September 2024

Vaccines are very safe. Your child is far more likely to be hurt by a vaccine-preventable disease than by a vaccine. All vaccines go through rigorous safety testing, including clinical trials, before they are approved for the public. Countries will only register and distribute vaccines that meet rigorous quality and safety standards.

Aug 29, 2024 India is reeling under a critical need for corneal transplants, with over 100,000 transplants required annually whereas only 25,000 out of these requirements are met each year. This makes it feasible for only one out of every four individuals with corneal blindness to avail the required surgery, while 75 per cent of the cases are left untreated. Faridabad: Corneal blindness is the second leading cause of blindness in India with a current burden of 1.1 million people. The incidence rate of corneal blindness in India has seen an increase in recent years. This rise is attributed to factors such as a growing ageing population, a higher incidence of corneal infections, injuries, and conditions like keratoconus. India is reeling under a critical need for corneal transplants, with over 100,000 transplants required annually whereas only 25,000 out of these requirements are met each year. This makes it feasible for only one out of every four individuals with corneal blindness to avail the required surgery, while 75 per cent of the cases are left untreated, said doctors at Amrita Hospital, Faridabad. Celtain regions in India are more prone to corneal blindness due to various factors like healthcare access, environmental conditions, and socioeconomic status. Rural and economically disadvantaged areas tend to have higher incidences of corneal blindness due to limited access to medical care, lack of awareness about eye health, and higher rates of eye injuries and infections. Specific states like Uttar Pradesh, Bihar, Rajasthan, and Madhya Pradesh have reported higher rates of blindness, including corneal blindness. These regions face challenges such as inadequate eye care facilities, lower rates of eye donation, and higher exposure to risk factors like agricultural injuries and infectious diseases. Corneal blindness is common in agricultural regions where eye injuries may lead to fungal infections. Dr Meenakshi Y Dhar, HOD, Ophthalmology, Amrita Hospital, Faridabad, said, “Injuries to the eye such as rupture of the cornea and chemical injmy to the eye can lead to damage to the cornea and subsequent blindness. Vitamin A deficiency in children, degenerative conditions like keratoconus and corneal dystrophies, congenital opacification of the cornea and post-surgical complications are some other causes of corneal blindness worldwide. The symptoms can vary based on the underlying cause of the corneal damage. Most patients experience blurred vision in the affected eye. Eye infections usually cause significant eye pain, watering, redness and severe photophobia in the acute phase. Visible scars on the cornea are often detectable during an eye examination.” Corneal blindness affects various age groups, but it is most prevalent among older adults. Specifically, most corneal blindness cases occur in individuals aged 50 years and above. This is largely due to the higher incidence of age-related eye conditions, such as corneal degenerations and dystrophies, in this demographic. However, corneal blindness can also affect younger individuals and children, palticularly in cases of congenital corneal disorders, injuries, or infections. Dr Rashmi Mittal, Senior Consultant and Corneal Transplant Specialist, Ophthalmology, Amrita Hospital, Faridabad said, “Treatments for corneal damage depend on the cause and severity, with corneal transplantation being the most definitive option for advanced cases. Other treatments include laser therapy, scleral contact lenses, amniotic membrane transplants, and stem cell therapy. Preventive measures such as proper eye hygiene, prompt treatment of infections, vaccination, and health education can significantly reduce the risk of corneal blindness. Early diagnosis and treatment of corneal conditions are vital in preventing the progression to blindness, ensuring better treatment outcomes, reducing healthcare costs, and preserving the quality of life for affected individuals. Early detection and treatment not only prevent permanent damage to the cornea but also improves treatment outcomes. Additionally, getting treated during the initial phases of degeneration of the cornea can be less expensive compared to managing advanced disease.” To close the gap in the donor-patient ratio, promoting eye donations can be of great benefit as it can help individuals and society by restoring vision through corneal transplants, improving quality of life, and reducing healthcare costs. Increased donations foster community support, raise awareness about organ donation, and inspire others to contribute. Donated eyes also aid in research for new treatments and technologies in vision care. People of all age groups can donate their eyes after death. Even people with diabetes, hypertension, cataract surgery, myopia, and glaucoma can successfully donate their eyes. Consent for eye donation must be given either by the individual before death or by the family member after death. The only crucial thing to note is that eyes need to be removed within six hours of death to be viable for transplantation. Corneal blindness can also have a significant impact on a country’s economy and GDP in several ways such as reduced workforce productivity with resultant loss of economic contributions, educational impact leading to less skilled workforce, healthcare costs and other indirect costs to the families of the affected individuals. Addressing corneal blindness through preventative measures, early treatment, and support services can help mitigate these economic impacts and promote better economic outcomes. Improving eye donation rates in India requires addressing cultural, logistical, and awareness challenges. Collaborating with leaders and influencers to dispel misconceptions and promote eye donation as a noble act can increase donations. Enhancing infrastructure by upgrading eye banks, surgical facilities, and training healthcare professionals is crucial. Raising awareness through educational campaigns, community events, and testimonials can motivate more people to donate. Source: Economic Times

