Mexican Regulatory Framework for Herbal Remedies, Challenges in Pharmacovigilance and Marketing

Abstract

Introduction: Pharmacovigilance is essential for the protection of public health as it encompasses the detection and prevention of adverse effects of medicinal products. In Mexico, medicines are regulated through a six-level system, while herbal remedies occupy a particular position in health regulation.

Objective: To analyze the limitations of the Mexican regulatory framework regarding pharmacovigilance and the over-the-counter sale of herbal remedies, contrasting it with the recommendations of the World Health Organization.

Methods: A literature review and documentary analysis of Mexican regulations applicable to herbal remedies was conducted, including the General Health Law, the Regulations on Health Supplies, and Official Mexican Standards NOM-072-SSA1-2012, NOM-073-SSA1-2015, NOM-248-SSA1-2011, and NOM-220-SSA1-2016. Guidelines and recommendations from the World Health Organization were consulted, such as the Practical Manual for the Evaluation of Pharmacovigilance Systems, International Regulatory Cooperation for Herbal Medicines, 15th annual meeting of the WHO-IRCH netbook, and Traditional Medicine, as international references for comparative analysis.

Conclusions: The Mexican regulatory framework has significant limitations in the systematic documentation of adverse effects related to herbal remedies, especially considering that these products are freely available and are based mainly on traditional knowledge rather than formal scientific evidence. This situation contrasts with the recommendations of the World Health Organization, which promotes integrated pharmacovigilance systems for both conventional and traditional medicines. It is necessary to develop a specific pharmacovigilance system for herbal remedies and establish more effective mechanisms for documenting their adverse effects.