Proactive Pharmacovigilance of Unani drugs; Prospects and Challenges

Abstract

Ethnopharmacological relevance: Traditionally herbal (Unani) medicines are considered to be safe for therapeutic usage without any major harmful effects. However, besides beneficial therapeutic effects several suspected adverse effects have been reported in the literature as well asclinical practice that inter alia include hepatotoxicity, renal failure and allergic reactions. Since the safety of patients remains central to any kind of therapy, it becomes imperative for the relevant regulatory authorities to take appropriate measures required to safeguard the public health by ensuring that all herbal medicines are safe, effective and of standard quality. Therefore, the role of pharmacovigilance in Unani medicine is essential to determine which adverse effects cross the line of a drug�??s efficacy and safe therapeutic use. For safe and effective use of Unani drugs, constant vigil and monitoring is required for each medicine throughout its life cycle. This review aims to provide a systematic summary on the importance, gaps, challenges and prospects of pharmacovigilance in the Unani system of medicine. Materials and methods: Relevant literature regarding pharmacovigilance of traditional system of medicine including Unani drugs was retrieved from databases like Web of Science, Google Scholar, Baidu Scholar, Springer, PubMed, SciFinder and ScienceDirect. Information was also collected from classic books of Unani medicine and conference papers on pharmacovigilance of herbal drugs. Results: In order to achieve operational competence in the development of pharmacovigilance for Unani drugs and for the best practice model for Unani medicine, a systematic analysis of the areas to be focussed upon and the challenges ahead, starting from proper nomenclature of Unani drugs, cultivation, procurement, drying, transportation, processing, labelling and dispensing was undertaken. All the crucial areas were identified and an understanding for the recognition and management of adverse reactions due to Unani drugs was developed. Conclusions: Pharmacovigilance is a process of identification, documentation and monitoring of adverse drug reaction of selected medicine and reporting to the regulatory body, so that appropriate decisions can be made for the protection of public health. Herbal (Unani) medicines are generally considered as safe medicine, however several case reports of adverse drug reactions have been reported, so they need consistent monitoring for adverse effects. In this regard, this review will provide an insight for the need of the pharmacovigilance and regulation of Unani drugs including their procurement, processing, manufacturing, dispensing and formulation of a comprehensive policy for effective pharmacovigilance of these drugs.