May 2024

May 11,2024 New Delhi: The National Centre for Disease Control (NCDC) has said that the cause of death should be certified as heat stroke or hyperthermia where the measured antemortem body temperature at the time of collapse was more than or equal to 40.6 degrees Celsius. The ‘Autopsy Findings in Heat Related Deaths’, a set of guidelines released by the NCDC, defined heat-related death as a death in which exposure to high ambient temperature either caused the loss of life or significantly contributed to it. Deaths may also be certified as heat stroke or hyperthermia with lower body temperatures when cooling has been attempted prior to arrival at the hospital and/or when there is a clinical history of mental status changes and elevated liver and muscle enzymes, the document stated in the section ‘Criteria to Label Heat Stroke or Heat-Related Death’. It also said that in cases where the antemortem body temperature cannot be established but the environmental temperature at the time of collapse was high, an appropriate heat-related diagnosis should be listed as the cause of death or as a significant contributing condition. “A significant number of these deaths will occur in persons having some preexisting disease known to be exacerbated by heat stress. These deaths can be certified as heat-related, with the disease being considered a significant contributing condition, or vice versa,” the criterion stated. The NCDC document stated that recognition and confirmation of heat-related mortality has emerged as a challenge as different sectors use different case definitions, assessment mechanisms and linked response measures often leading to various estimates. “This highlights the importance of understanding characteristics of exposure, physiological factors affecting heat strain, illnesses, and death and adaptation measures (behavioural, institutional) utilised,” the guidelines said. Saying that autopsy findings are nonspecific, the document recommended that autopsy is not mandatory in all cases of heat-related illnesses. The diagnosis of heat-related death is based principally on investigative information; autopsy findings are nonspecific. The decision to autopsy should be based on the circumstances of the death, the age of the deceased, and the available resources, it said. The collection of blood, urine, and vitreous humor for toxicologic examination is highly desirable if the condition of the body allows it, the NCDC recommended, adding that when these specimens are collected and preserved, toxicologic analyses can be performed as resources become available. The NCDC underlined that all pathologists and forensic pathologists to be aware of the criteria to label a death as heat-related/heat stroke. Necessary training and sensitisation are required for pathologists and forensic pathologists, it stated. According to the document, rapid, severe decompression of the body’s heat dissipation mechanisms following short-term or sustained heat exposure leads to heat stroke. Source: Healthworld

May 13,2024 New Delhi: India’s drug regulator has formed an expert panel to evaluate several currently prescription drugs that can be sold over the counter (OTC) after various pharmaceutical companies lobbied the regulator to make their drugs an OTC product, people in the know told ET. The sub-committee, which includes various doctors from the country’s top government hospitals, representatives from Indian Council of Medical Research (ICMR), drug controllers from various states, will develop a mechanism for the drugs to be sold OTC, considering globally prevalent regulations and practices. The sub-committee formed last week has been asked to submit the report within three months. India’s drug regulator had earlier received representation from various companies that urged certain formulations be allowed to be sold as OTC. These formulations include Diclofenac patches which helps reduce and alleviate pain caused due to osteoarthritis, sprain etc. Transdermal diclofenac, which is used to treat short-term pain due to minor strains, sprains, and bruises in adults and children 6 years of age and older. Diclofenac is in a class of medications called nonsteroidal anti-inflammatory drugs (NSAIDs). Representations were also made for acetylsalicylic acid effervescent 500 tablets used for the treatment of pain and reduction of fever and has anti-inflammatory properties. Besides, Dextromethorphan used to temporarily relieve cough were also candidates for OTC sales. Source: Healthworld

