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<keyword id="15160768" type="General" weightage="20" keywordseo="presvu" source="Orion">PresVu</keyword> eye drops, developed by <keyword id="20007796" type="General" weightage="20" keywordseo="entod-pharmaceuticals" source="keywords">Entod Pharmaceuticals</keyword>, were launched with considerable media attention earlier this month as a novel solution for <keyword id="23035383" type="General" weightage="20" keywordseo="presbyopia" source="keywords">presbyopia</keyword>. Presbyopia is a condition where individuals aged 40 and above experience difficulty focusing on nearby objects, often requiring reading glasses. PresVu claimed to reduce or eliminate the need for these glasses, offering an alternative through its active ingredient, 1.25% Pilocarpine, which temporarily contracts the pupil, improving near vision.<br /><br />Entod Pharmaceuticals earlier announced that the product had approval from the <keyword id="20047866" type="General" weightage="20" keywordseo="drug-controller-general-of-india" source="keywords">Drug Controller General of India</keyword> (<keyword id="20046022" type="General" weightage="20" keywordseo="dcgi" source="keywords">DCGI</keyword>). These announcements created substantial buzz, as the treatment promised a non-invasive solution to a common problem affecting millions of people.<br /><h2>Regulatory backlash</h2>The situation escalated when the Drug Controller General of India suspended the marketing and distribution licence of PresVu eye drops. The suspension was issued due to unauthorised promotional campaigns by Entod, which made unverified claims about the drug's capabilities. The company had reportedly promoted PresVu not as a prescription drug, but as an over-the-counter (OTC) solution that could potentially replace reading glasses — a claim that regulators found highly misleading.<br /><br />The DCGI expressed concerns that such promotions could lead to misuse, with patients potentially self-administering the product without medical guidance, raising significant safety concerns. Furthermore, the regulatory body pointed out that while the product had been approved as a prescription drug, the marketing blitz implied it was a quick-fix solution available to anyone, which it was not.<br /><h2>Entod Pharmaceuticals responds</h2>Entod Pharmaceuticals quickly defended itself against these allegations, maintaining that their marketing campaign was based on the information cleared by the DCGI. According to Entod, the promotion highlighted only the approved uses of the <keyword id="4537914" type="General" weightage="20" keywordseo="eye-drop" source="Orion">eye drop</keyword>, and any misconceptions arose from how the media and public interpreted the information. The company asserted that it would challenge the suspension in court, emphasising that other pharmaceutical companies frequently follow similar marketing practices without facing such scrutiny.<br /><br />In a statement, Entod’s CEO, <keyword id="21011592" type="General" weightage="20" keywordseo="nikkhil-k-masurkar" source="keywords">Nikkhil K Masurkar</keyword>, clarified that the company had conducted phase 3 clinical trials in India to ensure the product’s safety and efficacy.<br /><div type="Article" hostid="261" msid="113251803" title="The next big market for weight-loss drugs: children" mstype="2" mssubtype="0"></div>“Our approval by DCGI was based on a valid controlled clinical trial in 234 patients which was successful in showing efficacy and safety of these eye drops in patients of Presbyopia, who used these drops without eyeglasses and could read additional lines on Snellen's chart which is yardstick of near vision impairment,” Masurkar commented in a statement.<br /><br />He insisted that the product’s promotional activities had followed standard protocols and blamed the viral nature of media reports for blowing the issue out of proportion. Despite these defences, the product remained suspended pending further investigations.<br /><br />"Such eye drops with the same active ingredient and same concentration have been approved by the US <keyword id="19918726" type="General" weightage="20" keywordseo="fda" source="keywords">FDA</keyword> and marketed in the US for the last three years without any serious complications. FDA didn’t take any action on the companies marketing the same in the USA,” Masurkar further elaborated.<br /><h2>Public and expert reactions</h2>The controversy garnered widespread attention, particularly from medical professionals. The Liver Doc, a prominent liver specialist that takes to social media to debunk pseudoscientific claims, criticised the situation on X (former Twitter), warning about the dangers of exaggerated medical claims in advertising.<br /><br />The doctor’s tweet emphasised that blaming Indian media for blowing Entod’s claims out of proportion was “shameless”, noting that the media merely reported exactly what the company had themselves claimed earlier.<br /><div type="twitter" handle="theliverdr" handlename="theliverdr" favoritecount="0" retweetcount="0" id="1833828866210849170"></div>As of September 12, 2024, the suspension of PresVu's marketing approval remains in place. Entod Pharmaceuticals is preparing to contest the decision in court, hoping to reinstate its flagship product in the Indian market. The regulatory investigation continues, with the DCGI seeking clarification on the exact nature of the promotions and whether they indeed violated ethical standards.<br /><div type="Article" hostid="261" msid="113229771" title="China&amp;#39;s drug regulator clears mpox vaccine; to undergo clinical trial" mstype="2" mssubtype="0"></div>Despite Entod’s defence, the controversy has raised important questions about the marketing of prescription drugs in India, with regulators, the media, and the public closely watching how this case will evolve. The outcome could set a precedent for how pharmaceutical companies in India can market innovative treatments, particularly when dealing with sensitive areas like vision correction.<br />

PresVu eye drops: Why has a pharma company fallen in controversy for claiming to cure near-sightedness?