Aug 30, 2024 The researchers also found that within a country and an age group, more women were consuming inadequate amounts of iodine, vitamin B12 and iron, compared to men, whereas more men were consuming inadequate amounts of magnesium, vitamin B6, zinc and vitamin C, compared to women. New Delhi: People across all age groups in India, both men and women, are consuming inadequate amounts of micronutrients critical for health, including iron, calcium and folate, as estimated in a study published in The Lancet Global Health journal. The study is the first to provide estimates of insufficient consumption of 15 micronutrients across 185 countries, taken through diets without the use of supplements, according to an international team, including researchers from Haward University, US. The findings suggested that around the world, almost 70 per cent, or over five billion, people do not consume enough iodine, vitamin E, and calcium. The researchers also found that within a countlY and an age group, more women were consuming inadequate amounts of iodine, vitamin B12 and iron, compared to men, whereas more men were consuming inadequate amounts of magnesium, vitamin B6, zinc and vitamin C, compared to women. In India, while more women consumed insufficient amounts of iodine, compared to men, more men consumed inadequate amounts of zinc and magnesium, compared to women, the team found. While analyses over the past 10 years have looked at micronutrient deficiencies, the researchers said large data gaps remain for many micronutrients and population groups. In this study, the authors used publicly available data from the Global Dietary Database to estimate the prevalence of insufficient nutrient intakes for 99.3 per cent of the global population. Men and women aged 10-30 years were most prone to low-levels of calcium intake, especially in South Asia, Southeast Asia and sub-Saharan Africa, the team said. The authors said that the findings could be used by public health professionals to target populations in need of dietary interventions. They added that since they did not account for intake of fortified foods or supplements, the results could possibly be an overestimate for some key nutrients in palticular locations where people consume high amounts of fortified foods and supplements. Source: Economic Times

Sep 12, 2024 The event is renowned as a platform for education, training, and knowledge exchange in the field of anaesthesiology,they said, adding that over 700 registered participants are expected to attend this year’s conference. A CME and hands-on workshop for paramedical and nursing staff will be held today, which will be inaugurated by Parth Sarathi Sen Sharma, Principal Secretary, Medical Education. The Department of Anaesthesia at King George’s Medical University (KGMU), Lucknow, is hosting the 5th International and 15th National Conference of the Indian College of Anaesthesiologists (ICA) from September 12 to 15, said Monika Kohli, Head of the Department, and Dr Tanmay Tiwari, the event’s Organizing Secretary Wednesday. The event is renowned as a platform for education, training, and knowledge exchange in the field of anaesthesiology,they said, adding that over 700 registered participants are expected to attend this year’s conference. They said the conference will be inaugurated on September 14 by Governor Anandiben Patel, and will be attended by Deputy Chief Minister Brajesh Pathak, Minister of State for Medical Education Mayankeshwar Sharan Singh, and Vice Chancellor KGMU, Prof Soniya Nityanand. Founded in 2008, the ICA is an autonomous academic organization dedicated to advancing education and training in anaesthesiology. This year’s theme, “Outcome Enhancement in Anaesthesia,” focuses on improving patient safety and clinical outcomes. The conference will include 12 workshops covering various aspects of anaesthesiology, with over 250 postgraduate students and over 150 experts from India and abroad participating. A CME and hands-on workshop for paramedical and nursing staff will be held today, which will be inaugurated by Parth Sarathi Sen Sharma, Principal Secretary, Medical Education. Source: Indian Express

Aug 23, 2024 The syrups contained ethylene glycol (EC), a commonly used chemical in products such as brake fluid and antifreeze. A court document from that criminal case said the EG concentration in the syrups reached as high as 99%, where international standards say only 0.1% of EG is safe for consumption. By Stanley Widianto Jakarta: An Indonesian court ordered two local companies to pay up to 60 million rupiah ($3,850) to each family whose children died of an acute kidney injmy or were seriously injured after consuming toxic cough syrup. More than 200 children in Indonesia died of the injury and about 120 more smvived, some of whom lived with disabilities which led to financial hardships for their parents. Indonesian courts have cited lax oversight by pharmaceutical companies, including local drugmakers and some suppliers, as well as the countlY’s food and drugs agency (BPOM), in hearings into the poisonings. In late 2022, more than 20 families launched a civil suit against the agency, the health ministry, and several companies. Judges at the Central Jakalta court found a clmgmaker and a supplier, Afi Farma and CV Samudera Chemical, at fault in the poisonings, according to a ruling released late on Thursday. The health ministry and the BPOM were cleared of wrongdoing. The court ordered the companies to pay the parents who brought the suit compensation of 50 million rupiah for children who died and 60 million rupiah for children who were injured. Parents had asked for 3.4 billion mpiah for each child that died, and 2.2 billion mpiah for survivors. Indonesia’s 2023 gross domestic product per capita was nearly $5,000, data from the country’s Statistics Bureau shows.     