May 03,2024 Washington: US President Joe Biden’s administration will allow certain immigrants illegally brought to the US as children greater access to federally run health insurance, the White House said on Friday, addressing a sensitive issue ahead of elections in November. With the move, an estimated 100,000 previously uninsured participants in the Deferred Action for Childhood Arrivals program, or DACA, are expected to enroll in the Health Insurance Marketplace and Basic Health Program, both created under the Affordable Care Act, the US Department of Health and Human Services (HHS) said. The DACA program was launched in 2012 under former President Barack Obama, to whom Biden was vice president. The program offers deportation relief and work permits to so-called “Dreamer” immigrants who were illegally brought to the US as children or overstayed a visa. “Dreamers are our loved ones, our nurses, teachers, and small business owners,” Biden said in a statement. “And they deserve the promise of health care just like all of us.” DACA enrollees will have access to related financial assistance, such as tax credits and reduced out-of-pocket costs under the change, which will be effective Nov. 1, according to a White House fact sheet. The White House did not immediately respond to a request for comment about any costs to the US government. Immigration has emerged as a top issue for voters ahead of the US presidential election in November pitting Biden, a Democrat, against Republican former President Donald Trump. Biden has sought to balance a tougher approach to border security with policies that protect asylum seekers and others in the US illegally. Trump, an immigration hardliner, tried to end DACA during his presidency but was denied by the US Supreme Court. About 530,000 people are currently enrolled in the program, which remains subject to an ongoing legal fight. HHS Secretary Xavier Becerra said on Thursday that people without health care insurance delay preventative or routine medical care, leading to unnecessary costs later. The regulation will give DACA participants access to the Basic Health Program, which serves low-income residents, according to a White House fact sheet. The change will not open access to two other low-income programs, Medicaid and the Children’s Health Insurance Program, as was initially proposed in 2023. Source: Healthworld

May 03,2024 Sao Paulo: Brazil declared itself on Thursday as free of foot and mouth disease without vaccination, and will request World Organisation for Animal Health (WOAH) to recognise that status as it seeks to open more markets for its meat exports. Foot-and-mouth disease causes fever and mouth blisters in animals with foot ruptures, such as cattle, swine, sheep, goats and other cloven-hoofed ruminants. Brazil’s Agriculture Ministry said in a statement it will ask for WOAH recognition next August, adding the request could be approved in May, 2025. Agriculture minister Carlos Favaro said in a live streaming video the self-declaration is “an important step towards a global recognition”. Brazil is the world’s largest beef exporter, with China and the United States as its main buyers. However, the lack of a status for foot and mouth disease free without vaccination in some states prevents Brazil from selling its beef to nations like Japan and South Korea, a scenario Favaro said he wants to change. Source: Healthworld

May 03,2024 Gurgaon: Doctors at six hospitals in India may soon start using an artificial intelligence tool, called Garbhini-GA2, to improve diagnosis of foetal abnormalities and get accurate gestational age for women who come for check-ups at later stages of their pregnancies. Researchers from IIT Madras and Translational Health Science and Technology Institute (THSTI), who have developed the tool, say it will help reduce infant and maternal mortality rates, especially for women who often don’t find out about pregnancies till the second trimester. THSTI-Faridabad is an institute under the central govt’s department of biotechnology. According to the National Family Health Survey, around 30-40 per cent of women who are pregnant come for their first scans in the second trimester, which means they don’t know their exact due date and doctors have to rely on dates of the last menstrual period to come up with an estimate. Garbhini-GA2, which is installed into ultrasound machines, is meant to do away with this in accurately diagnosing gestational age even in scans carried out in the second trimester, its developers said. “If you want to know the stage of pregnancy and due date, the most accurate estimate will come from the first trimester scan,” said Himanshu Sinha, associate professor at department of biotechnology in IIT-Madras. “The tool’s primary function is to provide accurate pregnancy dating, which is crucial for managing pregnancy care . Accurate dating allows obstetricians to schedule necessary scans and tests at the right time, ensuring that potential complications are detected and managed effectively. It also helps in determining the optimal delivery window, thus reducing the risks associated with preterm and post-term births,” said Dr Shinjini Bhatnagar, principal investigator of the GARBH-Ini programme and professor at THSTI-Faridabad. For now, researchers are in talks with six hospitals in NCR, Assam, Gujarat, Telangana and Puducherry. Researchers want to study the impact of the tool at six hospitals, and then roll it out across the country in collaboration with ultrasound manufacturers and hospitals. “The team is currently focusing on smaller hospitals, aiming to minimise problems of adverse birth outcomes where gestational dating is a significant issue. The ultimate aim is to integrate it into ultrasound machines for effective clinical deployment”, said Dr Ramachandran Thiruvengadam, assistant professor at Pondicherry Institute of Medical Sciences, one of the collaborating institutions in the project. The Garbh-Ini initiative, introduced by the central govt in May 2015 at the Civil Hospital in Gurgaon, initially involved a study of women who were followed from early pregnancy to delivery and post-partum. This cohort formed the foundation for Garbhini-GA2, which was developed by feeding troves of data to a machine learning tool that can read ultrasound scans. Source: Healthworld

