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In a significant step, the Centre has given full exemption from basic customs duty on all drugs as well as food for special medical purposes imported for treatment of all rare diseases and personal use under the National Policy for Rare Diseases 2021, through a general exemption notification. This would facilitate the smooth availability of drugs for the treatment of critical and rare diseases, official sources said. The government has also fully exempted <keyword id="13288104" type="General" weightage="80" keywordseo="pembrolizumab" source="Orion">Pembrolizumab</keyword> (<keyword id="2760505" type="General" weightage="80" keywordseo="keytruda" source="Orion">Keytruda</keyword>), used in the treatment of various forms of cancers, from basic customs duty. Drugs or medicines generally attract basic customs duty of 10 per cent, while some categories of life-saving drugs and vaccines attract a concessional rate of 5 per cent or nil charges. To avail of this exemption, the individual importer has to produce a certificate from the central or state director of health services or from the district medical officer or civil surgeon of the district. While exemptions have already been provided to specified drugs for the treatment of spinal muscular atrophy or Duchenne muscular dystrophy, the government has been receiving many representations seeking customs duty relief for drugs and medicines used in the treatment of other rare diseases. Drugs or special foods required for the treatment of these diseases are expensive and need to be imported. It is estimated that for a child weighing 10 kg, the annual cost of treatment for some rare diseases may vary from Rs 10 lakh to more than Rs 1 crore per year with treatment being lifelong and drug dose and cost, increasing with age and weight. This exemption will result in substantial cost savings and provide much-needed relief to the patients. SEE ALSO: <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/business/auto/news/honda-activa-125-2023-launched-in-india-with-new-features-and-variants/slidelist/99110129.cms">Rev your engines: Honda Activa 125 2023 launched in India with new features and variants</a> <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/science/news/ancient-dna-is-restoring-the-origin-story-of-the-swahili-people-of-the-east-african-coast/articleshow/99109859.cms">Ancient DNA is restoring the origin story of the Swahili people of the East African coast</a>

Centre gives full basic customs duty exemption on import of drugs for rare diseases

<ul class="summary-list"><li>Fecal transplants, which are made up of <keyword id="6700510" type="UNKNOWN" weightage="60" keywordseo="poop">poop</keyword> and microbes, could be used to tackle melanoma.</li><li>The procedure involves transplanting healthy poop into the gut of a <keyword id="28956" type="PERSON" weightage="60" keywordseo="skin-cancer">skin cancer</keyword> patient.</li><li>A study suggests that these transplants could help patients respond better to immunotherapy.</li></ul>Fecal transplants are being touted as a promising new treatment for patients with a serious form of skin <a href="https://www.businessinsider.com/how-to-reduce-your-risk-of-cancer-2019-2">cancer</a>, according to research seen by <a href="https://www.theguardian.com/society/2021/feb/04/faecal-transplants-could-help-patients-with-form-of-skin-cancer?CMP=Share_iOSApp_Other">The Guardian</a>.The transplants, which are made up of poop and microbes, could be used to help those suffering due to melanoma.The procedure would involve transplanting <keyword id="1095772" type="PERSON" weightage="60" keywordseo="stool">stool</keyword> from a healthy donor into the gut of a melanoma patient, the paper said.This, in turn, may help the patient respond better to immunotherapy, the research suggests.Read more: <a href="https://www.businessinsider.com/how-mark-cuban-jumpstarted-doctors-mission-to-slash-drug-prices-2021-1">How a Dallas doctor teamed up with 'Shark Tank' investor Mark Cuban to cut rare drug prices by 90% or more.</a>Melanoma, the most serious type of skin <keyword id="6355291" type="UNKNOWN" weightage="60" keywordseo="Cancer">cancer</keyword>, frequently requires different types of immunotherapy for treatment.There are signs from this study that suggest that the chances of successful immunotherapy treatment might be boosted by fecal transplants.In the study, healthy stool was taken from seven people who had responded positively to the immunotherapy drug pembrolizumab. The stool was then transplanted into the guts of 15 melanoma patients.After receiving the transplant, the patients were prescribed pembrolizumab every three weeks. They were then monitored over a period of a year, reported The Guardian.The research showed that six of the patients responded positively to the drugs, with three of them seeing a large decrease or total eradication of the skin cancer.Among all of the patients, there were promising signs of an increased survival time. The median survival time was boosted from seven months to 14 months, the paper said.While the results offer hope for treating melanoma patients, the study was only conducted on a small number of patients. The authors of the study told The Guardian that they hope to carry out the trials on a large group of melanoma patients and to test the impact of fecal transplants on other cancers.

