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Protecting Consumers, Promoting Accountability: An Analysis of Product Liability under the Consumer Protection Act

Product Liability, an essential component of consumer protection, experienced a significant change with the introduction of the Consumer Protection Act, 2019 (“2019 Act”) in India. For the first time in Indian law, product liability was clearly defined under this extensive legislation. The 2019 Act specifies that product liability involves the duty of product manufacturers, sellers, or service providers to compensate consumers for any damages caused by faulty products or inadequate services linked to those products. This new Act replaced the previous Consumer Protection Act of 1986, received the President’s approval, and was officially announced in the Gazette of India on August 09, 2019. Although it was passed in 2019, most of its sections, including those about product liability, came into effect on July 20, 2020. This legislative change aimed to enhance consumer protection, implement stricter rules, and introduce new measures to handle changing market trends. Notably, the inclusion of product liability in the 2019 Act signaled a move away from the old “buyer beware” approach, moving towards a system where sellers are made accountable—aptly described as “seller beware.” This change highlights a shift in the mindset of consumer protection, focusing on proactive steps to guarantee product safety and responsibility throughout the supply chain. Product liability: Product Liability signifies the legal responsibility borne by a creator, vendor, or service provider for distributing a defective item. Customarily, the producer must comply with all stipulations, warranties, and conditions, fulfilling the standard anticipations of buyers. Product liability can be understood through the lenses of tort law and contract law. Within tort law, product liability might arise when a creator, vendor, or service provider fails in their duty of care towards consumers. Alternatively, strict liability could be enforced as producers are held responsible for ensuring the items they offer to consumers are in satisfactory condition. In the realm of contract law, product liability can emerge from a breach of contract or warranty by the creator, vendor, or service provider. The incorporation of product liability in the Consumer Protection Act 2019 marks a positive progression in the enhancement of consumer rights, necessitating an exploration of its diverse facets in the Indian scenario. Evolution of product liability in India: The Evolution of Product Accountability in India In the times preceding the enactment of the Consumer Protection Act of 2019, the Consumer Protection Act of 1986 was the primary legislation safeguarding consumer interests, albeit without an explicit mention of product accountability. Despite this, individuals could pursue remedies under the Act’s clauses concerning ‘defects’ and ‘shortcomings.’ The advent of the CPA 2019, which specifically addressed product liability, signified a significant transformation in the legal domain, providing enhanced clarity and broadening the scope for consumers to seek recompense for injuries inflicted by faulty merchandise. The structure governing product responsibility in India has progressed in tandem with various other statutes, such as the Food Safety and Standards Act of 2006, the Legal Metrology Act of 2009, and industry-specific guidelines instituted by regulatory authorities like the Bureau of Indian Standards (BIS) and the Automotive Research Association of India (ARAI). These legislative measures augment the CPA 2019 by guaranteeing the upkeep of product safety criteria across diverse sectors. Product Responsibility as per the CPA 2019: The CPA 2019 distinctly outlines product responsibility, offering a detailed legal structure for consumers to claim recompense for harm or damages stemming from faulty goods. Chapter VI of the legislation is devoted to product responsibility cases, detailing the obligations of producers, vendors, and service providers. It enumerates specific bases on which responsibility can be determined, such as production errors, design imperfections, insufficient instructions or alerts, and violations of explicit guarantees. The legislation also introduces the notion of ‘harm,’ encompassing physical injury, damage to assets (excluding the defective item itself), and psychological pain or emotional suffering. Notably, the Act dismisses claims related to financial or business losses. Key Elements of Product Liability Case To commence a product liability case, certain components must be clearly demonstrated: • Injury: The individual must have experienced injury or damage due to a flawed product. • Flawed Product: The injury must be a direct consequence of a flaw within the product itself. • Accountability: The imperfection must be linked to the maker, distributor, or service provider. The CPA 2019 specifies the distinct accountabilities for each entity participating in the distribution network: • Manufacturer Accountability: A producer is accountable for any injury resulting from design flaws, production errors, or the failure to honor warranties or provide sufficient guidance. • Service Provider Accountability: A service provider can be deemed responsible if their carelessness or non- compliance with legal norms causes injury. • Seller Accountability. Vendors might also bear responsibility if they exert significant control over the product or neglect to offer proper instructions or alerts. Protections and Exemptions: The Consumer Protection Act of 2019 outlines multiple defenses against claims of product liability. For example, a producer of goods isn’t responsible for injuries stemming from the improper use or modification of the item by the user. Likewise, if the producer has supplied sufficient cautions or guidelines, they might not be deemed responsible for any ensuing damage. The legislation also considers exceptions for producers when the product is utilized under particular circumstances, such as in factory environments or by experts under skilled oversight. Sanctions and Implementation: The Consumer Protection Act of 2019 enforces severe repercussions upon producers, vendors, and service entities deemed accountable for faulty goods. Consumer tribunals, alongside the Central Consumer Protection Authority (CCPA), possess the jurisdiction to mandate the withdrawal of perilous products, remunerate purchasers, and levy punitive reparations for carelessness. When it comes to deceptive marketing, the legislation stipulates incarceration and substantial monetary penalties for those at fault. The CCPA holds a pivotal position in the application of the Act’s stipulations, ensuring the preservation of consumer entitlements and the compliance of manufacturers with safety protocols. This body is endowed with the capability to scrutinize infringements, command product retrievals, and undertake requisite measures to safeguard consumer welfare. Possible Defences To A Product Liability Case: When