May 04,2024 New Delhi: Malaria infection is linked with genetic changes, known to be brought about by ageing, according to a new study. Researchers extracted genetic material from blood samples of more than 1,800 adults from the African countries of Tanzania, Botswana, Ethiopia, and Cameroon, where malaria is known to be endemic, or constantly present. According to the 2023 World Health Organisation (WHO) Malaria report, published in ‘The Lancet Microbe’ journal, around 70 per cent of the global burden of the mosquito-borne disease is concentrated in 11 countries, including India and 10 African countries. The team, including researchers from the University of Pennsylvania, US, analysed the DNA in white blood cells crucial to immunity and fighting infections – and measured the lengths of telomeres present at the ends of chromosomes, which carry the genes. Telomeres protect the chromosome ends from sticking to each other or getting frayed. They are known to shorten with age and can also help predict an individual’s risk of getting affected by ageing-related diseases and death. “We highlight the contributions of genetic and environmental factors influencing telomere length in leukocytes (white blood cells), and we have uncovered a potential role of malaria in shortening of telomere length across sub-Saharan Africa,” said Sarah Tishkoff of the University of Pennsylvania, a co-senior author on the study published in The American Journal of Human Genetics. The researchers found shorter telomere lengths in the white blood cells of adults indigenous to regions where malaria is highly endemic, compared to those in adults indigenous to regions with low malaria endemicity. Malarial infection is known to cause massive destruction of white blood cells. The authors said that this process, coupled with that making new cells to restore this loss, could be a possible mechanism through which the disease shortens the length of telomeres. They also found that the extent to which malaria was endemic to a region had a greater impact on telomere lengths, compared to environmental factors previously identified and known to impact telomere lengths. “This association between malaria and telomere lengths of white blood cells appears larger than any other known exposure or behaviour that has been investigated in large-scale studies,” said Tishkoff. While previous studies have suggested a link between malaria infection and telomere shortening, the researchers said it remained unknown whether repeated infections throughout life could have a lasting effect on the telomere lengths in people living in malaria-endemic regions. The authors also said that a longitudinal (long-term) study in children and adults indigenous to regions of high and low malaria endemicity would provide more insightful information. Source: Healthworld

May 03,2024 London: U.S. attorneys for a woman who claims her colon cancer was caused by the now discontinued heartburn drug Zantac on Thursday told a jury in Chicago that pharmaceutical companies GSK and Boehringer Ingelheim knew the product could cause cancer if it was not handled properly but failed to warn the public. Mikal Watts, who is representing 89-year-old Angela Valadez, said the companies knew that Zantac’s active ingredient, ranitidine, would turn into a cancer-causing substance called NDMA as it aged or was exposed to extreme temperatures, but did not ensure it was properly handled by transporters, distributors and stores. Valadez’s case is one of tens of thousands against GSK, Boehringer Ingelheim and other pharmaceutical companies, which have worried investors in recent years. It will offer the first test of whether the cancer claims in the long-running litigation will persuade a jury, since all cases previously set for trial settled or were dropped. GSK and Boehringer Ingelheim are the only defendants in the trial, after other companies settled. Watts told the jury the pills would change color as they degraded, but the companies would cover it up. “They know we’re not going to take a product that looks bad, so they put a paint job on it,” Watts said. Attorneys for GSK, which developed the active ingredient in Zantac but later sold the brand to other companies, and Boehringer Ingelheim, which sold the drug from 2006 until 2017, countered that Zantac has been repeatedly proven to be safe and effective and that no scientific or medical study had connected Zantac to cancer. There is “no objective evidence linking Ms. Valadez’s cancer to Zantac,” GSK’s attorney Tarek Ismail told the jury. “No genetic test, lab report, imaging study… nothing whatsoever.” Valadez, who said she took Zantac every day for at least 18 years, had a host of risk factors that made her more likely to develop colon cancer, Ismail said. First approved in 1983, Zantac became the world’s best selling medicine in 1988 and one of the first-ever drugs to top $1 billion in annual sales. It was originally marketed by a forerunner of GSK and later sold successively to other companies. In 2020, the U.S. Food and Drug Administration asked drugmakers to pull Zantac and its generic versions off the market after NDMA was found in samples of the drug. Thousands of lawsuits began piling up in federal and state courts. A new version of Zantac now on the market has a different active ingredient and does not contain ranitidine. Source: Pharma