Fecal transplants, made up of poop and microbes, are being touted as a promising new treatment for skin cancer patients

Saskia UppenkampZach Weinberg, left, and Nat Turner, the founders of Flatiron Health.<ul><li>In 2016, the FDA and Flatiron Health, an oncology technology company, started a collaboration to figure out what could be learned using "real world" clinical data.</li><li>That "real world" data comes from cancer patients' health records that Flatiron analyzes.</li><li>In data presented at an upcoming conference, the FDA and Flatiron will show how this data could one day inform how we treat cancer. </li></ul>The FDA is turning to unconventional sources of data to get a better picture of how drugs it's approved are being used in real life. In 2016, the FDA teamed up with Flatiron Health, a $1.2 billion <a href="http://www.businessinsider.com/what-like-when-google-ventures-invested-flatiron-health-2016-9">New York-based healthcare technology startup</a> that collects clinical data from cancer patients - such as what medications a patient has taken and how he or she has responded to them.Amy Abernethy, Flatiron's chief medical officer, told Business Insider that the goal of the collaboration is to figure out what you can learn from real world data. Right now, that data is locked up in electronic health records, which tend to be organized to help bill insurers, rather than detail, say, the rate at which the tumor is shrinking, in a way that could be pulled out for a study.Now, we're getting the first look at that answer in data presented as part of the American Society of Clinical Oncology annual conference, which starts Friday.It's the first time Flatiron, which was founded in 2012, is presenting at ASCO, Abernethy said. In total, the company's database was <a href="http://abstracts.asco.org/199S/search.php?zoom_query=Flatiron&amp;zoom_page=1&amp;zoom_per_page=10&amp;zoom_and=0&amp;zoom_sort=0">used in 14 studies</a> presented at the conference. The FDA and Flatiron Health have been collaborating to explore how the FDA might be able to use real-world data (that clinical information Flatiron collects) to inform how drugs the agency approves are used outside of the clinical trials that are the basis for their approval.For one of their first studies, the two looked into how cancer immunotherapy drugs, specifically <a href="http://www.businessinsider.com/what-cancer-treatment-did-jimmy-carter-use-2015-12">PD-1 checkpoint inhibitors</a>, are being used in the real world in patients with non-small-cell lung cancer. Dr. Sean Khozin, one of the authors on the study and a senior medical officer at the FDA, told Business Insider that Flatiron is just one of many companies the agency is working with to check out how alternative sources of data can be used to better inform the agency.Pulling from Flatiron's database, which compiles clinical data taken out of de-identified electronic health records, <a href="http://abstracts.asco.org/199/AbstView_199_192598.html">the researchers found</a> that patients who used one of two checkpoint inhibitors - pembrolizumab, (otherwise known as Keytruda), and nivolumab, (Opdivo) - had low rates of being tested for PD-L1 expression. For those taking pembrolizumab, there needs to be a certain threshold of PD-L1 expressed on the tumor for treatment, <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125514s012lbl.pdf">according to the FDA's label</a>. And of those who were tested, it rarely happened using the test the FDA had approved as a companion diagnostic.The findings suggest that the therapies aren't used quite like how they're approved by the FDA, which could make a difference in how the treatments pan out. Besides randomized controlled clinical trials, there are a number of ways researchers can study how a particular cancer treatment is playing out in the real world: there are retrospective studies, observational studies, and even prospective research done using patient registries.Abernethy said Flatiron's process is similar to a registry trial, but because data from over the years is already available in the database, the trials don't take as long as they might otherwise.The results weren't necessarily surprising, Abernethy said, but it does set the stage for further research. "It starts to set a line in the sand to understand what's happening in the community and why," Abernethy said. Going forward, the data Flatiron and the FDA analyze could help fine-tune cancer treatment guidelines. For example, if the cancer patients in the Flatiron database that are using the checkpoint inhibitors tend to get better results when they're older, that could suggest that doctors should more actively consider putting them on that course of treatment than they might have based on the clinical trial data alone. And, ultimately, the hope is that more electronic health record data becomes useable for researchers looking to answer questions about how drugs are being used in the real world. Khozin said that since the data in electronic health records isn't as easy to get, especially at a large enough scale. But, Khozin said, he thinks someday soon that will begin to change, at which point insights like the one the FDA found with Flatiron will be easier to access. <h3>NOW WATCH: <a href="http://www.businessinsider.com/do-fidget-spinners-help-with-adhd-focus-children-clinical-psychologist-psychology-toys-2017-5">A psychologist debunks the claim that fidget spinners help kids focus</a></h3> Please enable Javascript to watch this video

