trials, randomised clinical trials, hydroxychloroquine/placebo, to actually make a definitive decision around safety and efficacy," he told reporters.The first one is a small retrospective study at the VA. "And similar to the data we talked about before with the French study, this is something that a doctorate would need to consider as part of a decision in writing a prescription for hydroxychloroquine," he said. "But the preliminary data are helpful to providers. I want to ask them (doctors) to incorporate the data as we have it come forward. It's not definitive data. It doesn't help us make a decision from a regulatory review.""But doctors should incorporate that in the decision-making they make on a one-on-one basis," Hahn said in response to a question. Congressman Bill Pascrell said the report analysing hydroxychloroquine as a potential COVID-19 treatment at veterans hospitals is a bombshell indictment of the damage Trump and his administration does to Americans by putting politics before science. "The world class medicine and doctors we enjoy today are the fruit of generations of painstaking work by our ancestors. Evidence-based science is the only way out of this crisis, not unproven miracle therapies personally favored by Donald Trump," he said."Trump's frequent touting of this treatment was deeply irresponsible, and may have heaped unnecessary pain and suffering, not to mention false hope, upon Americans struck by this terrible illness.""I have repeatedly warned the FDA about the danger of prizing Trump's political pressure over scientific process. Unless we are guided by science and science alone, we will have more unnecessary deaths on our hands," Pascrell said. LKJ RHL

Plan to use hydroxychloroquine for COVID-19 treatment receives setback

Dubai, Apr 16 () India is fast-tracking procedures to supply hydroxychloroquine, a drug considered to be efficient in fighting the coronavirus, to the UAE after a request from the country's government, media reports here quoted the Indian envoy as saying.India's Ambassador to the UAE Pavan Kapoor said there is a huge demand for the anti-malarial drug from many countries and India is considering it on a case to case basis."As the drug is on the restricted list, we are obviously giving exception to the UAE, given the friendly relations between the two countries," Khaleej Times quoted Kapoor as saying.The global demand for hydroxychloroquine (HCQ) manufactured by India got a boost after some studies indicated that the drug, when paired with azithromycin, helped clear patients of the virus at a much faster rate than seen usually."There was a request from the government of the UAE to help out with the supply of HCQ," the Gulf News quoted Kapoor as saying.Kapoor said a few companies in the UAE requested the government to import the drug to the country."We received a note verbale from the UAE government also seeking support for the supply through those companies," he said."Whatever requests were made, we made sure that they reached the right authorities in the right format since this is a restricted medicine," Kapoor said.He said India is permitting the export of HCQ on a case-by-case basis on the request from governments of friendly countries. With the UAE government backing up the local companies' request for import for the medicine, he said, India is fast-tracking the procedures.The UAE Ministry of Health and Prevention on Wednesday announced 432 new cases of the Covid-19 coronavirus, bringing the total number of cases to 5,365.The country has reported 33 deaths, including five expats of different nationalities. In a humanitarian gesture, India on Wednesday gifted life-saving drugs, including Hydroxychloroquine tablets, to Mauritius and Seychelles to help them deal with the coronavirus pandemic that has infected 2 million people worldwide.Mauritius Vice Prime Minister Leela Devi Luchoomun Dookun received the consignment of half a million Hydroxychloroquine tablets that arrived here on Wednesday evening through a special Air India cargo flight from Delhi, the Indian High Commission in Port Louis said in a statement. Mauritius is one of the first countries to receive supplies of this medicine after a special exemption was granted for a few countries. NSA

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