April 2024

Apr 25,2024 New Delhi: On the eve of the World Malaria Day, the World Health Organisation (WHO) emphasised on the need for heightened focus on addressing the obstacles to health equity, gender equality and human rights in malaria responses. Saima Wazed, WHO Regional Director for South-East Asia, stressed on redoubling efforts to overcome challenges posed by malaria and ensure all individuals, irrespective of their socio-economic status or geographical location, have access to prevention, diagnosis and treatment services for the disease. “Moreover, by leveraging digital technology, we can better understand the diverse health needs of populations, collect and analyse data and monitor progress in real-time, enabling us to identify and address health inequities through both proven interventions and innovation in service delivery,” Wazed said. “On World Malaria Day 2024, we unite under the theme ‘Accelerating the fight against malaria for a more equitable world’,” she said. This theme, which is in sync with this year’s World Health Day theme — “My Health, My Right” — underscores the urgent need to address the stark inequities that persist in access to malaria prevention, detection and treatment services. Wazed said in recent years, global efforts to reduce malaria have stagnated, posing a significant threat to public health and exacerbating inequalities within communities. Everyone has the right to quality, timely and affordable malaria services, yet this remains elusive for many, perpetuating a cycle of inequity that disproportionately affects the most vulnerable among us, she stated. Infants and young children, especially those under five, are particularly affected, with disparities in access to education and financial resources compounding their risk, Wazed said, adding that pregnant women also face heightened risks as pregnancy reduces immunity to malaria, making them more susceptible to infection and severe disease. She added that refugees, migrants, internally displaced people and indigenous people are also at heightened risk of malaria. “Malaria remains a significant public health challenge in our region, affecting nine out of eleven countries and accounting for a third of the global burden outside Africa,” the WHO regional director for South-East Asia said. “Despite the formidable obstacles we face, I am heartened by the progress we have made in recent years. In recent years, our region witnessed a substantial decline in malaria cases and deaths, marking the most significant reduction among all WHO regions,” she added. Wazed said their journey towards malaria elimination is still far from over. “While several countries are on track to meet the Global Technical Strategy (GTS) targets, challenges persist, particularly, in countries like Indonesia and Myanmar, where case incidence has seen an increase,” she said. Accelerate the fight against malaria for a more equitable world by ending discrimination and stigma, engaging communities in health decision-making and bringing healthcare close to where people live and work through primary health care, Wazed said. Source: Healthworld

Apr 21,2024 New Delhi: The Union health ministry has asked all states and UTs to investigate any violations and take appropriate action, including suspension of registration, against hospitals performing illegal organ transplants, officials said on Sunday. In a letter to all states and UTs, Dr Atul Goel, Director General of Health Services (DGHS), Government of India, urged all states and Union Territories to ensure regular collection and sharing of data of all transplant cases, including those of foreigners, with the National Organ and Tissue Transplant Organisation (NOTTO) on a monthly basis. The ministry’s direction comes over two weeks after an organ trafficking racket, involving Bangladeshi nationals, being run in Haryana and Rajasthan was busted. Referring to media reports mentioning commercial dealings in organs involving foreign citizens, Dr Goel stated, “It has also been noted from the registry of NOTTO that there has been a surge in the number of organ transplants of foreigners in the country, which calls for monitoring of such transplants by the state or UT government authority concerned.” Goel, in the letter issued on April 10, directed that appropriate authority of the state appointed as per the Transplantation of Human Organs and Tissues Act (THOTA), 1994, should investigate the transplant cases of foreign nationals in their respective states. He also asked the officials to take appropriate actions whenever a breach of any provision of the Act or any of the rules made thereunder are noted. “Investigate any violation of the THOTA, 1994 and rules thereunder and take appropriate action including suspension of registration for performing Organ Transplant, of the hospitals involved in illegal activities,” the letter said. “It should be ensured that a unique NOTTO-ID for both donor and recipient is generated by the hospital from NOTTO website (www.notto.mohfw.gov.in), in all cases of organ transplant, whether from a living donor or deceased donor,” the letter said. Besides NOTTO-ID being mandatory for considering allocation of organ in case of deceased donor transplant, this ID in case of a living donor transplant, shall also be generated at the earliest, at least within 48 hours of the transplant surgery, the minsitry said, it added. The letter called for devising a system of regular inspection of the registered transplant or retrieval hospitals by the state appropriate authority, so as to maintain on-site monitoring of their activities, quality of transplantation, post operative follow-up of donor and recipient and outcome of the transplantation. “Time and again, letters have been written to states for sharing of data related to organ donation and transplantation with NOTTO. However, complete data is still not being received. It is again requested to ensure regular collection and sharing of data of all transplant cases, including those of foreigners, with NOTTO on monthly basis,” the ministry said. The healthy ministry also asked all states and UTs to submit an action-taken report on the instructions within 15 days. Source: Healthworld

