Team JGJ

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

Apr 15,2024 Mysuru: Former chairman of Indian Space Research Organisation AS Kirankumar on Sunday called upon budding doctors to ensure better quality healthcare services to the people. He was speaking at the 95th graduation ceremony of Mysuru Medical College and Research Institute’s (MMCRI) 2018 batch students at KSOU Convocation Hall here. He asked the students who acquired knowledge during their college days to serve the society with commitment, passion and service. Even the last man in the society must benefit from quality healthcare services, he said. As rapid technological developments like mobile technology, nano-technology, molecular medicine, biosensors, actuators, healthcare, data analytics, artificial intelligence like innovative medical technologies impact the medical care system in the modern world, he said Indian healthcare system must also upgrade, adopt these developments to ensure better healthcare service to save the lives of people. As India is gifted with a vast traditional medicine system from time immemorial, he sought for a synergised and integrated approach towards this medicine system. ‘Kirankumar asked the policy makers of the nation to change its role and approach to capture the space ecosystem, to use available technology to provide solutions the nation is facing today if India wants to be the largest economy in the world, besides land on the Moon by 2040 by building space stations. MMCRI dean and director Dr KR Dakshayini wanted its alumni students, who are working both in and outside the country, to take part in MMCRI centenary celebrations, which will be held shortly. She also asked them to ensure quality healthcare service to people wherever they are working. Dr TM Harshitha and Dr Darshan received overall topper awards. MMCRI alumni association president Dr HN Dinesh, MMCRI student welfare officer Dr S Chandrashekhar, Teachers Association president Dr PL Basavanna, Dr Arjun and others were present. Source: Healthworld

Apr 15,2024 New Delhi: After the medical journal Lancet’s claim on the lack of accuracy and transparency in sharing data on health raised concerns, government sources asserted that India has a robust system of documenting births and deaths under the Registration of Births and Deaths Act, 1969, through the Civil Registration System (CRS). “India has a robust system of documenting births and deaths under the Registration of Births and Deaths Act, 1969, through the Civil Registration System. It provides a unified process of continuous, permanent, compulsory, independent and universal recording of births and deaths. Under the CRS, deaths are reported to the registrar of births and deaths in the concerned area for registration through around three lakh registration units nationwide,” according to a government source. “Although births and deaths are to be reported within 21 days of the occurrence of the event, the Act provides for late registrations as well,” the sources said. The Lancet raised questions about India’s continuing claim that only 0.48 million people died as a result of the COVID-19 pandemic, saying that WHO and other estimates are six to eight times larger (including excess deaths, most of which will be due to COVID-19). “Every state generates a report within one year after the index calendar year. This leeway is given to accommodate late reporting and to collate data,” a source explained, rubbishing the claims by Lancet. The government sources further said that more than 90 per cent of births and deaths are registered online on the state or national portals. “Over the years, the civil registration system has matured, and with rising awareness and ownership, the registration of births and deaths has become more inclusive. Today, more than 90 per cent of births and deaths are registered online on the state or national portals,” they added. Source: Healthworld

London: The cybersecurity firm BrandShield has taken down more than 250 websites selling fake versions of popular weight-loss and diabetes drugs in the GLP-1 class, the company’s CEO Yoav Keren told Reuters. BrandShield, which shared this information exclusively with Reuters, said that out of the 279 pharmacy websites the company closed last year for selling drugs intended to treat metabolic conditions, more than 90 per cent were related to GLP-1 medicines, according to Keren. Novo Nordisk’s Ozempic and Wegovy and Eli Lilly’s Mounjaro and Zepbound are GLP-1 drugs, which were developed for type 2 diabetes but also reduce food cravings and cause the stomach to empty more slowly. The drugs have been shown to help patients lose on average as much as 20 per cent of their weight, fueling explosive demand and a burgeoning global market for fake versions. Cases of harm linked to fake versions of Ozempic and other GLP-1s have been reported in at least nine countries, including Belgium, Britain, Switzerland and the United States. “I wouldn’t be surprised to see criminals try to use the growing popularity of these drugs to sell more counterfeits,” said Keren. Websites taken down for selling bogus GLP-1s represented just over 15 per cent of the 1,655 websites BrandShield reported last year for peddling counterfeit drugs in areas, including hormone-related drugs, central nervous system medicines and cancer treatments. Websites selling counterfeit GLP-1s were less common in 2022 when the company identified 34 such sites to be closed, although it was not targeting all of the GLP-1 drugs that year as it did in 2023, said Keren. He said his firm last year did not find the same concentration of a particular class of drug in any treatment category as it did for GLP-1s as metabolic treatments. BrandShield worked with the Pharmaceutical Security Institute (PSI), an industry-backed organization, to take down these websites. PSI’s members, which include Lilly and Novo, chose which drugs to target, according to Keren. The CEO said his company gets these websites taken down by collecting evidence that their products are counterfeit and submitting that to the service providers hosting the site. When permitted or requested by its drugmaker customers, BrandShield will share that intelligence with law enforcement agencies. The U.S. Food and Drug Administration said in December it was investigating counterfeit Ozempic in the legitimate U.S. supply chain. BrandShield also took down 3,968 listings on social media platforms for fake drugs in all categories last year, almost 60 per cent of which were found on Facebook, according to a new report from the company. The company removed more than 6,900 illegal drug listings across social media platforms and marketplaces in total, including 992 marketplaces in India, 544 in Indonesia, 364 in China and 114 in Brazil. Keren said the company did not have data on how many of these social media listings and marketplaces were selling fake versions of GLP-1s. Source: Pharma

