Herbal Medicine Around the World: How Brazil, India, the USA, and Europe Regulate It
DOI:
https://doi.org/10.1590/s2175-97902026e24688Keywords:
Integration, Standardization, Global, Legislation, Regulation, InternationalAbstract
Herbal medicines (HM), derived from whole plants or their parts, play a crucial role in primary health care, with approximately Eighty percent of the global population relying on them. The World Health Organization (WHO) is tasked with establishing guidelines for their use, safety, and quality. Despite these standards, risks associated with self-dosing and variability in regulatory frameworks persist. Regulatory approaches differ worldwide, including Brazilian legislation through ANVISA, Indian regulations under the Drugs and Cosmetics Act, the European Medicines Agency (EMA), and the US Food and Drug Administration (FDA). Each framework enforces high standards for quality, safety, and efficacy, involving rigorous testing on human subjects. While significant strides have been made in standardization and therapeutic consistency, challenges remain. Integrating international standards aims to address these issues, focusing on reducing the risks associated with unsafe and ineffective herbal medicines for consumers. Our review tries to reflect on the various herbal regulations across Brazil, India, European Union, and USA and bring out a comparative opinion on various aspects as well as the need for harmonization of these regulations.
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