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Greenwashing: Govt unveils new guidelines to rein in misleading ‘eco- friendly’ ads

15 Oct 2024 New Delhi: Companies using terms such as ‘eco-friendly’, ‘organic’ and ‘natural’ in their advertisements must substantiate their claims and include adequate qualifiers and disclosures under a new law against greenwashing. Under new guidelines issued Tuesday, companies claiming environmental benefits in advertisements to promote their products or services must ensure that consumers receive accurate and transparent information, said consumer affairs secretary Nidhi Khare. Misleading or false advertising could result in penalties or even jail terms. Mint was the first to report on 12 October on the government’s plans to tighten the screws on greenwashing in corporate promotions. These new rules come amid growing concerns over greenwashing—where companies mislead consumers about their environmental practices to enhance their brand image. Companies claiming environmental benefits in advertisements to promote their products or services must ensure that consumers receive accurate and transparent information, consumer affairs secretary Nidhi Khare said while announcing the new rules. The Guidelines for Prevention and Regulation of Greenwashing or Misleading Environmental Claims 2024 apply to environmental claims by manufacturers, service providers and traders whose goods, products, or services are advertised. “No person to whom these guidelines apply shall engage in greenwashing or misleading environmental claims,” Khare said. “All environmental claims must be supported by accessible, verifiable evidence from independent studies or third-party certifications.” “This is a welcome step that makes information easily accessible to consumers, thereby enhancing consumer awareness and promoting responsible advertising with accuracy, transparency, and accountability,” said Karun Mehta, partner, Khaitan & Co., a law firm. What’s in a term? Generic terms such as clean, green, eco-friendly, eco-consciousness, good for the planet, minimal impact, cruelty-free, carbon-neutral, pure, sustainable, and regenerative cannot be employed without adequate qualifiers and substantiation. For instance, if a product is marketed as sustainable, it must be backed by reliable data and documentation that can be verified by consumers or regulatory bodies. And if a product is described as recyclable, the advertisement must be clear if that applies to the product’s entire structure or just a specific part. The new guidelines also emphasise the importance of using consumer- friendly language, particularly when introducing technical terms such as environmental impact assessment, greenhouse gas emissions, and ecological footprint. Advertisers are encouraged to explain these concepts in simple terms to help consumers understand their meaning and implications, the guidelines state. In terms of transparency, the guidelines mandate that any company making an environmental claim must disclose all material information in the relevant advertisement or communication. This can be accomplished by incorporating a QR code or a link to a webpage in the advertisement, allowing consumers to access detailed information.The guidelines also specify that advertisers avoid cherry-picking data from research studies to highlight favourable observations while obscuring less favourable findings. “When making environmental claims, it is essential to clarify whether the claim refers to the product as a whole, a specific component, the manufacturing process, packaging, the manner of use, or its disposal,” Khare said. The guidelines also state that comparative environmental claims that juxtapose one product or service against another must be based on verifiable and relevant data, and disclose exactly what specific aspects are being compared. Rights and penalties Per Section 24 of the Consumer Protection Act, the Central Consumer Protection Authority can impose penalties for misleading corporate claims, with fines of up to ₹50,000, which may escalate to ₹1 crore for repeated violations. As per Section 21 of the Act, which establishes penalties for misleading advertisements, first-time offenders may face fines of up to ₹10 lakh, while repeat offenders can be fined up to lakh with possible imprisonment of up to two years. Additionally, Section 40 protects the rights of consumers, allowing them to seek compensation for any damages or losses incurred due to violations. India’s regulations on green claims and greenwashing are similar to those in the United Kingdom and the European Union. All three focus on transparency and accountability in environmental claims made by companies. The UK’s Competition and Markets Authority introduced a Green Claims Code in 2021 to protect consumers from misleading green claims. The European Union’s Green Claims Directive requires companies to back up their green claims with life-cycle assessments and third-party verifications. According to the European Parliament’s website, the European Commission proposed this directive on 22 March 2023 to improve transparency and combat greenwashing. The European Parliament adopted its position in March this year, and its council approved a general approach on 17 June. Interinstitutional negotiations are set to begin shortly, as per the website. Source: Live Mint