Siti Habiba, the lawyer for the parents, said the families were disappointed by the ruling, as the money was given “as though we were beggars.” “This breaks a lot ofthe victims’ hearts,” she said, adding the court ignored the parents’ government oversight concerns by not finding the health ministry and the BPOM at fault. The court document, posted on its website, did not include reasons for the decision. Afi Farma’s lawyer Reza Wendra Prayogo told Reuters on Friday the firm was “disappointed” with the civil case ruling and the company was still considering its next legal step. Last year, a criminal court found East Java-based clmgmaker Afi Farma guilty of negligence and jailed officials for not testing the ingredients sent by its supplier. The syrups contained ethylene glycol (EG), a commonly used chemical in products such as brake fluid and antifreeze. A court document from that criminal case said the EG concentration in the syrups reached as high as 99 per cent , where international standards say only 0.1 per cent of EG is safe for consumption. The company has repeatedly denied negligence. Reuters could not immediately contact CV Samudera Chemical, an Indonesian soapmaker, whose toxic ingredient made its way to Afi Farma, according to the court document of the Afi Farma criminal case in 2023. The World Health Organization said the contaminated medicines had also killed children in Gambia and Uzbekistan in 2022. Source: Economic Times

Sep 11, 2024 IQVlA’s Al solutions streamline workflows, drive automation to connect process improvements, and provide insights into individual activities, improving patient safety and commercial performance. SAN ANTONIO, Sept. 11, 2024 /PRNewswire/ Frost & Sullivan recently assessed the artificial intelligence (Al) quality and regulatory solutions space for the healthcare industry and, based on its findings, recognizes IOVIA with the 2024 Global Customer Value Leadership Award. The company is the first to offer intelligently connected integration for all quality, regulatory, and safety processes across healthcare, accelerating digital transformation through software-as-a-service (SaaS) and intelligence-driven simplification, automation, and the integration of functions, processes, and systems, as opposed to other solutions that lack such wide-ranging functionality. Compared to competitors, IQVIA highlights its value through industry-leading capabilities, comprehensive cloud solution portfolio, management and implementation consulting, business and IT managed services, and tech-enabled services. IQVlA’s quality and regulatory solutions digitalize and streamline the end-to-end activities of Quality Assurance and Regulatory Affairs (QARA) across organizations, enabling businesses to bring products to market and maintain their presence. The company’s end-to-end solution for QARA eliminates work duplication, delivering value across the entire organization rather than focusing solely on individual pillars. Within the quality and regulatory sphere, the company provides an ecosystem with about 18 modules. Sankara Narayanan, Industry Director, Frost & Sullivan, observed “One key aspect of IQVIA is its commitment to deploying quality management with a commercial focus, emphasizing both patient safety and commercial performance. Its Al can drive optimizations, insights, and efficiencies, allowing QARA professionals to improve patient safety and product quality within the bounds of financial prudence. Ultimately, IQVIA enables commercial performance through improved operational efficiencies and effective resource utilization.” In addition, IQVIA provides data mining capabilities with solutions such as Vigilance Detect for literature and social media monitoring. Moreover, the solution helps organizations mitigate the risk of human fatigue, improve performance over time, and achieve global quality compliance. IQVIA integrates SmartSolve with other such solutions to enable healthcare organizations to adopt a modular and scalable approach to end-to-end solutions. As a healthcare company, IQVIA prioritizes providing compliant, safe, effective, financially savvy, relevant, and customer-centric healthcare solutions rather than simply chasing technological advancements. “lQVlA’s value proposition enables top-line growth, operational effectiveness, efficiency, and compliance, significantly boosting companies’ commercial performance and professional activities. It tackles the increasing complexities of global regulations, optimizes resource allocation to achieve the set financial performance, and provides strategies for complex healthcare challenges through right- first-time activities and a single source of truth,” added Sankara Narayanan. With its strong overall performance, IQVIA earns Frost & Sullivan’s 2024 Global Customer Value Leadership Award in the Al regulatory and quality solutions space for the healthcare industry. Each year, Frost & Sullivan presents this award to the company that has demonstrated excellence in implementing strategies that proactively create value for its customers, with a focus on improving the return on investment that customers make in its services or products. The award recognizes the company’s unique focus on augmenting the value that its customers receive, beyond simply good customer service, leading to improved customer retention and customer base expansion. Frost & Sullivan Best Practices Awards recognize companies in various regional and global markets for demonstrating outstanding achievement and superior performance in leadership, technological innovation, customer service, and strategic product development. Industry analysts compare market participants and measure performance through in-depth interviews, analyses, and extensive secondary research to identify best practices in the industry. Source: prnews Wire

