June 27,2024 New Delhi: Following the controversy sparked by the alleged claims of paper leaks and irregularities in the NEET UG results, which escalated to widespread protests across the country, when the government unexpectedly announced the postponement of the NEET PG entrance test in less than 12-hour before its schedule, at Prima facie it gave of a impressions of some serious problems in the system. Caught in this double whammy, multiple attempts made by top officials failed to provide justifications and convinced students and other stakeholders leading to its widespread criticism and embarrassment of the newly elected government at both Political and societal front However, several experts from the medical industry and its related academia have opined a different view. Experts from both academia and industry spoke about the NEET row and voiced strong support for the government’s recent measures, emphasizing that these actions are essential for the broader good. Dr Sharad Agarwal, Ex IMA President, said, “IMA is relieved by the action of central government regarding the misconduct in the NEET UG examination by accepting our demand of a CBI probe to find the culprits. We thank the government for removing Subodh Kumar, the outgoing DG of NTA and replacing him with Pradeep Kumar, this will help in a fair probe and for constituting a high-level committee which will provide suggestions to make the exam free of corruption.” Commenting over the unexpected postponement of NEET PG test the doctor said, “We are a little apprehensive about the last moment postponement of NEET PG exam it caused a lot of inconvenience to thousands of aspirants who had outstation exam centres and This could have been done at least 24 hours prior to the exam but we believe there must be some reasons for this last moment decision “We hope the sanctity of this exam will be maintained and it will regain the confidence of all aspirants, ” Dr Agarwal added. Underlining the need of such steps Dr Mohanan Kunnummal, VC Kerala University of Health sciences emphasised, “The Indian medical graduates has earned a great reputation both India and abroad, they serve the whole globe and we have establish a brand name and this name will be maintained only if our selection process is transparent and honest.” “The complaints related to the result will be cleared within a few days and NEET PG will definitely happen soon but before that we have to clean up the whole mess of allegations and the Govt. is committed to maintain the transparency of this examination, ” Dr Kunnummal added. Backing the steps taken by the Central Government and providing assurance to students Dr Madhuri Kanitkar, Vice Chancellor, Maharashtra Health University said, “Several issues have come up in the results of NEET UG whereas NEET PG has been canceled but whatever decision has been taken in the best interest of students and very soon all deserving students will start their studies in various institutions.” A similar opinion was voiced by another academician Dr Datteswar Hota NMC, Vice Chancellor, Orissa University. who stated, “The decision is in the greater interest of the students to ensure the selection of meritorious and deserving ones. We have overcome many crises in the past and I am sure this time also we will find an early solution to this problem with collective wisdom.” Highlighting the compulsions behind such decisions Dr MK Ramesh, Vice Chancellor, Rajiv Gandhi Health University, Karnataka added, “Doubts have been raised regarding the credibility of these exams (NEET UG and the NEET PG)…. in such a situation the government has taken a tough stand but this is inevitable in order to bring back the confidence to a system certain tough measures have to be taken, shortly the new dates will be announced and all students will get the opportunity to write their exams in an honest environment.” Experts from the industry have also backed these efforts, mentioning the steps taken to address the problem Dr Harish Chellani, Professor and Head of Department Pediatric, Safdarjung Hospital said, “Proactive steps have been taken to ensure transparency in various competitions and make this exam full prof , including the appointment of a new DG of the NTA; Entrusting CBI for comprehensive investigation of the matter and constitution of a high-level committee for reforming the mechanism of the examination process, making improvements in data security protocols, along with the structure and functioning of NTA. Voicing a similar stance Dr Ajay Swaroop, Chairman, Sir Gangaram Hospital, added, “The government has taken appropriate Immediate steps to alleviate the problem a retest has been ordered and a thorough investigation is taking place to plug the loopholes and to avoid such events in future.” The ongoing discourse around the NEET examination reflects the complex balancing act required to reform education in a diverse and populous country like India. As the government and experts continue to defend the necessity of NEET, it is clear that any long-term solution must address the multifaceted challenges faced by students while striving to uphold the integrity and fairness of the medical admission process. Source: Healthworld

