Global Regulation for Herbal Products
Last Updated: 04/04/2024
Reports of the use of Herbal medicines date back thousands of years, globally. In the last few decades, naturopathy has drawn a lot more attention from the public in industrialized nations, leading to an increase in the usage of herbal and medicinal plants. An inventive study endeavour aimed at identifying the benefits of conventional medical systems about their safety and effectiveness may lead to an improved application of these supplementary medical systems.
Herbal products are governed globally under a variety of classifications, some of which include:
- Complimentary medicines
- Natural health products
- Prescription medicines
- Over the counter medicines
- Health Supplements
- Traditional Herbal Medicines, etc.
India
Herbal drugs represent a main part of all the known systems of health in India such as Ayurveda, Yoga, Unani, Naturopathy, Siddha and Homeopathy except Allopathy. In India, the Central Drugs Standard Control Organization (CDSCO), AYUSH, AND the D&C Act 1940 & 1945 (amendment) control herbal medicines. 2
The Department of AYUSH serves as the regulatory body, stipulating that the production or distribution of herbal medications must secure a manufacturing license as mandated.
The Drugs and Cosmetics (D&C) Act governs the licensing, composition, production, labelling, packaging, quality, and exportation of herbal formulations. Within this act, Schedule “T” outlines the requirements for Good Manufacturing Practice (GMP) that are necessary for the creation of herbal medicines. To ensure the quality of these medicines, official pharmacopeia’s and formularies are referenced. The first schedule of the D&C Act enumerates authorized texts that are essential for licensing any herbal product, which are categorized into:
Table: Schedules for Herbal Products in CDSCO 1
The USA
In the United States, the Food and Drug Administration (FDA) categorizes botanical products as drugs, foods, or dietary supplements, depending on their claimed benefits or intended use. For example, a botanical product intended for use in treating a disease would generally be regulated as a drug; Botanical Drugs (e.g., consists of vegetable material, complex mixtures, lack of a distinct active ingredient) are required to be marketed with an approved New Drug Application (NDA) as per FDA guidelines. A botanical product taken by mouth, labeled as a dietary supplement, and intended for use to affect the structure or function of the body would generally be regulated as a dietary supplement; a raw or dried botanical intended for use as an ingredient to flavor food would generally be regulated as a food or as a food additive, depending on whether the botanical was generally recognized as safe for its intended use in food; and a lotion containing botanical ingredients and intended for use in moisturizing the skin would generally be regulated as a cosmetic1
The FDA oversees dietary supplements under the Dietary Supplement Health and Education Act (DSHEA) of 1994, which exempts these products from premarket approval. However, marketers are obligated to ensure their products are safe and that their labels comply with FDA regulations. Any claims made about the supplements must adhere to FDA’s regulatory guidelines. Furthermore, the production of dietary supplements must align with the current Good Manufacturing Practices (GMP) specifically set for dietary supplements. 3
European Union
In Europe, there are three major regulatory paths for introducing a herbal medicinal product to market in EU member states: 2
- Full Marketing Authorization: This route involves submitting a comprehensive dossier detailing the product’s quality, safety, and efficacy. The dossier must include information from physicochemical, biological, or microbial tests, along with data from pharmacological, toxicological, and clinical trials, as per Directive 2001/83/EC.
- Simplified Procedure for Traditional Herbal Medicinal Products: This process is for herbal medicines that do not need medical supervision and have a long history of traditional use. If there is no sufficient scientific evidence to demonstrate well-established medicinal use, but there is significant traditional evidence, a simplified registration under Directive 2004/24/EC is available.
For the latter, the long-standing traditional use of the product is considered proof of its efficacy, though authorities may still request evidence to verify its safety. Quality control standards necessitate the inclusion of physicochemical and microbiological testing in the product’s specifications. The product must meet the quality standards outlined in the pharmacopoeias of the member state or the European Pharmacopoeia. The application must be supported with bibliographic evidence showing that the product has been used medicinally for at least 30 years, including a minimum of 15 years within the European Community. Applications for traditional use registration that do not meet the 15-year European Community requirement but are otherwise eligible for simplified registration under the directive should be submitted to the Committee for Herbal Medicinal Products.
Article 16a(1) of Directive 2001/83/EC
- As long as there is enough evidence of safety and efficacy, there is no need for clinical studies or tests to determine safety and effectiveness.
- Involves evaluating safety and efficacy data, primarily from bibliographic sources.
- Required to have been in use for a minimum of 30 years, with at least 15 of those years spent inside the EU
- Meant to be used without a doctor’s supervision and aren’t given via injection
Article 10a of Directive 2001/83/ECx1
- Scientific research proving that the medication’s active ingredients have been used for at least 10 years in the EU for established medical purposes, with proven efficacy and a reasonable degree of safety
- Involves evaluating safety and efficacy data, primarily from bibliographic sources.
Article 8(3) of Directive 2001/83/EC
- Data on efficacy and safety from the company’s own research or from a combination of research projects and references
Conclusion:
Herbal therapy for diabetes offers a globally recognized approach to manage diabetes, along with their associated complications. While , (allopathic) treatments may have limitations in efficacy, pose risks of adverse effects, and often come with high costs, herbal remedies provide a natural, affordable, and effective alternative for individuals worldwide.
Despite regulatory efforts aimed at enhancing the marketplace, significant challenges persist, leading to considerable variability in the quality and safety of products, particularly herbal ones. There is an ongoing need for sustained initiatives and the development of advanced methods to evaluate dietary supplements’ quality, focusing on aspects such as purity, bioavailability, and safety. We at Guires FRL CDMO provide end-to-end solutions when it comes to herbal product development from scratch to launch. With high expertise and experience, we take immense pride in ensuring smooth and hassle-free experience with assured safety for our clients.
References:
- Singh, S., & Shukla, V. K. (2021). Current regulations for herbal medicines in India. International Journal of Drug Regulatory Affairs, 9(2), 30-34.
- https://www.ema.europa.eu/en/human-regulatory-overview/herbal-medicinal-products
- https://www.fda.gov/regulatory-information/search-fda-guidance-documents/complementary-and-alternative-medicine-products-and-their-regulation-food-and-drug-administration#f8
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