The central government has prohibited as many as 156 <keyword id="22893276" type="General" weightage="20" keywordseo="combination-drugs" source="keywords">combination drugs</keyword> that are often administered as painkillers, multivitamins, and antibiotics, for fever and cold, among others.<br /><br />In a gazette notification dated August 21, the government said that the use of the drug Fixed Dose Combination of Amylase, Protease, Glucoamylase, Pectinase, Alpha Galactosidase, Lactase, Beta-Gluconase, Cellulase, Lipase, Bromelain, Xylanase, Hemicellulase, Malt diastase, Invertase, Papain is likely to involve risk to human beings whereas safer alternatives to the said drug are available.<br /><br />Upon recommendations of the <keyword id="20092000" type="General" weightage="20" keywordseo="Drugs-Technical-Advisory-Board" source="keywords">Drugs Technical Advisory Board</keyword>, the central government, in the greater interest of the public, has prohibited the manufacture for sale, sale, and distribution for human use of those drugs across the country with immediate effect.<br /><br />The move from the government comes after the matter was examined by an expert committee appointed by the central government, and the said expert committee considered the administration of this Fixed Dose Combination as "irrational".<br /><br />The Drugs Technical Advisory Board also examined the said FDC and recommended that "there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of the Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable," the notification read.<br /><br />The list of banned drugs also includes drugs used for hair treatments, antiparasitic, skincare, anti-allergic. The medicines combined in more than one drug in a single pill are Fixed dose combination drugs FDC, these drugs are also known as cocktail drugs.<br /><br />The Indian Pharmaceutical Alliance supports the decision of the government. Sudarshan Jain, Secretary General, IPA told that, "this has been going for many years and there was a committee which reviewed the whole thing... This is a right step in the interest of patients and all aspects have been taken into consideration."<br /><br />"They have given the opportunity to give the data to support their products, so the right products will continue and when there is no data to support then companies have to withdraw it," Jain added.<br /><br /><strong>SEE ALSO:<br /><br /><a href="https://www.businessinsider.in/business/auto/webstories/2024-tvs-jupiter-vs-honda-activa-6g-which-110cc-scooter-should-you-buy/slidelist/112730069.cms">2024 TVS Jupiter vs Honda Activa 6G – which 110cc scooter should you buy?</a><br /><br /><a href="https://www.businessinsider.in/tech/how-to/how-to-add-music-to-instagram-profile/articleshow/112732934.cms">You can now add music to your Instagram profile – here's how</a><br /><br /></strong><a href="https://www.businessinsider.in/business/auto/news/audi-q8-facelift-launched-in-india-with-a-1-17-crore-price-tag/slidelist/112707701.cms"><strong>Audi Q8 facelift launched in India with a ₹1.17 crore price tag</strong></a><br />

India bans 156 commonly used combination drugs citing possible risks to humans

Having been declared a global health emergency by <keyword id="6366244" type="General" weightage="20" keywordseo="who" source="Orion">WHO</keyword> just a few weeks ago, the dreaded <keyword id="20965747" type="General" weightage="20" keywordseo="mpox" source="keywords">Mpox</keyword> (formerly <keyword id="7616951" type="General" weightage="20" keywordseo="monkeypox" source="Orion">monkeypox</keyword>) has slowly been closing in on India. And now, days after our neighbour <keyword id="19899252" type="General" weightage="20" keywordseo="pakistan" source="keywords">Pakistan</keyword> confirmed its second Mpox case this month, India has also reported its first one this season. While feeling uncertain is understandable, the situation is far from dire just yet.<br /><br />On Monday, September 9, 2024, the <keyword id="19896140" type="General" weightage="20" keywordseo="health-ministry" source="keywords">Health Ministry</keyword> confirmed that a previously suspected case of Mpox was a travel-related infection. The patient, a young male, recently returned from a country experiencing ongoing Mpox transmission. Laboratory tests confirmed the presence of the West African clade 2 of the Mpox virus, which is distinct from the more dangerous clade 1 currently under a public health emergency.<br /><br />In its statement, the Ministry emphasised that this case is isolated and in line with the 30 previous Mpox cases reported in India since July 2022. The Ministry clarified that this case does not contribute to the WHO-declared public health emergency associated with clade 1 of Mpox, which has spread primarily in parts of <keyword id="19924003" type="General" weightage="20" keywordseo="africa" source="keywords">Africa</keyword>.<br />  <div type="Article" hostid="261" msid="112542249" title="WHO has declared mpox a global health emergency. What happens next?" mstype="2" mssubtype="0"></div><br /><h2>Patient condition and response measures<br /></h2>The infected individual is isolated at a designated tertiary care isolation facility. The Ministry reports that the patient is clinically stable, with no systemic illness or pre-existing conditions. Public health authorities have initiated contact tracing and monitoring to ensure the infection remains contained, stating that no widespread public health risk exists at this time.<br /><h2>Mode of transmission and symptoms<br /></h2>The global Mpox outbreak has primarily affected young males, with a median age of 34. The main mode of transmission has been sexual contact, followed by non-sexual person-to-person contact. The most commonly reported symptom is a rash, which can manifest either systemically or in the genital region, followed by fever.<br /><br />WHO data shared by the Ministry indicates that approximately 51.9% of Mpox cases involve individuals living with HIV. This underscores the need for targeted healthcare and awareness, especially in high-risk populations.<br />  <div type="Article" hostid="261" msid="112561654" title="WHO calls for increased surveillance, sharing of data, vaccines to combat monkeypox outbreak" mstype="2" mssubtype="0"></div><br /><h2>Increased vigilance and preparedness<br /></h2>Following the confirmation of this case, the Health Ministry has issued directives to all states and union territories, urging healthcare workers, particularly those in skin/STD clinics and NACO (<keyword id="20887701" type="General" weightage="20" keywordseo="national-aids-control-organisation" source="keywords">National AIDS Control Organisation</keyword>) clinics, to stay alert to the signs and symptoms of Mpox. These clinics must be prepared for immediate isolation, clinical management, and treatment of complications, adhering to established protocols.<br /><br />The Ministry has also advised enhanced screening and testing of suspected Mpox cases, especially at airports and other points of entry, to prevent further transmission.<br /><h2>Awareness and risk communication<br /></h2>The Ministry has issued guidelines to state AIDS control societies, urging them to be vigilant in identifying suspect cases, especially among vulnerable populations such as female sex workers (FSW) and men who have sex with men (MSM). Communities must be made aware of the disease’s transmission and symptoms, as well as the importance of timely reporting.<br /><br />Clear risk communication, particularly to healthcare workers and intervention sites such as skin and paediatric clinics, is crucial to prevent the spread of the virus. While the Ministry advocates for robust preventive measures, it also stresses the importance of avoiding undue panic among the general public.<br /><br />For now, the Ministry’s actions aim to ensure that India remains well-prepared to handle isolated Mpox cases, while working to prevent any major outbreak in the country.<br />  <div type="Article" hostid="261" msid="112550492" title="Danish monkeypox-vaccine maker surges 17% after global health emergency declared" mstype="2" mssubtype="0"></div><br />

Mpox has finally infiltrated India, but how worried should we be about the viral disease?

