PHARMACOVIGILANCE OF RASAUSHADHI: A CRITICAL REVIEW OF ADVERSE EVENT REPORTS, SAFETY SIGNALS AND THE REPORTING SYSTEM IN INDIA
Background: Rasaushadhi (herbo-mineral and herbo-metallic formulations) carry particular safety concerns because they intentionally contain metals such as mercury, lead and arsenic. India has had a national pharmacovigilance programme for Ayurveda, Siddha and Unani drugs since 2008, restructured in 2017, yet signals relating to Rasaushadhi continue to come mainly from case reports and market surveys. Objective: To review the sources of safety information on Rasaushadhi, the structure and performance of the pharmacovigilance system for Ayush drugs, and the barriers to effective reporting. Methods: A critical narrative review of case reports and case series, market surveys, preclinical and clinical safety studies, surveys of practitioners, and descriptions of the national pharmacovigilance programme. Results: The most serious documented harms are metal poisonings, including lead poisoning clusters and chronic arsenic poisoning with blood arsenic of 93–330 µg/L after months to years of use. Market surveys have found heavy metals in every one of 42 over-the-counter products in one Indian study. Practitioner surveys show low reporting: in one, 92% of Ayurveda doctors had heard of pharmacovigilance but only 5% knew how to report an adverse reaction. Clinical trials rarely include metal biomonitoring, and causality assessment tools are not adapted to multi-ingredient formulations. Conclusion: Pharmacovigilance of Rasaushadhi needs active surveillance with laboratory confirmation, product-level identification, training of practitioners and pharmacists, and integration of metal biomonitoring into clinical studies.