PSM News

June 20,2024 New Delhi: Sun Pharmaceutical Industries Ltd on Wednesday said it has received a warning letter from the US health regulator for its Dadra facility over violation of manufacturing norms. The warning letter by the US Food and Drug Administration (USFDA) summarises violations with respect to Current Good Manufacturing Practice (cGMP) regulations, Sun Pharma said in a regulatory filing. The contents of the warning letter shall be made public by the USFDA in due course, it added. This intimation is further to our communication dated April 11, 2024, about Dadra facility receiving OAI status by the USFDA. On April 11, Sun Pharma had informed stock exchanges that its Dadra facility had received Official Action Indicated (OAI) status from the USFDA. It followed an inspection at the company’s Dadra facility from December 4 to December 15, 2023. Source: Pharma

June 21,2024 Geneva: The World Health Organisation and drugmaker Eli Lilly and Co are warning people to be wary of fake versions of popular weight-loss and diabetes medicines. WHO said Thursday that it has fielded several reports of fake semaglutide – the active ingredient in Novo Nordisk’s Wegovy and Ozempic – in all geographic regions of the world since 2022. Lilly said in an open letter that it was “deeply concerned” about growing online sales and social media posts involving phony or compounded versions of tirzepatide, the active ingredient behind its drugs Mounjaro and Zepbound. The Indianapolis-based company said it was the only lawful supplier of those drugs, and it does not provide tirzepatide to compounding pharmacies, wellness centers or online retailers. Lilly said fake versions of its drugs frequently advertised or sold online are never safe to use. Novo Nordisk has issued similar warnings in the past about its medications. WHO said patients can protect themselves by using prescriptions from licensed physicians to buy the medications. The agency said patients also should avoid buying the drugs from unfamiliar sources. Lilly said any products marketed as tirzepatide and not Mounjaro or Zepbound were not made by the drugmaker and are not approved by the US Food and Drug Administration. (AP) SCY SCY. Source: Pharma

June 19,2024 New Delhi: An expert committee is likely to meet soon to deliberate on a contentious proposal to assess the feasibility of allowing generic substitutions for prescription drugs, said people familiar with the matter. The proposal has become a bone of contention between the Indian Pharmaceutical Alliance (IPA), which represents the country’s big drug makers, and the All India Drug Action Network (AIDAN), a network of several health organisations. The IPA is opposing the proposal to allow government-run Jan Aushadhi Kendras to dispense substitutes of prescription medications, claiming that it would open floodgates of similar demands by trade channels, such as general pharmacy stores, “which will not be in the interest of patients”. The IPA represents drugmakers such as Sun Pharmaceutical Industries, Dr Reddy’s Laboratories, Torrent Pharmaceuticals, Piramal Pharma, Aurobindo Pharma, Emcure Pharmaceuticals, Intas Pharmaceuticals, Glenmark Pharmaceuticals, Lupin, Cipla and Cadila Pharmaceuticals. The IPA has also said the absence of proper regulatory oversight could result in spurious drugs being dispensed to patients. AIDAN, on the other hand, said the permission to Jan Aushadhi Kendras to substitute brands with generic name medicines would be “in the interest of patients”. “A committee will take up this matter to deliberate the concerns of all stakeholders,” said one of the persons, who did not wish to be identified. AIDAN wrote to the health minister this week urging the government “to work for the consumer and leave no stone unturned towards making life saving medicines (available) at affordable price”. The Central Drugs Standard Control Organisation (CDSCO) has been mulling a proposal to make changes to the Drugs and Cosmetics Act, 1940, and its regulations to allow the substitution of drugs specified under schedules H, H1, and X with a view to promoting quality generic medicines at affordable prices. Source: Pharma

June 17, 2024 Mumbai : The FSSAI Western Region office has suspended the license of an ice cream manufacturer in Pune after a 26-year-old doctor from Malad West alleged that he found a human finger in an ice cream cone on Wednesday. “The premises of the ice cream manufacturer have been inspected by a team of FSSAI’s Western Region Office and its license has been suspended,” said FSSAI in a reply to ANI However, the report of the forensic lab is still pending. FSSAI further said that the ice cream manufacturer who delivered the ice cream is based in Indapur, Pune, and has a central license as well. “The manufacturer is based at Indapur, Pune and has a central license,” FSSAI said. For further investigation team FSSAI has collected samples from the premises of the seller. “The State FDA has also inspected the seller’s premises at Mumbai and samples of the batch have been taken,” the food safety body added. According to Branded Ferro, the complainant, his sister visited him, and he ordered three ice creams from Yumno through a grocery app, which arrived at 10:10 pm. In his Police complaint, he said, that as he took a byte from a cone he felt something unusual in his mouth and when he checked it properly then he got to see finger-like flesh. Later, he clicked the picture and shared it on the Instagram page of the company. Source: Healthworld