Aug 27, 2024 IMDX Monkeypox Detection RT-PCR Assay by Siemens Healthineers has received manufacturing approval from the Central Drugs Standard Control Organisation (CDSCO). This is a significant achievement for our “Make in India” initiative and a critical advancement in the fight against the Monkeypox public health emergency. By Shalini Bharadwaj New Delhi: The World Health Organisation (WHO) has announced its second public health emergency of International concern due to Monkey Pox. The new strain of this vims (Clad-I) is considered to be more transmissible and has higher mortality rates. Now, India has developed its own home-grown indigenous RT-PCR testing kit to fight against Mpox, which has been approved by Central Protection Drugs Standard Control Organisation (CDSCO). IMDX Monkeypox Detection RT-PCR Assay by Siemens Healthineers has received manufacturing approval from the Central Dmgs Standard Control Organisation (CDSCO). This is a significant achievement for our “Make in India” initiative and a critical advancement in the fight against the Monkeypox public health emergency. “IMDX Monkeypox Detection RT-PCR Assay will be manufactured at our molecular diagnostics manufacturing unit in Vadodara, which has a manufacturing capacity of 1 million reactions per year. The fact01Y is all set to make the kits available,” said Siemens Healthcare Private Ltd. “The IMDX Monkeypox Detection RT-PCR Assay is a ground-breaking molecular diagnostic test that targets two distinct regions in the viral genome, spanning both clade I and clade II variants of the virus. This ensures thorough detection across various viral strains, providing comprehensive results. Notably, this assay is platform-agnostic and seamlessly fits into existing lab workflows with standard PCR setups, eliminating the need for new instruments. The ability to use existing COVID testing infrastructure would enhance efficiency.” It went further. Hariharan Subramanian, Managing Director, Siemens Healthcare Private Limited, said that the urgency for precise and accurate diagnostics couldn’t be more cmcial than now. “By providing India with advanced assay kits tailored to combat Monkeypox, we are taking a proactive stance in battling this disease and prioritising prompt and precise detection that can tmly make a difference in saving lives. These kits are a testament to our focus on improving ‘Access to Care’ and these assay kits are a significant step towards that goal,” he said. According to Siemens Healthcare Private Ltd, the test results will be available in 40 minutes. “With results available in just 40 minutes, significantly faster than traditional methods (which take 1-2 hours), the assay helps reduce the turnaround time for reporting, leading to quicker responses. Clinically validated by ICMR-National Institute of Virology, Pune, the assay boasts an impressive 100 per cent sensitivity and specificity. IMDX Monkeypox RTPCR Assay kits adhere to Indian statutory guidelines and comply with the highest global standards,” it said. Source: Economic Times

Sep 12, 2024 Hyderabad: A new study conducted by Dr Bhaktiyar Choudary and his team at Hyderabad Spine Clinics Institute has revealed a significant connection between vitamin D deficiency and frozen shoulder syndrome (FSS) along with its impact on repetitive strain injuries, affecting the spine. The research, focusing on diverse Indian population, said that low levels of vitamin D are prevalent across various age groups and are particularly associated with development of FSS which, in turn, can lead to spinal issues. he study emphasises that inadequate vitamin D, often caused by factors like urban pollution, limited sunlight exposure, and dietary inadequacies, is a major contributor to joint issues, including FSS. This condition not only limits shoulder movement but also exerts pressure on the spine, potentially leading to severe back and neck pain, and in some cases, permanent disabilities. The research underscores the importance of addressing vitamin D deficiencies early to prevent long-term musculoskeletal problems. Dr Choudary’s team found that individuals with severe vitamin D deficiency are likely to remain deficient throughout their lives, complicating recovery due to damage to vitamin D receptor sites in the body. The study also highlights the role of repetitive strain injury in exacerbating spinal problems, noting that the majority of those with frozen shoulder also suffer from significant spinal pain. The findings call for increased awareness and proactive management of vitamin D levels to mitigate the risks associated with FSS and related spinal injuries. Researchers suggest that eating staple food on time, getting exposed to sunlight, managing intestinal problems, stopping or reducing alcohol intake, monitoring vitamin levels, and supervising the intake of supplements, managing stiff joints can help patients.

