Marks Electronic - India

📢 Important Update: DCGI Orders Withdrawal of Olaparib for Certain Treatments 📢 We bring you a critical update from the Drug Controller General of India (DCGI). Following recent consultations with oncology experts, it has been decided to withdraw AstraZeneca's anti-cancer drug Olaparib (100mg and 150mg) for patients with gBRCA mutation and advanced ovarian or breast cancer who have undergone three or more prior lines of chemotherapy. This decision is based on post hoc analysis indicating potential adverse effects on overall survival. State regulators are directed to discontinue the marketing of Olaparib for these specific indications and update the package inserts accordingly. The drug remains available for other approved uses. Key Highlights: 🔹 Withdrawal based on potential detrimental effects observed in certain patient subgroups. 🔹 Directive affects Olaparib marketing for advanced ovarian and breast cancer with gBRCA mutation post multiple chemotherapy lines. 🔹 Communication and decision finalized post SEC (Oncology) experts' review on March 19-20, 2024. 🔹 Olaparib continues to be available for other approved indications. We aim to keep you informed on significant regulatory changes affecting healthcare and pharmaceutical practices. For further details, please refer to the official DCGI communication dated May 16, 2024. #HealthcareUpdate #PharmaNews #Oncology #CancerTreatment #DrugSafety #HealthcareProfessionals #PharmaceuticalIndustry #MedicalUpdates #PatientSafety

National Health Claim Exchange Platform to Launch Soon, Simplifying Health Insurance Claims The Union Health Ministry is on the brink of revolutionizing the health insurance landscape with the upcoming launch of the National Health Claim Exchange (NHCX) platform, aimed at streamlining the health insurance claim process. Developed by the National Health Authority (NHA) as part of the Ayushman Bharat Digital Mission (ABDM), the NHCX platform will enhance the efficiency and transparency of claims processing. The NHCX platform will serve as a unified communication channel between payers (insurance companies) and service providers (hospitals and clinics). By ensuring interoperability and faster processing of insurance claims, this platform promises to reduce operational costs and improve the overall claims experience for policyholders and healthcare providers alike. Key Highlights: Launch Timeline: Expected within the next two to three months. Integration: Approximately 40-45 health insurance companies and 200-250 hospitals nationwide. Efficiency: Transition from manual to automated claims processing, leveraging FHIR-compliant e-claims format and standard APIs. Interoperability: Facilitates seamless data exchange, enhancing operational efficiency and transparency. Stakeholder Support: Endorsed by the Insurance Regulatory and Development Authority (IRDAI), with major insurers like Tata AIG General Insurance Company, Paramount TPA, and Bajaj Allianz Insurance Company already integrated. This initiative marks a significant step towards digitizing India's healthcare infrastructure, promising a more efficient and user-friendly experience for all stakeholders involved in the health insurance ecosystem. #HealthInsurance #DigitalHealth #InnovationInHealthcare #HealthcareIT #Interoperability