India is on the brink of a significant medical innovation with the upcoming launch of <keyword id="23029757" type="General" weightage="20" keywordseo="PresVu-eye-drops" source="keywords">PresVu eye drops</keyword>, a groundbreaking treatment aimed at reducing dependency on <keyword id="23034012" type="General" weightage="20" keywordseo="reading-glasses" source="keywords">reading glasses</keyword>. Developed by Mumbai-based <keyword id="20007796" type="General" weightage="20" keywordseo="Entod-Pharmaceuticals" source="keywords" meta.keywordsubtype="org" meta.entityname="Entod Pharmaceuticals" meta.hostid="261" meta.entityid="Entod Pharmaceuticals">Entod Pharmaceuticals</keyword>, PresVu has recently received approval from the Drug Controller General of India (DCGI) and is scheduled to hit the market in early October 2024.<br /><h3 style="line-height:1.2;margin-top:14pt;margin-bottom:4pt;">What is PresVu?</h3>PresVu eye drops are designed to treat <keyword id="23035383" type="General" weightage="20" keywordseo="presbyopia" source="keywords">presbyopia</keyword>, a common age-related condition that affects the eye's ability to focus on nearby objects. This condition, which typically begins in the early 40s, leads to a gradual decline in <keyword id="23035385" type="General" weightage="20" keywordseo="near-vision" source="keywords">near vision</keyword>, making reading glasses a necessity for millions. As per estimates, nearly one third of Indian adults suffer from the condition. PresVu offers a novel solution, aiming to restore visual independence to those suffering from mild to moderate presbyopia.<br />  <div type="Article" hostid="261" msid="112800837" title="Scientists want to help drug addicts recover — by giving them psychedelics" mstype="2" mssubtype="0"></div><h2>How does it work?</h2>The drug contains <keyword id="23035386" type="General" weightage="20" keywordseo="pilocarpine-hydrochloride" source="keywords">pilocarpine hydrochloride</keyword> — a plant-derived compound that has been used for decades to treat various eye conditions and dry mouth. The drops are intended for daily use, with effects lasting several hours, allowing users to perform tasks like reading without the need for glasses. As per the company, the effects of the drops will be apparent within 15 minutes, but complete benefits are only apparent after 15 days of use.<br /><br />The treatment has been thoroughly tested in clinical trials across India and has shown promising results in improving near vision.<br />  <div type="Article" hostid="261" msid="112738885" title="India bans 156 commonly used combination drugs citing possible risks to humans" mstype="2" mssubtype="0"></div><h2>Market impact and accessibility</h2>The introduction of PresVu is expected to make a significant impact in India, where the prevalence of presbyopia is rising. As per media sources, each vial will be priced at Rs 345, making it an affordable alternative to reading glasses. Each vial is designed to last about a month, making it a cost-effective solution for long-term use.<br /><br />Entod Pharmaceuticals has ambitious plans for PresVu, targeting not just the Indian market but also emerging markets in Africa and Southeast Asia. The company sees this as a step towards becoming a global innovator in ophthalmology, with future plans to out-licence products in the US market.<br /><br /><em>(Editor's note: PresVu eye-drops have since been suspended by the DCGI for making exaggerated marketing claims related to the product)</em><br />

Say bye-bye to reading glasses! Mumbai drug-maker to soon introduce eye drops to treat presbyopia in India

India has borne the cross of being the world’s diabetes capital for way too long. Now, a superhero drug that could save the country’s diabetics is on its way to India, but it could drag along with it all the chaos that usually accompanies these heroes.<br /><br />Amid all the fanfare around popular weight loss drug <keyword id="19918897" type="General" weightage="20" keywordseo="Ozempic" source="keywords">Ozempic</keyword> in the West, India’s Central Drug Standard Control Organisation (CDSCO) has granted approval to Eli Lilly's <keyword id="20758984" type="General" weightage="100" keywordseo="Tirzepatide" source="keywords">Tirzepatide</keyword>. Tirzepatide will make its debut in the Indian market under the brand name <keyword id="20078155" type="General" weightage="20" keywordseo="Mounjaro" source="keywords">Mounjaro</keyword> for the treatment of type 2 diabetes. Further, it is currently under review to be sold as an obesity drug under the name <keyword id="19992558" type="General" weightage="20" keywordseo="zepbound" source="keywords">Zepbound</keyword>, as well.<br /><br />Tirzepatide’s is a novel medication that combines the benefits of glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonists. These properties allow Tirzepatide to mimic natural hormones responsible for regulating blood sugar levels in the body.<br />    <div type="Article" hostid="261" msid="110634839" title="Eli Lilly&amp;#39;s Wegovy rival Zepbound will help make weight-loss drug market worth $130 billion by 2030, Goldman Sachs says" mstype="2" mssubtype="0"></div><br /><h2>How Tirzepatide reduces your appetite<br /></h2>The medication works by stimulating insulin release from the pancreas in response to food intake, thereby lowering blood sugar levels after meals. Additionally, it suppresses the release of glucagon, a hormone that typically raises blood sugar levels. This dual action not only helps in managing postprandial glucose spikes but also reduces glucose production by the liver.<br /><br />Moreover, Tirzepatide slows down stomach emptying, which moderates the rate at which glucose enters the bloodstream after eating. This comprehensive approach to diabetes management extends to curbing appetite and food intake, potentially aiding in weight loss — a benefit that has garnered attention in global markets.<br /><br /><h2>How affordable is Tirzepatide?<br /></h2>The simple answer is that it’s not — at least not to the average Indian. Reports suggest that each dose of Tirzepatide will cost the consumer around Rs 20,000 per week — and the recommended dose for this drug is once a week. In a month, they will end up spending a little over Rs 80,000.<br /><br />In comparison, the retail price of other commonly sold <keyword id="22456472" type="General" weightage="20" keywordseo="type-2-diabetes-drug" source="Orion">type 2 diabetes drug</keyword> combinations like sitagliptin+pioglitazone+metformin hydrochloride and dapagliflozin+metformin+vildagliptin cost a few hundred rupees per month.<br /><br />So, it remains doubtful that the average Indian would opt for Tirzepatide to treat diabetes. The drug could, however, find a market among Indians in higher income groups that are actively looking for weight loss drugs.<br /><br />Ozempic has already found an illegal route into India via celebrities, wealthy locals and expatriates. It is also easily available in the gray market — so much so that diabetes patients in need of the drug are unable to get their hands on it due to the excessive demand.<br />    <div type="Article" hostid="261" msid="111022230" title="Top doctor warns against taking weight loss drugs such as Ozempic to get &amp;#39;beach body ready&amp;#39; for summer" mstype="2" mssubtype="0"></div><br /><h2>Side-effects of the weight loss drug<br /></h2>Despite its effectiveness, Tirzepatide does come with potential side effects — and not just on your pockets. Commonly reported adverse effects include nausea, diarrhea, decreased appetite, vomiting, and abdominal discomfort. Serious complications such as pancreatitis, low blood sugar levels, allergic reactions, vision changes and gallbladder issues are rare but require immediate medical attention if experienced.<br /><br />Before starting Tirzepatide, healthcare providers are advised to educate patients on its proper use and potential risks, particularly regarding low blood sugar management. Individuals using oral contraceptives should consult their healthcare provider, as Tirzepatide may affect their efficacy.<br /><br />For those wanting to take the drug for weight loss, it is also being said that Tirzepatide does not guarantee that individuals retain their weight even after stopping its consumption. Continued exercise and a healthy diet are necessary to remain obesity-free.<br /><br />With Eli Lilly planning to launch Mounjaro in India by 2025 due to the pending completion of ongoing regulatory reviews, it remains to be seen if Tirzepatide will fly in India or not. But it will certainly give the Indian upperclass a more legal way to lose weight.<br />    <div type="Article" hostid="261" msid="109374002" title="Another perk of weight-loss drugs? Eli Lilly&amp;#39;s Zepbound may alleviate sleep apnea, too" mstype="2" mssubtype="0"></div><br />

