Introduction: Children are vulnerable to adverse drug reactions (ADRs) and medical device-related adverse events (MDAEs), yet the Integrated Management of Neonatal and Childhood Illness (IMNCI) has no routine step to detect them.

Objective: To describe neonatal and paediatric ADRs and MDAEs reported at a tertiary care centre and propose an IMNCI-aligned, artificial intelligence (AI)-supported safety framework.

Methods: Safety events were identified through pharmacovigilance and materiovigilance surveillance among children aged 0-18 years at S.M.S. Medical College and attached hospitals, Jaipur (wards, intensive care, outpatient, emergency and specialty services). From April 2026 to September 2026, ADRs and MDAEs were reported to the Pharmacovigilance and Materiovigilance Programmes of India. Anonymised cases were described by demographics, suspected medicine/device, manifestation, seriousness, causality (ADRs: WHO-UMC; MDAEs: MvPI guidelines) and outcome. Analysis was descriptive.

Results: Of 82 patients, 46 (56.1%) were male; 34 (41.5%) were aged 6-12 years, 30 (36.6%) under 1 year and 18 (22.0%) 1-5 years. Among 52 ADRs and 30 MDAEs, cutaneous/hypersensitivity reactions and IV cannula infiltration/extravasation or phlebitis were commonest; 19 ADRs and 11 MDAEs were serious.

Proposed framework: We propose adding ADR/MDAE screening to IMNCI follow-up and referral for children under 5 years, supported by an AI layer that structures reports, links drugs or devices to events, flags dechallenge and rechallenge, and prioritises concerns for clinician review. Future work will evaluate the framework.

Conclusion: Over a third of reported ADRs and MDAEs were serious, and most affected children were under 5 years, the IMNCI age group. AI-supported screening within IMNCI could strengthen early detection, reporting and patient safety.

Jaya Sharma is a faculty member and researcher whose work focuses on pharmacovigilance, materiovigilance and medication safety in neonatal and paediatric care. She is completing her Ph.D. in Pharmacology at S.M.S. Medical College, Jaipur, after postgraduate training at R.U.H.S. College of Medical Sciences, Jaipur.

She published the case report “Paediatric pure motor Guillain-Barré syndrome without antecedent infection: An uncommon clinical scenario” in the Karnataka Paediatric Journal, the journal of the Indian Academy of Paediatrics, Karnataka State Branch, India. The report highlights the diagnostic challenges of an atypical presentation and the importance of early recognition and appropriate management, and it has received 1,885 full-text views and 6,038 downloads.

She has contributed to nearly 15 publications in national & international journals indexed in Pubmed, Scopus and holds a UK registered design for diagnostic equipment (Design No. 6472098). She also serves as Deputy Coordinator, Pharmacovigilance and Materiovigilance, at JNUIMSRC, Jaipur, India. She aims to contribute to safer, evidence-based care for children and neonates.