Systematic Review of Global Practices and Challenges in Pre- and Post-Marketing Surveillance of Polyherbal Formulations

Background and aims: Polyherbal preparations have emerged as promising solutions for various diseases and conditions globally, owing to their combined benefits derived from multiple herbal plants. Despite their widespread utilization, significant gaps remain in the safety and efficacy of polyherbal products, particularly regarding the lack of pre-marketing and post-marketing surveillance. Methods: The pre-marketing and post-marketing surveillance of polyherbal formulations were assessed through a review of literature from various sources, including books and databases such as PubMed, Google Scholar, and ScienceDirect, covering the period from 2007 to 2023. Only sources published in the English language were included in this review. A total of twenty randomly selected polyherbal preparations were subjected to a detailed examination for further identification, screening, eligibility assessment, and inclusion in the study. Results: All selected polyherbal products available in the global market had undergone some form of pre-marketing surveillance, including in vivo, in vitro studies, or meta-analyses. However, post-marketing surveillance was found to be lacking for 85% of the selected polyherbal products. The limited data on long-term safety and efficacy, coupled with the absence of consistent follow-up, underscores a critical gap in ensuring product safety. Conclusion: The increasing prevalence of polyherbal products in the market underscores the necessity for enhanced pre-clinical, clinical, and post-marketing studies. Improved regulation and monitoring are essential to ensure that these formulations are effective, safe, and associated with fewer side effects.