June 26,2024 New Delhi: The Union Health Ministry has issued guidelines for of “leftover, de-identified and anonymous” samples generated from a diagnostic or surgical procedure on the patients for commercial use. These specimens include organs, parts of organs, cells, tissues, cell products such as blood, blood products (even positive for eHBsAG/HCV/HIV/Syphilis and expired blood), urine, saliva, DNA/RNA, hair, nail clippings, or any other cells, body fluids etc. The source for these specimens may be patients, autopsy specimens, abandoned wastes, tissue banks, IVF clinics and organ donation centers among others, the health ministry said recently. After these samples have undergone the required clinical and laboratory testing for the patient, there are large quantities of leftover samples that may remain available in the hospitals. These samples may be referred to as a biomedical waste, sometimes may be a biohazard, and require appropriate methods for disposal, the ministry said. The hospital itself may have no added value for these samples, nor the capacity to store these samples after the provision of patient care. Such samples are usually discarded as hospital waste, it stated. According to the ‘Guidelines for Ethical use of Leftover de-identified/ Anonymous Samples for Commercial Purpose’ issued recently, these leftover samples if de-identified or anonymous can serve as a precious resource for research and development activities to develop diagnostics, advance innovations, or for the development of kits, identify specific disease markers, or determine relevant health parameters and other such purposes and may have huge value. “There has been keen interest from commercial companies in procuring and using the leftover and de-identified samples for the development of commercial kits/products or technologies that have the potential to improve future patient outcomes, provide diagnostic accuracy, or offer therapeutic advancements ultimately benefiting society,” the guidelines said. It, however, underlined that the hospitals must ensure the samples are completely anonymous and de-identified irreversibly/non-identifiable material/ leftover biological samples which are not specifically intended for research purposes and are going to be discarded after clinical diagnostics or care. These could be pooled samples or samples without any traceable_link/ or without any identifiers that could potentially lead back to the patient. Robust data security measures must be in place to protect any residual information associated with the samples. Companies should maintain transparent and open communication with the relevant institutions and hospitals, the guidelines stated. “Commercial kits and technologies that are prepared should be affordable, ensuring broader accessibility for patients and healthcare providers in the country,” it stressed. The patients own the biological samples and data collected and the institutions are the custodians acting on their behalf and as per ICMR National Ethical Guidelines, 2017, informed consent is required from the patients for any secondary use of samples for ‘research’. However, if the clinical samples are anonymous /de-identified irreversibly/ left over after clinical care, they lose identity and there is no way for the institutions to go back to patients to obtain informed consent for any secondary use, the guidelines said. “Therefore, for the use of deidentified/ anonymous left over samples, use may be permitted with a ‘waiver of informed consent’.” the guidelines said. There would be no loss to patient’s rights or autonomy in such case as the left-over samples are de-identified and cannot be traced to the patient. The guidelines emphasized that de-identified samples that contain clinical information could still become identifiable and, therefore, could lead to a breach in the confidentiality of the patient. “If the samples are identified/coded/ can be reversible to identify the patient, and samples are not leftover, samples contain clinical/personal information or they are research samples this guideline will not be applicable,” it stressed. Companies must adhere to local, national, and international regulations governing the collection, storage, and secondary use of biological samples. This includes obtaining necessary approvals such as ethical clearance as well as establishing formal agreements such as MoUs/MoA and MTAS. In case of deviation, violation of regulations and disputes between parties, government regulatory agencies take action through appellate bodies like the High Court or Supreme court. Source: Healthworld