Sep 12, 2024 BACKGROUND Insulin efsitora alfa (efsitora) is a new basal insulin designed for once-weekly administration. Data on safety and efficacy have been limited to small, phase 1 or phase 2 trials. METHODS We conducted a 52-week, phase 3, parallel-design, open-label, treat-to-target trial involving adults with type 2 diabetes who had not previously received insulin. Participants were randomly assigned in a 1:1 ratio to receive efsitora or degludec. The primary end point was the change in the glycated hemoglobin level from baseline to week 52; we hypothesized that efsitora would be noninferior to degludec (noninferiority margin, 0.4 percentage points). Secondary and safety end points included the change in the glycated hemoglobin level in subgroups of participants using and not using glucagon-like peptide-I (GLP-I) receptor agonists, the percentage of time that the glucose level was in the target range of 70 to 180 mg per deciliter in weeks 48 through 52, and hypoglycemic episodes. RESULTS A total of 928 participants underwent randomization (466 to the efsitora group and 462 to the degludec group). The mean glycated hemoglobin level decreased from 8.21% at baseline to 6.97% at week 52 with efsitora (least-squares mean change, —1.26 percentage points) and from 8.24% to 7.05% with degludec (least-squares mean change, —1.17 percentage points) (estimated treatment difference, —0.09 percentage points; 95% confidence interval [CI] , —0.22 to 0.04), findings that showed noninferiority. Efsitora was noninferior to degludec with respect to the change in the glycated hemoglobin level in participants using and not using GLP-I receptor agonists. The percentage of time that the glucose level was within the target range was 64.3% with efsitora and 61.2% with degludec (estimated treatment difference, 3.1 percentage points; 95% CI, 0.1 to 6.1). The rate of combined clinically significant or severe hypoglycemia was 0.58 events per participant-year of exposure with efsitora and 0.45 events per participant-year of exposure with degludec (estimated rate ratio, 1.30; 95% CI, 0.94 to 1.78). No severe hypoglycemia was reported with efsitora; six episodes were reported with degludec. The incidence of adverse events was similar in the two groups. CONCLUSIONS In adults with type 2 diabetes who had not previously received insulin, once-weekly efsitora was noninferior to once-daily degludec in reducing glycated hemoglobin levels. (Funded by Eli Lilly; QWINT-2 ClinicalTria1s.gov number, NCT05362058.) Source: Nejm

Sep 07, 2024 A simple regulatory remedy would be for the apex court to mandate state drug controllers to disclose all file- notings that form the basis of approval of “patent and proprietary” Ayush drugs For over two years now, the Supreme Court has been hearing a public interest litigation (PIL) filed by the Indian Medical Association (IMA), on misleading advertisements made by Patanjali regarding its Ayurvedic products. The Ayurvedic industry poses a multi-dimensional challenge to public health in India today. It is important for both the Supreme Court and the lawyers advising it to be aware of the historical challenges in regulating the health care industry, lest they spend time reinventing the wheel. Traditionally, there are five levers to regulate the pharmaceutical industry: Advertising, safety, efficacy, standardisation, and good manufacturing practices. The Ayush (Ayurvedic, Yoga, Unani, Siddha, and Homoeopathy) industry today is subject to only the first lever — that is, its advertising is regulated. The common explanation offered by the Ayush industry to evade providing data on the safety and efficacy of their products is that these have been used for centuries by many satisfied consumers. Except, this argument is not true on three counts. First, it is well known that one particular branch of Ayurveda encourages the use of heavy metals, which is harmful to humans. There are well-researched and peer-reviewed studies published in the Journal oftheAmerican Medical Association (JAMA) as far back as 2004 that document a heavy-metal problem with Ayurvedic drugs. Other studies have focussed specifically on lead poisoning in Indian-origin patients known to consume Ayurvedic products. Second, most Ayush products sold in India are classified as “patent and proprietary” — a category introduced via an amendment