Apr 21,2024 New Delhi: Recently, a report published on the official website of Hong Kong’s food regulatory authority– Centre for Food Safety (CFS) on April 5th mentioned that three spice products in India have cancer-causing chemicals that contain a pesticide known as ethylene oxide. Here’s all you need to know about this shocking report. Food regulators in Hong Kong and Singapore released a report in the first week of April and warned the masses to avoid adding spices products from India as they were tested with cancer causing substances Ethylene oxide. The list of spices include three spice products from two big Indian companies MDH and one from Everest that have exceeded the permissible limit of chemicals. However, the companies haven’t responded to the report of levels exceeding the permissible limit. The International Agency for Research on Cancer has classified ethylene oxide as a ‘Group 1 carcinogen’. Hong Kong’s food regulatory authority, said that three spice products of MDH — Madras Curry Powder (spice blend for Madras Curry), Sambhar Masala (Mixed Masala Powder), and Curry Powder (Mixed Masala Powder) — along with Everest’s Fish Curry Masala contains a pesticide, ethylene oxide. This study was conducted under its routine food surveillance programme, the CFS took the products from three retail outlets in Hong Kong. “The test results showed that the samples contained a pesticide, ethylene oxide,” said to a CFS spokesperson. As per a report by IANS, it was mentioned that the regulator instructed the vendors “to stop the sale and remove from shelves the affected products”. “According to the Pesticide Residues in Food Regulation (Cap. 132CM), food for human consumption containing pesticide residue may only be sold if consumption of the food is not dangerous or prejudicial to health. An offender is liable to a maximum fine of $50,000 and imprisonment for six months upon conviction,” the CFS spokesperson said. AS per CFS noted that “investigations are ongoing” and “appropriate action” may be initiated in the matter. Meanwhile, the Singapore Food Agency (SFA) also ordered a recall of Everest’s Fish Curry Masala due to the presence of ethylene oxide at levels “exceeding the permissible limit”. The SFA posted a release on its website on April 18 that said it “has directed the importer, Sp Muthiah & Sons Pte. Ltd., to recall the products. The recall is ongoing.” The SFA mentioned in the report that ethylene oxide is not fit for consumption, but is “used to fumigate agricultural products to prevent microbial contamination”. However, under Singapore’s food regulations, ethylene oxide can be “used in the sterilization of spices”. It was also mentioned that there is no immediate risk to consuming foods with low levels of ethylene oxide, but the carcinogenic properties of this pesticide may trigger cancer cells on prolonged consumption and may lead to health hazards in the long run. As per the SFA, noting that exposure to the “substance should be minimized as much as possible”. Source: Healthworld

Apr 21,2024 Thiruvananthapuram: Health minister Veena George has instructed the director of health department to take further action under Kerala Public Health Act, 2023, in the wake of bird flu outbreak in two wards in Alappuzha. Panchayat-level committees under the Act have been instructed to meet urgently in all the panchayats of Alappuzha. Nearby panchayats and municipalities are under surveillance and should be monitored at the district level and progress reports should be reported at state level. It has also been directed to strengthen ‘One Health’ committees in all districts, she said. The minister said bird flu has not affected humans in the state till date. However, prior precautions are necessary to prevent spreading. Everyone should follow the health department’s guidelines. The department is monitoring fever and other symptoms in the affected areas. People in these areas should consult their doctor if they develop any respiratory problems. Source: Healthwold