June 27,2024 Hyderabad: Dr Reddy’s Laboratories Ltd on Wednesday said it has signed a definitive agreement with Haleon plc, a leading consumer healthcare company, for purchase of shares of its group company Northstar Switzerland SARL, to acquire a global portfolio of consumer healthcare brands outside of the United States for a total consideration of GBP 500 million. A press release from the city-based drug maker said Dr Reddy’s will acquire Haleon’s global portfolio of consumer healthcare brands in the Nicotine Replacement Therapy (‘NRT’) category consists of Nicotinell, a global leader in the category with an extensive footprint in over 30 countries spanning Europe, Asia including Japan, and Latin America and local market-leading brand names of the product- Nicabate in Australia, Thrive in Canada, and Habitrol in New Zealand and Canada. The proposed acquisition will be inclusive of all formats such as lozenge, patch, gum as well as pipeline products, in all applicable global markets outside of the United States, it said. Nicotinell is the second biggest brand globally (excluding the United States) in the NRT category. It holds the first or second position in 14 of the top 17 global markets, with the lozenge/ mini lozenge format holding top position globally. Nicotinell ranks among the top 15 biggest brands among all OTC brands in Europe (excluding Russia, Italy), and ranks 32 among all OTC global brands (excluding the US). The portfolio generated approximately GBP 217 million in revenue in 2023. “Dr. Reddy’s will acquire the share capital of Northstar Switzerland SARL for a total consideration of GBP 500 million with an upfront cash payment of GBP 458 million and performance-based contingent payments of up to GBP 42 million, payable in 2025 and 2026,” it said. The closing of the transaction is subject to satisfactory completion of customary conditions to closing, including regulatory approvals. The transaction is expected to close in early Q4 of calendar year 2024, it further said. Upon closing of the transaction, Dr. Reddy’s will acquire the NRT business in all countries outside of the United States. However, operations will transition to Dr. Reddy’s in a phased approach to ensure successful integration of the business. Erez Israeli, Chief Executive Officer of Dr. Reddy’s said “We see the acquisition of this global portfolio of consumer healthcare products led by the global brand Nicotinell as a logical extension of our efforts in consumer healthcare OTC in recent years, and of our purpose of ‘Good Health Can’t Wait.’ The business to be acquired from Haleon has maintained steady sales and strong profitability over the years. The portfolio is attractive for its customer loyalty, its global nature, and the access it provides to key customers, he further said. Source: Pharma

June 25,2024 New Delhi: A groundbreaking study published in the Journal of Metabolic Health reveals that low-salt diets can lead to systemic insulin resistance, raising significant health concerns. The study, based on 23 human clinical trials, indicates that such diets contribute to a host of metabolic disorders, including diabetes, cardiovascular diseases, polycystic ovary syndrome (PCOS), non-alcoholic fatty liver disease (NAFLD) and obesity. Dr Ameet G Sattur, Consultant Interventional Cardiologist, Sattur Heart Care, noted the cardiology perspective, explaining, “Low-salt diets are indicated for some heart ailments and as a part of dietary restriction for patients with hypertension. They can trigger insulin resistance, elevating the risk of hypertension and increasing the risk of cardiovascular issues such as heart disease and stroke. While sodium restriction may lower blood pressure in some, it often leads to adverse metabolic outcomes. Twin Health’s tailored dietary plans consider individual metabolic responses, offering a safer and more effective approach to managing chronic conditions.” The study highlights several mechanisms through which low-salt diets impact insulin sensitivity, including activation of the sympathetic nervous system, reduced skeletal muscle blood flow, and increased stress hormones like noradrenaline and aldosterone. These changes can lead to severe metabolic disruptions, making it essential to reassess the universal recommendation of low-salt diets. Dr Maluk Mohammed, Co-founder, Twin Health, added, “Low-salt diets are linked to significant metabolic disruptions, but our Whole Body Digital Twin technology can provide a solution. By analysing over 3,000 data points daily, we deliver personalised nutrition recommendations that balance macro, micro, and biota nutrients, ensuring better health outcomes.” Focussing on nutritional perspective, Kanikka Malhotra, Clinical Dietitian and Diabetes Educator said, “Low-salt diets are often recommended for lowering blood pressure but can have unintended consequences like worsening insulin resistance. This resistance leads to elevated blood glucose levels, and weight gain. Twin Health’s personalised nutrition approach, however, can help mitigate these risks by providing balanced, individualised diet plans.” Insulin resistance, the study explains, occurs when the body’s cells become less responsive to insulin, leading to elevated blood glucose levels and a cascade of metabolic issues. It affects glucose regulation, lipid metabolism, and even mitochondrial function, contributing to conditions like non-alcoholic fatty liver disease and polycystic ovary syndrome. As India grapples with rising rates of chronic metabolic diseases, the findings highlight the need for personalised nutrition strategies. Twin Health’s approach, leveraging advanced AI and digital twin technology, offers a promising alternative to conventional dietary guidelines. By focusing on individual metabolic needs, Twin Health aims to improve overall health outcomes and reduce the burden of chronic diseases. Source: Healthworld

