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- Vol. 5 Issue 3
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Digital Healthcare Pharmacovigilance in India: Adverse-Event Reporting, Data Interoperability, and AI-Assisted Safety Signal Detection
Authors
1 2 3 4 Department of Computer Science and Engineering, International Centre of Excellence in Engineering and Management (ICEEM), Chhatrapati Sambhaji Nagar, Maharashtra, India.
Article Information
- Published In
- Volume 5, Issue 3 (2026)
- Published Online
- September-December 2026
- Pages
- 620-625
- Article Type
- Original Article
References
[1] Indian Pharmacopoeia Commission. Launch of the Adverse Drug Monitoring System (ADRMS) Online Portal. 21 August 2024. https://www.ipc.gov.in/news-highlights/1315-launch-of-the-adverse-d rug-monitoring-system-adrms-online-portal.html (accessed 26 October 2026).
[2] Centre for Development of Advanced Computing (C-DAC). Adverse Drug Reactions Monitoring System: Project Details. https://cdac.gov.in/index.aspx?id=project_details&projectId=Adverse DrugReactionsMonitoringSystem (accessed 26 October 2026).
[3] Indian Pharmacopoeia Commission. Pharmacovigilance Programme of India: ADR reporting resources and forms. https://www.ipc.gov.in/PvPI/adr.html (accessed 26 October 2026).
[4] Indian Pharmacopoeia Commission. Pharmacovigilance Programme of India: Guidance document and toolkit for adverse drug reaction reporting. https://ipc.gov.in/PvPI/toolkit.html (accessed 26 October 2026).
[5] Osoro IN, Suhaib KP, Rani JR, Rajanandh MG. Barriers to and facilitators of healthcare professionals in ADR reporting in a tertiary care hospital in India. BMC Health Services Research. 2025;25:166. https://doi.org/10.1186/s12913-024-12139-w.
[6] Bhagavathula AS, Elnour AA, Jamshed SQ, Shehab A. Health professionals’ knowledge, attitudes and practices about pharmacovigilance in India: a systematic review and meta-analysis. PLoS ONE. 2016;11(3):e0152221. https://doi.org/10.1371/journal.pone.0152221.
[7] Sahu A, Das NR. ADR Monitoring and Reporting in India. Indian Journal of Pharmacy Practice. 2024;17(3):198-204. https://doi.org/10.5530/ijopp.17.3.33.
[8] Ahmad M, Srivastava R. A Scoping Review of the Pharmacovigilance System in India Region. International Journal of Multidisciplinary Science and Innovation. 2026;2(2):44-54. https://doi.org/10.62896/ijmsi.2.s2.07.
[9] Li Y, Tao W, Li Z, Sun Z, Li F, Fenton S, Xu H, Tao C. Artificial intelligence-powered pharmacovigilance: a review of machine and deep learning in clinical text-based adverse drug event detection for benchmark datasets. Journal of Biomedical Informatics. 2024;152:104621. https://doi.org/10.1016/j.jbi.2024.104621.
[10] Kim TY, Oh WS, Jeong DH. Large language models in adverse drug reaction detection and pharmacovigilance: a systematic review of current applications, challenges, and future directions. Diagnostics. 2026;16(15):2435. https://doi.org/10.3390/diagnostics16152435.
[11] Kusnadi G, Wangge G, Perdana A. Artificial intelligence and computational methods in the Asia-Pacific pharmacovigilance landscape: a systematic review. International Journal of Public Health. 2026;71:1610026. https://doi.org/10.3389/ijph.2026.1610026.
[12] International Council for Harmonisation (ICH). E2B(R3) Individual Case Safety Report (ICSR) Specification and Related Files. Package version 1.11, January 2026. https://admin.ich.org/node/348 (accessed 26 October 2026).
[13] FDA (United States). Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products. August 2024.https://www.fda.gov/regulatory-information/search-fda-guidance-doc uments/fda-regional-implementation-guide-e2br3-electronic-transmis sion-individual-case-safety-reports-drug.
[14] FDA (United States). Data Mining at the Center for Biologics Evaluation and Research. https://www.fda.gov/science-research/data-mining/data-mining-center -biologics-evaluation-and-research (accessed 26 October 2026).
[15] Uppsala Monitoring Centre. About VigiBase: the global medicines safety database.https://idmpinfo.who-umc.org/vigibase-data-access/about-vigibase/ (accessed 26 October 2026).