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SC reaffirms doctors’ accountability under Consumer Protection Act

08 Nov 2024 The Supreme Court on Thursday dismissed a request to revisit its landmark 1995 judgment, which had classified medical services under the Consumer Protection Act (CPA) and held that healthcare providers, including doctors and hospitals, could be held accountable under the Act for service deficiencies. A three-judge bench comprising justices Bhushan R Gavai, Prashant Kumar Mishra and KV Viswanathan addressed a reference by a two-judge bench that sought reconsideration of the Shantha ruling while discussing the distinct status of legal professionals, who are excluded from the CPA’s purview. However, the bench on Thursday found the referral unnecessary, observing that the Shantha decision remained legally sound and relevant to ensure accountability in health care. “We find that the issue before the Court was with regards to the legal profession and the court, in unequivocal terms, came to a conclusion that the legal profession is not covered by the provisions of the Consumer Protection Act. Since the court came to the aforesaid finding, irrespective of the finding of this court in Shantha, the reference was not necessary. The question as to whether the other professionals excluding legal profession could be covered under the Act can be considered in appropriate cases, having a factual foundation,” stated the bench, closing the reference. It further clarified that “the reference was not necessary” because the Shantha ruling addressed the specific contractual and fiduciary responsibilities that medical professionals owe to their patients, unlike the nature of services offered by legal professionals. To be sure, the Bolam Test — a standard that has long been recognised in medical negligence cases, has been consistently reaffirmed by the Supreme Court of India. Originating from the 1957 English case Bolam Vs Friern Hospital Management Committee, this test states that a doctor is not negligent if they act in accordance with a practice accepted by a responsible body of medical professionals. In the Indian context, the Supreme Court endorsed the Bolam Test in the case of Jacob Mathews Vs State of Punjab (2005), holding that only if a doctor lacks requisite skills or fails to exercise reasonable competence should liability be imposed. By a judgment on October 24, the Supreme Court further emphasised that medical professionals cannot be held liable for negligence solely because a surgery or treatment does not produce the expected results, asserting that culpability of doctors must stem from clear evidence pointing to a deviation from accepted medical practices. On May 14, a bench of justices Bela M Trivedi and Pankaj Mithal ruled that lawyers cannot be sued in consumer courts for poor service, clarifying the extent of their liability under CPA of 1986, re-enacted in 2019. This judgment held that legal representation for a fee does not constitute a service under law, noting the legislature did not intend to include professions or professionals within the purview of the Act, which aims at addressing consumers’ grievances against services rendered by a businessman or a trader in regard to goods or products. Considering the “sui generis (unique)” nature of services lawyers provide in making the judicial system efficient, effective and credible, their services could not be compared with the services rendered by other professionals, the court said. This judgment had come in response to a clutch of petitions challenging a 2009 decision by the National Consumer Disputes Redressal Commission. The commission had held that services rendered by lawyers fall within the definition of “service” under Section 2(0) of the CPA, 1986, which was re-enacted in 2019. In the same verdict, the Supreme Court also proposed a review of its 1995 ruling in the Shantha case, which held that health care services are covered under CPA, allowing doctors to be sued for deficiency in service and negligence. “The said decision deserves to be revisited having regard to the history, object, purpose and the scheme of the CPA and in view of the opinion expressed by us that neither the ‘profession’ could be treated as ‘business’ or ‘trade’ nor the services provided by the ‘professionals’ could be treated at par with the services provided by businessmen or traders, so as to bring them within the purview of the CPA,” said the bench. It is pursuant to this reference that the matter came up before a three-judge bench on Thursday. Source: Hindustan Times

