SYMPOSIUM - HERBAL DRUGS AND BOTANICALS - RESEARCH ARTICLES
Year : 2015 | Volume
: 7 | Issue : 4 | Page : 293--296
Current status of herbal product: Regulatory overview
Department of Regulatory Affairs, Amway Enterprises Pvt. Ltd, Gurgaon, Haryana, India
Department of Regulatory Affairs, Amway Enterprises Pvt. Ltd, Gurgaon, Haryana
A review of the regulatory status of herbal drugs/products was done for few countries forming part of Asia, Africa, America, Europe, and Australia, to understand various categories under which the trade of herbal products is permitted and their premarketing requirements. A critical assessment was done, to know the hindrances in the process of harmonization of herbal products. It has been found that there is a lack of harmonization in the regulatory requirements of herbal products internationally, besides the issues of availability of herbs and their conservation. These are hindering the international trade and growth of the herbal products segment.
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Sharma S. Current status of herbal product: Regulatory overview.J Pharm Bioall Sci 2015;7:293-296
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Sharma S. Current status of herbal product: Regulatory overview. J Pharm Bioall Sci [serial online] 2015 [cited 2022 Jul 1 ];7:293-296
Available from: https://www.jpbsonline.org/text.asp?2015/7/4/293/168030
International Trade of Herbal Drugs is subject to compliance with the International treaties like Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES). CITES, who regulate the international trade of certain species, which are threatened with extinction or which would be reaching the status of being endangered, if their overexploitation is not checked.
Internationally, herbal products are regulated under different classifications, some of which are:
Complimentary medicines Natural health products Prescription medicines Over the counter medicines Supplements Traditional herbal medicines, etc.
The regulatory requirements of these vary considerably. While prescription medicines are strictly regulated, the extent of control on supplements is relatively low.
A review of the regulatory status of the herbal medicines across the globe is given in the present article.
International Regulatory Overview
Herbal drugs are regulated under the Drug and Cosmetic Act (D and C) 1940 and Rules 1945 in India, where regulatory provisions for Ayurveda, Unani, Siddha medicine are clearly laid down. Department of AYUSH is the regulatory authority and mandate that any manufacture or marketing of herbal drugs have to be done after obtaining manufacturing license, as applicable.
The D and C Act extends the control over licensing, formulation composition, manufacture, labeling, packing, quality, and export. Schedule "T" of the act lays down the good manufacturing practice (GMP) requirements to be followed for the manufacture of herbal medicines. The official pharmacopoeias and formularies are available for the quality standards of the medicines. First schedule of the D and C Act has listed authorized texts, which have to be followed for licensing any herbal product under the two categories:
ASU drugs Patent or proprietary medicines.
Herbal products in Malaysia fall under the category of regulated products. Any marketer intending to place the herbal products in the market require to register the productfirst. The applicant is required to be registered with the Malaysia Registrar of Business or Suruhanjaya Syarikat Malaysia under two classifications:
Traditional products Health supplements.
While the authorities mandate only labeling "traditionally used for" in front of any claim made on the traditional product, only those functional claims, which are listed by the authority are allowed in supplements.
The herbal medicines are regulated in the Philippines as traditionally used herbal products. The regulators require that the preparations from plant materials, whose claimed application is based only on traditional experience of long usage, which should be at least five or more decades as documented in medical, historical, and ethnological literatureare permitted to be marketed under this category.
The Bureau of Food and Drugs (BFAD), who are the regulators in the country, mandate registration of the traditionally used herbal products before manufacture, import or market. The extent of control of BFAD includes the brand names of the traditional herbal products as well, and their prior clearance is required, before filing for product registration.
Authentication of the plant specimen needs to be obtained from the Philippine National Museum or any BFAD recognized taxonomist, and for imported products, the certificate of authenticity of the plants from the authorized government agency of the country of origin is accepted. The quality control requirements further lay down that the pharmacopoeial standards. BFAD further mandates that product indications should not require supervision by a physician.
In Nigeria, the trade of herbal products is regulated by National Agency for Food and Drug Administration and Control (NAFDAC) who has classified these products as "Herbal Medicines and Related Products." Premarketing registration of herbal medicines and related products is mandatory in Nigeria. All advertisements require a preclearance from NAFDAC. No advertisement can be made as a cure for any disease conditions listed in "Schedule 1" to the Food and Drug Act 1990.
Saudi Arabia 
Herbal products are classified in Saudi Arabia as traditional products. They are allowed if they have at least 50 consecutive years of traditional use. Their dose and the method of preparation must be same as those used, traditionally.