June 15,2024 There is a common belief that food cooked at home is not processed & healthier and that food cooked in an industrial kitchen is processed and unhealthy. This is not true. As the food cooked in an industrial kitchen is made in bulk quantity, with standardised recipes as per food standards issued by food regulatory authorities (like FSSAI, Tea Board, Spice Board, DAHD etc.) and adhering to stricter health and safety norms during the preparation. What is Food Processing? Food processing which refers to transforming food ingredients like grains, meat, vegetables, fruits, etc. with minimal waste into a value-added and convenient processed product can be done in a home kitchen or in a large-scale kitchen usually known as an industrial manufacturing unit. The technique, ingredients, food additives , packaging, and transportation are almost similar and vary only in the case of size and volume. The process of oil-preserved pickle made by our granny at home is similar to manufacturing the same at the industrial level which includes sorting, cleaning, pickling, and packing. It is not incorrect to say that large-scale food processing has eased our fast-paced and hustled lives and made more space and time for interaction with our loved ones. Does processing decreases nutritional value of the food? The most common myth prevalent for processed foods is that it will decrease the nutritional value of the food but it is not always true. In fact, some foods must be necessarily processed prior to consumption to remove harmful / toxins naturally present e.g. Milk must be boiled or pasteurised to kill harmful bacteria to make it safe for human consumption, Most of the anti-nutritional compounds of the pulses that are present in the seed coat are sensitive to heat and can be substantially reduced by milling, cooking, germination, fermentation, and heat processing. Germination induces enzymes to split up carbohydrates, lipids, and proteins into basic methods and stimulates proteases involved in destroying proteins, thus enhancing the bioavailability of nutrients. Vitamin C and the B complex vitamins increase dramatically and encourage the production and productivity of seedlings. During fermentation, lactic acid bacteria synthesise vitamins and minerals, produce biologically active peptides with ensymes such as proteinase and peptidase, and remove some non-nutrients. Fermented foods provide many health benefits such as anti-oxidant, anti-microbial, anti-fungal, anti-inflammatory, anti-diabetic, and anti-atherosclerotic activity. Juicing helps in breaking down complex carbohydrates to simpler forms for easy digestion and assimilation by the body. Another way in which food processing enhances nutritive value of foods is fortification with essential nutrients like vitamins, minerals, omega-3, dietary fiber etc. Some examples are: Milk is fortified with Vitamin A and D to address nation-wide associated deficiencies. Common Edible Salt is fortified with Iodine to address nation-wide associated deficiencies. Non-carbonated waters are fortified with certain minerals like Calcium, Potassium, Magnesium, etc. to replenish lost minerals during exercise or sports activity. Fruit Juices are fortified with certain minerals and vitamins like Vitamin C, D, K, B complex, E, Iron, Calcium etc. to enhance nutritive value of the juices. Edible oils are fortified with omega-3, Vitamin A to enhance its nutritive value. Biscuits and other bakery items are fortified with vitamins, minerals, and dietary fiber to enhance its nutritive value and avoid digestive issues related to cereals. Source: Healthworld

NEW MASTER CIRCULAR issued by IRDAI repeals 55 previous circulars. Major reforms FOR health insurance policies – especially beneficial for Sr Citizens. Insurers have been advised to move to 100 % cashless claim settlements – and empanel all categories of hospitals considering affordability for all population segments. Stricter time limits for portability. CIS – Customer Information Sheet to be provided with every policy document giving complete details of the medical insurance policy. These are MAJOR LANDMARK reforms in the health insurance sector that come into effect immediately.