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CM Yogi Adityanath proposes new law to prevent food contamination, ensure consumer rights

16 Oct 2024 In a bid to combat food contamination from “human waste and contaminated substances,” Chief Minister Yogi Adityanath announced on Tuesday that the government plans to introduce a new law aimed at safeguarding consumers’ rights, reported TOI. This law will require food and beverage sellers to provide essential information to consumers and mandate that establishments display signboards and ensure staffwear identification badges. The CM emphasised the need for strict penalties for those using pseudonyms or providing false information. He stated that any infiltrators or illegal foreign nationals working in food establishments would face serious consequences. “There should be provisions for the harshest punishment against those using pseudonyms or providing false information. If any personnel in a food establishment is an infiltrator or an illegal foreign national, strict action must be taken,” the CM said. “Each food establishment must ensure that no food is contaminated within its premises. It will be mandatory to install a sufficient number of CCTV cameras in the kitchens and dining areas of food establishments for continuous monitoring, with at least one month’s footage made available to the district administration upon request,” the chief minister said while reviewing the proposed law at a meeting, according to the TOI report. The BJP leader addressed recent alarming incidents where food items, such as juice and bread, were allegedly tainted with harmful substances, calling them “horrific” and detrimental to public health. He highlighted that such “vile attempts” are unacceptable and can negatively impact social harmony, noted TOI. The meeting followed criticism of a recent order requiring eateries along the Kanwar route to display the names of all personnel, aimed at allowing devotees to make informed dining choices. The proposed law will impose strict regulations on hotels, restaurants, roadside eateries, and street vendors to ensure food purity and maintain consumer trust. Offenders could face imprisonment and fines, with violations treated as cognizable and non-bailable offences. Additionally, operators will be required to enforce hygiene standards, including the use of head covers, masks, and gloves by food preparers and servers, as well as provide personnel details to relevant authorities. Source: Economic Times

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More than 53,000 RTI complaints returned in one year, Maharashtra tops list

13 Oct 2024 New Delhi: Over 53,000 complaints and appeals that reached Central and State Information Commissions were returned in one year citing rules, with transparency activists raising concerns over the practice saying it could discourage urban poor and rural households from fighting till the end. Source: Deccan Herald

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Railway blankets washed once a month? RTI sparks passenger concerns

