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New Delhi, Apr 22 () The government on Wednesday asked all state drug controllers to ensure availability of essential medicines and medical devices required in the treatment of COVID-19. In a meeting with the state drug controllers, Union Pharma Secretary P D Vaghela asked them "to provide all support to manufacturing units with the help of local administration and concerned authorities by regular interaction so that there is no shortage of medicines and medical devices". They were also requested to ensure the utilisation of manufacturing capacity to full extent so that sufficient stocks without any hindrance can be made available at all levels, the ministry of chemicals and fertilizers said in a release. They were instructed to ensure that hoarding and price escalation of drugs and medical devices do not happen and to initiate action in such cases, the release said. The pharma secretary also asked them to monitor availability of the hydroxychloroquine, azythromycin and paracetamol formulations, the release said. The state drug controllers were also asked to monitor the list of essential drugs circulated by the Ministry of Health &amp; Family Welfare on regular basis and to provide the data, it added. They were asked to provide information of drugs and devices manufacturing units in their states, the release said. AKT ANUANU

COVID-19: Govt asks state drug controllers to ensure availability of drugs, med devices

Hyderabad, Feb Pharma major Dr. Reddy's Laboratories Ltd on Friday announced that it has initiated the process with the <keyword id="282629" type="COMPANY" weightage="20" keywordseo="Drugs-Controller">Drugs Controller</keyword> General of India (<keyword id="172241" type="COMPANY" weightage="20" keywordseo="DCGI">DCGI</keyword>) for Emergency Use Authorization (<keyword id="2503801" type="COMPANY" weightage="20" keywordseo="EUA">EUA</keyword>) of the well-studied human adenoviral vector-based platform vaccine candidate, <keyword id="9739267" type="PERSON" weightage="20" keywordseo="Sputnik-V">Sputnik V</keyword>. As part of the review process, Dr. Reddy's will present the safety profile of the phase 2 study, and interim data of the phase 3 study, which is expected to complete by February 21, the Hyderabad-based firm said. Dr. Reddy's partnered with the Russian Direct Investment Fund (<keyword id="18165" type="COMPANY" weightage="20" keywordseo="rdif">RDIF</keyword>) in September 2020 to conduct the clinical trials of the Sputnik V and for its distribution rights in India. The vaccine is currently undergoing the phase 3 clinical trial in India. Sputnik V has demonstrated an efficacy rate of 91.6 per cent in the interim analysis of the phase 3 clinical trial, which included data on 19,866 volunteers in Russia, who received both the first and second doses of the vaccine. Sputnik V maintained a consistent efficacy at 91.8 per cent even among the group of 2,144 volunteers over 60 years old. "The efficacy of Sputnik V was reported to be 91.6 per cent by the Lancet, which is an impressive development in the fight against Covid-19. The initiation of the EUA process will be a critical step forward for us in ensuring speedy access to the Sputnik V vaccine in India," said G.V. Prasad, Co-chairman and Managing Director, Dr. Reddy's Laboratories. Sputnik V developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Ministry of Health of Russia on August 11, 2020 and became the world's first registered vaccine against Covid-19 based on the human adenoviral vector platform. More than 250 clinical studies over two decades have proven the safety, efficacy, and lack of negative long-term effects of adenoviral vaccines. Sputnik V is one of only three vaccines in the world with an efficacy of 91.6 per cent and has most authorizations granted with 26 countries globally. The vaccine has already been administered to more than two million people worldwide. SEE ALSO: <a href="https://www.businessinsider.in/entertainment/news/pewdiepies-lyrics-targeting-cocomelon-and-jk-rowling-that-may-have-gotten-youtube-angry-enough-to-pull-the-video-down/articleshow/81102941.cms">PewDiePie's lyrics targeting CocoMelon and JK Rowling may have gotten YouTube angry enough to pull the video down</a> <a href="https://www.businessinsider.in/business/ecommerce/news/flipkart-gets-leaner-with-a-300-million-jabong-write-off-as-ceo-kalyan-krishnamurthy-lists-out-the-priorities-for-2021/articleshow/81105083.cms">Flipkart gets leaner with a $300 million Jabong write-off as CEO Kalyan Krishnamurthy lists out the priorities for 2021</a> <a href="https://www.businessinsider.in/stock-market/news/happiest-minds-is-leveraging-its-partnerships-with-big-players-like-google-microsoft-aws-salesforce/articleshow/81105035.cms">Happiest Minds is a smaller company that does the same thing as MindTree and L&amp;T Infotech — but clearly it is doing it a lot better</a> <a href="https://www.businessinsider.in/tech/news/india-may-require-twitter-facebook-and-others-to-remove-unlawful-content-within-36-hours/articleshow/81104740.cms">India may require Twitter, Facebook and others to remove unlawful content within 36 hours</a>

