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🚨MUST READ - Pharmacovigilance - It refers to science and activities related to the detection, assessment, understanding and prevention of adverse effects or any other drug - related problems. Adverse drug reaction - Noxious response to a drug which is unintended and which occurs at doses normally used in man for prophylaxis, diagnosis or therapy of disease or for modification of physiological functions of body. Adverse event - An advance event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does necessarily have to have a casual relationship with treatment. #Ayursuraksha - to report about ADRs.

🔺 रत्न के दोष - १. ग्रास २. त्रास ३. बिन्दु ४. जलगर्भता ५. रेखा

CURRENT AFFAIRS Giloy Takes the Global Stage: Research Publications Soar Over 300% in a Decade New Studies Reveal Promising Role of Giloy in Immunity & Clinical Research Posted On: 28 FEB 2025 The data from PubMed, a globally recognised database for biomedical and life sciences research, reveals a staggering 376.5% increase in the number of research publications around Giloy (Tinospora cordifolia) over the past decade, highlighting a growing global interest in the plant's therapeutic potential. On searching the database for studies on ‘guduchi or tinospora cordifolia or amrita’, the results show 243 studies published in 2014. In contrast, in 2024, the number rose to 913, i.e. 376.5% increase.

ICMR Publishes Addendum: Ethical Requirements for Research in Integrative Medicine A significant step in encouraging the scientific community to explore Integrative Medicine with greater credibility and confidence: Secretary, Ayush Posted On: 05 MAR 2025 The Indian Council of Medical Research (ICMR) has published an addendum to the ICMR National Ethical Guidelines for Biomedical and Health Research Involving Human Participants (2017) to provide a structured ethical framework for Research in Integrative Medicine (RIM). This initiative marks a significant milestone in strengthening the scientific foundation of Ayush-based integrative healthcare by ensuring ethical rigour and regulatory compliance in research that explores the integration of traditional and modern medical practices. Secretary, Ministry of Ayush, Vaidya Rajesh Kotecha highlighted the significance of the development and said, “The addition of these ethical guidelines marks a significant step in encouraging the scientific community to explore Integrative Medicine with greater credibility and confidence. By providing a structured ethical framework, we aim to inspire researchers to advance evidence-based integration of traditional and modern medicine, ensuring safe, effective, and scientifically validated healthcare solutions for all". Integrative Medicine (IM) involves a multimodal approach, where Ayush systems are integrated alongside modern/conventional medicine to enhance patient care and improve health outcomes. With growing global interest in holistic and personalised medicine, it is observed that ethical and regulatory clarity is essential to ensure the credibility, safety, and efficacy of integrative approaches. This addendum aims to guide researchers, institutions, Ethics Committees (ECs), and regulatory bodies involved in Integrative Medicine research, ensuring that scientific integrity and patient safety remain paramount. The addendum introduces key measures to enhance the ethical and regulatory framework for Integrative Medicine research. Ethics Committees overseeing such research must now include two Ayush subject-matter experts, with at least one being external to the institution, ensuring well-rounded and informed deliberations. Informed consent standards have been strengthened, requiring that research participants receive clear, tailored information about Integrative Medicine interventions while adhering to India's standard ethical guidelines for biomedical and clinical research. Additionally, Ayush-approved medicines used in integrative research will not require extra safety trials or preclinical studies. However, non-codified traditional medicines must undergo the entire regulatory approval process. To ensure compliance, all research must align with the Drugs & Cosmetics Act (1940), New Drugs & Clinical Trial Rules (2019), and Good Clinical Practice (GCP) guidelines specific to Ayush systems.

The NAMASTE portal is an initiative by the Government of India aimed at facilitating the registration and management of various aspects related to the pharmaceutical and biotechnology sectors. NAMASTE stands for "National Ayush Mission for Science and Technology Ecosystem." Key features of the NAMASTE portal typically include: 1. Registration: It allows stakeholders in the pharmaceutical and biotechnology industries to register their entities, products, and services. 2. Regulatory Compliance: The portal helps users navigate regulatory requirements and ensures compliance with the relevant laws and guidelines. 3. Information Sharing: It serves as a platform for sharing information related to research, innovation, and best practices in the pharmaceutical and biotechnology sectors. 4. Collaboration: The portal encourages collaboration among various stakeholders, including researchers, manufacturers, regulators, and healthcare professionals. 5. Support for Startups: NAMASTE often provides support and resources for startups in the health and wellness sectors, helping them to innovate and bring their products to market. The goal of the NAMASTE portal is to enhance the efficiency and transparency of the regulatory process while promoting innovation in the pharmaceutical and biotechnology fields. For the most current and detailed information about the NAMASTE portal, including its specific functionalities and updates, it is advisable to refer to official government sources or announcements.

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