BUILDING A SAFER PEDIATRIC AYURVEDA SYSTEM: PHARMACOVIGILANCE GAPS AND THE CHILD-SAFE MONITORING FRAMEWORK
DOI:
https://doi.org/10.5281/zenodo.22296859Keywords:
Ayurveda, adverse drug reaction, children, herbal medicine, medication safety, pharmacovigilance, pediatric pharmacology, traditional medicine.Abstract
Background
Ayurvedic medicines are commonly used in children for preventive and therapeutic purposes. However, pediatric safety cannot be inferred from traditional use alone. Children differ from adults in drug absorption, metabolism, organ maturity, dose requirements and ability to communicate adverse effects. Product quality, caregiver administration, concurrent medicines and duration of exposure also influence safety.
Objective
To identify current gaps in pediatric pharmacovigilance of Ayurvedic medicines and propose a practical monitoring framework.
Methods
A focused integrative review was conducted using World Health Organisation guidance, pediatric pharmacovigilance recommendations, Indian AYUSH pharmacovigilance resources and relevant literature on herbal medicine safety.
Findings
Major gaps include underreporting, poor product and batch identification, incomplete dose documentation, inadequate recording of herb–drug interactions, limited developmental follow-up and weak linkage between clinical reporting and product-quality laboratories. Existing systems rarely analyse pediatric reports by developmental age or capture caregiver administration errors.
Conclusion
Pediatric Ayurvedic pharmacovigilance requires a dedicated approach that integrates child characteristics, precise product identification, exposure assessment, longitudinal follow-up, causality evaluation, and analytical investigation. The proposed CHILD-SAFE Ayurveda framework may support standardised reporting, signal detection and regulatory action.
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