June 12,2024 New Delhi: Exposure to heat was found to stress the heart of adults by increasing the blood flow to the organ’s walls, according to a new study. The researchers also found evidence of obstructed blood flow induced because of the heat in some of the adult participants with heart disease, even though they did not display symptoms externally. The researchers, including those from Canada’s Montreal Heart Institute, said these adults may benefit by staying cool to counter the heat’s stress on their hearts. For the study, published in the journal Annals of Internal Medicine, the team recruited 61 adults — 20 healthy young adults, 21 healthy older adults and 20 older adults with coronary artery disease (CAD) — to see how exposure to extreme heat impacted the heart. CAD is a condition in which blood vessels supplying to the heart are narrowed because of plaque buildup, thereby limiting blood flow. The researchers artificially raised the core body temperature of the participants by 1.5 degrees Celsius and measured their myocardial blood flow (MBF) – blood reaching muscles of the heart wall – before exposure and also at every increase of 0.5 degrees Celsius to their core temperature. The authors found that blood flow to the heart muscles increased in all participants when their body temperature increased by 1.5 degrees Celsius. Using imaging techniques, the authors further observed that seven of the participants with CAD experienced heat-induced myocardial ischemia in which blood flow to the heart is obstructed due to blockage in vessels. The participants, however, did not outwardly show symptoms of the condition. In an accompanying editorial from Annals of Internal Medicine and the University of Pennsylvania Perelman School of Medicine (US), the researchers said that exposure to heat can significantly stress the heart by inducing a supply-demand mismatch in vessels. With temperatures around the world on the rise, identifying vulnerable people with conditions of the heart and blood vessels is imperative, it said. Repeated exposures can result in a “symptomatic or silent” blood flow problems, which could partly explain the increased risk for adverse cardiovascular events observed because of heat exposure in population studies, it said. Source: Healthworld

June 12,2024 Copenhagen: The WHO on Wednesday blamed four major industries — tobacco, ultra-processed foods (UPFs), fossil fuel and alcohol — for 2.7 million deaths a year in Europe, accusing them of obstructing public policies that could hurt their profits. These “four industries kill at least 7,000 people in our region every day,” Hans Kluge, the director of the World Health Organization Europe region which counts 53 countries including Central Asia, said in a statement. The consolidation of these industry sectors into a small number of multinationals “has enabled them to wield significant power over the political and legal contexts in which they operate, and to obstruct public interest regulations which could impact their profit margins,” the WHO said as it released a report. Industry tactics included exploiting vulnerable people through targeted marketing strategies, misleading consumers, and making false claims about the benefits of their products or their environmental credentials, it argued. “These tactics threaten public health gains of the past century and prevent countries from reaching their health targets,” it added. Industry lobbying was hampering efforts to tackle non-communicable illnesses such as cardiovascular disease, cancer and diabetes, said the WHO. Almost 60 percent of adults and a third of children in Europe are overweight or obese, according to the WHO. The most recent data, from 2017, showed that one death in five attributed to cardiovascular disease and cancer in Europe was the result of unhealthy eating habits. The WHO urged countries to fight back by enforcing stronger regulations on the marketing of unhealthy products, monopolistic practices and lobbying. “People must take precedence before profit, always,” Kluge said. The report, “Commercial determinants of noncommunicable diseases in the WHO European Region”, is available at the WHO website. Source: Healthworld

June 11,2024 New Delhi: Researchers from the George Institute for Global Health India in collaboration with researchers from Indira Gandhi Government Medical College (Nagpur), and the London School of Hygiene and Tropical Medicine (UK) have conducted a survey shedding light on the staggering financial burden faced by Tuberculosis (TB) patients in India. Their findings underscore the urgent need for both policy and public interventions to alleviate this burden on patients and the nation. The study was led by Dr Susmita Chatterjee, Senior Health Economist, George Institute for Global Health, New Delhi, along with Palash Das, Research Fellow, George Institute for Global Health, New Delhi; Gayatri Bhambure, Research Assistant, George Institute for Global Health, New Delhi; Dr Radha Munje, Department of Respiratory Medicine, Indira Gandhi Government Medical College, Nagpur; Anna Vassall, Professor, Health Economics, Department of Global Health and Development, London School of Hygiene and Tropical Medicine, London. The study conducted against the backdrop of the World Health Organisation’s End TB strategy, which serves as a blueprint for countries to achieve zero catastrophic costs for TB-affected households, reveals concerning statistics about the economic toll of the disease in India. With the nation bearing the highest TB burden globally, the reported incidence reached 2.42 million cases in 2022. The George Institute researchers followed a cohort of 1,482 drug-susceptible TB patients across four states in India: Assam, Maharashtra, Tamil Nadu, and West Bengal. Employing World Health Organisation guidelines, the study calculated treatment costs, incorporating both direct (ie actual money spent) and indirect costs such as time, productivity, and income loss. Speaking about the research, Dr Chatterjee said, “Following the largest cohort of drug-susceptible TB patients till date, our study concluded that a significant proportion of study participants faced catastrophic cost and the proportion was much higher when income loss because of TB treatment was considered in total cost calculation method. Therefore, ensuring uninterrupted livelihood during TB treatment is an absolute necessity.” She also added, “Our study showed significant delay from symptom onset to diagnosis and our study participants spent more than half of total treatment cost even before starting the treatment. Further, during this period they also propagated the disease. Therefore, reducing the pre-diagnosis delay should be the policy priority.” Shockingly, depending on the method of indirect cost calculation, between 30 per cent to 61 per cent of study participants faced catastrophic costs. Defined as out-of-pocket expenses exceeding 20 per cent of pre-TB annual household income, catastrophic costs pose a significant threat to the financial stability of millions of TB-affected households in the country. Of particular concern was the fact that for over half of the participants who faced catastrophic cost, costs became catastrophic even before commencing TB treatment due to delays in diagnosis. The average delay of 7-9 weeks from symptom onset to treatment initiation, twice the accepted delay period, resulted in substantial financial burdens from repeated consultations, tests, and travel expenses. The study’s implications are profound, calling for immediate action at both policy and community levels. Supply-side interventions such as intensifying private sector engagement and rapid diagnosis are crucial, alongside demand-side initiatives like community awareness campaigns. Addressing the delay in diagnosis through early case detection and active community engagement is paramount to reducing economic burdens. The study also advocates for the reimbursement of pre-treatment expenses through health insurance, emphasising the need for improved coverage and utilisation. Policies safeguarding TB patients from unemployment and income loss are also imperative to mitigate financial hardships associated with the disease. The findings of this study serve as a clarion call for concerted efforts from policymakers, healthcare providers, and communities to alleviate the economic burden of TB treatment in India. By implementing comprehensive strategies, we can not only reduce financial hardships on patients but also move closer to achieving the ambitious targets set forth by the End TB strategy. The results of the study have been published in PLOS Global Public Health. Source: Healthworld

