Quality and safety of herbal medical products: Regulation and the need for quality assurance along the value chains1 (original) (raw)
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Booker et al Turmeric Value Chains-JEP-2014
Ethnopharmacological relevance: Herbal medicine value chains have generally been overlooked compared with food commodities. Not surprisingly, revenue generation tends to be weighted towards the end of the chain and consequently the farmers and producers are the lowest paid beneficiaries. Value chains have an impact both on the livelihood of producers and on the composition and quality of products commonly sold locally and globally and consequently on the consumers. In order to understand the impact of value chains on the composition of products, we studied the production conditions for turmeric (Curcuma longa) and the metabolomic composition of products derived from it. We aimed at integrating these two components in order to gain a better understanding of the effect of different value chains on the livelihoods of some producers. Materials and methods: This interdisciplinary project uses a mixed methods approach. Case studies were undertaken on two separate sites in India. Data was initially gathered on herbal medicine value chains by means of semi-structured interviews and non-participant observations. Samples were collected from locations in India, Europe and the USA and analysed using 1 H NMR spectroscopy coupled with multivariate analysis software and with high performance thin layer chromatography (HPTLC). Results: We investigate medicinal plant value chains and interpret the impact different value chains have on some aspects of the livelihoods of producers in India and, for the first time, analytically assess the chemical variability and quality implications that different value chains may have on the products available to end users in Europe. There are benefits to farmers that belonged to an integrated chain and the resulting products were subject to a higher standard of processing and storage.
Value chain analysis has been applied to a variety of consumer goods, but only in the last 10 years has it been applied to medicinal plant production. By examining medicinal plant value chains (MPVCs), it is possible to gain a better understanding of the role of different actors and inputs in the chain and their influence over chain management. Understanding the process is a vital step toward suggesting any meaningful strategies for improvement. The cultivation of medicinal plants is a relatively new industry, and wild collection represents the main route of supply in terms of the number of species collected . On many occasions, wild medicinal plants are preferred by traditional healers and consumers over cultivated ones [20], as there is a general feeling that wild plant species are more clinically effective.
Journal of Ethnopharmacology, 2014
Ethnopharmacological relevance: Herbal medicine value chains have generally been overlooked compared with food commodities. Not surprisingly, revenue generation tends to be weighted towards the end of the chain and consequently the farmers and producers are the lowest paid beneficiaries. Value chains have an impact both on the livelihood of producers and on the composition and quality of products commonly sold locally and globally and consequently on the consumers. In order to understand the impact of value chains on the composition of products, we studied the production conditions for turmeric (Curcuma longa) and the metabolomic composition of products derived from it. We aimed at integrating these two components in order to gain a better understanding of the effect of different value chains on the livelihoods of some producers. Materials and methods: This interdisciplinary project uses a mixed methods approach. Case studies were undertaken on two separate sites in India. Data was initially gathered on herbal medicine value chains by means of semi-structured interviews and non-participant observations. Samples were collected from locations in India, Europe and the USA and analysed using 1 H NMR spectroscopy coupled with multivariate analysis software and with high performance thin layer chromatography (HPTLC). Results: We investigate medicinal plant value chains and interpret the impact different value chains have on some aspects of the livelihoods of producers in India and, for the first time, analytically assess the chemical variability and quality implications that different value chains may have on the products available to end users in Europe. There are benefits to farmers that belonged to an integrated chain and the resulting products were subject to a higher standard of processing and storage.
Fitoterapia, 2012
Fundamental to herbal medicine quality is the use of 'authentic' medicinal herb species. Species, however, 'represent more or less arbitrary and subjective man-made units'. Against this background, we discuss, with illustrative examples, the importance of defining species boundaries by accommodating both the fixed (shared) diagnostic and varying (within-species) traits in medicinal herb populations. We emphasize the role of taxonomy, floristic information and genomic profiling in authenticating medicinal herb species, in addition to the need to include within species phytochemical profile variations while developing herbal extract identification protocols. We outline the application of species-specific genomic and phytochemical markers, chemoprofiling and chemometrics as additional tools to develop qualifying herbal extract references. We list the diagnostic traits available subsequent to each step during the medicinal herb extract manufacturing process and delineate limits to qualification of extract references.