23 Oct 2024 Frequent travellers on Indian Railways may want to think twice before settling in for a cozy ride. A recent disclosure, obtained through a Right to Information (RTI) request by The New Indian Express, has revealed a glaring lapse in hygiene practices: While bed sheets and pillow covers in air-conditioned coaches are washed after every journey, blankets are cleaned just once a month — or even less frequently. This hygiene gap has left many passengers questioning the cleanliness of the bedding they rely on during their travels, raising concerns about whether Indian Railways is doing enough to ensure passenger comfort and safety. Clean sheets, dirty blankets: A hygienic disparity Passengers travelling in air-conditioned coaches receive a neatly packaged set of bedding, which includes bed sheets, pillow covers, and blankets. While the cost of these items is included in the train fare, there is a glaring disparity in how they are maintained. According to the RTI response, bed sheets and pillow covers are washed after every journey, ensuring a fresh set for each new passenger. However, the same cannot be said for blankets. Rishu Gupta, section officer of Environment and Housekeeping Management (EnHM) at the Ministry of Railways, confirmed that wool blankets are only washed once a month, or twice in rare cases when they are particularly soiled. This has caused discontent among passengers who feel they are paying for bedding that does not meet basic hygiene standards. Housekeeping confirms limited blanket cleaning Housekeeping staff on long-distance trains confirmed that the infrequent washing of blankets is a common practice. One staff member, with over ten years of experience, disclosed that blankets are only sent for washing once a month, and even then, only if they are visibly dirty. “We only give the blankets for washing if there’s a foul smell or if something like vomit or food spills on them. Otherwise, we just fold them up and use them again, he admitted. This casual approach to cleanliness has left many passengers questioning how often they are actually getting a clean blanket. While bed sheets and pillow covers are routinely laundered, the blankets are simply folded and stored for the next journey unless a complaint is raised or a visible issue is detected. A history of inadequate hygiene Concerns over blanket hygiene are not new. A 2017 report from the Comptroller and Auditor General (CAG) had already flagged serious issues, revealing that some blankets went unwashed for as long as six months. Despite this damning report, Indian Railways’ blanket cleaning protocols appear to have seen little improvement, with the recent RTI confirming that minimal cleaning is still the norm. Calls to replace wool blankets In light of these revelations, experts and former railway officials are now calling for Indian Railways to phase out wool blankets altogether. A retired senior officer from the EnHM division suggested that these heavy blankets, which are difficult to clean, are no longer fit for purpose. “The blankets are too heavy, and ensuring they are properly washed is a challenge. It’s high time the Railways replaced them with lighter, easier-to-maintain alternatives, she said. Passengers seem to agree. Many have expressed dissatisfaction with the blankets provided, pointing out that their dark colours — typically black or brown — often hide stains, making it hard to tell when they are truly clean. Railways’ laundry management in question Indian Railways operates a vast laundry network, with 46 departmental laundries and 25 Build- Own-Operate-Transfer (BOOT) laundries across the country. Departmental laundries are owned by the Railways, but the staff are often employed on a contractual basis. In BOOT laundries, the land belongs to Indian Railways, while private contractors manage the washing equipment and staffing. Despite these resources, the cleanliness of blankets continues to be a sticking point. While the infrastructure is in place to maintain clean bedding, the current protocols for washing blankets do not appear to be sufficient, leaving passengers with doubts about the hygiene of the bedding they use during long-distance travel. Source: Business Standard

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Consumer Court Orders Bengaluru Matrimony Site To Pay ₹60,000 For Failing To Find Match

06 Nov 2024 GUWAHATI: The District Consumer Disputes Redressal Commission in Bengaluru has directed Dilmil Matrimony, a matchmaking website, to pay t60,ooo to a man after it failed to fulfil its promise of finding a bride for his son. The ruling was made by Commission President Ramachandra MS along with members Nandini H Kumbhar and Savitha Airani. Highlighting that it failed to provide even a single match, the court found Dilmil Matrimony deficient in its service, criticising its tendency to advertise “honest matchmaking services” and promising to fulfil client preferences. The case began when Vijaya Kumar approached Dilmil Matrimony’s office on March 17, 2024, and paid ₹30,000 for a service package, expecting the platform to find a suitable match for his son within 45 days. However, despite multiple follow-ups and visits, the company failed to offer any potential matches. When Kumar sought assistance, Dilmil Matrimony allegedly responded unhelpfully and used inappropriate language, further denying his request for a refund. Following the lack of response to a legal notice sent on May 9, Kumar went ahead and filed a complaint with the consumer forum. The Commission proceeded with the case in the absence of Dilmil Matrimony, whose representatives failed to appear for hearings despite being served notice. The Commission ruled that Dilmil Matrimony’s failure to deliver the promised services amounted to a deficiency in sewice and unfair trade practice, resulting in a breach of consumer trust. Consequently, it directed the website to refund 00,000 along with interest and ordered additional compensation for Kumar: Qo,ooo for inconvenience, for mental agony, and to cover litigation costs. The total compensation, therefore, amounts to ₹60,000. Source: Guwahati Plus

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Eylea offers equivalent efficacy with fewer injections for wet AMD, DME management: Dr Ashish Gawde