Dr.Reddy's gets authorisation to start rolling out Sputnik V COVID-19 vaccine in India

Indian Pharma company <keyword id="15908017" type="General" weightage="100" keywordseo="marion-biotech" source="Orion">Marion Biotech</keyword> Pvt Ltd has halted the production of cough syrup following allegations by Uzbekistan that at least 18 children died in the country after consuming the medicine. A joint inspection of the manufacturer's Noida facility was carried out by the teams of the Uttar Pradesh Drug Control Department and CDSCO. The Central Drugs Standard Control Organisation (CDSCO) is in contact with the national drug regulator of Uzbekistan regarding the matter. "Immediately on receipt of the information, joint inspection of the NOIDA facility of the manufacturer, Marion Biotech, was carried out by UP Drug Control and CDSCO team and further action as appropriate would be initiated based on the inspection report," said the Union health ministry on Thursday. The samples of the cough syrup have been taken from the manufacturing premises and sent to Regional Drugs Testing Laboratory (RDTL), Chandigarh for testing. Meanwhile, Marion Biotech Pharma company has said that it has sent samples of the said cough syrup for testing and has also halted the production of the product. Hasan, the Legal Head of Marion Biotech, expressed grief over the deaths on behalf of the company and said that an inquiry into the matter was being conducted by the government. He added that samples were collected and action would be taken on the basis of the report. Marion Biotech is a licensed manufacturer and holds a license for manufacturing Dok1 <keyword id="26842" type="General" weightage="50" keywordseo="max" source="Orion">Max</keyword> syrup and <keyword id="50839" type="General" weightage="50" keywordseo="tablet" source="Orion">Tablet</keyword> for export purposes granted by <keyword id="282629" type="General" weightage="50" keywordseo="drugs-controller" source="Orion">Drugs Controller</keyword>, Uttar Pradesh. Uzbekistan's health ministry, on Tuesday, said that 18 children suffering from an acute respiratory disease died after taking excessive doses of cough syrup Dok 1 Max, manufactured by Marion Biotech. Experts say that cough syrups sometimes contain "unacceptable levels" of Di<keyword id="7488410" type="General" weightage="50" keywordseo="ethylene-glycol" source="Orion">ethylene Glycol</keyword> and Ethylene Glycol. The syrup becomes harmful if there is even a slight difference in their quantity. SEE ALSO: <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/science/health/news/urgent-need-to-develop-antibiotics-for-newborns-say-global-experts/articleshow/96592721.cms">Urgent need to develop antibiotics for newborns say global experts</a> <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/india/news/nirmala-sitharaman-discharged-from-aiims/articleshow/96598659.cms">Nirmala Sitharaman discharged from AIIMS</a>

Indian drugmaker Marion Biotech halts manufacture of cough syrup, probe underway

<ul><li>According to a govt survey on drugs, 3.16% of drugs tested were below standards.</li><li>0.02% of the drugs tested were found to be fake. </li><li>Proposal to the government to print 14-digit unique codes on packaging to identify drugs. </li></ul>India has a <keyword id="908551" type="UNKNOWN" weightage="20" keywordseo="fake-medicine">fake medicine</keyword> problem, and its government is attempting a crack down. According to a survey conducted in 2014 and 2016 to check the proportions of substandard drugs in India, 3.16% of the samples tested were substandard, while 0.02% were fake. In order to confront the problem, India's highest advisory body on drugs, Central Drugs Standard Control Organization (<keyword id="6375144" type="ORGANIZATION" weightage="20" keywordseo="cdsco">CDSCO</keyword>), will discuss a mechanism to stop the distribution of fake medicines in a meeting on 16th May. A proposal has been drafted according to which consumers will be able to check whether the medicine that they purchased is genuine by texting a unique code printed on the packaging of the medicine to a hotline number, <a href="https://www.livemint.com/Industry/LbXFNE7RQDStVQ23mlmK6L/Govt-planning-unique-codes-to-check-menace-of-fake-medicines.html">said a report on Livemint</a>. Initially, the government plans to build a data bank of 300 medicine brands and customers’ consumption patterns in various parts of the country. Further, companies that manufacture drug will be asked to print a unique 14-digit alphanumeric code on the packaging of the drug. Consumers can then check their authenticity by sending the code to a predesignated number. Fake medicines lead to drug resistance and even cause a significant number of deaths according to public health reports. According to the <keyword id="6529293" type="ORGANIZATION" weightage="20" keywordseo="central-drug-standard-control">Central Drug Standard Control</keyword> organisation, even samples from big drug makers were found to be of sub-standard quality during a survey that was carried out by the National Institute of Biologicals. The government expects to bring down the percentage of substandard and <keyword id="113726" type="PERSON" weightage="20" keywordseo="fake-drugs">fake drugs</keyword> in the country to 2% in the next 3 years. According to a report released by the World Health Organisation (WHO) in 2017, approximately 10.5% of all medicines in low and middle-income countries including India are substandard. The Drug regulatory body has also been doing some risk-based inspection of drug manufacturing plants as a part of this initiative to match global standards.