June 25,2024 New Delhi: Despite several technological advancements, incorporation of innovations like Artificial Intelligence (AI), Machine Learning (ML) and acquiring domain specialisation the Healthcare Industry which earlier claimed to have much better prepared for monitoring and detecting potential epidemiological risks found itself in disarray with the latest development in the far east. The recent outbreak of a flesh-eating bacteria also known as Streptococcal Toxic Shock Syndrome (STTS) which claimed around 1000 lives in Japan provides adequate subsistence to the above argument. ET Healthworld engaged with several experts to dissect the problem and understand its unforeseen aspects. Providing insights over the rare disease Dr Neha Rastogi Panda, Consultant-Infectious Diseases, Fortis Memorial Research Institute, Gurugram said, “Flesh-eating bacteria claiming lives in Japan is a Group A Streptococcus (GAS) bacteria, are commonly found in the throat and on the skin, causing illnesses from mild infections like strep throat and impetigo to severe diseases such as necrotizing fasciitis and Streptococcal Toxic Shock Syndrome (STSS).” Responding to a query related to the possible diagnostic strategies she suggested, “Rapid antigen detection tests (RADT) or throat cultures, which identify the presence of the bacteria in the throat or other infected sites and Blood or tissue cultures can be used to confirm severe infections like STSS.” Acknowledging the recent upsurge Dr Panda cautioned that it can be fatal without prompt medical intervention and early medical intervention is crucial for managing symptoms and preventing severe complications.suggesting preventive measures. While touching upon its preventive measures she added, “Good hygiene practices like regular hand washing, covering the mouth and nose when coughing or sneezing, and promptly treating wounds. Early medical intervention is crucial for managing symptoms and preventing severe complications. Sharing her insights over the potential sources of this rare bacteria another expert Dr Mala Kaneria, Consultant, Infectious Diseases, Jaslok Hospital and Research Centre, Mumbai voiced, “The source of infection is usually a skin wound or an open wound, which can begin with fever, myalgia, body ache and malaise and rapidly progress to limb pain, necrosis (peeling of skin and underlying tissues) and eventually to septicaemia (blood stream infection and multiorgan involvement), with the development of hypotension, increased heart rate (tachycardia), breathlessness and liver, kidney and heart involvement.” On being asked about most vulnerable demographics and their management Dr Kaneria commented, “Individuals above the age of 40-50 years are more likely to suffer serious consequences, probably owing to coexisting morbidities while prompt admission in the intensive care unit and timely administration of higher antibiotics and intravenous fluids can be lifesaving. Addressing the elephant in the room i.e the severity of the problem with the context of India Dr Divya Joshi, Consultant-Infectious disease, Fortis Hospital Bannerghatta Road, Bangalore underlined , “While a surge of flesh-eating bacteria in Japan is concerning but India’s immediate risk is likely low. Though Japan has seen a significant rise in infections this year, exceeding previous annual totals, it’s important to note this is happening regionally and may be due to factors specific to Japan following the COVID-19 pandemic.” Decoding the possible reasons behind this recent upsurge Dr Vasanth Nagvekar, infectious disease consultant, H.N. Reliance Hospital commented, “The exact reason for its spread among humans is unclear, although there is speculation about the post-COVID immunological status of individuals potentially playing a role, but this remains uncertain. In the near future, experts did not anticipate the possibility of the disease outbreak in India. Citing a past event, Dr Nagvekar added, “A similar incident occurred in the UK in 2022 involving the highly toxigenic strain MUK1. Therefore, for now, we need to remain vigilant, and there is no cause for concern in India.”he recent outbreak of flesh-eating bacteria, known as Streptococcal Toxic Shock Syndrome (STSS), in Japan has raised concerns within the medical community. While experts do not anticipate an imminent outbreak in India, they emphasize vigilance, good hygiene practices, and note that those above 50 are the most vulnerable demographic.” Experts agree that, although the immediate risk of an STSS outbreak in India is low, ongoing vigilance and adherence to preventive measures are essential to mitigate potential threats. Source: Healthworld