Oct 18, 2024 In an insightful interview with ETPharma’s Rashmi Mabiyan Kaur, DrAshish Gawde, CountlY Medical Director, Pharmaceuticals, South Asia, Bayer, discusses the significant challenges faced by patients with retinal diseases, including financial burdens, geographical disparities, and lack of awareness. Dr Gawde emphasizes the transformative role of technology, from AI to telemedicine, in revolutionizing the diagnosis and management of eye diseases. Edited excerpts below: Q. In your experience, what are the biggest challenges patients with retinal diseases face in accessing eye treatments? The most pressing challenges include the financial and emotional burdens associated with frequent, long-term treatments for conditions such as Diabetic Macular Edema (DME) and Wet Age-related Macular Degeneration (AMD). These treatments often need to be sustained over the long term, and this can impact adherence, as patients may prioritize immediate concerns over regular care. Access to timely and effective treatment for retinal diseases remains a significant hurdle for many patients. Additionally, geographical disparities can affect treatment access. Individuals in rural or underserved areas may need to travel long distances to reach specialized care, which can impact adherence and lead to delays in treatment. Furthermore, a lack of awareness about retinal diseases contributes to late diagnoses, with many individuals seeking treatment only after experiencing considerable vision loss. This highlights the urgent need for comprehensive education on early warning signs and the importance of routine eye examinations. To address these challenges, Bayer has implemented innovative patient support initiatives like the “Eylea 4 U” program, which ensures timely access to treatment. Collaborations with organizations such as Arogya Finance enhance our capacity to reach patients effectively, ensuring they receive the care necessary for optimal outcomes. Q. How has EYLEA changed the landscape of treatment for patients with retinal diseases? The launch of Eylea (aflibercept solution) has marked a pivotal shift in the management of retinal diseases such as wet AMD and DME. Eylea is clinically proven to be superior in efficacy to other treatment options available for retinal diseases. Now, with the new dose regimen, Eylea offers similar efficacy but with fewer injections. The dosing regimen can be personalized based on each patient’s unique needs. This advancement not only enhances patient adherence but also improves overall quality of life, allowing individuals to maintain greater independence in their daily activities. Eylea’s development reflects a broader movement toward personalized treatment strategies. This individualized approach ensures optimal care and minimizes the burden often associated with frequent injections in previous treatment regimens. Q. How do you envision the role of technology evolving in the treatment and management of eye diseases? The future of ophthalmology is being redefined by the rapid integration of technology, presenting exciting prospects for the diagnosis and management of eye diseases. Innovations such as artificial intelligence (AI) are revolutionizing diagnostic accuracy, enabling healthcare providers to detect conditions like Diabetic Retinopathy and AMD at earlier stages. This technological advancement ensures that patients receive timely interventions, ultimately preserving vision. Telemedicine also plays a transformative role, allowing patients in remote areas to access specialized care without the logistical challenges of travel. This increased accessibility is crucial for populations that may otherwise delay necessary treatment. Q. How is Bayer working towards making eye disease treatment options more accessible in India? We are committed to enhancing the accessibility of treatments for eye diseases across India, particularly in areas where specialized care is less available. We support patients with initiatives like the Eylea Easy Pay program, offering flexible and affordable payment options to improve access to Eylea (aflibercept solution) in India. Such initiatives provide manageable payment solutions for patients undergoing treatment for retinal diseases, reducing the logistical burdens associated with ongoing care and promoting adherence to treatment regimens. In addition to financial support programs, Bayer has established outreach initiatives that emphasize the importance of regular eye examinations and early intervention. By engaging with communities, we aim to educate patients on the risks associated with untreated retinal diseases and empower them to seek timely care. Q. How do you see the future of ophthalmology and treatments in eye care? The future of ophthalmology is on the brink of remarkable advancements, driven by continuous innovation in treatments and preventive care strategies. There is a palpable sense of optimism surrounding the development of new therapies, including gene therapies, that promise to offer solutions for genetic retinal disorders. As research progresses, breakthroughs are anticipated that will address conditions previously deemed untreatable, significantly enhancing the quality of life for countless patients. Moreover, the integration of technology — particularly artificial  intelligence and telehealth solutions  is expected to improve  diagnostic accuracy and broaden access to care. With a growing  emphasis on preventive measures, the goal is to reduce the incidence of  vision loss caused by conditions like Wet AMD and DME through early  detection and timely intervention. We are committed to playing a pivotal role in this evolving landscape by investing in the research and development of innovative therapies and forging partnerships that advance eye care. Our overarching aspiration is to create a future where preventable blindness is significantly reduced, and every individual has access to the comprehensive eye care they deserve. Source: Economic Times