🔍 New "Test and Treat" Methods Revolutionize TB Prevention and Treatment 🔍 Tuberculosis (TB) remains a major healthcare challenge, especially in low and middle-income countries. To meet the United Nations Sustainable Development Goals (SDGs) of at least an 80% reduction in TB incidences by 2030, nations must enhance their detection, prevention, and treatment measures. In a significant step forward, delegates from 34 countries, including India, Ghana, Ethiopia, Zimbabwe, Nigeria, and Bangladesh, convened and endorsed the "Goa Declaration". This declaration urges world leaders to adopt evidence and science-based strategies to find, treat, and prevent TB, integrating these approaches into existing programs to demonstrate high-impact interventions. 🔹 Key Outcomes from the Goa Declaration: Active Case Finding Initiatives: In Delhi, intensified efforts using ultraportable x-ray and molecular test vans are bringing screening and diagnostic tools closer to vulnerable populations. This makes same-day "test and treat" strategies a reality. Advancement in Molecular Testing: The shift from traditional smear microscopy to molecular tests like the Truenat molecular test kits from MolBio is proving transformative. These tests deliver near real-time results, significantly accelerating diagnosis and treatment. Impact on Vulnerable Populations: These strategies have been particularly effective among homeless people, migrant workers, night shelter inmates, sex workers, prison inmates, people living with HIV, drug users, and workers exposed to silica. Global Implementation: Goa, Andhra Pradesh, and Maharashtra have replaced smear microscopy with upfront molecular testing. The World Health Organization aims for 100% molecular testing by 2027. In the Philippines, mobile testing units are screening, diagnosing, and treating people with TB across islets, significantly increasing the number of people screened. Bangladesh Success Story: Despite challenges, Bangladesh has almost halved TB mortality since 2015, showcasing the effectiveness of accelerated TB testing and treatment. 🌍 Future Targets (2023-2027): Reach 90% of TB patients with diagnostic, treatment, and social support services. Ensure 100% of people tested for presumptive TB receive WHO-recommended molecular tests. Provide health and social benefit packages to all TB patients to avoid catastrophic costs. Treat at least 45 million people globally, including 4.5 million children and 1.5 million with drug-resistant TB. Offer TB Preventive Therapy (TPT) to 90% of high-risk populations. Together, these measures are pivotal in accelerating the fight against TB, paving the way to achieving global health targets and safeguarding millions of lives. #Tuberculosis #HealthcareInnovation #PublicHealth #GlobalHealth #SustainableDevelopmentGoals

🔔 CDSCO Urges Timely Reporting of Medical Device Adverse Events to MvPI 🔔 In a recent circular dated May 15, 2024, the Central Drugs Standard Control Organisation (CDSCO) has emphasized the importance of timely reporting of adverse events related to medical devices through the Materiovigilance Programme of India (MvPI). This directive aims to enhance the safety and performance monitoring of medical devices, including in-vitro diagnostic devices, under the regulation of the Drugs and Cosmetics Act, 1940, and Medical Devices Rules, 2017. 📋 Key Highlights: Regulation and Licensing: All medical devices, including in-vitro diagnostic devices, must be licensed under the said rules to ensure their quality, safety, and performance in the market. Post-Market Surveillance (PMS): Robust systems and processes must be established by licence holders for the identification, documentation, and timely reporting of adverse events associated with medical devices. PMS is crucial for identifying and mitigating risks to safeguard public health. Materiovigilance Programme of India (MvPI): Launched by the Ministry of Health and Family Welfare (MoHFW), the MvPI aims to improve patient safety by monitoring and analyzing adverse events related to medical devices. The Indian Pharmacopeia Commission (IPC) serves as the National Coordination Centre for MvPI. Role of Medical Device Industry: The participation of the medical device industry is critical for the success of MvPI. All licence holders are urged to use the MvPI platform for reporting adverse events to enhance risk identification and mitigation procedures. Action Required: Licence holders are requested to take appropriate action for timely reporting of adverse events related to medical devices to MvPI. Guidance documents for effective utilisation of MvPI are available on the IPC website. For training needs, stakeholders can contact mvpi-ipc@gov.in. 📧 Contact Information: For further information or training requests, please reach out to mvpi-ipc@gov.in. By enhancing our vigilance and reporting systems, we can collectively ensure the highest standards of safety and efficacy for medical devices in India. Your cooperation and prompt action in this regard are highly valued. #MedicalDevices #PatientSafety #MvPI #Healthcare #CDSCO #PublicHealth #RegulatoryCompliance

