Herbal Products Regulations in a Few Countries-A Brief Overview

Abstract

Herbal medicines have been used by mankind from time immemorial. Moreover, many modern medicines are originated from plant sources. In earlier days, patients were dependent on herbs for treatment and well-being. However, due to the advent of the industrial revolution and modern science, the scenario of treating diseases has changed over a period of time. Majority of patients started preferring allopathy medicines due to their several advantages over herbal medicines. However, due to long term treatment by allopathic medicines for chronic diseases led to side effects, patients are now drifting back to the traditional medicines. Herbal medicines have their own drawbacks, viz., lack of safety and efficacy data, standardization difficulties, not well established legislative controls and a few issues with adverse drug reactions. Drug regulations per se were always the prime focus and they are said to be dynamic. There are a few differences in regulations of herbal drugs among various countries. Regulatory authorities of countries are working to evolve the regulations to govern herbal medicines more effectively. A brief overview of the regulations related to a few developing and developed countries have been dealt here.

Medicinal herbs and multiple sclerosis: Overview on the hard balance between new therapeutic strategy and occupational health risk

“…To date, herbal drug regulation, differ across countries ( Bhat et al, 2019 ), and regulatory authorities and the scientific community are working to evolve regulations of herbal medicines more effectively and convergence of different environments. In Europe, these products are instead called using the terms botanical or herbal.…”

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“…There is a rise in the use of herbal medicines across countries, which can also be referred to with terms including alternative medicines, botanical products, complimentary medicines, natural products and traditional medicines, with an appreciable proportion of the world’s population now using herbal medicines to treat some of their diseases ( Byard et al, 2017 ; Alsayari et al, 2018 ; Eddouks et al, 2020 ; Geck et al, 2020 ; Market Data Forecast, 2021 ). Overall, it is expected that the herbal medicine market will grow at an annual compounded growth rate of over 7.2% between 2021 and 2026 due to their lower costs, accessibility, and belief that herbal medicines can promote healthier life-styles, treat diseases such as the metabolic syndrome and gastrointestinal problems, and typically have less side-effects than prescribed medicines, which can be a concern with the toxicity of some prescribed medicines ( Calitz et al, 2015 ; Nuryunarsih, 2016 ; Alsayari et al, 2018 ; Bhat et al, 2019 ; Ekar and Kreft, 2019 ; Eddouks et al, 2020 ; Holleran et al, 2020 ; Market Data Forecast, 2021 ). This is despite concerns with the evidence base of some herbal medicines ( Geck et al, 2020 ; Holleran et al, 2020 ; Popattia et al, 2021 ), as well as potentially adverse effects including increased liver and kidney toxicity exacerbated by some herbal medicines containing heavy metals and naturally occurring organic toxins ( Calitz et al, 2015 ; Brown, 2017 ; Byard et al, 2017 ; Kum et al, 2021 ).…”

“…However of concern are the differences in the legislation surrounding the regulations and sale of herbal medicines across countries ( Dwyer et al, 2018 ; Bhat et al, 2019 ). In the United States, for instance, the Food and Drug Administration (FDA) requires that herbal supplements labels should include information pertaining to its name, name and address of the manufacturer, and a complete list of the ingredients including the amount of each active substance (@mayo Clinic, 2021 ).…”

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“…Subsequently, such transformations are occurred in the pathogens for other antibiotics make them multi-drug resistant (MDR) that are known as “superbugs.”[ 4 16 17 18 ] Nevertheless, the developing countries were continued to use these traditional therapeutic methods as the WHO reported that >80% population of these countries depend on naturally occurring herbal drugs due to its cost-effectiveness. [ 19 20 21 ]…”