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Shortest treatment for drug-resistant TB to roll out in Jan

Oct 25, 2024 Mumbai: The National Tuberculosis (T B) Elimination Programme has started training sessions for doctors to introduce BPaL, the shortest treatment for drug-resistant TB to date. BPaL, a combination of bedaquiline, pretomanid and linezolid, can treat drug-resistant forms of TB in just six months compared with the present average of 18 months. The treatment is expected to be launched in early Jan, following the completion of trainer-doctor training in all states over the next two months. DrVikas Oswal, a Chembur-based pulmonologist and member of the NTEP technical expert team, said, “On Wednesday, we completed the first national three-day training module on the new TB treatment guidelines and BPaL for Delhi’s doctors.” The training for Maharashtra’s public health doctors is scheduled to take place in Pune during the second half of Nov. The training-of-trainers programme must be completed in all states before the BPaL treatment can be implemented. BPaL has been eagerly anticipated and has already been introduced in more than 40 countries. Indian authorities approved the combination a few months ago, following the results of a three-year trial that demonstrated a 90% cure rate. The Indian trial involved 403 patients with drug-resistant T B, of whom 352 were cured while one patient with COPD passed away. Eleven patients experienced a recurrence, and 19 others had severe adverse reactions during the 12-month followup. The trial also confirmed that a daily dosage of 600mg of the antibiotic linezolid is as effective as the originally prescribed 1,200mg. “The Indian study proved that 600mg to 300mg of linezolid is also as effective as 1,200mg,” said Dr Oswal. The most significant advantage of BPaL for patients, compared to older regimens, is that only three tablets need to be taken daily, and there are no daily injections. Public health experts expect the shorter and fewer-drug regimen will lead to a decrease in the drop-out rate associated with MDR-TB. Source: Economic Times

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Pharma bodies flag risks of refurbished medical gear imports

Oct 25, 2024 New Delhi: Medical device makers have raised concerns over the import of refurbished medical devices into India, highlighting potential risks to patient safety and violations of the medical regulat01Y framework. Lobby groups have asked the health minister JP Nadda to intervene and recall the policy that allows unregulated influx of second-hand medical equipment such as CT scanners, MRI machines, and surgical robots into the country. The ministry of environment, forest and climate change recently issued a memorandum stating a revised list of high end and high value used or refurbished medical equipment. According to Rajiv Nath, forum coordinator, AiMeD, the office memorandum is in violation ofthe National Medical Devices Policy 2023 launched by the PM as it permits import of pre owned medical equipment into India. The investments made by Indian and overseas manufacturers under the Make in India initiatives by the government are now under threat of becoming non- performing assets, he said. He said the ministry has expanded the list of equipment which is “very confusing and unsettling for investors who will only bring manufacturing technologies to India if the policy environment is predictable and consistent with the National Medical Devices policy 2023 that was meant to be binding on all government departments. Now not only many projects recently put up for high end medical equipment are jeopardised, but also patients are at risk of being treated with non-calibrated non- regulated medical equipment,” he said. Nath said India is being treated as a dumping ground for e-waste as obsolete equipment gets resold in the countlY while overseas manufacturers make hay “doubling sales.” Earlier in May, the Patient Safety and Access Initiative of India Foundation (PSAIIF), a not-for-profit organisation based in Delhi that works on improving access to quality healthcare, filed a Public Interest Litigation (PIL) before the Delhi High Court raising objections over the regulatory framework concerning the quality, safety, and efficacy of second-hand or used medical devices in India. The writ petition filed before the court had demanded a complete review of the regulatory mechanism related to the import of medical devices into the country that are used or refurbished. In a letter to the health minister, medical device manufacturers have sought intervention to stall and recall the intemninisterial policy issue from further execution. They have also sought setting up an expert committee to propose regulatory controls and amendments for enabling re-manufacturing and resale of Indian made refurbished equipment by the original equipment manufacturer beyond the warranty life cycle to ensure patient safety and calibrated accuracy. Source: Economic Times

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