Title : Public safety risks of unregulated herbal OTC products: A case for strengthening ADR reporting and public awareness in Pakistan
Abstract:
The widespread use of herbal and over-the-counter (OTC) products in Pakistan has raised significant public safety concerns due to limited regulatory oversight and underreporting of adverse drug reactions (ADRs). Despite the Drug Regulatory Authority of Pakistan (DRAP) establishing pharmacovigilance guidelines and e-reporting systems for therapeutic goods, many herbal OTC products remain unregistered or inadequately monitored, increasing the risk of adverse events among consumers. This study examines the current landscape of unregulated herbal OTC products in Pakistan, highlighting gaps in safety monitoring, regulatory compliance, and public awareness. Through analysis of available ADR data, regulatory frameworks, and market surveys, key risk factors associated with unregulated products are identified. The findings underscore the urgent need for strengthening ADR reporting mechanisms, enhancing public education on safe herbal product use, and implementing rigorous post-market surveillance strategies. Integrating traditional medicine into a robust pharmacovigilance framework can safeguard public health while promoting responsible use of herbal and OTC products in Pakistan. Recommendations include targeted awareness campaigns, mandatory ADR reporting for manufacturers, and collaboration between regulatory authorities and healthcare professionals to improve safety monitoring and consumer confidence.
