The safety of herbal medicines in low- and middle-income countries (LMICs): current landscape and promoting the pharmacovigilance practices.

About eighty-eight percent of people worldwide rely on traditional and complementary medicine for their primary healthcare needs, with many pharmacies in developed countries offering plant-based over-the-counter medications. However, the increasing use of medicinal products, especially when combined with pharmaceuticals, poses health risks that are often underreported, particularly in low- and middle-income countries. Before 2012, Pakistan had no specific laws or regulatory bodies to oversee the manufacturing of herbal and alternative medicines. The establishment of the Drug Regulatory Authority of Pakistan (DRAP) in 2012 marked the beginning of regulatory oversight for herbal medicines for licensing, enlistment and Pharmacovigilance (PV). In 2015, DRAP created a national pharmacovigilance centre, and by 2018, it became a full member of the WHO's Program for International Drug Monitoring (PIDM). The Pharmacovigilance Rules of 2022 require all therapeutic product manufacturers to report adverse drug reactions (ADRs) and mandate the submission of Periodic Benefit Risk Evaluation Reports (PBRER) for various drugs. However, there are provisions allowing for PBRER submission waivers in certain cases. While Pakistan's pharmacovigilance system currently focuses on pharmaceutical and biological medicines, there is a pressing need to expand its scope to include herbal and traditional products. Strengthening the system involves setting robust quality and safety standards, conducting scientific research, regulating manufacturing practices, and ensuring proper labelling of herbal medications.