https://journalofsopi.com/index.php/sopi/issue/feed Journal of Pharmacovigilance & Drug Safety 2026-01-02T14:44:06+00:00 Dr. Yogesh Kumar Goyal, MD editorjournalsopi@gmail.com Open Journal Systems <p style="text-align: justify;">In the modern era of clinical application of knowledge of pharmacology, it is a big dilemma in hoosing between the good and the best drug. In making a decision for treatment planning clinician must consider the additional features of local and systemic issues, patient's economic status as well as potential adverse effect of the drug.</p> <p style="text-align: justify;">There are large number of drug trial going on world wide to observe the effect of a particular drug or a molecule. However, the scenario has changed drastically in last 20 years. What it was with the western/ developed world is now shifting over to developing world.</p> <p style="text-align: justify;">India is set to grab clinical trial business, making the subcontinent world's preferred destination for clinical trials. The big reason being low cost of trial along with friendly drug control system with&nbsp;competent work force and patient availability. Indian investigators and clinical trial research professionals have already demonstrated their medical and scientific skills in various global clinical trials. It is time now to capitalize on this opportunity. Indian investigators and research professionals can prove their ability and show to the world and register their presence now as well as for future.</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> https://journalofsopi.com/index.php/sopi/article/view/161 Maʿūl Shaʿīr (Barley Water): Traditional Unani Perspectives Integrated with Phytochemistry and Modern Clinical Insights 2025-12-13T10:20:54+00:00 Samreen Farha mohdqais26@gmail.com Mohammad Saad Ahmad Khan mohdqais26@gmail.com <p>Background: Maʿūl Shaʿīr, commonly known as barley water, is a time-honored formulation in Unani medicine, used for its detoxifying, cooling, and nutritive properties.<br>Objective: To analyze the historical Unani references, pharmacological profile, therapeutic actions, and recent biomedical evidence of Maʿūl Shaʿīr, ensuring integration between classical and modern systems.<br>Methods: A thorough review of classical Unani literature, including Al-Qanun fi al-Tibb, Khazain al- Adwiya, and Qarabadeen-e-Azam, was conducted. Additionally, four key scientific publications were analyzed to extract recent findings related to barley’s composition, mechanisms, and clinical outcomes.<br>Result: Classical Unani texts describe Maʿūl Shaʿīr as cold in the second degree and moist in the second degree. It is a refrigerant, diuretic, anti-inflammatory, expectorant, and antipyretic. Modern research corroborates the antioxidant, hypolipidemic, antidiabetic, and hepatoprotective effects of this compound, largely attributed to β-glucans, polyphenols, flavonoids, vitamins, and minerals.<br>Conclusion: Maʿūl Shaʿīr is a significant dietary therapeutic agent that merges traditional Unani insights with contemporary clinical potential. It warrants further randomized trials to validate its efficacy and promote its integration in global health care.</p> 2025-12-13T00:00:00+00:00 Copyright (c) 2025 Samreen Farha, Mohammad Saad Ahmad Khan https://journalofsopi.com/index.php/sopi/article/view/162 Emerging Frontiers in Pharmacovigilance: Harnessing Digital Innovations and AI for Enhanced Drug Safety Monitoring in Modern and Traditional Medicine 2025-12-13T16:16:14+00:00 Arshad Hasan dr.arshadhasan@yahoo.com Ishrat Fatma dr.arshadhasan@yahoo.com <p>Pharmacovigilance, the science of detecting, assessing, understanding, and preventing adverse drug reactions (ADRs), has evolved significantly since its formal inception following the thalidomide tragedy. This review examines the historical progression of pharmacovigilance, highlighting the limitations of traditional methods and the paradigm shifts driven by technological advancements. It explores the transformative role of digital technologies, including big data analytics, social media integration, and mobile health (mHealth) applications, in enhancing drug safety monitoring. The application of artificial intelligence (AI) and machine learning (ML) in signal detection, natural