June 26,2024 Pune: Pune reported its first two cases of Zika virus infection this year, an official said. A 46-year-old doctor and his teenage daughter have tested positive for the Zika virus. Assistant Health Officer at Pune Municipal Corporation, Rajesh Dighe, said, “A 46-year-old doctor and his teenage daughter, who live in the Erandwane area of Pune city, were found positive for the Zika virus. Both were discharged from the hospital. First, a sample from the doctor was sent to NIV Pune after symptoms were seen in him. The report was received on June 21. Later, a sample of his family was also sent for testing; the daughter reported being positive for the virus, while other family members have tested negative for the virus.” “In response to the cases, the Pune Municipal Corporation (PMC) visited the area and conducted a thorough inspection. They have issued an advisory to citizens, urging them to keep their surroundings clean to prevent any potential outbreak,” he further added. Dr Rajesh Dighe, Assistant Health Officer at PMC, explained that the Zika virus is transmitted through the bite of an infected Aedes aegypti mosquito, which also transmits diseases like dengue and chikungunya. The PMC has taken precautionary measures, including fumigation, to prevent the spread of the virus. The PMC is urging citizens to follow the guidelines and take necessary precautions to prevent the spread of the Zika virus. They have assured that they are closely monitoring the situation and taking the necessary measures to control the spread of the virus in the city. (ANI) Source: Healthworld

June 26,2024 New Delhi: The Indian pharmaceutical industry, often celebrated as the ‘pharmacy of the world,’ has been a steadfast contributor to the nation’s economic growth and now the sector is moving very rapidly in MedTech and biosimilars technology, moving away from generic drugs. “From generics, we are now moving very fast into biosimilars. We are moving equally fast in MedTech. And you will see that in the years to come, this industry will grow rapidly further, and most independent market-based research firms project the Indian pharma and MedTech industry as the industry with the best and the most glowing future,” said Arunish Chawla, Secretary, Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers to ANI. The MedTech (or Medical Technology) is a segment under the larger umbrella of healthcare systems. The segment focuses on designing and manufacturing a wide range of medical products/devices for diagnosis, prevention, monitoring, treatment and patient care. However, biosimilars are similar biologic products that are similar to an approved reference biological product in terms of quality, safety, and efficacy. The formulation, route of administration, dose, and strength of biosimilars must also be similar to the reference product. Chawla also stated that, according to a study in the United States 50 per cent of all generic drugs and 40 per cent of all prescription medicines were sourced from India. “In a study done in the United States in 2022, it was found that 50 per cent of all generic drugs and 40 per cent of all prescription medicines were sourced from India,” he said. The Secretary also highlighted that the Indian pharma industry is growing double-digit year on year, and it has achieved the double-digit growth in real terms over the last 10 years. He added that India has the highest number of WHO (World Health Organization) and US FDA (Food and Drug Administration)-certified plants. Nearly half the vaccines that WHO and UNICEF (United Nations Children’s Fund) supply globally as part of their programmes are sourced from India. (ANI) Source: Pharma

June 26,2024 New Delhi: India’s apex drugs regulatory body has found the samples of around 50 drugs, including that of widely-used paracetamol, pantoprazole and some antibiotics for treating bacterial infections, as not of standard quality. Of these sub-standard drugs, 22 are manufactured in Himachal Pradesh, according to the alert issued by the Central Drugs Standard Control Organisation (CDSCO) for the month of May. Besides Himachal Pradesh, the samples were collected from Jaipur, Hyderabad, Waghodia and Vadodara in Gujarat , Andhra Pradesh and Indore, among other places. A total of 52 samples have failed the quality test conducted by the CDSCO, according to the drug alert issued on June 20. Sources said state drug regulators have reportedly sent notices to the pharmaceutical companies concerned and the failed samples would be recalled from the market. The list of the sub-standard drugs contains Clonazepam tablets that are used to treat seizures and anxiety disorders, pain reliever Diclofenac, anti-hypertension drug Telmisartan, Ambroxol, which is used in the treatment of respiratory diseases, Fluconazole, an antifungal, and some multivitamin and calcium tablets. The samples of around 120 drugs manufactured in Himachal Pradesh had failed the test parameters last year. Source: Pharma

