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Abstract

Pharmacovigilance, a vital component of the healthcare system, has evolved over 170 years to become a structured activity aimed at monitoring the risks and benefits of drugs. This article explores the historical milestones in the evolution of pharmacovigilance, from early clinician warnings in scientific journals to the establishment of electronic registries. Through vigilant monitoring of drug side effects, pharmacovigilance has made substantial contributions to preventing and addressing potential problems promptly. However, emerging challenges necessitate ongoing evolution in data collection and analysis methods to identify new side effects and drug interactions. Global pharmacovigilance systems aim to regulate the risk-to- benefit ratio of medicinal drugs, enhancing patient safety and overall quality of life. The article highlights the significant transformation in European Pharmacovigilance with the establishment of the European Medicines Agency (EMA) in 1995 and the introduction of Surveillance in 2001. Directive 2010/84/EU in 2012 brought crucial changes, including modified adverse drug reaction definitions, increased patient involvement, and enhanced transparency. A literature survey emphasizes the global perspective on pharmacovigilance. Studies from India underscore the importance of implementing Good Pharmacovigilance Practice (GPP) to improve regulatory compliance, clinical trial safety, and post-marketing surveillance. The challenges and future perspectives of pharmacovigilance in India are discussed, emphasizing the need for a well-functioning system. The historical evolution of pharmacovigilance in India is detailed, starting with revisions to Schedule Y in 2000 and the establishment of the National Pharmacovigilance Program in 2004-05. Despite India's growing prominence in clinical trials and pharmaceuticals, challenges like low ADR reporting rates persist. Case studies illustrate the practical application of pharmacovigilance, showcasing its role in identifying adverse drug events, conducting thorough reviews, and ensuring patient safety. The article concludes with recommendations for strengthening India's pharmacovigilance system, addressing challenges, and emphasizing the importance of integrating patient perspectives. In the future, the focus should be on developing a robust pharmacovigilance system that identifies emerging adverse drug reactions, integrates patient perspectives, and incorporates good pharmacovigilance practices into regulatory processes.

Keywords

Pharmacovigilance, EudraVigilance

Reference

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Supekar Amol V.
Corresponding author

Navmaharastra shikshan mandal Abasaheb kakade college of B . Pharmacy .Bodhegaon

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Tagare Chetan B.
Co-author

Navmaharastra shikshan mandal Abasaheb kakade college of B . Pharmacy .Bodhegaon

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Girhe Akshay R.
Co-author

Navmaharastra shikshan mandal Abasaheb kakade college of B . Pharmacy .Bodhegaon

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Zirpe Pandhari B.
Co-author

Navmaharastra shikshan mandal Abasaheb kakade college of B . Pharmacy .Bodhegaon

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Tanpure Sidharth S.
Co-author

Navmaharastra shikshan mandal Abasaheb kakade college of B . Pharmacy .Bodhegaon

Supekar Amol V. , Tagare Chetan B. , Girhe Akshay R. , Zirpe Pandhari B. , Tanpure Sidharth S., Antibiotic Resistance: Global Threat To Public Health, Int. J. of Pharm. Sci., 2024, Vol 2, Issue 2, 438-448. https://doi.org/10.5281/zenodo.10676321

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