Apr 21,2024 New Delhi: Natco Pharma failed to maintain cleanliness, sterilise equipment and utensils at appropriate intervals at its Telangana-based plant, as per the US health regulator. In the warning letter to the company, US Food and Drug Administration said its investigators observed various violations at the finished pharmaceuticals plant located at Kothur Village in Telangana. The USFDA inspected the facility from October 9 to 18, 2023. “Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilise equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements,” the US health regulator noted. It further said: “Your cleaning procedure for your non-dedicated equipment is inadequate.” Cross-contamination is not uniform, and the testing of control samples and placebo batches failed to scientifically prove that products are free of contaminants from visibly dirty equipment, USFDA stated. “You do not sufficiently address contamination recovered from product contact surfaces, and you fail to acknowledge that other locations and other sampling may reveal high levels of contamination,” it added. The US health regulator further stated that the company failed to thoroughly investigate any discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed. The USFDA sought a comprehensive, independent assessment of your overall system for investigating deviations, discrepancies, complaints, out-of-specification (OOS) results, discrepancies, failure, and records management system. Provide a report that evaluates whether staff possesses proper investigation competencies, effectively conducts root cause analysis, and assures a corrective action and preventive action (CAPA) effectiveness, it said. “We acknowledge your commitment to temporarily suspend production of all drugs manufactured on all dedicated and non-dedicated equipment for the US market while you remediate the CGMP violations,” it added. If the drug maker plans to resume any manufacturing operations, notify this office before resuming production, USFDA said. A warning letter is issued when the US health regulator finds that a manufacturer has significantly violated its regulations. India has the highest number of USFDA compliant pharma plants outside of the US. As per a report, the country has more than 600 USFDA registered manufacturing sites, constituting nearly 12.5 per cent of all registered manufacturing sites operating outside the US. Source: Pharma

Apr 22,2024 Washington: The role of India in the medical product field represents both a unique opportunity and an important responsibility, the head of the US Food and Drug Administration has said, ahead of the annual India-US BioPharma & Healthcare Summit. The summit will take place in Boston later this week. Dr Robert Califf, US FDA Commissioner will be one of the keynote speakers at the 18th edition of the annual largest gathering of pharma and healthcare sectors from the two countries, organised by USA India Chamber of Commerce. During the day-long summit, Dr Califf will share insights from his significant visit to India last September, which holds paramount importance for both countries, USA India Chamber of Commerce said in a statement on Sunday. “I recently visited India with a central purpose in mind-to strengthen our collective efforts to advance the development and availability of medical products that both our countries and the rest of the world need,” he said. “I knew, going into my trip, that our FDA investigators had identified issues in India demanding our attention relating both to manufacturing quality and concerns about the conduct of clinical trials performed in support of drug applications and so I repeatedly spoke about the importance of prioritising a culture of quality and practices that ensure the integrity of manufacturing and clinical data,” Dr Cliff said. “One of the key messages during my visit to the capital city of New Delhi and the pharmaceutical and technology hub Hyderabad was that India’s role in the medical product space represents both a unique opportunity and an important responsibility. I returned to the U.S. from India, enthusiastic about our future together in our common mission to improve human health,” he said. Among prominent speakers at the summit are Biogen CEO Chris Viehbacher, R&D heads like Andrew Plump of Takeda, Marcus Schindler of Novo Nordisk, Robert Plenge of BMS, and academic leaders Marc Tessier-Lavigne of Stanford and George Daley of Harvard Medical School. “Indian government’s innovation-driven top leadership, coupled with India’s substantial skilled manpower, positions the country as a trusted Partner of Choice for BioPharma research and development, clinical research, and manufacturing,” said Karun Rishi president of USAIC. “With its ability to scale up manufacturing capacity while maintaining high-quality standards, India is primed to play a pivotal role in producing life-saving medicines for global consumption, addressing critical concerns regarding BioPharma supply chain and health security,” he said. Notable figures from the Indian pharma industry, including Dilip Shanghvi of Sun Pharma and Hari Bhartia of Jubilant Bhartia Group, will participate in the summit. Source: Healthworld