to the Drugs and Cosmetics Act (D&C Act) in 1982. These products, created with new ingredients that can’t be traced to the old texts from where the industry generally draws its legitimacy, are practically “new drugs.” When this category was created, there was no requirement that these products be tested to establish their safety and efficacy. In 2010, the Drugs and Cosmetics Rules were amended to introduce Rule 158B, which required the industry to provide evidence of safety and efficacy. However, there was a catch. It did not require the industry to collect such evidence through standards that are applicable to modern medicine, for example, double-blinded, randomised clinical trials. Instead, it prescribed “pilot studies” as the preferred methodology, and nobody really knows what that meant. The Ayush ministry first said that it meant “clinical trial” before changing its mind in 2018 and clarifying that no “clinical trials” were required for Ayush products. Third, India does not have a robust pharmacovigilance system to monitor adverse events as a result of Ayush products. In short, nobody has been keeping an eye on the adverse events faced by patients consuming Ayush products. Individual doctors often publish case studies, but this a poor proxy for a systematic pharmacovigilance programme that tracks adverse events resulting from use of these products. Since the Ayush industry has a licence to sell products without demonstrating any evidence of safety or efficacy, it is critical to exercise the only lever that can restrain the excesses of the industry, namely advertising regulations. However, the Ayush ministry deleted Rule 170 of the D&C Rules during the pendency of the IMA PIL in July 2024. The history of Rule 170 of the D&C Act is crucial in understanding the modus operandiof the Ayush industry. Its origin can be traced back to continuous pressure piled on the Ayush ministry by the parliamentary standing committee (PSC) on health over the brazen claims being made by the Ayush industry. In four different reports tabled in 2013, 2015, 2016, and 2018, the PSC repeatedly flagged this issue, pointing out that the existing law — Drugs and Magic Remedies (Objectionable Advertisements) Act — regarding advertising of drugs was not effective in checking the claims of the Ayush industry, through advertisements that boasted of drugs that could cure cancer, AIDS, and diabetes. After repeated pressure from the PSC, the Ayush ministry first floated the idea of Rule 170 on April 4, 2016, when it published a draft of the rule in the Gazette of India, inviting public feedback. This proposed draft created an ex-ante mechanism — the industry needed to seek permission for its advertisements from regulators before using them in their marketing campaigns. The regulator was to verify whether the advertisement made misleading claims about the effectiveness of the drug. For 37 medical conditions, it prohibited any advertisement by the industry. The draft Rule 170 faced immense pushback from the industry. It did not get notified for years; the PSC continued to pile pressure on the Ayush ministry, questioning its “laidback” approach in a report tabled in 2018. Finally, on December 21, 2018, the ministry notified it into law. In early 2019, the Ayush industry challenged the constitutionality of the rule before three different high courts, claiming it infringed on their freedom of speech. This is, at best, a questionable claim given India has a censorship regime for cinema and the fact that, in 1954, in a landmark case lost by the Ayush industry, the Supreme Court ruled that the fundamental right to speech did not include commercial speech such as advertisements. In any event, the legality of Rule 170 should have been swiftly decided by the high courts. Instead, the high courts stayed the rule without deciding on the matter. As a result, it was never enforced against the industry. Fast forward to the IMA’s PIL, where the issue of Rule 170 and the lack of its enforcement came up before the court. The Ayush ministry issued a notification on July 2, 2024, while the case was sub judice, omitting Rule 170 from the law. A rule that was created to hold the industry accountable was removed from the law without ever being enforced. The Supreme Court has stayed the deletion of the rule, but this stay is an untenable remedy in the