Weight loss and diabetes drug Tirzepatide will cost Rs 80,000 per month in India

<keyword id="19919396" type="General" weightage="20" keywordseo="Tripura" source="keywords">Tripura</keyword> is presently facing a surging <keyword id="22356081" type="General" weightage="20" keywordseo="HIV-epidemic" source="keywords">HIV epidemic</keyword> ripping through its student population. Fueled by <keyword id="22349851" type="General" weightage="20" keywordseo="injectable-drug-use" source="keywords">injectable drug use</keyword>, this crisis has infected at least 828 students and tragically claimed the lives of 47. The situation stretches across 220 schools and 24 colleges, highlighting the alarming ease of transmission.<br /><br />Officials from the Tripura State AIDS Control Society (TSACS) paint a grim picture. New cases are detected daily, with estimates ranging from five to seven. This data, meticulously collected from 164 health facilities across the state, offers a comprehensive view of the outbreak's geographic and demographic reach.<br /><br />The crisis appears to be disproportionately impacting students from affluent families. Often, both parents hold government jobs, possibly indicating higher disposable incomes. However, officials think that this dynamic can delay the detection of drug use and HIV infection, hindering early intervention, as per TOI.<br /><br />While this news may come as a surprise to many outside the northeast, the region has actually been battling a drug problem for several years now, which has sparked a concerning shift in its HIV epidemic. <br /><br /><h2>The growing threat of injectable drug use<br /></h2>As of November 2023, Tripura had over 5,200 active HIV/AIDS cases. While sexual transmission had dipped below 2% as of last year, injectable drug use among students became the primary mode of transmission of the deadly disease.<br /><br />In just a few years, injectable drug use has skyrocketed to a staggering 95% among students aged 14-20. This surge is attributed to the easy availability of injectable drugs, leaving students particularly vulnerable.<br /><br />The statistics paint a bleak picture. As of July 2023, Tripura has witnessed a 300% increase in AIDS patients over the previous decade, TOI reported. The report further stated that injectable drug users were estimated to be 43 times more likely to contract HIV compared to the general adult population. This issue is particularly concerning in northeastern states like Tripura, Mizoram, Nagaland, and Manipur.<br /><br />HIV cases have seen a dramatic rise. From a mere 11 in 2015-16, the number jumped to 757 in 2022 alone. And just over six months into 2024, the state has already seen over 800 HIV cases among students due to drug use. However, experts do point to increased surveillance, awareness and better screening are also contributing to an increased number of cases being reported in recent years.<br /><br />Experts warn that this trend indicates a potential full-blown epidemic. Curbing it requires extensive counselling and mass testing among vulnerable youth. However, obtaining prior consent for testing creates a significant hurdle.<br /><br />The <keyword id="174281" type="General" weightage="20" keywordseo="tripura-government" source="Orion">Tripura government</keyword> is actively seeking solutions. Amending the law to allow mandatory HIV testing under specific circumstances is being explored. Additionally, the focus remains on strengthening existing strategies to combat HIV/AIDS.<br /><br />Tripura's Chief Minister has pointed a finger at foreign nations such as Myanmar, accusing them of fueling the illegal drug trade in the state. He has vowed to crack down on drug traffickers, highlighting Tripura's position as the leading drug seizure state in the Northeast.<br /><br />With the recent surge in the state’s HIV cases, Tripura's fight against AIDS has entered a new chapter. Addressing the rising IDU trend among students is crucial to prevent a further escalation of the epidemic. Through a combination of stricter regulations, targeted interventions, and increased awareness, Tripura can hope to control this public health challenge.<br />

How did over 800 students test HIV positive in Tripura?