[16] Uppsala Monitoring Centre. VigiBase FAQ: data standardisation, quality assurance, and interpretationCaveats. https://edit.who-umc.org/vigibase-data-access/vigibase-faq/ (accessed 26 October 2026).
[17] Tandon VR, Mahajan V, Khajuria V, Gillani Z. Under-reporting of adverse drug reactions: a challenge for pharmacovigilance in India. Indian Journal of Pharmacology. 2015;47(1):65-71. https://doi.org/10.4103/0253-7613.150344.
[2] Centre for Development of Advanced Computing (C-DAC). Adverse Drug Reactions Monitoring System: Project Details. https://cdac.gov.in/index.aspx?id=project_details&projectId=Adverse DrugReactionsMonitoringSystem (accessed 26 October 2026).
[3] Indian Pharmacopoeia Commission. Pharmacovigilance Programme of India: ADR reporting resources and forms. https://www.ipc.gov.in/PvPI/adr.html (accessed 26 October 2026).
[4] Indian Pharmacopoeia Commission. Pharmacovigilance Programme of India: Guidance document and toolkit for adverse drug reaction reporting. https://ipc.gov.in/PvPI/toolkit.html (accessed 26 October 2026).
[5] Osoro IN, Suhaib KP, Rani JR, Rajanandh MG. Barriers to and facilitators of healthcare professionals in ADR reporting in a tertiary care hospital in India. BMC Health Services Research. 2025;25:166. https://doi.org/10.1186/s12913-024-12139-w.
[6] Bhagavathula AS, Elnour AA, Jamshed SQ, Shehab A. Health professionals’ knowledge, attitudes and practices about pharmacovigilance in India: a systematic review and meta-analysis. PLoS ONE. 2016;11(3):e0152221. https://doi.org/10.1371/journal.pone.0152221.
[7] Sahu A, Das NR. ADR Monitoring and Reporting in India. Indian Journal of Pharmacy Practice. 2024;17(3):198-204. https://doi.org/10.5530/ijopp.17.3.33.
[8] Ahmad M, Srivastava R. A Scoping Review of the Pharmacovigilance System in India Region. International Journal of Multidisciplinary Science and Innovation. 2026;2(2):44-54. https://doi.org/10.62896/ijmsi.2.s2.07.
[9] Li Y, Tao W, Li Z, Sun Z, Li F, Fenton S, Xu H, Tao C. Artificial intelligence-powered pharmacovigilance: a review of machine and deep learning in clinical text-based adverse drug event detection for benchmark datasets. Journal of Biomedical Informatics. 2024;152:104621. https://doi.org/10.1016/j.jbi.2024.104621.
[10] Kim TY, Oh WS, Jeong DH. Large language models in adverse drug reaction detection and pharmacovigilance: a systematic review of current applications, challenges, and future directions. Diagnostics. 2026;16(15):2435. https://doi.org/10.3390/diagnostics16152435.
[11] Kusnadi G, Wangge G, Perdana A. Artificial intelligence and computational methods in the Asia-Pacific pharmacovigilance landscape: a systematic review. International Journal of Public Health. 2026;71:1610026. https://doi.org/10.3389/ijph.2026.1610026.
[12] International Council for Harmonisation (ICH). E2B(R3) Individual Case Safety Report (ICSR) Specification and Related Files. Package version 1.11, January 2026. https://admin.ich.org/node/348 (accessed 26 October 2026).
[13] FDA (United States). Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products. August 2024.https://www.fda.gov/regulatory-information/search-fda-guidance-doc uments/fda-regional-implementation-guide-e2br3-electronic-transmis sion-individual-case-safety-reports-drug.
[14] FDA (United States). Data Mining at the Center for Biologics Evaluation and Research. https://www.fda.gov/science-research/data-mining/data-mining-center -biologics-evaluation-and-research (accessed 26 October 2026).
[15] Uppsala Monitoring Centre. About VigiBase: the global medicines safety database.https://idmpinfo.who-umc.org/vigibase-data-access/about-vigibase/ (accessed 26 October 2026).
[16] Uppsala Monitoring Centre. VigiBase FAQ: data standardisation, quality assurance, and interpretationCaveats. https://edit.who-umc.org/vigibase-data-access/vigibase-faq/ (accessed 26 October 2026).
[17] Tandon VR, Mahajan V, Khajuria V, Gillani Z. Under-reporting of adverse drug reactions: a challenge for pharmacovigilance in India. Indian Journal of Pharmacology. 2015;47(1):65-71. https://doi.org/10.4103/0253-7613.150344.
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