Apr 23,2024 Mumbai: Insurance regulator Irdai is pushing companies to ensure that health covers are available to all age groups, as well as those with pre-existing diseases, mental health issues and women, to ensure that there is greater coverage and no one is denied the facility. While the regulations have been tweaked, many are interpreting it to mean a mandate from the regulator to ensure that those over 65 are not denied health insurance. Sources told TOI without mandating detailed norms, Irdai is going to monitor how companies are going to respond to the new regulations issued recently. “The idea is to ensure that appropriate products should come in the market. The regulator has left it to the market to decide the premium and other elements to address the requirements of the wider public,” said a source familiar with the deliberations in the Hyderabad-based regulatory agency. So far, insurers have often denied health covers to first-time buyers who are over 60 years and very often refuse to renew insurance once a claim is made, even for the younger segment. While insurers are mandated to provide lifelong renewability of health insurance, they are not forced to offer insurance to first-time buyers beyond the age of 65. Many insurers have a maximum age of entry at 65, although some such as Star Health accept new proposals from even older people. Besides, several prospective buyers are turned away citing “pre-existing disease”, leaving such consumers to fend for themselves without any insurance. “These risks can be covered which may mean a higher premium,” a source explained. “Most citizens shy away from health insurance because they find the terms and conditions confusing, especially when it comes to pre-existing ailments as well as waiting periods. With these new guidelines, it is an endevour of the regulator to ensure standardisation to make life simple for the citizens when it comes to understanding of health insurance. The new regulation intends to make health insurance even more inclusive, especially for senior citizens, persons with disabilities and persons with chronic ailments,” said Tapan Singhel MD & CEO Bajaj Allianz General Insurance. Sources said that there is no mandate yet asking companies to offer policies to all. Insurers say this would be a challenge while underwriting a first-time buyer of say 90 as the higher risk would make the policy prohibitively expensive. Already companies are facing an issue with drop out of healthy seniors whose premium breach 20 per cent of the sum insured once they cross 75 years. Source: Healthworld

Apr 09,2024 Mumbai: After suffering from lower abdominal pain for the last two months, 32-year-old Nashik resident Dhrusti Bhonsale (pictured) got her inflamed appendix removed in a novel way: from her mouth. Doctors from state-run JJ Hospital didn’t make a single external cut while operating on Bhonsale on April 1, successfully using the NOTES technique for the first time. NOTES stands for natural orifice transluminal endosurgery, in which doctors use natural orifices to perform procedures. Endoscopy is usually a diagnostic procedure used to look inside the body. But since 2008, surgeons have developed a way to use it as a surgical tool. And, while doctors perform appendectomy using laparoscopy, Bhonsale was very clear that she didn’t want another surgical cut after undergoing two C-sections. “So, our doctors decided to spare her even the tiny cuts of laparoscopy by using NOTES,” said JJ Hospital dean Dr Pallavi Saple. The surgery team led by Dr Ajay Bhandarwar has previously removed thyroid growth through armpits to avoid surgical scars. “The patient was initially disappointed to hear that even a laparoscopic surgery would have post-operative scars, and asked us for a scarless surgery,” said Dr Bhandarwar. Dr Shirish Bhagwat said there is an ongoing debate over the benefits of NOTES over laparoscopy and robotics. “For the patient, the biggest advantage with NOTES is the lack of external cuts that ensures fast healing,” he said. Doctors use an endoscope to reach the stomach, then use special equipment to cut through it into the abdominal space. “The appendix is cut and then brought out using the scope,” said Dr Amol Wagh, a member of the team that performed NOTES on Bhonsale. However, the procedure has a steep learning curve, said Dr Bhandarwar. “Moreover, it needs special equipment that add to the costs.” He said the technique could become a gamechanger scarless surgery once instrumentation and ergonomics improve. Bhonsale said her pain began two months ago with nausea. She went to a Nashik hospital, which referred her to JJ Hospital. While she was initially managed conservatively with medication, doctors had to operate on her as the pain worsened. Bhonsale, who was discharged on Monday, said she has been feeling well for the last few days. “After the months of pain, I am relieved and have no scars either.” Source: Healthworld