🌟 New All-in-One Vaccine May Prove Effective Against All Coronaviruses 🌟 A groundbreaking study by leading universities in the UK and the US unveils a promising all-in-one vaccine designed to safeguard against a broad spectrum of coronaviruses, including those yet to emerge. Published in 'Nature Nanotechnology,' the research heralds a proactive approach to vaccine development, aimed at anticipating and combatting future viral threats. Developed by scientists from the Universities of Oxford and Cambridge in the UK and Caltech in the US, the vaccine employs a pioneering strategy termed "proactive vaccinology." This approach involves constructing a vaccine preemptively, training the immune system to recognize specific regions of eight different coronaviruses, including SARS-CoV-2, which triggered the COVID-19 pandemic, and others circulating in bats with pandemic potential. Rory Hills, a graduate researcher at the University of Cambridge, underscores the vaccine's preemptive nature, stating, "Our focus is to create a vaccine that will protect us against the next coronavirus pandemic, and have it ready before the pandemic has even started." Remarkably, the vaccine induces immune responses against coronaviruses not represented in its composition, offering a robust defense against both known and unknown strains. Professor Mark Howarth of the University of Cambridge underscores the urgency of proactive vaccine development, emphasizing the need to surpass past achievements in pandemic response. The vaccine, named 'Quartet Nanocage,' utilizes a nanoparticle structure adorned with chains of viral antigens, facilitating a broad immune response across various coronaviruses. This innovative design, simpler than existing vaccine approaches, holds promise for expedited clinical trials. Funded by the UK's Biotechnology and Biological Sciences Research Council, this groundbreaking research not only offers hope in the fight against COVID-19 but also lays the groundwork for future vaccine development against emerging viral threats. #COVID19Vaccine #CoronavirusResearch #VaccineDevelopment #PandemicPrevention #PublicHealth #MedicalInnovation #ProactiveVaccinology #NatureNanotechnology #ResearchBreakthrough

Trivitron portable SonoRad K40 Color Doppler Ultrasound system is a compact, advanced, and innovative color ultrasound system that is equipped with advanced technology and powered by RF ultrasonic metadata platform that makes it best for the routine scanning. The color mode offers accurate and efficient diagnosis and is used for a wide range of applications to assist medical practitioners. For more information visit: https://lnkd.in/gK9Emmbi or call us at +91 9840080008 #SonoRadK40 #ColorDopplerUltrasound #ColorDoppler #Ultrasound #WeAreTrivitron #TrivitronHealthcare

🌟 AstraZeneca Reaffirms Vaccine Safety Amidst Rare Side Effect Concerns 🌟 Amid recent concerns over potential rare side effects of the AstraZeneca-Oxford COVID-19 vaccine, the pharmaceutical giant stands firm in its commitment to patient safety while emphasizing the overall safety profile of the vaccine. The AstraZeneca spokesperson stated, "Patient safety is our highest priority, and regulatory authorities have clear and stringent standards to ensure the safe use of all medicines, including vaccines." Recent reports have highlighted rare cases of Thrombosis Thrombocytopenia Syndrome (TTS) associated with the AstraZeneca vaccine, prompting scrutiny. However, the company stresses that extensive clinical trial data and real-world evidence consistently support the vaccine's safety and efficacy. Despite these rare occurrences, regulatory agencies worldwide continue to assert that the benefits of vaccination outweigh the risks of such extremely rare side effects. The vaccine, named Covishield and Vaxzevria, utilizes a viral vector platform, employing a modified chimpanzee adenovirus to carry the COVID-19 spike protein into human cells. This technology, akin to that used for Ebola vaccines, aims to bolster the immune system's response against the virus. In 2023, the World Health Organisation (WHO) identified TTS as a serious adverse event following immunisation with adenovirus vector-based COVID-19 vaccines, including AstraZeneca's. Interim emergency guidance was issued to raise awareness and aid healthcare providers in managing potential TTS cases. Addressing concerns, Union Health Minister Mansukh Mandaviya cited a detailed study by the Indian Council of Medical Research (ICMR), which concluded that COVID-19 vaccines were not responsible for heart attacks. Lifestyle factors and individual health conditions were identified as underlying causes. As the global vaccination effort continues, transparency, ongoing research, and collaboration remain essential to ensure public trust and safety in COVID-19 vaccines. #AstraZeneca #COVID19Vaccine #VaccineSafety #PatientSafety #PublicHealth #MedicalResearch