India plans on building text message-based medicine identification system

<div class="KonaFilter image-container display-table float_right"><div><div class="image on-image"></div></div></div>High prescription drug prices in the US aren't going anywhere.Tensions over this issue flared up Monday, when&#xa0;<a href="http://www.businessinsider.com/epipen-price-increases-about-500-percent-2016-8">senators started to ask questions</a>&#xa0;about the EpiPen, a device&#xa0;used in emergencies to treat anaphylaxis, a severe allergic reaction that <a href="http://www.mayoclinic.org/diseases-conditions/anaphylaxis/basics/definition/con-20014324">can make people go into shock</a>, struggle to breathe, or get a skin rash.&#xa0;Since 2009, when a two-pack of EpiPen went for $100, the price has gone up about 500%, though the price varies among pharmacies.On Tuesday, Mylan (the company that makes the EpiPen) was down 4% on the news that lawmakers were getting involved in the debate.&#xa0;In response to questions about its high list price, Mylan noted in an email&#xa0;to Business Insider that about 80% of people with commercial insurance who also used a "My EpiPen Savings Card" received the device for $0, and pointed to changing healthcare plans with increased deductibles as the reason for the recent pricing pressure families are feeling.&#xa0;But it begs the question: How did we get into this mess? Why are our drug prices so notably different from other countries, say in Europe or Canada?A <a href="http://jama.jamanetwork.com/article.aspx?articleid=2545691">report released Tuesday in the Journal of the American Medical Association</a>&#xa0;took a deep dive into the question of&#xa0;why the US has such high drug prices&#xa0;and offered&#xa0;some possible short-term solutions to the problem.&#xa0;"Although prices are often justified by the high cost of drug development, there is no evidence of an association between research and development costs and prices," the researchers from Brigham and Women's Hospital in Boston <a href="http://jama.jamanetwork.com/article.aspx?articleid=2545691">found</a>. "Rather, prescription drugs are priced in the United States primarily on the basis of what the market will bear."Here's what the authors&#xa0;singled out as the main drivers that's led to the US having such high drug prices compared to other countries around the world.&#xa0;<h2>1. New drugs get an exclusive, for better or worse.</h2>The US is one of the countries that spends the most when it comes to researching and developing new treatments. As such, companies that first develop a drug are able to have an exclusive on it&#xa0;for a set amount of time before they face competition from cheaper versions. That means they're able to set their own prices (which can <a href="http://www.businessinsider.com/the-rising-cost-of-cancer-treatment-2016-6">often be high to begin with</a>), or they can increase the price in the years leading up to when they expect to lose a lot of money to competition.&#xa0;Some drug companies also do everything they can to fend off generic competition, by adding other patents,&#xa0;or making sometimes incremental changes to the drug or device so that they can retain exclusive rights even after the original patent expires. That's where you start to see problems,&#xa0;Ameet Sarpatwari, an epidemiologist at Brigham and Women's Hospital and one of the study's authors&#xa0;told Business Insider.&#xa0;"The real question is, do those improvements&#xa0;do what they actually offer; are they really innovative?" he said.<h2>2. The US has no&#xa0;power to negotiate.</h2>Unlike other governments, the US doesn't have much of a hand in how drug prices are set, especially when they're under that market exclusivity, which essentially leaves the US&#xa0;"handcuffed,"&#xa0;Sarpatwari said.