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

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

Mumbai, The rupee appreciated 7 paise to settle at 83.30 (provisional) against the US dollar on Friday, following positive cues from equity markets and strong domestic macroeconomic data. Forex analysts said easing crude oil prices in the international markets also favoured the local currency. <br /><br />Global crude price retreated from the level of USD 84 to USD 80 per barrel as oil-producing countries' grouping OPEC+ agreed not to reduce output in 2024, they added. <br /><br />At the interbank foreign exchange, the rupee opened stronger at 83.29 against the dollar and traded between the peak of 83.25 and the lowest level of 83.36 against the American currency intra-day. <br /><br />It finally settled at 83.30 (provisional) against the greenback, registering a gain of 7 paise over the previous close. <br /><br />The rupee settled 5 paise lower at 83.37 against the dollar on Thursday. <br /><br />Meanwhile, the dollar index, which gauges the greenback's strength against a basket of six currencies, was trading 0.19 per cent lower at 103.30 on Friday. <br /><br />Global oil benchmark Brent crude futures declined 0.23 per cent to USD 80.67 per barrel. <br /><br />On the domestic equity market front, Sensex surged 492.75 points, or 0.74 per cent, to settle at 67,481.19 points. The Nifty advanced 134.75 points, or 0.67 per cent, to 20,267.90 points. <br /><br />A monthly survey on Friday said India's manufacturing sector continued with its robust performance in November. The seasonally adjusted S&amp;P Global India Manufacturing Purchasing Managers' Index (PMI) rose to 56 last month from the eight-month low of 55.5 recorded in October. <br /><br />Foreign institutional investors were net buyers in the capital market on Thursday as they purchased shares worth Rs 8,147.85 crore, according to exchange data. <br /><br />According to the government data released on Thursday, India's gross domestic product (GDP) growth of 7.6 per cent during July-September beat most estimates, including 6.5 per cent projected by the <keyword id="6354335" type="General" weightage="80" keywordseo="reserve-bank-of-india" source="Orion">Reserve Bank of India</keyword> (<keyword id="30067" type="General" weightage="80" keywordseo="rbi" source="Orion">RBI</keyword>), retaining the country's tag of the world's fastest-growing major economy. <br /><br />Also, another data released simultaneously showed that the output of eight key infrastructure sectors jumped 12.1 per cent in October 2023 against 0.7 per cent expansion in the year-ago period. <br /><br />The government's fiscal deficit at the end of October touched 45 per cent of the full-year budget estimate, as per the data released by the <keyword id="513373" type="General" weightage="80" keywordseo="controller-general-of-accounts" source="Orion">Controller General of Accounts</keyword> (CGA).