June 25,2024 Amidst the fervent protests by NSUI and NEET aspirants against paper leaks, another group of disheartened students raised their voices at Jantar Mantar on Monday. Students from AYUSH courses gathered to demand the cancellation of the National Exit Test (NExT) for the batches before 2023. This protest follows a history of dissent. Previously, due to strong protests, the implementation of NExT for MBBS students was postponed to the 2023 batch. However, AYUSH students have been required to take this exam starting from the 2018 batch. Jatin, an AYUSH student, said: “NExT was regulated in November 2023. In the regulation, they said students who joined internships before November 29, 2023, would not have to take the NExT, but those who joined afterwards would have to take it. However, when we took the exam, we were not made aware of such a test. The exam was applied to the National Medical Commission MBBS students from the 2024 batch, but for us, the AYUSH students, they applied the exam from 2015 and 2018 onwards instead. Our only demand is that this new regulation should be applied to the new batch and not the older ones.” The students also highlighted the government’s previous statements in 2020 that an exit exam would be introduced within three years. In 2022, they filed a Right to Information request to clarify whether older batches would be subjected to the exam. Roshan, another protester, questioned the fairness of imposing an unplanned exam at the end of their course. “Usually students are informed about the course duration, the number of exams, and the timeline for receiving their degree and registration before enrolling in any programme, including AYUSH. Based on this information, they make their enrollment decision. Therefore, it is unfair to impose an unexpected exam on students at the end of their course without prior preparation,” he said. The NCISM Regulations, 2023, which came into force on December 20, 2023, state that a National Exit Test (NExT) for each discipline, including Ayurveda, Siddha, Unani and Sowa-Rigpa of the Indian System of Medicine, will be conducted by the commission through a designated authority. The gazette notification further states that the NExT exam for AYUSH disciplines is required for granting a licence to practice as a medical practitioner in the respective discipline and for enrollment in the State Register or National Register as a registered medical practitioner of the Indian Systems of Medicine after completing a one-year internship. As the protest continued, the students reiterated their demand for fair treatment and reconsideration of the retroactive application of new exam regulations. The growing discontent among AYUSH students underscores the need for a reassessment of how these regulations are implemented and communicated. Tribune India

June 24,2024 New Delhi: The Gujarat government commenced a statewide campaign to eradicate Sickle cell disease. Around 65,000 people are to be examined under the initiative undertaken by the state government. The campaign began in Mandvi Tehsil of Gujarat, and is primarily focused on rural areas. The government began its campaign on World Sickle Cell Day (June 19) and it will end on July 3rd. Teams of doctors have been deployed in parts of the state, and over 50 hospitals have been involved in the campaign. Notably, sickle cell disease is a series of genetic red blood cell abnormalities that adversely affect haemoglobin levels in the body. Due to genetic mutations, RCBs become sickle-shaped. Currently, there is no cure for this disease. Chief District Health Officer, Dr. Anil Patel, said, “Like every year we are spreading sickle cell disease awareness.” Symptomatic individuals will be sent to the district hospital for further treatment. Some of the symptoms of this disease are anaemia, joint pain, breathing problems, and jaundice. Notably, Prime Minister Narendra Modi launched a nationwide campaign to curb sickle cell disease. Around 10 per cent of Gujarat’s population, which is around 8.5 million, have been affected by the disease. Earlier in the month of April, microbiologist Dr Yazdi Maneksha Italia, who pioneered the development of India ‘s first sickle cell anaemia control programme of the Gujarat government, was conferred with the Padma Shri award. Italia is among the 21 contributors to the counselling modules on sickle cell disease by the Union Ministry of Tribal Affairs and Ministry of Health and Family Welfare, which aims to eliminate Sickle Cell Anaemia by 2047. On winning the award, Italia said, “We are working in a tribal area, and sickle cell anaemia is a tribal health issue. It is a hereditary disease that is passed on from parents to children, and the treatment given for it is also different. We have been doing it for 40 years. Now the government has implemented it for the nation, and by 2047 we will reduce the number of patients with sickle cell anaemia to zero, so this is a very good thing. (ANI) Source: Healthworld