The FDA and a $1.2 billion startup are analyzing how drugs are used after approval - and it could one day change how we treat cancer

<div class="KonaFilter image-container display-table float_right"><div><div class="image on-image"><a href="https://www.flickr.com/photos/microbeworld/6055678631">University of Pennsylvania via Microbe World / Flickr</a>In this 2011 image, tiny beads (yellow) are used to force T-cells to divide before they are given to leukemia patients.</div></div></div>For people with advanced forms of lung cancer, chemotherapy might not be the only - or even the best - option. The drug, marketed as Keytruda, is one of a new set of drugs called immunotherapy. The drug targets the programmed cell death 1 (or PD-1) receptor and allows the body's own immune system go after the cancer cells.Merck, the maker of Keytruda, just finshed a new trial on the drug, for patients who haven't yet been treated for advanced non-small cell lung cancer. The results are <a href="http://www.nejm.org/doi/full/10.1056/NEJMoa1606774?query=featured_home">published in the New England Journal of Medicine</a>. About a third of all these patients with non-small cell lung cancer have cells that express at least 50% of this PD-L1 protein (which relates to the PD-1 receptor the drug is targeting). The 305 patients who took part in the trial were either assigned Keytruda or platinum-based chemotherapy. Progression-free survival - a clinical endpoint that basically means the cancer hasn't grown - was a median of 10.3 months in those who received Keytruda, while those in the chemotherapy group had a median progression-free survival of 6 months. The overall survival rate at six months for those on Keytruda was 80.2%, while it was 72% for chemotherapy."All these data taken together really represent a sea change in the treatment of the lung cancer patient," Merck's senior vice president of clinical development, Roy Baynes told Business Insider, referring to this trial, as well as another that looked at what happens when chemotherapy is combined with immunotherapy.This is the first randomized controlled trial to show that imunnotherapy is better than standard chemotherapy as a first treatment for people with this type of lung cancer, he said.<h2>Steep competition</h2>Keytruda isn't the only PD-1 drug trying to prove it works for this group of lung cancer patients: In August, Bristol-Myers Squibb, a company with a competing drug called Opdivo said its version of the study <a href="http://www.businessinsider.com/bristol-myers-stock-down-on-failed-cancer-trial-2016-8">didn't hit its primary endpoint of progression-free survival</a> in patients with at least 5% PD-L1 expression in tumors (a wider net than what Merck's was looking at).Both Opdivo (nivolumab) and Keytruda (pembrolizumab) are approved for a seemingly ever-growing list of cancer types. And <a href="http://www.businessinsider.com/the-rising-cost-of-cancer-treatment-2016-6">they're not cheap</a>. Opdivo brought in $840 million in second-quarter sales alone, while Keytruda made $314 million over the same time period."It might well be that Keytruda monotherapy in high PDL1 expressers remains the go-to regimen, representing a high bar for combination therapy to cross," Bernstein analyst Tim Anderson said in a note Friday, before the full data was released.But, although there is a lot of excitement over new immunotherapies like these two, there's still a lot that needs to be figured out about how these treatments work and who will respond to them. "Immunotherapy with checkpoint inhibitors will displace chemotherapy in yet another subset of patients with lung cancer," Dr. Bruce Johnson of the Dana-Farber Cancer Institute wrote in an editorial published Sunday in NEJM. "We await the results of long-term follow-up of large cohorts of patients who were treated with another checkpoint inhibitor, nivolumab, to see whether the initial survival data advantage in the population translates to survival of 20% or greater at 3 years and beyond." <div class="margin-top"> <h3>NOW WATCH: <a href="http://www.businessinsider.com/simple-trick-prevent-morning-breath-2016-9">A simple nighttime habit that can prevent bad morning breath</a></h3> <div> <div> <div class="ooyala-video-player" data-video-autoplay="false" data-video-id="wxb3AwNjE6Zi_Cdp550sVWZwrWewVcDI" data-player-variable="ooyalapopvideo" id="ooyalaplayer_popvideo" style="width:1280px;height:720px"></div> </div> </div> </div>

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Centre gives full basic customs duty exemption on import of drugs for rare diseases

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Fecal transplants, made up of poop and microbes, are being touted as a promising new treatment for skin cancer patients

Joshua Zitser

The FDA and a $1.2 billion startup are analyzing how drugs are used after approval - and it could one day change how we treat cancer

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A new kind of treatment is working better than chemotherapy in some lung cancer patients

Lydia Ramsey

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