Rupee tracks buoyant equity markets, rises 7 paise to 83.3/USD

Imagine a bustling jewellery market teeming with diamonds and gold. Amidst this glittering chaos, a small stall is trying to sell handcrafted gemstones. Even as newer and shinier outlets keep cropping up, all vying for attention, this gemstone store offers some of the oldest yet valuable jewels at a discount. Though they lack immediate sparkle, these rare gems reveal their value to the discerning buyer. <br /><br /> This is how South Korea appears for many experts in global capital markets: a trove of undervalued gems, overshadowed by brighter, more aggressively marketed investment options. This undervaluation, known as the "<keyword id="24399183" type="General" weightage="20" keywordseo="korean-discount" source="keywords">Korean Discount</keyword>," reflects how South Korean companies are priced much lower than their global peers despite robust fundamentals — strong financial performance and consistent profitability. Contributing factors are many, ranging from opaque governance structures to geopolitical risks. But the fact stays, if you are a seasoned conglomerate listed in South Korea, you are likely undervalued.<br /><br /> <keyword id="19906087" type="General" weightage="20" keywordseo="hyundai" source="keywords">Hyundai</keyword> Motor India Ltd. (HMIL), a subsidiary of the Korean giant Hyundai Motor Company (HMC), recently sought to escape this valuation trap by listing in India, a market where investor optimism commands premium pricing. But its valuation raised many eyebrows! <br /><br /> Now that a month and a half has gone by since its listing, time is apt to examine if this gamble paid off. Will <keyword id="93460" type="General" weightage="100" keywordseo="hyundai-india" source="Orion">Hyundai India</keyword> justify its high valuation? Or does the listing highlight broader questions about the overheated valuation dynamics of Indian markets?<br /><br /> <b>A record-breaking <keyword id="19898327" type="General" weightage="20" keywordseo="ipo" source="keywords">IPO</keyword> but questions remain</b><br /><br /> Hyundai Motor India’s mega Initial Public Offering (IPO), launched in October 2024, broke records by raising ₹27,870 crore, making it India’s largest-ever IPO. The offer was oversubscribed by 2.37 times, highlighting robust demand. But many investors remained sceptical: was this IPO an honest attempt to expand Hyundai’s footprint in India or was it trying to offer a way to cashout for existing investors and promoters? <br /><br /> Or perhaps, is it an attempt by the Korean chaebol — a large family-owned business conglomerate — to break free from the aforementioned “Korean Discount”?<br /><br /> When shares listed on October 22, these concerns seemingly weighed on the minds of most investors and the stock promptly dipped 5% below the issue price on the day. A tepid grey market performance had already foreshadowed this muted debut in the Indian markets. Now, after almost 35 trading sessions on Indian market, the stock remains almost exactly at price it listed on October 22 at Rs 1820—no gain, no loss.<br /><br /> <b><h3>The gamble of hyper-valuation</h3></b>Much of this hesitation stemmed from Hyundai’s valuation. On listing, Hyundai was valued at $18 billion, positioning it as one of India’s most valuable automotive companies. However, such high valuations often temper investor enthusiasm, resulting in more cautious short-term outcomes. <br /><br /> For most investors, the Price-to-Earnings (P/E) ratio is the most preferred parameter to gauge if a company is overvalued or undervalued. With a P/E ratio of 26.3, HMIL was priced significantly above the Indian automotive industry average of 24.4. <br /><br /> Globally, automotive companies operate with much lower P/E ratios, reflecting mature market conditions and slower growth trajectories. HMIL’s South Korean parent Hyundai Motor Company (HMC) trades at a meagre 3.07, believe it or not! For Indian investors, the high premium hinted at overvaluation despite Hyundai’s strong domestic position.<br /><br /> Such stark difference in valuation obviously sparked debates — is the Indian market assigning a premium to Hyundai Motor India’s growth potential, or is it simply reflecting the general exuberance around the prospects of the Indian economy?<br /><br /> Another concern is the allocation of IPO proceeds. Hyundai’s IPO was structured as an offer for sale (OFS), meaning all funds raised would flow to the parent company rather than Hyundai India’s operations. Although Hyundai has committed to investing in R&amp;D for EVs and hybrids, critics argue that the lack of immediate reinvestment in India’s operations reflects a missed opportunity for domestic growth.<br /><br /> Despite the early disappointment, Hyundai was confident that the valuation was fair. It did have some factors going for it, in addition to the fact that other auto giants like Mahindra &amp; Mahindra and <keyword id="19909974" type="General" weightage="20" keywordseo="maruti-suzuki" source="keywords">Maruti Suzuki</keyword> command even higher P/E ratios. And looking at the company fundamentals, it does seem like Hyundai is playing a long-term game.<br /><br /> <b><h3>Hyundai in India: A proven track record</h3></b>Despite the initial stumble, Hyundai India’s long-term story is compelling. Since entering the Indian market in 1996, the automaker has sold over 8 million vehicles and firmly occupies the second spot in the domestic passenger vehicle market, trailing only Maruti Suzuki. Hyundai’s blockbuster SUV offerings, like the Creta and Venue, have been critical in building this dominance. Despite some challenge from Maruti Suzuki Brezza and Tata Punch, Creta has retained the tag of ‘most-selling SUV in India’ successfully so far this year.<br /><br />  <div type="image" title="Hyundai" agency="Business Insider India" msid="116156234" hostid="261" caption="&amp;lt;p&amp;gt;Selling over 17,000 units per month on average this year, Creta has edged past major competitors to be the most-selling SUV in India in 2024. As Indian consumers preference continues to shift gradually towards premium products over budget segments, Hyundai stands to benefit (Wikimedia Commons / Canva)&amp;lt;/p&amp;gt;"></div><br />Selling over 17,000 units per month on average, Creta has edged past major competitors to be the most-selling SUV in India in 2024. As Indian consumers preference continues to shift gradually towards premium products over budget segments, Hyundai stands to benefit (Wikimedia Commons / Canva)<br /><br /> Hyundai India’s market share of 14% in October 2024 underscores its clout. The company’s ability to tap into India’s premiumisation trend, where consumers increasingly prefer high-end vehicles, positions it well for growth. With plans to expand in electric vehicles (EVs) and hybrid technology, Hyundai is poised to capitalise on both domestic demand and export opportunities. The company’s ability to capitalize on its strong brand, extensive dealer network, and leadership in segments like SUVs and exports will determine its future performance.<br /><br /> Hyundai’s strategic focus on expanding electric vehicle production also aligns with global trends towards sustainability, potentially positioning it as a leader in the segment. By listing in India, Hyundai aims not only to expand its operations but also to make India a global manufacturing and export hub for its products, especially SUVs and EVs.<br /><br /> Therefore, despite early setbacks, Hyundai’s gamble seems to have paid off. The stock has rebounded, gaining 5% in the past month. More good news came in this week, as positive projections from Morgan Stanley and JPMorgan forecast an impressive 17-28% upside for the stock over the next year, reflecting growing investor optimism.<br /><br /> <b><h3>A strategic pivot from the Korean Discount?</h3></b>The Korean Discount has long plagued South Korea’s chaebols, including Hyundai. Experts attribute this to several factors:<br /><br /> <ul> <li>Chaebol Governance: South Korea’s conglomerates, known as chaebols, are often criticised for opaque governance structures and excessive family control.</li> <li>Geopolitical Risks: Tensions with North Korea contribute to investor caution, adding a layer of perceived risk.</li> <li>Limited Domestic Liquidity: South Korea’s relatively small investor base can constrain market activity and valuation potential.</li> </ul> By listing in India, Hyundai sought to unlock better valuations for its subsidiary, leveraging the optimism of Indian markets. India’s stock market has a trailing P/E ratio of 24.4, far above South Korea’s Kospi average of 16-17. The Indian market’s appetite for high-growth stories provides a fertile ground for companies like Hyundai to escape the valuation constraints of their home market. A successful IPO could encourage other such conglomerates to follow suit, setting a precedent.<br /><br /> While Hyundai India has a robust track record, its future success hinges on navigating key challenges:<br /><br /> <ul> <li>Supply Chain Vulnerabilities: Hyundai relies heavily on its Chennai plant, making it vulnerable to disruptions.</li> <li>Intensifying Competition: Domestic rivals like <keyword id="19906967" type="General" weightage="20" keywordseo="tata-motors" source="keywords">Tata Motors</keyword> and MG Motors are making aggressive inroads into the EV market.</li> <li>Policy Risks: The automotive sector’s reliance on government incentives for EVs and hybrids adds a layer of unpredictability.</li> </ul> High valuations come with risks. Hyundai will need to prove that it can sustain its growth trajectory in India, fend off competition from established players like Maruti Suzuki and Tata Motors, and navigate challenges such as supply chain disruptions and regulatory hurdles. If Hyundai successfully capitalises on its strong brand and market leadership, it could not only redefine its value but also serve as a case study for other Korean companies seeking better recognition and valuations in global markets.<br /><br /> <b><h3>Is Hyundai saga a reflection of overheated Indian markets?</h3></b>The bigger question here is, does Hyundai’s IPO highlights a broader narrative about Indian markets’ premium valuations? With a trailing P/E ratio of 24.4, Nifty 50 index is among the highest in emerging markets. India’s stock markets consistently command a premium due to robust retail participation, strong economic growth prospects, and a burgeoning middle class.<br /><br /> While this premium reflects optimism about India’s long-term growth story, it also signals potential risks of overvaluation, particularly in sectors like technology, automotive, and consumer goods. With a record ₹94,017 crore outflow by Foreign Portfolio Investors (FPIs) in October 2024, concerns about overheated valuations are mounting. Sustaining such unprecedented valuations required companies to consistently perform above global averages, and retaining robust earnings growth quarter after quarter remains a challenge in today’s uncertain world.<br /><br /> For Hyundai, the high valuation is both an opportunity and a risk. While it underscores investor confidence, it narrows the margin of safety, making the stock vulnerable to corrections during economic downturns. Take for example, the high-profile IPO of Life Insurance Corporation of India (LIC) that raised over ₹21,000 crore. Its listing was met with disappointment as the stock began trading at a 9% discount to its issue price, and subsequent performance has remained subdued. <br /><br /> LIC’s post-IPO journey also highlights how inflated valuations can lead to long-term underperformance, as the stock gave only 12% return over the past 30 months when even the Nifty 50 index went up by over 44%. This happens when when the company's growth narrative fails to align with its pricing. Despite being a household name with a dominant market share, LIC's stock has struggled to meet expectations, partly due to concerns about its operating efficiency and the limited use of IPO proceeds for growth initiatives. <br /><br /> Make no mistake, Hyundai Motor India’s IPO is a landmark event! It showcases the potential for Korean companies to leverage emerging markets like India for better valuations. It also shows that strong fundamentals can help justify a company such premium valuations even amidst bearish economic prospects.<br /><br /> However, it also serves as a cautionary tale about the risks of overvaluation. For Hyundai, the next steps involve proving its long-term growth story, navigating competitive challenges, and maintaining investor confidence.<br /><br /> For Indian markets, Hyundai’s IPO underscores the need to balance optimism with realistic expectations as they continue to evolve as global investment hotspots. To sustain the country’s economic narrative as a land of unmatched opportunities, corporate India must work on improving long-term fundamentals and mitigating long-term risks. As global investors watch closely, Hyundai India’s success or failure could shape how international companies view India as a listing destination in the years to come.<br />