🌟 Advancements in Tuberculosis Treatment 🌟 Experts are pioneering revolutionary immune-enhancing therapies, known as host-directed therapies (HDT), to combat tuberculosis (TB) effectively, even targeting drug-resistant strains. Associate Professor Susanna Brighenti from the Centre for Infectious Medicine (CIM), ANA Futura at the Karolinska Institutet, Stockholm, Sweden, will present groundbreaking research on this at the upcoming ESCMID Global Congress. TB remains a global health concern, with millions diagnosed annually and significant mortality rates, especially from multidrug-resistant TB (MDR-TB). Traditional antibiotic treatments often pose challenges due to lengthy regimens and antibiotic resistance. HDT, however, bolster the body's immune responses, offering a promising avenue for improved TB treatment. These therapies aim to restore or induce antimicrobial functions within infected cells, targeting immune pathways to enhance bacterial killing and reduce inflammation. Assoc Professor Brighenti's research focuses on small molecule compounds like histone deacetylase (HDAC) inhibitors, which enhance antibacterial host defense. HDAC inhibitors have shown remarkable potential, reducing Mtb growth by up to 75% within immune cells, even without antibiotics. When used in conjunction with standard therapy, they could significantly enhance patient outcomes, potentially reducing treatment duration and dosage. Implementing immunotherapy alongside antibiotics could revolutionize TB treatment, akin to its impact on cancer and autoimmune diseases. Short-term therapeutics, readily available and FDA-approved for other conditions, could serve as initial interventions, while more precise, tailored treatments hold promise for MDR-TB patients in the future. This pioneering approach heralds a new era in TB management, offering hope for improved clinical outcomes and curbing the spread of drug resistance. Embracing personalized medicine, tailored to individual patient needs, represents the future of TB treatment. #TuberculosisTreatment #HostDirectedTherapies #MedicalAdvancements #Immunotherapy #HealthcareInnovation #ESCMIDGlobalCongress #DrugResistance

India embarks on a transformative journey in healthcare regulation with the development of a specialized pricing framework for medical devices. The initiative aims to address regulatory challenges, promote fair competition, and drive growth in the healthcare sector, heralding a new era of affordability and innovation. Click the link below to learn more: https://lnkd.in/gUJZPtCJ

Government Expands Committee for Drug and Medical Device Pricing Reforms, Includes More Industry Representation In a significant move towards enhancing healthcare accessibility and affordability, the government has expanded the committee tasked with spearheading reforms in drug and medical device pricing. This expansion aims to ensure better representation from the industry, fostering collaboration and informed decision-making. The newly expanded committee now includes special invitees from key industry bodies such as the Organisation of Pharmaceutical Producers of India (OPPI), US-India Strategic Partnership Forum (USISPF), Medical Technology Association of India (MTal), Confederation of Indian Industry (CII), Association of Indian Medical Device Industry (AiMed), and Federation of Pharma Entrepreneurs (FOPE), among others. The committee's mandate encompasses evaluating the availability of medicines and medical devices, reviewing pricing structures for essential medicines, and devising strategies to incentivize industry growth and enhance sustainability in exports. Consultations with industry experts and associations will kickstart soon to gather insights and perspectives. While the government will retain the final decision-making authority, the committee comprises three core members, including the Secretary of the Department of Pharmaceuticals, Chairman of the National Pharmaceutical Pricing Authority, and Senior Economic Adviser of the Department of Pharmaceuticals. Key areas of focus include striking a balance between price and availability of essential medicines, implementing institutional reforms within the NPPA, and designing a framework for price moderation in medical devices while promoting industry growth and reducing dependence on imports. This proactive approach underscores the government's commitment to fostering a conducive environment for healthcare innovation, affordability, and accessibility. #HealthcarePolicy #DrugPricingReforms #MedicalDevicePricing #IndustryCollaboration #GovernmentInitiative #HealthcareAccessibility