According to the evidence provided, they may fall under the sub-categories:
Pharmacopoeial evidence for traditional products Nonpharmacopoeial evidence for traditional products.
For the former, the medicinal ingredients, quantity, recommended dose, route of administration, duration of use, dosage form, directions of use, risk information should be same as the Pharmacopoeia and the method of preparation must be traditional.
For the latter category, any two independent references must be provided to supplement the evidence supporting the safety and efficacy of the product, from clinical studies, pharmacopoeias, and textbooks
references, peer-reviewed published articles, data from nonclinical studies on pharmacokinetics, pharmacodynamics, toxicity information, reproductive effects, and the potential genotoxicity or carcinogenicity of an ingredient or information based on previous marketing experience of a finished product.
Therapeutic Goods Administration, the regulatory agency of Australia, regulate herbal products under the category of complementary medicine. Ayurvedic medicine, traditional Chinese medicine, and Australian indigenous medicines are all covered under this category.
Complementary medicines which do not require medical supervision are permitted and have to be entered on the Australian Register for Therapeutic Goods (ARTG) before marketing. The low-risk medicines require to be listed while the medicines for comparatively higher risk therapeutic conditions require registration on the ARTG. Only evidence-based claims which are entered on the ARTG are allowed.
United States of America ,
The botanical products are classified as a drug, food or a dietary supplement by the United States Food and Drug Administration on the basis of the claims or end use. A product that is used to prevent, diagnose, mitigate, treat or cure a disease would fall under the category of drug. If the intended use of a botanical product is to affect the structure or function of the human body, it may be classified as either a drug or a dietary supplement. As per FDA, the drug must be marketed under an approved New Drug Application (NDA).
FDA regulates the dietary supplements under the Dietary Supplement Health and Education Act of 1994. These do not require premarket approval and it's the responsibility of the marketer to ensure the safety and labeling compliance of their products with the regulations. The claims need to comply with the regulatory guidelines issued by the FDA. The manufacturing of dietary supplements should be done as per the current GMP for dietary supplements.
Since January 1, 2004, Health Canada regulates herbal remedies and traditional medicines such as Ayurvedic medicine, under the natural health products regulations. The regulations mandate that a manufacturer, packer, labeler or importer need to have a prior registration with Health Canada before commencing any such activity.
The process involves registration of the manufacturing site/s along with the products. Complete data on product composition, standardization, stability, microbial and chemical contaminant testing methods and tolerance limits, safety and efficacy along with ingredient characterization, quantification by assay or by input needs to be submitted to Natural Health Product Directorate (NHPD). The authority mandate that NHPs must comply with the contaminant limits and must be manufactured as per the GMP norms.
European Union 
The European Medicine Agency have laid down two ways of registration of herbal medicinal products: (1) A full marketing authorization by submission of a dossier, which provides the information on quality, safety and efficacy of the medicinal products including the physicochemical, biological or microbial tests and pharmacological, toxicological and clinical trials data; under directive 2001/83/EC. (2) For traditional herbal medicinal products, which do not require medical supervision, and where evidence of long traditional of use of medicinal products exists, and adequate scientific literature to demonstrate a well-established medicinal use cannot be provided, a simplified procedure under directive 2004/24/EC exists.
The evidence of traditional use is accepted as evidence of efficacy of the product. However, authorities may still ask for evidence to support safety. Quality control requirements require physicochemical and microbiological tests to be included in the product specifications. The product should comply to the quality standards in relevant pharmacopoeias of the member state or European Pharmacopoeia. The bibliographic evidence should support that the product has been in medicinal use for at least 30 years out including at least 15 years within the European community. The application for traditional use registration shall be referred to the Committee for Herbal Medicinal Products, if the product has been in the community for less than 15 years, but otherwise qualifies for the simplified registration procedure under the directive.
Factors such as growing trend of consumer acceptance of herbal products for healthcare, beauty care and diet supplementation, globally, focus of researchers and pharmaceutical industry on herbal sector for economical reasons, and more and more countries according legal status to herbal products and permitting legalized trade of these products in their countries indicate growth opportunity for herbal products. However, challenges like developing globally acceptable products due to differences in regulatory requirements related to quality, safety and efficacy data, differences in the status of ingredients and excipients are hindering the growth of herbal drug industry. Global harmonization of regulations on herbal products would work in the direction of providing the much-needed impetus to this potential segment.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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