Tackling the 'Korean Discount': A deep dive into curious case of Hyundai Motor India's market listing

<ul><li>DCGI has approved market authorisation for the COVID-19 vaccine <keyword id="10678894" type="General" weightage="100" keywordseo="covovax" source="Orion">Covovax</keyword> as a heterologous booster dose for adults.</li><li>The DCGI's approval came following recommendations by the <keyword id="3923779" type="General" weightage="50" keywordseo="subject-expert-committee" source="Orion">Subject Expert Committee</keyword> of the Central Drugs Standard Control Organisation (<keyword id="6375144" type="General" weightage="50" keywordseo="cdsco" source="Orion">CDSCO</keyword>).</li></ul>The <keyword id="6386816" type="General" weightage="50" keywordseo="drug-controller-general-of-india" source="Orion">Drug Controller General of India</keyword> (DCGI ) has approved market authorisation to COVID-19 vaccine Covovax as a heterologous booster dose for adults who have been administered two doses of <keyword id="9617748" type="General" weightage="50" keywordseo="covishield" source="Orion">Covishield</keyword> or <keyword id="9485939" type="General" weightage="50" keywordseo="covaxin" source="Orion">Covaxin</keyword>, official sources said on Monday. The DCGI's approval came following recommendation by the Subject Expert Committee of the Central Drugs Standard Control Organisation (CDSCO). <br /><br /> Prakash Kumar Singh, Director of Government and Regulatory Affairs at the <keyword id="95879" type="General" weightage="50" keywordseo="serum-institute-of-india" source="Orion">Serum Institute of India</keyword> (<keyword id="52604" type="General" weightage="80" keywordseo="sii" source="Orion">SII</keyword>), had recently written to the DCGI for the approval of Covovax heterologous booster dose for those aged 18 years and above in view of escalating COVID-19 pandemic situation in some countries, an official source had said. <br /><br /> "The Subject Expert Committee of the CDSCO on Wednesday deliberated on the issue and had recommended for market authorisation of Covid jab Covovax as a heterologous booster dose for adults who have been administered two doses of Covishield or Covaxin," an official source said. <br /><br /> The DCGI had approved Covovax for restricted use in emergency situations in adults on December 28, 2021, in the 12-17 age group on March 9, 2022, and in children aged 7- 11 years on June 28 last year subject to certain conditions. <br /><br /> Covovax is manufactured through technology transfer from Novavax. It has been approved by the European Medicines Agency for conditional marketing authorisation. It was granted emergency-use listing by the <keyword id="43588" type="General" weightage="50" keywordseo="world-health-organization" source="Orion">World Health Organization</keyword> (WHO) on December 17, 2021. <br /><br /> In August 2020, US-based vaccine maker Novavax Inc. had announced a licence agreement with the SII for the development and commercialization of NVX-CoV2373, its COVID-19 vaccine candidate in <keyword id="3658" type="General" weightage="50" keywordseo="india" source="Orion">India</keyword> and low-and-middle-income countries.<br /><br />SEE ALSO:<br /><a href="https://www.businessinsider.in/tech/news/amazon-great-republic-day-sale-2023-best-deals-and-offers-on-tvs/articleshow/96987966.cms">Amazon Great Republic Day Sale 2023 – Best deals and offers on TVs</a><br /><a href="https://www.businessinsider.in/tech/apps/news/these-audio-setting-tweaks-can-make-music-sound-better-on-spotify/articleshow/96876010.cms">These audio setting tweaks can make music sound better on Spotify</a><br />

Serum Institute's Covovax gets DCGI approval as a heterologous booster dose

<keyword id="20448705" type="General" weightage="20" keywordseo="Waymo" source="keywords" meta.keywordsubtype="org" meta.entityname="Waymo" meta.hostid="261" meta.entityid="Waymo">Waymo</keyword>, the self-driving car whiz kid from Alphabet (aka Google’s big parent company), just made a splash by launching its robotaxis in Los Angeles! This means that anyone with the Waymo One app can now call up a driverless cab across a whopping 129-square-kilometre stretch of the city. It’s like having a robot chauffeur — without the awkward small talk!<br /><br />This isn’t Waymo’s first rodeo with robotaxis. They’ve been rolling around Phoenix since 2020 and then hit up San Francisco last year. In Los Angeles, after a short trial for some lucky early testers, Waymo opened up rides to the public. Now anyone can zip around L.A. traffic in style, with the car’s AI brain in control.<br /><br />Waymo’s journey started as a secret project back in 2009 and has come a long way since then. The company’s <keyword id="19967698" type="General" weightage="20" keywordseo="self-driving-cars" source="keywords">self-driving cars</keyword> have logged over 20 million miles without any major accidents — a record that certainly leaves human drivers in the dust. Meanwhile, Waymo’s competitor, Cruise (owned by General Motors), ran into some trouble when one of its <keyword id="21485769" type="General" weightage="20" keywordseo="driverless-cars" source="keywords">driverless cars</keyword> was involved in an accident with a pedestrian, resulting in a license suspension in California.<br />    <div type="Article" hostid="261" msid="107634470" title="A crowd set fire to a Waymo taxi in San Francisco, as tensions about driverless tech grow" mstype="2" mssubtype="0"></div>But Waymo’s big moves in the US raise an interesting question: what would happen if robotaxis rolled out in a place like India? The impact could be massive! India has millions of taxi drivers, and many rely on their daily fares to support their families. Not only is the work gruelling, such “gig workers” often earn shockingly less, and at increasingly shrinking profit margins. One source even noted earning only around Rs 30,000 a month while working as an Ola captain from Bengaluru.<br /><br />Thus, a widespread shift to driverless cars could be a serious blow to their livelihoods, especially in a country struggling with rampant levels of inflation. Therefore, there exists an issue of livelihoods on one hand and technological progress on the other, so if companies like Waymo ever bring robotaxis to India, it could shake things up in a big way.<br />    <div type="Article" hostid="261" msid="102751416" title="Sex in self-driving cars: Passengers are reportedly hooking up in San Francisco&amp;#39;s driverless taxis" mstype="2" mssubtype="0"></div>However, on the other side of the spectrum, there are undoubtedly some benefits to moving towards a fully-automated robotaxi fleet. For instance, road accidents cause over 1,50,000 deaths annually in India. Autonomous vehicles,which are designed to follow traffic rules strictly and reduce human error, could help lower these numbers. Additionally, driverless taxis could make transportation more accessible and affordable, especially in densely populated cities with high demand.<br /><br />Furthermore, such robotaxis would also provide a solution for passengers who experience language barriers or inconsistent service quality, as these vehicles are designed for efficient, standardised rides. There is also the hope that they could reduce traffic congestion and pollution with AI-driven routes that minimise idle time and fuel use.<br /><br />Waymo may be rejoicing in the spotlight at the moment, but there are several other companies in the robotaxi race, including Tesla, which has its “Cybercab” in the works, and Amazon’s Zoox, aiming to hit the streets of Las Vegas next year. Baidu’s Apollo is already making robotaxi runs in some Chinese cities, but each company faces its own unique set of challenges.<br /><br />In India, where roads are a blend of honking scooters, zig-zagging rickshaws, and plenty of cows on the streets, introducing robotaxis would require some serious tech tricks and regulatory green lights. Until then, L.A. can enjoy the driverless rides while the rest of us wait to see how this wild technology shapes the future.<br />