&#xa0;The US government is actually prohibited by law from negotiating drug prices with pharmaceutical companies, "based in part on considerable lobbying and arguments that government negotiating power could decrease revenues for the pharmaceutical industry," the <a href="http://jama.jamanetwork.com/article.aspx?articleid=2545691#JustificationsforHighDrugPrices">authors wrote</a>. "This made prescription drugs under Part D one of the few aspects of health care for which Centers for Medicare &amp; Medicaid Services does not negotiate or set prices."That's <a href="http://www.wsj.com/articles/why-the-u-s-pays-more-than-other-countries-for-drugs-1448939481">not the case in other countries</a>, where governments evaluate the cost-effectiveness of drugs and set maximum prices.<div class="KonaFilter image-container display-table"><div><div class="image on-image"></div></div></div><h2>3. Bringing in generic competition can be a challenge.</h2>One of the reasons why people are aggravated by the EpiPen's high costs are that there aren't many alternatives available. One of EpiPen's competitors, called <a href="https://www.auvi-q.com/licensing-announcement">Auvi-Q</a>, has <a href="http://www.wsj.com/articles/sanofi-recalls-auvi-q-allergy-injectors-1446152933">been recalled since last October</a>. The other, called Adrenaclick, is a little different to use (it uses two caps instead of one, for example) and costs more than $400 without insurance, <a href="http://www.goodrx.com/adrenaclick?drug-name=adrenaclick">according to GoodRx</a> (though <a href="http://www.consumerreports.org/drugs/can-you-get-a-cheaper-epipen/">significantly cheaper options</a> may be available with coupons).And generic versions of the EpiPen <a href="http://ir.adamispharmaceuticals.com/phoenix.zhtml?c=99350&amp;p=irol-newsArticle&amp;ID=2175190">have not</a>&#xa0;yet been<a href="http://www.fiercepharma.com/sales-and-marketing/fda-swats-down-teva-s-epipen-copy-putting-mylan-cruise-control"> approved by the Food and Drug Administration</a>; two have received "complete response letters" in the past year, meaning the FDA still has some questions that need to be addressed&#xa0;before they can approve the drug.In other cases, however, the reason branded drugs aren't facing competition is that generic alternatives are stuck in a backlog. In the report, Sarpatwari and his fellow authors noted that a way to fix this could be to import drugs from other countries with standards similar to the FDA's, to keep price gouging from happening.&#xa0;"It's not sufficient to say the problem will go away once generics come in,"&#xa0;Sarpatwari said. "What the evidence shows is that you need to make sure that there [are]&#xa0;a healthy number of competitors."<h2>4. There's not much research that stacks&#xa0;competing drugs against one another.</h2>For doctors looking to prescribe a certain drug, there's typically a wealth of information they can find for individual drugs, but less information that compares one drug to a competitor.&#xa0;"There's asymmetry on the information that's available,"&#xa0;Sarpatwari said. In response, the report suggested that more research go into looking at how drugs stack up to one another, so that doctors could get a clear picture of whether they'd have to prescribe the costly branded version, or the less expensive generic or competing branded drug that's a fraction of the cost.&#xa0;"We need to do a better job conducting comparative cost research,"&#xa0;Sarpatwari said.&#xa0;<h2>So why don't&#xa0;drug companies lower their prices?</h2>Despite all the public outcry over certain drugs with high prices, none of those drugs have come down on their list price, instead choosing to offer a variety of discounts. So why not lower the list price, even a bit, to get the public off your back?"The answer is, you don't want to be the first one who caves,"&#xa0;Sarpatwari said.&#xa0;"They're worried that it will start a chain effect." And, really, they don't have to do it, he said. "That's the disturbing part of all of this." <div class="margin-top"> <h3>NOW WATCH: <a href="http://www.businessinsider.com/how-to-watch-perseid-meteor-shower-this-week-2016-8">How to watch the most incredible meteor shower of the year </a></h3> <div> <div> <div class="ooyala-video-player" data-video-autoplay="false" data-video-id="VvaHY3NTE6t3YEBSTSEp4WBZvQ6lUt-W" data-player-variable="ooyalapopvideo" id="ooyalaplayer_popvideo" style="width:1280px;height:720px"></div> </div> </div> </div>