May 03,2024 New Delhi: A top Indian medical scientist has asked people not to panic as any side effect of a COVID-19 vaccine is a “rare occurrence”. Former Indian Council of Medical Research (ICMR) scientist R Ganga Ketkar, who was at the helm of affairs during the COVID pandemic, said symptoms of Thrombosis with Thrombocytopenia Syndrome (TTS) – a serious adverse event that causes blood clots – can only occur within five to 30 days of receiving a COVID vaccine and not now. This comes as British pharmaceutical major AstraZeneca, which developed Covishield vaccine along with the University of Oxford, has admitted that the vaccine can cause a rare side effect. “The benefits of the vaccine outweigh the risks,” Ketkar told ET. “People should not worry as the number of cases are pretty small and TTS develops within 5-30 days after receiving the vaccine and not now.” He said as the number of doses increases, the risk of TTS goes down. “There is no reason to worry at this point in time,” Ketkar added. He said that vaccine developers continue post marketing surveillance, which means that they monitor the safety of vaccines once they reach the market. “One thing people should remember is that whether it is a medicine or vaccine, there will be a rare occurrence of diseases, but one will have to look at the benefits,” he said. AstraZeneca is facing class action suits in the UK over allegations that the vaccine caused death and serious injury, including TTS that causes blood clots and a low blood platelet count. In India, Serum Institute of India manufactured the Covishield vaccine under licence from AstraZeneca. Ketkar said there is a need to clear out myths. “If people worry, they tend to google and get influenced. It is possible if they think in a negative light, childhood vaccination will be hit.” He said that unnecessary “unscientific” messages can only spread further panic in the society, and that should be stopped. According to reports, AstraZeneca has admitted in a legal document that its COVID vaccine “can, in very rare cases, cause TTS”. “In India, Covishield, which was used to vaccinate 90 per cent of India’s population, has done well,” a senior person from the COVID working group told ET, playing down concerns of adverse events, despite the rare risk of TTS. Source: Pharma