No Driver? No Problem! Waymo’s driverless robotaxis make Los Angeles debut — but what could the tech mean for India?

A disturbing report by The Economic Times has revealed that over 100 <keyword id="21300086" type="General" weightage="20" keywordseo="cough-syrup" source="keywords">cough syrup</keyword> samples manufactured in India failed quality control tests. The Central Drugs Standard Control Organisation (<keyword id="20109095" type="General" weightage="20" keywordseo="CDSCO" source="keywords">CDSCO</keyword>) analysed over 7,000 batches of cough syrup, finding that 353 did not meet quality standards.<br /><br />The reasons for these failures are particularly concerning. Nine batches contained di<keyword id="21957039" type="General" weightage="20" keywordseo="ethylene-glycol" source="keywords">ethylene glycol</keyword> (DEG) or ethylene glycol (EG), toxins previously linked to the deaths of children in Gambia, Uzbekistan, and Cameroon. These toxins can cause serious health problems, including vomiting, convulsions, circulatory issues, and acute kidney failure.<br /><br />  <div type="Article" hostid="261" msid="94675384" title="Indian drug regulator kicks off probe on cough syrup linked to deaths of Gambian children" mstype="2" mssubtype="0"></div><br /><h2>What are <keyword id="15176477" type="General" weightage="20" keywordseo="diethylene-glycol" source="Orion">diethylene glycol</keyword> and ethylene glycol?</h2>For the unversed, DEG is a colourless, odourless and sweetish chemical. It is also a common industrial liquid used in many products, like antifreeze, car brakes, wallpaper removal solutions and in making fabrics and dyes. <br /><br />Similarly, EG is also a colourless and odourless alcoholic compound with a sweet-tasting and syrupy composition. It has known applications as an automotive antifreeze and as a raw material for manufacturing polyester fibres. It is also usually present in products like hydraulic brake fluids, stamp pad inks, ballpoint pens, solvents, paints, cosmetics and plastics.<br /><br />However, cough syrup manufacturers sometimes use EG and DEG as a replacement to non-toxic solvents like glycerine or propylene glycol simply because they are cheaper.<br /><br />Unfortunately, swallowing DEG and EG can be very dangerous. If someone drinks it, it can cause serious problems throughout their body and nervous system, leading to coma, seizures, nerve damage, and even liver and kidney failure, as per the CDC.<br /><br /><h2>Who is responsible?</h2>According to The Economic Times, the CDSCO blames unsecured supply chains and inadequate testing for the presence of these toxins. This news comes after a series of global alerts issued by the World Health Organization (WHO) in 2022 regarding cough syrups manufactured in India that were linked to the deaths of over 140 children worldwide.<br /><br />The first alert came in October 2022, when the WHO flagged four cough syrups produced by Haryana-based Maiden Pharmaceuticals. Authorities in Gambia linked these medications to 66 deaths, primarily from acute kidney failure.<br /><br />In December 2022, the WHO recommended avoiding two cough syrups made by Marion Biotech after Uzbekistan reported 18 child deaths linked to their Dok 1 Max syrup.<br /><br />Most recently, in August 2023, the WHO issued another alert for a batch of Indian common cold syrup found to contain unacceptable levels of DEG and EG as contaminants. This marked the fifth such alert issued by the WHO since 2022 regarding Indian-made cough syrups.<br /><br /><h2>CDSCO considers waiving testing requirement before exploring cough syrups</h2>The discovery of toxic components in something that’s as commonly sold as cough syrup should have prompted authorities to tighten texting processes.<br /><br />However, the apex drugs regulatory authority, is reportedly examining stakeholders’ proposal to waive the requirement for testing cough syrups being exported to the US, the UK, Canada, the European Union, Japan, Australia, Singapore, Korea and Switzerland at the prescribed laboratory.<br /><br />These repeated failures and global health warnings raise serious concerns about the safety of cough syrups manufactured in India. The Indian government is urged to take immediate action to address these issues by strengthening quality control measures, securing supply chains and ensuring thorough testing to prevent further tragedies.<br /><br />  <div type="Article" hostid="261" msid="96935179" title="WHO alert against use of Indian cough syrups in Uzbekistan" mstype="2" mssubtype="0"></div><br />

You Searched For "drug controller general of india" and got 12 results

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India bans 156 commonly used combination drugs citing possible risks to humans

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Weight loss and diabetes drug Tirzepatide will cost Rs 80,000 per month in India

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

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Rupee tracks buoyant equity markets, rises 7 paise to 83.3/USD

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Tackling the 'Korean Discount': A deep dive into curious case of Hyundai Motor India's market listing

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Serum Institute's Covovax gets DCGI approval as a heterologous booster dose

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No Driver? No Problem! Waymo’s driverless robotaxis make Los Angeles debut — but what could the tech mean for India?

Ankush Banerjee

Why are over 300 batches of Indian cough syrup being deemed "toxic"?

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