Why the price of prescription drugs in the US is out of control

<ul><li>The government has curbed the powers of the National Pharmaceuticals Pricing Authority (<keyword id="312730" type="ORGANIZATION" weightage="20" keywordseo="NPPA">NPPA</keyword>) when it comes to setting and putting caps on drug prices. </li><li>Instead, a committee under <keyword id="2665691" type="PERSON" weightage="20" keywordseo="Niti-Aayog">Niti Aayog</keyword> will be tasked with recommending <keyword id="1097060" type="PERSON" weightage="20" keywordseo="Price-controls">price controls</keyword> and monitoring the prices of specific <keyword id="14721" type="COMPANY" weightage="20" keywordseo="Drugs">drugs</keyword> and health products. </li><li>With the committee taking over, it seems the government will have a freer hand when it comes to setting or lifting price controls. </li></ul>In a move that is likely to be met with backlash, the Indian government has curbed the powers of the National Pharmaceuticals Pricing Authority (NPPA) when it comes to setting drug prices, according <a href="https://timesofindia.indiatimes.com/india/govt-forms-niti-led-panel-to-monitor-pricing-of-drugs/articleshow/67633122.cms">to media reports</a>. Instead, the government, acting through the Ministry of Chemicals and Fertilisers, has decided to establish a committee under Niti Aayog, its public policy think tank, that will be tasked with recommending price controls and monitoring the prices of specific drugs and health products to ensure their affordability. The committee will comprise a number of government officials in the Niti Aayog and the finance and health ministries. The proposal to establish the committee was <a href="https://www.livemint.com/Industry/AgCJNCUusBmjRmqVjAP67J/NITI-Aayogs-proposals-may-curb-drug-price-regulators-power.html">mooted in April last year</a> by the Niti Aayog, which reportedly said that the NPPA should monitor prices instead of fixing them. The NPPA was established as an autonomous regulator in 1997 to oversee prices of drugs and products on the National List of Essential Medicines (NLEM), which is prepared by the health ministry, and set price caps. For example, it was the body that instituted<a href="https://www.business-standard.com/article/companies/nppa-cuts-stent-price-again-mnc-demand-for-sub-categories-rejected-118021201439_1.html"> a cap on the price of heart stents </a>and was responsible for revisions to the policy. Up until now, the health ministry made recommendations to the NPPA on price controls. Drugs that are listed on the NLEM, the number of which currently amounts to 750, can only be sold at prices set by the NPPA. Those that aren’t on the list are allows a 10% hike in annual prices subject to the discretion of the regulator - a responsibility it is no longer expected to have. With the committee taking over, it seems the government will have a freer hand when it comes to setting or lifting price controls. Hence, the move has <a href="https://www.indiatoday.in/india/story/govt-constitutes-niti-aayog-led-committee-to-monitor-pricing-of-drugs-activists-question-move-1436216-2019-01-22">raised the ire of activists</a> with the All India Drug Action Network (AIDAN). If the committee is swayed by corporate interests, it will have negative implications on the affordability and accessibility of these drugs. More importantly, the authority of the NPPA to enforce price controls could also be endangered. With its ability to set prices curtailed, the ability to enforce those controls could also be a casualty. The move to curb the NPPA’s powers isn’t surprising. Under the current central administration, the <keyword id="6364581" type="UNKNOWN" weightage="20" keywordseo="autonomy">autonomy</keyword> of a number of institutions, most notably <a href="https://www.businessinsider.in/the-resignation-of-the-governor-of-indias-central-bank-sends-a-clear-indication-about-the-erosion-of-institutional-autonomy-under-the-modi-administration/articleshow/67040287.cms">the Reserve Bank of India </a>and the Central Bureau of Investigation, have been compromised. As the country heads into elections, one hopes the public will take notice after feeling the effect of some of these incursions. SEE ALSO: <a href="https://www.businessinsider.in/the-resignation-of-the-governor-of-indias-central-bank-sends-a-clear-indication-about-the-erosion-of-institutional-autonomy-under-the-modi-administration/articleshow/67040287.cms">The resignation of the governor of India’s central bank sends a clear indication about the erosion of institutional autonomy under the Modi administration</a> <a href="https://www.businessinsider.in/niti-aayog-to-open-applications-for-atal-innovation-mission-for-msmes-startups-and-inventors-in-india/articleshow/63923666.cms">NITI Aayog to open applications for Atal Innovation Mission for MSMEs, startups and inventors in India</a>

The Indian government just reduced the autonomy of the regulator that makes drugs affordable

