HERBAL AND DIETARY SUPPLEMENT-INDUCED HEPATOTOXICITY: RETHINKING PHARMACOVIGILANCE STRATEGIES IN THE INDIAN CONTEXT
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Abstract
Herbal and dietary supplements (HDS) are consumed extensively worldwide, often under the perception of being safe. However, herb-induced liver injury (HILI) has emerged as an important subset of drug-induced liver injury (DILI), with wide regional variability. Reports suggest that HDS account for about 20% of DILI cases in the United States and nearly 30% in European registries, whereas Asian data show heterogeneity, ranging from 70% in Singapore to 14% in India. The Indian scenario is particularly complex, with most data derived from tertiary-care studies rather than national registries. Pharmacovigilance efforts are currently split between the Pharmacovigilance Programme of India (PvPI), with Adverse Drug Reaction Monitoring Centres (AMCs), and the Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy (AYUSH) pharmacovigilance network. Despite these structures, under-reporting, fragmented reporting systems, and lack of laboratory integration remain major barriers. This review discusses global and Indian perspectives on HDS-related hepatotoxicity and outlines future opportunities, including digital health tools, blockchain-based supply-chain monitoring, and integration of public health surveillance, to strengthen herbal safety monitoring in India.
Introduction
Herbal and dietary supplements (HDS) constitute one of the fastest-growing sectors of global healthcare, driven by increasing consumer demand for “natural” therapies. According to the latest Statista report, the global market for HDS is projected to reach nearly USD 300 billion by 2028 [1]. India is both a leading producer and a significant consumer in this sector, exporting Ayurvedic medicines and nutraceutical products to over 150 countries [2]. Although these products enjoy widespread cultural acceptance, concerns are rising over their safety, with hepatotoxicity emerging as one of the most serious adverse effects.
HerB-induced liver injury (HILI) contributes to 15–20 % of all reported drug-induced liver injuries (DILI) worldwide [3]. In India, the situation is complicated by extensive polyherbal use, inadequate labeling, and minimal post-marketing monitoring. The Pharmacovigilance Programme of India (PvPI) and the Ministry of Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy (AYUSH) pharmacovigilance network operate independently, leading to fragmented data [4,5]. Bridging these systems is essential for effective detection and prevention of herbal-related liver injury.
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Dr. Fatima Rani
MD Pharmacology, Junior Resident, King George's Medical University, Lucknow, UP, India.
Dr. Shubham Biswas
MD Pharmacology, Junior Resident, King George's Medical University, Lucknow, UP, India.
Dr. Siddhant Mehrotra
MD Pharmacology, Junior Resident, King George's Medical University, Lucknow, UP, India.
Dr. Sarvesh Singh
MD Pharmacology, Professor, King George's Medical University, Lucknow, UP, India.