Apr 09,2024 Geneva: More than 3,500 people die from hepatitis viruses every day and the global toll is rising, the World Health Organisation warned on Tuesday, calling for swift action to fight the second-largest infectious killer. New data from 187 countries showed that the number of deaths from viral hepatitis rose to 1.3 million in 2022 from 1.1 million in 2019, according to a WHO report released to coincide with the World Hepatitis Summit in Portugal this week. These are “alarming trends,” Meg Doherty, head of the WHO’s global HIV, hepatitis and sexually-transmitted infection programmes, told a press conference. The report said that there are 3,500 deaths per day worldwide from hepatitis infections — 83 percent from hepatitis B, 17 percent from hepatitis C. There are effective and cheap generic drugs which can treat these viruses. Yet only three percent of those with chronic hep B received antiviral treatment by the end of 2022, the report said. For hep C, just 20 percent — or 12.5 million people — had been treated. “These results fall well below the global targets to treat 80 percent of all people living with chronic hep B and C by 2030,” Doherty said. The overall rate of hepatitis infections did fall slightly. But WHO chief Tedros Adhanom Ghebreyesus emphasised that the report “paints a troubling picture”. “Despite progress globally in preventing hepatitis infections, deaths are rising because far too few people with hepatitis are being diagnosed and treated,” he said in a statement. Africa accounts for 63 percent of new hep B infections, yet less than one in five babies on the continent are vaccinated at birth, the report said. The UN agency also lamented that the affected countries did not have enough access to generic hepatitis drugs — and often paid more than they should. Two thirds of all hepatitis cases are in Bangladesh, China, Ethiopia, India, Indonesia, Nigeria, Pakistan, the Philippines, Russia and Vietnam, according to the report. “Universal access to prevention, diagnosis, and treatment in these 10 countries by 2025, alongside intensified efforts in the African region, is essential to get the global response back on track,” the WHO said in a statement. Source: Healthworld

Apr 13,2024 The first drug shown to slow Alzheimer’s disease hit the U.S. market over a year ago, but sales have lagged, major hospital systems have taken months to start using it and some insurers have rejected coverage. Doctors also expect some patients will hesitate to take Leqembi due to its limited impact and potential side effects. They say it will take years to learn how best to deploy the drug and that work must be done to improve diagnosis. “This is the start of a very exciting journey,” said Dr. Ambar Kulshreshtha, a suburban Atlanta family physician focused on dementia patients. More than 6 million Americans, and millions more worldwide, have Alzheimer’s disease, the most common cause of dementia. There’s no cure, but Leqembi clears a sticky brain protein called amyloid that’s a key indicator of Alzheimer’s. Studies showed that it can delay the progression of the disease by a few months when given to people with mild symptoms. Some experts say the delay may be too subtle for patients to notice. The drug also can cause brain swelling and bleeding. Patients need regular brain scans to monitor for that. The Food and Drug Administration gave Leqembi full approval last summer for patients with early stages of the disease. The federal Medicare program for people ages 65 and over covers Leqembi and the cost of scans needed to diagnose patients. The drug’s maker, Japan’s Eisai, initially expected to have 10,000 patients taking the IV drug by the end of March. Company executives have since backed off that projection, though they say sales are growing. Hospitals and health systems have needed more time than expected to set up their systems for delivering Leqembi, said Alexander Scott, an Eisai executive vice president. “It’s not like we are adding a drug to an existing system,” he said. “They are building the system for the drug.” The Cedars-Sinai health system in Los Angeles started administering the drug in early March. Getting there required months of meetings to iron out a plan to coordinate diagnosis, treatment and then monitoring for problems. “We were very careful about it,” said Dr. Sarah Kremen, a behavioral neurologist. Source: Healthworld