<ul><li>An investigation by the <keyword id="6386816" type="ORGANIZATION" weightage="20" keywordseo="drug-controller-general-of-india">Drug Controller General of India</keyword> (DGCI) e-commerce giants <keyword id="18635" type="CITY" weightage="20" keywordseo="Amazon">Amazon</keyword> and <keyword id="6354742" type="COMPANY" weightage="20" keywordseo="Flipkart">Flipkart</keyword> were allegedly found to be selling ‘adulterated’ and ‘unregulated’ beauty products on their websites, according to a Mint report. </li><li>The DGCI has asked online retailers to stop such sales. The retailers have reportedly committed to removing these products. </li><li>Cosmetics worth ₹40 million were confiscated from around the country during the investigation.</li></ul>E-commerce giants Amazon and Flipkart were recently served notices from India’s drug regulator Drug Controller General of India (DGCI) for allegedly selling certain <keyword id="721787" type="UNKNOWN" weightage="20" keywordseo="Fake-cosmetics">fake cosmetics</keyword>, Mint <a href="https://www.livemint.com/Companies/ecmOFt9kc8RUTRJjQT5TgJ/Amazon-Flipkart-promise-to-stop-sale-of-fake-cosmetics.html">reported</a>. The online retailers have reportedly said that they will stop the sale of adulterated products in question on their websites sold by certain sellers, according to the Mint <a href="https://www.livemint.com/Companies/ecmOFt9kc8RUTRJjQT5TgJ/Amazon-Flipkart-promise-to-stop-sale-of-fake-cosmetics.html">report</a>. Cosmetics <a href="https://www.medianama.com/2018/11/223-amazon-flipkart-fake-cosmetic-sellers-india-dcgi/">worth</a> ₹40 million were confiscated from around the country during the investigation, it added. In the last three years, online retailers Snapdeal and Shopclues have also faced similar issues and were asked to pull off products from their platforms. The beauty products in question include serums, skin-whitening creams, and stem-cell based cosmetics that fall l under the illegal imports category with some products containing ingredients unfit for human use. As per another <a href="https://www.timesnownews.com/business-economy/companies/article/amazon-flipkart-commit-to-stop-sale-on-fake-cosmetics-on-their-websites/312428">study</a> highlighting the problem of fake cosmetics, one out of every five products sold online is fake. About 35% of the online consumers reported receiving fake products under the cosmetics category in the span of six months, according to poll results. Spokespeople at Amazon and Flipkart could not be reached for comment.

Amazon, Flipkart asked to pull fake beauty products from websites in India: Report

<keyword id="9440093" type="COMPANY" weightage="20" keywordseo="covifor">Covifor</keyword>, the generic version of Covid-19 drug Remdesivir, will be available in India for Rs 5,400 per 100 <keyword id="9459307" type="UNKNOWN" weightage="20" keywordseo="mg-vial">mg vial</keyword>, Hyderabad-based Hetero Labs announced on Wednesday. Following the approval to Covifor by <keyword id="9440959" type="COMPANY" weightage="20" keywordseo="the-drug-controller-general">the Drug Controller General</keyword> of India , <keyword id="2982370" type="COMPANY" weightage="20" keywordseo="Hetero-Healthcare-Ltd">Hetero Healthcare Ltd</keyword>, a group company of Hetero, announced that it is set to deliver the first set of 20,000 vials. They will be made available in two equal lots of 10,000 each. One lot will be immediately supplied to Hyderabad, Delhi, Gujarat, Tamil Nadu, Mumbai and other parts of Maharashtra while the other lot will be supplied to Kolkata, Indore, Bhopal, Lucknow, Patna, Bhubaneshwar, Ranchi, Vijayawada, Cochin, Thiruvananthapuram and Goa within a week to meet the emergency requirements, the company said. "Through Covifor, we hope to reduce the treatment time of a patient in a hospital, thereby reducing the increasing pressure on the <keyword id="91332" type="PERSON" weightage="20" keywordseo="Medical-Infrastructure">medical infrastructure</keyword>, overburdened currently due to accelerating Covid-19 infection rates. We are working closely with the government and medical community to make Covifor quickly accessible to both public and private healthcare settings across the country," said M. Srinivasa Reddy, Managing Director, Hetero Healthcare. Covifor is the first generic brand of Remdesivir which is indicated for the treatment of Covid-19 patients in adults and children, hospitalised with severe symptoms of the disease. The drug is available in 100 mg vial (injectable). It needs to be administered intravenously in a hospital, or critical care setting, under the supervision of a registered medical practitioner. Covifor is anticipated to play a significant role in bringing down the mortality rates caused by Covid-19, given its proven positive clinical outcomes, the company added. SEE ALSO: <a href="https://www.businessinsider.in/india/news/data-of-coronavirus-patients-state-wise-in-india/articleshow/74669748.cms">Coronavirus cases in India state wise</a> <a href="https://www.businessinsider.in/topic/coronavirus">Coronavirus News and Updates</a>