May 05,2024 Guwahati: A study conducted by physician-scientists from Assam Medical College Hospital (Dibrugarh), supported by ICMR-recognised multidisciplinary research laboratory, has revealed that 55 per cent of Covishield vaccine recipients experienced only minor side effects like fever and headache. These symptoms occurred within a week of getting inoculated with the first dose. Researchers confirmed no long-term adverse effects after a year. “In our study, we found that 55 per cent experienced minor adverse events such as fever, headache, body ache and pain at the injection site. The remaining 45 per cent of the recipients had no adverse events at all. After the second dose, only 6.8 per cent showed minor adverse events following immunisation (AEFI). Most importantly, no participant showed any major adverse events during the entire one year period of study,” said associate professor of pathology at AMCH, Gayatri Gogoi, the principal investigator of the study done in Assam’s Dibrugarh district. The major (serious and severe) adverse events were defined as disabling, rare life-threatening conditions that may lead to long-term problems. “The young individuals had more minor adverse events than the elderly individuals. What is also intriguing to note is that those who had comorbidities or other health conditions showed less adverse events,” she added. The study was conducted from July 2021 when the first Covishield vaccine for the public was introduced and participants were followed up till June 2022 after receiving the approval of the Institutional Ethics Committee to conduct the same. This data of research findings was recently accepted for publication in a well-known PubMed indexed journal named Journal of Family Medicine and Primary Care. The doctor-research investigators felt the need of sharing the real-time research data from Dibrugarh district, led by Gayatri Gogoi, who is also a renowned cancer researcher, along with Dr Gourangie Gogoi, professor of community medicine at AMCH, Dr Bhupendra Narayan Mahanta, professor of medicine (currently posted at Lakhimpur Medical College Hospital) and Dr Mithu Medhi, professor of microbiology (currently posted at Kokrajhar Medical College Hospital) after completing a study on Covishield vaccine effectiveness and AEFI or side effects. The study design was done in consultation with Dr Biswajyoti Borkakoty, head of Regional Viral Research & Diagnostic Laboratory, Regional Medical Research Centre-NE Region (ICMR), Dibrugarh as nodal officer from this region for the pandemic time. The researchers said during the peak of the Delta variant wave in June 2021, it was found that 61 per cent of the participants had been infected with the SARS-CoV-2 virus. The remaining 39 per cent were sero-negative, meaning they had not contracted the virus and had received the Covishield vaccine. Regarding the effectiveness or antibody development, 93 per cent remained positive and the antibody level was much higher in case of the vaccinated. Among those participants previously infected by SARS-CoV-2 virus, the first dose of Covishield vaccine acted as booster dose and was enough to enhance high rise of antibody titre in contrast to SARS-CoV-2 uninfected participants. “The final inference was that natural virus infections confer stronger immune responses than Covishield vaccine alone,” said Gogoi. Source: Healthworld

May 10,2024 New Delhi: Soaring temperatures in many parts of India are fuelling demand for medications that manage chronic conditions. This includes medications for high blood pressure (antihypertensives), cholesterol (lipid-lowering drugs), and blood clotting (platelet aggregation inhibitors). Sales of oral electrolytes and sunscreens are also seeing a surge, according to market researcher Pharmarack. Industry data shows sales of antihypertensive drugs have risen to ₹1,134 crore in April from ₹1,129 crore in March and ₹1,119 crore in February. It recorded ₹13,468 crore in Moving Annual Turnover (MAT) in the 12 months through April 2024. Likewise, sales of lipid-lowering drugs rose from ₹520 crore in February to ₹541 crore in April. Hot and humid weather in various parts of the country is pushing sales of platelet aggregation inhibitors, which work in different places of the clotting cascade and prevent platelet adhesion. Sales of such drugs increased from ₹112 crore in February to ₹114 crore in April. Recent heatwave episodes across the Indian landscape may have led to discomfort in the vulnerable population causing a surge in demand for chronic therapies like antihypertensives, lipid-lowering drugs, and platelet aggregation inhibitors,” Sheetal Sapale, vice president, commercial, Pharmarack told ET. Meanwhile, rising temperatures and the need for hydration management is triggering a twofold increase in oral electrolyte consumption this year. “The concerted efforts of pharmaceutical companies in conducting awareness campaigns have yielded promising results, fostering a proactive approach towards health consciousness among the populace. This push has resulted in a significant double-fold multiplication in oral electrolytes consumption over the past five years, particularly in response to rising temperatures and the need for hydration management,” Sapale said. With prevailing high temperatures, the cosmo derma segment also saw an uptick in both value and unit consumption. In April, buoyed by escalating skincare preferences among consumers, segments such as emollients, protectives, and sunscreens experienced steady growth, as per Pharmarack. Overall, in April, the Indian Pharmaceutical Market(IPM) showed robust growth, reaching a notable value of ₹16,413 crore, marking a 9.2% increase in value compared to a year earlier. On a MAT basis, the IPM demonstrated its resilience, reaching ₹1,99,288 crore with a value growth of 7.3%. Source: Pharma