June 11,2024 New Delhi: Sildenafil, commonly known by its brand name Viagra, the wonder drug for men suffering from erectile dysfunction, can also help people prevent problems related to memory. A recent study has found that the drug increases cerebral blood flow and enhances the function of blood vessels in individuals who are at risk of developing vascular dementia. Vascular dementia is a condition that affects cognitive functions, such as memory, reasoning, planning, and judgement. This type of dementia occurs due to reduced blood supply to the brain, resulting in damage to brain tissue. The research conducted by scientists at the University of Oxford, the results of which appeared in journal Circulation Research, represents a significant advancement in the battle against dementia. The findings could provide a crucial turning point in the efforts to combat the disease, said city doctors. Dr Praveen Gupta, principal director, neurology, Fortis Gurgaon, distinguished between vascular and Alzheimer’s disease dementia, noting that while the end result was comparable, the underlying pathophysiology differed. “In Alzheimer’s, dementia occurs due to deposition of Amyloid beta plaques in the brain, which prevents connectivity of neurons causing cognitive or brain dysfunction,” he explained. “In vascular dementia, the damage to brain cells occurs due to the obstructions in blood vessels.” The underlying processes leading to these two types of dementia are distinct, despite their similar outcomes in terms of cognitive impairment. According to a study titled ‘Vascular cognitive impairment in India’, the burden of vascular contribution to cognitive impairment and dementia is substantially high in India. There are approximately 5.3 million dementia patients in India and nearly 40 per cent are estimated to be sufferers of vascular dementia. Gupta said the Oxford studies provide promising early results that could pave the way for treatment. However, larger studies were needed to demonstrate the efficiency of sildenafil before it could be considered standard treatment. Dr Manjari Tripathi, head of AIIMS’ neurology department, explained that the primary risk factors for vascular dementia included blood pressure, smoking, diabetes, hypertension, obesity, obstructive sleep apnea and atherosclerosis. She said that vascular dementia could manifest in different forms. One type is multi-infarct dementia (MID), which develops as a consequence of multiple small strokes that lead to brain damage. Another type is strategic infarct dementia, where a single infarct occurs in a crucial region of the brain, such as the anterior nucleus of the thalamus, resulting in dementia even with a solitary infarct. “Strokes can affect individuals of all ages. The cognitive impairments resulting from a stroke, such as diminished reasoning, logical thinking, attention and judgment, are often more severe compared to those observed in Alzheimer’s dementia,” said Tripathi. “The onset of these cognitive deficits can be sudden and profound, regardless of the patient’s age. While Alzheimer’s dementia typically progresses gradually, the impact of a stroke on cognitive functions can be immediate and substantial.” Agreeing that the Oxford research was groundbreaking in linking sildenafil with improvement in vascular dementia, Dr Rajeev Mehta, senior psychiatrist, Sir Ganga Ram Hospital, added, “It is important to note that in vascular dementia, memory deficiency or forgetfulness occurs in steps.” However, further comprehensive multi-centric trials were needed to substantiate these findings, said Dr Jitendra Nagpal, chairman, Institute of Mental Health, Moolchand Hospital. That said, any benefit to chronic sufferers was a welcome step in cognitive recovery, he added. Source: Healthworld