Generic COVID-19 drug priced at ₹5,400 per vial by Hyderabad-based Hetero

All the manufacturing activities at the Indian Pharma company, Marion Biotech Pvt Ltd, have been stopped following allegations by Uzbekistan that at least 18 children died in the country after consuming the medicine. The manufacturing activities have been stopped after the inspection by the Central Drugs Standard Control Organisation (<keyword id="6375144" type="General" weightage="80" keywordseo="cdsco" source="Orion">CDSCO</keyword>). A joint inspection of the manufacturer's Noida facility was carried out by the teams of the <keyword id="15923942" type="General" weightage="50" keywordseo="uttar-pradesh-drug-control-department" source="Orion">Uttar Pradesh Drug Control Department</keyword> and CDSCO. "Following inspection by @CDSCO_INDIA_INF team in view of reports of contamination in cough syrup Dok1 Max, all manufacturing activities of Marion Biotech at NOIDA unit have been stopped yesterday night, while further investigation is ongoing", said <keyword id="700200" type="General" weightage="50" keywordseo="union-health" source="Orion">Union Health</keyword> Minister <keyword id="2607815" type="General" weightage="80" keywordseo="mansukh-mandaviya" source="Orion">Mansukh Mandaviya</keyword> in a tweet on Friday. However, further investigation is in progress by government agencies. The samples of the cough syrup have been taken from the manufacturing premises and sent to the Regional Drugs Testing Laboratory (RDTL), <keyword id="6360078" type="General" weightage="80" keywordseo="chandigarh" source="Orion">Chandigarh</keyword> for testing. SEE ALSO: <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/india/news/leaders-condole-death-of-pms-mother-recall-her-simplicity-high-values/articleshow/96616064.cms">Leaders condole death of PM's mother, recall her simplicity, high values</a> <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/science/health/news/urgent-need-to-develop-antibiotics-for-newborns-say-global-experts/articleshow/96618564.cms">Urgent need to develop antibiotics for newborns say global experts</a>

Uzbekistan cough syrup issue: Manufacturing at Marion Biotech stopped after probe

Bengaluru, <keyword id="350365" type="DOMAIN" weightage="20" keywordseo="AstraZeneca-India">AstraZeneca India</keyword> on Tuesday said it has received marketing authorisation from <keyword id="2906413" type="COMPANY" weightage="20" keywordseo="The-Drugs-Controller-General-of-India">the Drugs Controller General of India</keyword> (DCGI) for use of <keyword id="8033475" type="PERSON" weightage="20" keywordseo="fasenra">Fasenra</keyword> for the management of patients with <keyword id="5305913" type="UNKNOWN" weightage="20" keywordseo="Severe-Asthma">severe asthma</keyword>. Fasenra is not an inhaler or a steroid and is administered once in eight weeks under the skin via injection as maintenance therapy. It is an add-on maintenance treatment for patients with severe eosinophilic asthma. It is designed to target cells in the body called eosinophils, which are a key cause of the eosinophilic subtype of asthma. Studies have also shown that patients on Fasenra could reduce their oral steroid intake significantly, thereby reducing the potential steroid-related side-effects. The marketing authorisation from DCGI paves the way for the launch of Fasenra in India subject to other requisite regulatory approvals, AstraZeneca India said. "AstraZeneca has always been at the forefront of innovative solutions for non-communicable diseases. Despite currently available therapies, a significant unmet need for effective management of severe asthma continues to exist globally as well as in India," Gagandeep Singh Bedi, <keyword id="24973" type="PERSON" weightage="20" keywordseo="managing-director">Managing Director</keyword>, AstraZeneca India, said in a statement. "The regulatory approval of Fasenra in India will provide better medicine for the management of eosinophilic asthma and support patients to attain a <keyword id="7631990" type="UNKNOWN" weightage="20" keywordseo="better-quality">better quality</keyword> of life". Asthma is a common, heterogeneous, chronic inflammatory disease of the airways that affects people of all ages and imposes a substantial burden on patients, their families, and the community. It causes respiratory symptoms that are interspersed with attacks of breathlessness, which may require urgent health care and may result in emergency admission in hospital or sometimes be fatal. The burden of asthma is immense as it causes limitations in daily activities, loss of school and work days, lung function impairment, reduced quality of life, and an adverse socioeconomic burden. SEE ALSO: <a href="https://www.businessinsider.in/stock-market/news/top-stocks-to-watch-spicejet-interglobe-aviation-tata-motors-pfizer-asian-paints-niit-lupin-and-others/articleshow/79849749.cms">Top stocks to watch – SpiceJet, InterGlobe Aviation, Tata Motors, Pfizer, Asian Paints, NIIT, Lupin, and others</a> <a href="https://www.businessinsider.in/stock-market/news/how-to-check-mrs-bectors-food-specialities-ipo-allotment-status-online/articleshow/79808672.cms?upcache=2">Mrs Bectors Food Specialities IPO allotment today: Here’s how to check share allotment status</a> <a href="https://www.businessinsider.in/business/startups/news/google-microsoft-invest-in-dailyhunt-for-its-short-video-platform-josh-making-it-the-latest-unicorn-in-india/articleshow/79850804.cms">Google, Microsoft invest in DailyHunt for its short video platform Josh – making it the latest unicorn in India</a>