Apr 15,2024 Medical emergencies strike without warning, leaving us vulnerable and scrambling for the best course of action. In these moments of crisis, cashless health insurance emerges as a true lifesaver. It removes the immediate financial burden associated with critical medical care, allowing patients to focus on their recovery. The health insurance market has been witnessing significant growth, with an increasing number of individuals opting for health insurance policies. The health insurance market size was valued at USD 12.86 billion in 2022 and is expected to grow at a compound annual growth rate of 11.55% from 2023-2030. According to the Insurance Regulatory and Development Authority of India (IRDAI), the health insurance sector in India was growing at a rate of over 20% annually. The Government of India has been taking initiatives to promote health insurance coverage across the country. The Pradhan Mantri Jan Arogya Yojana (PMJAY), also known as Ayushman Bharat, aims to provide health insurance coverage to over 500 million people from vulnerable households. While PMJAY primarily focuses on providing coverage for hospitalization expenses, it has also led to increased awareness about health insurance in general. Technology plays a crucial role in solving the issues of awareness and accessibilty. With the help of artificial intelligence, complex policy terms are made easier to understand. Most major insurance companies now offer user-friendly mobile apps, which let you manage your policies anytime, anywhere – right from your phone. In just a few clicks, one can buy a new policy, renew an existing one, or even make changes to the coverage. Furthermore, with the integration of AI and machine learning algorithms, insurers can now assess claims much faster and more accurately. Making healthcare even easier in India, the health insurance industry has teamed up for a game-changer called ‘Cashless Everywhere’. This means one can get cashless treatment at any hospital in their network, regardless of the insurance company. Financial strain can worsen a patient’s condition and delay crucial interventions. However, cashless health insurance eliminates this hurdle. By guaranteeing payment to hospitals within the network, it ensures patients receive immediate and necessary treatment, regardless of their ability to pay at the moment. Furthermore, cashless insurance removes financial barriers, allowing doctors to prioritize treatment without waiting for approvals or verifications. This expedites care and improves the chances of a successful outcome. The speed at which cashless insurance facilitates treatment is another crucial benefit. During a medical emergency, every minute counts. The streamlined process eliminates the need for arranging finances or securing deposits, enabling doctors to begin treatment promptly. This can be particularly life-saving in situations requiring immediate intervention. Furthermore, cashless health insurance empowers patients to choose the best course of action without financial constraints clouding their judgment. With the immediate financial burden lifted, patients can prioritize their health and focus on receiving the most effective treatment available within the network. This empowers them to make informed decisions based on their medical needs rather than financial limitations. Source: Healthworld

Jul 14,2023 New Delhi: India’s lawmakers will consider a new drugs bill next week on rules for importing, manufacturing and selling medicines, according to a parliamentary notice on Thursday, as the country seeks to draw lessons from a deadly cough syrup scandal. India’s “pharmacy of the world” image has suffered some damage after cough syrups made there were linked to the death of at least 89 children in Gambia and Uzbekistan last year. The bill is aimed at ensuring “quality, safety, efficacy, performance and clinical trial of new drugs … with the objective of highest possible regulatory standards and a transparent regulatory regime,” the notice said. It was not immediately clear what the changes were in the new Drugs, Medical Devices and Cosmetics Bill, 2023, which will replace an earlier drugs law if passed by the parliament when it reconvenes after a break on July 20. India’s $41 billion pharmaceutical industry is one the largest in the world and has for years helped provide cheaper alternatives to Western products, especially to poor and developing nations. But the recent cough syrup-related deaths and at least one other instance of an India-made eye drop being linked to three deaths in the United States, has cast a shadow on the industry’s image. India has made tests mandatory for cough syrup exports since last month. Companies that manufactured the syrups linked to deaths in Gambia and Uzbekistan have denied any wrongdoing. Source: Pharma