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@article{186136,
        author = {Aditi Tripathi and Abhash Kumar and Deep Das},
        title = {Digital Transformation of Pharmacovigilance in India: Current Landscape and Future Horizons},
        journal = {International Journal of Innovative Research in Technology},
        year = {2025},
        volume = {12},
        number = {6},
        pages = {5382-5400},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=186136},
        abstract = {A digital integrated and predictive and data-driven ecosystem of pharmacovigilance is also a paradigm shift within India compared to traditional manual reporting. It is transforming with the development of artificial intelligence, machine learning, natural language processing and analytics of big data in conjunction with regulatory updates via the Central Drugs Standard Control Organization, Indian Pharmacopoeia Commission), and the Pharmacovigilance Program of India. Integration of national digital health systems, such as the Ayushman Bharat Digital Mission, interoperability standards, such as FHIR and MedDRA, and their implementation by the healthcare networks are making data flow across them fluid. The emergence of mobile-based ADR tools, cloud computing and blockchain technologies has contributed to the increased efficiency of reporting, transparency and the ability to trace data. Although these progresses have been made, the following issues remain, such as fragmented data systems, insufficient digital literacy, imbalanced infrastructure, and the fear of compliance with the Digital Personal Data Protection Act, 2023. Standardization, capacity building of workforce, and sustainable cross-sector collaboration have to be considered by India to realize a fully predictive vision of pharmacovigilance by 2030. Further development of India can lead to a successful model of smart, patient-centered drug safety surveillance that can be enhanced through additional regulatory leadership and technological incorporation.},
        keywords = {},
        month = {November},
        }