AstraZeneca's Fasenra gets regulator nod for launch in India for asthma treatment

<div class="KonaFilter image-container display-table float_right"><div><div class="image on-image">ReutersSenate Minority Leader Chuck Schumer, accompanied by Senator Martin Heinrich and Senator Amy Klobuchar.</div></div></div>Democrats are rolling out "<a href="http://www.businessinsider.com/dems-pitch-better-deal-with-populist-new-agenda-after-2016-election-2017-7">A Better Deal</a>," an economic platform aimed at winning back voters the party lost in the 2016 election.One of the biggest points on the populist agenda? Tackling the rising cost of prescription drugs. The emphasis on drug pricing is one of the three main pillars included in the platform, along with plans to raise wages and "cracking down" on corporate monopolies.As part of the agenda, Democrats hope to allow Medicare to negotiate drug prices, as well as set up an agency that can fine companies that implement excessive price increases. The policies Democrats <a href="https://graphics.axios.com/pdf/better-deal-drug-prices.pdf">hope to put in place</a> include: <ul><li>Setting up an independent agency that would call out companies with drugs that have drastically increased in price. The agency would be able to investigate drugmakers and impose fines. </li><li>Allowing Medicare, specifically Part D, to negotiate drug prices. Part D <a href="https://www.cms.gov/outreach-and-education/outreach/partnerships/downloads/11315-p.pdf">covers most prescription drugs</a>, and it accounts for 30% of <a href="http://www.businessinsider.com/companies-that-would-be-impacted-by-medicare-negotiating-drug-prices-2017-3">biotech companies' gross sales</a>. The government currently can't negotiate prices for drugs under this program. </li><li>Companies that increase the price of their drugs by a certain amount would have to justify the hike to the Department of Health and Human Services 30 days before the price went into effect. In particular, the hope is to have this provision address price hikes to drugs that Medicare spends the most money on. </li></ul>This isn't the first time Democrats have pushed for drug pricing legislation. In 2017 alone, a number of bills addressing everything from <a href="http://www.businessinsider.com/ron-wyden-introduces-pharmacy-benefit-managers-transparency-bill-2017-3">pharmaceutical middlemen</a> to <a href="http://www.businessinsider.com/members-of-house-and-senate-introduce-drug-importation-bill-2017-2">drug importation when prices are high</a> have been introduced in the House and the Senate.On the other side of the aisle, President Donald Trump <a href="http://www.businessinsider.com/trump-wants-drug-pricing-added-to-ahca-2017-3">has called for lower drug prices as well</a>, though he has been largely quiet on the topic in the past few months apart from a <a href="http://www.businessinsider.com/drug-pricing-executive-order-trump-administration-2017-6">reported draft drug pricing executive order</a>. Food and Drug Administration commissioner <a href="http://www.businessinsider.com/scott-gottlieb-on-what-the-fda-can-do-about-drug-prices-2017-5">Scott Gottlieb has also been vocal</a> about finding ways for the agency to take on the rising prices, even though the FDA doesn't directly play a role in setting prices. <div class="margin-top"> <h3>NOW WATCH: <a href="http://www.businessinsider.com/donald-trump-wwe-vince-mcmahon-2016-11">Trump's history with WWE explains a lot about his persona</a></h3> <div> <div> <div class="ooyala-video-player" data-video-autoplay="false" data-video-id="Fkc2QzMTE6Y-AsNDkseGQbTp57hESZU9" data-player-variable="ooyalapopvideo" id="ooyalaplayer_popvideo" style="width:1280px;height:720px"></div> </div> </div> </div>

You Searched For "drugs controller" and got 11 results

COVID-19: Govt asks state drug controllers to ensure availability of drugs, med devices

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Indian drugmaker Marion Biotech halts manufacture of cough syrup, probe underway

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India plans on building text message-based medicine identification system

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Why the price of prescription drugs in the US is out of control

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The Indian government just reduced the autonomy of the regulator that makes drugs affordable

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Amazon, Flipkart asked to pull fake beauty products from websites in India: Report

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Generic COVID-19 drug priced at ₹5,400 per vial by Hyderabad-based Hetero

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Uzbekistan cough syrup issue: Manufacturing at Marion Biotech stopped after probe

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AstraZeneca's Fasenra gets regulator nod for launch in India for asthma treatment

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Democrats are putting drug-pricing controls at the heart of their economic platform

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