language processing (NLP), and the development of AI-enabled pharmacovigilance platforms are critically assessed, emphasizing their potential to improve the speed and accuracy of ADR identification. Furthermore, this review addresses the unique challenges and strategies for pharmacovigilance in traditional medicine, where safety profiles are often underreported. It investigates the importance of integrating digital and AI-driven tools to monitor traditional remedies, including the use of blockchain for supply chain transparency. Finally, the review discusses current regulatory frameworks and the importance of global collaboration in establishing standardized pharmacovigilance practices. By synthesizing historical perspectives with emerging digital innovations, this paper underscores the importance of a comprehensive, inclusive approach to drug safety monitoring, aimed at optimizing patient outcomes and reinforcing public trust in both modern and traditional medicinal products.</p> 2025-12-13T16:14:52+00:00 Copyright (c) 2025 Arshad Hasan, Ishrat Fatma https://journalofsopi.com/index.php/sopi/article/view/166 Report on 5th National Pharmacovigilance Week celebration by ADR Monitoring Centre, JNMC, AMU, Aligarh 2025-12-24T08:30:03+00:00 Syed Ziaur Rahman mohdqais26@gmail.com Gufran Ali mohdqais@gmal.com Rashaad Ahmad Khan mohdqais@gmail.com <p>Ministry of Health &amp; Family Welfare, Government of India, launched a nationwide Pharmacovigilnace Programme of India (PvPI) to monitor the safety of medicinal product in Indian population. Indian Pharmacopoeia Commission (IPC) is functioning as national Coordination Centre (NCC) to collate ADR reports and recommends Central Drug Standard Control Organisation (CDSCO) for regulatory intervention (1,2)</p> <p>&nbsp;</p> <p>In line with a mission to safeguard health of Indian population, In 2021 Government of India has taken an initiative to celebrate Nation Pharmacovigilance Week from 17<sup>th</sup> to 23<sup>rd</sup> September every year, which serves as platform for communication and knowledge enrichment to the various stake holders in the field of safety of medicinal product for ultimate benefit of patients (3)</p> <p>&nbsp;</p> <p>ADR Monitoring Centre (AMC), Jawaharlal Medical College &amp; Hospital (JNMCH), Aligarh Muslim University (AMU), Aligarh is one of the AMC running under PvPI since 2011. This year AMC, JNMCH, AMU celebrated the 5th “National Pharmacovigilance Week” from 17th -23rd September 2025 with the designated theme " Your safety, just a click away: report to PvPI " as per the directives of PvPI, IPC, Ministry of Health &amp; Family Welfare, Government of India. A total 1513 participants attended the week-long programme (4)</p> <p>Society of Pharmacovigilance, India (SoPI) provided a platform to hold events during 5<sup>th</sup> NPW 2025. In past few years so many CMEs conducted by AMC, JNMC, AMU in association with SoPI. (5,6)</p> 2025-12-24T08:30:03+00:00 Copyright (c) 2025 Syed Ziaur Rahman, Gufran Ali, Rashaad Ahmad Khan https://journalofsopi.com/index.php/sopi/article/view/167 #MedSafetyWeek at Aligarh (India) – A report 2026-01-02T14:44:06+00:00 Syed Ziaur Rahman mohdqais26@gmail.com Gufran Ali mohdqais26@gmail.com Rashaad Ahmad Khan mohdqais26@gmail.com <p>Every year, #MedSafetyWeek brings together people from around the world to focus on one shared message: medicines are most effective when they are also safe1. This simple idea carries great importance, especially in countries like India where the use of medicines is widespread across diverse healthcare settings. This year, Aligarh, a small city in the state of Uttar Pradesh, contributed thoughtfully to the global conversation. A special programme was organised by the Adverse Drug Reaction Monitoring Centre (AMC) at Ibn Sina Academy and Jawaharlal Nehru Medical College (JNMC), in collaboration with the Society of Pharmacovigilance, India (SoPI). The event took place under the guidance of the Pharmacovigilance Programme of India (PvPI), coordinated by the Indian Pharmacopoeia Commission (IPC), which also serves as a National Coordinating Centre for Pharmacovigilance Programme of India (PvPI).</p> 2025-12-24T08:38:12+00:00 Copyright (c) 2025 Syed Ziaur Rahman, Gufran Ali, Rashaad Ahmad Khan