Vishwa Kumari Nisansala De Silva
* 
, Ruwini Nishadini Senarathne
, Shehara Lakchani Abeysinghe Gunawardana
Abstract
Background and aims: Polyherbal preparations have emerged as promising solutions for various diseases and conditions worldwide, owing to their combined benefits from multiple herbal plants. Despite their widespread use, there remains a major gap in safety and effectiveness of polyherbal products including lack of pre-marketing and post-marketing surveillance. Methods: The pre-marketing and post-marketing surveillance of polyherbal formulations were assessed using literature from book sources and databases like PubMed, Google Scholar, and ScienceDirect (2007-2023). Only sources published in the English language were considered. The randomly selected twenty polyherbal preparations underwent detailed examination for further identification, screening, eligibility, and inclusion. Results: All selected polyherbal products in the global market had undergone some form of pre-marketing surveillance such as in-vivo, in-vitro or meta-analyses. However, post-marketing surveillance was lacking for 85% of selected polyherbal products. Limited data on long-term safety and efficacy, along with the absence of consistent follow-up, highlight a critical gap in ensuring product safety. Conclusion: The rise in polyherbal products in the market emphasizes the need for improved pre-clinical, clinical, and post-marketing studies. Better regulation and monitoring are essential to ensure these formulations are effective, safe, and have fewer side effects.