A Proposal for a Quality System for Herbal Products
Journal of Pharmaceutical Sciences, 2013
Today, there is an increasing worldwide demand for botanicals. Developing countries heavily rely on plant-derived medicines for their primary healthcare. One reason amongst many is the relatively inexpensive process economics and the lack of stringent product governance associated with the exploitation of traditional plant medicines compared with modern medicine. Developed countries impose stringent good manufacturing practices and quality control measures on drug products derived from any manufacturing process, regardless of the primary raw material. However, several factors hamper the full-scale application of traditional plant medicines: lack of implementation of effective quality assurance in the manufacturing process; lack of traceability in the supply chain and associated value additions; and inefficient identification of molecular species that affect the therapeutic efficacy of the final product. There lacks an assessable, causative, and prognostic relationship between the raw materials, the manufacturing process and the final product quality. This article suggests some solutions that may be adopted by the phytodrug industry to widen its global reach and retain its credibility. Primarily among them is the implementation of hazards analysis and critical control point in the manufacturing process and employment of process analytical technology for ensuring minimal deviation from the manufacturing process of phytotherapeutics.
Turmeric (Curcuma longa L.) products: What quality differences exist?
Journal of Herbal Medicine, 2019
Background: Curcuma longa L. (root and rhizome), commonly known as turmeric, is a plant of high medicinal and economic value globally, including within the EU where it is mainly used as a food and food supplement. Its key active ingredients have been studied extensively, but concerns remain about the composition and thus the quality of extracts and products on the market. Recently, problems of adulteration with other Curcuma species and general poor quality have been detected within crude turmeric powders and final products. This study aimed to investigate the chemical variation of turmeric finished products available in the UK and identify the quality of turmeric products obtained from specific stages of the supply chain, with a focus on quality differences in the UK. 1 H-NMR spectroscopy metabolomics coupled to Principle Component Analysis (PCA) and HPTLC methods were used for the phytochemical and metabolomics investigation of 72 turmeric samples, including crude powders, intermediate products from different manufacturing stages and commercial products obtained from health food stores and the Internet. A significant variation in the chemical composition of turmeric finished products, especially in the ones containing turmeric extracts, was found. Several products were found to contain only curcumin or curcuminoids, while the other active ingredients and marker compounds of C. longa were lacking. Products obtained from different stages of the Pukka value chain presented similar chemical composition, with the intermediate products (S57-59) showing the highest amount of active ingredients. Consequently, the manufacturing practices involved in the production of turmeric food supplements are critical stages to obtain high-quality final products. Often the focus has been only on the primary material, its natural variation and forms of production. This study highlights the importance of developing well-controlled integrated systems for the quality assurance of dietary supplements throughout the supply chain from seed to final product.
Research Square (Research Square), 2023
Phytochemical standardization of herbal materials involves establishing consistent levels of one or more active ingredients or markers. It ensures the authenticity and quality of herbal materials, extracts, and medicinal products. We successfully applied the Herbal chemical Markers ranking system (Herb MaRS) originally proposed for quality assurance of complex herbal products, to establish markers for controlling the quality of herbal raw materials. We used the most commercially consumed plant materials in Uganda, as a case study.
Quality, Safety, and Efficacy of Herbal Products through Regulatory Harmonization
Therapeutic Innovation & Regulatory Science, 2011
n a t u r a l h e a l t h p r o d u c t s 45 Quality of herbal medicines is a great concern to consumers and regulators throughout the world. The quality of herbal medicines mainly depends on regulatory requirements of respective countries. To probe the role of regulatory standards and their harmonization in improving quality, safety, and efficacy, legislation on herbal medicines of different countries was analyzed. Results show that different countries have been changing and upgrading quality re-quirements over the last few years, and those who have no legislation presently have started framing suitable legislation. Like other countries, India has also adopted prudent measures to improve the quality of herbal medicines. Though there is a general trend to incorporate stringent measures worldwide, there is little initiative to harmonize regulations, which is essential for providing quality herbal medicines globally.
Herbal Drug Standardization: A Systemic Review
Journal of Drug Delivery and Therapeutics
The demand for herbal medicinal products and materials is rising, and maintaining their quality is therefore becoming increasingly important. Numerous physical, chemical, and geographical factors that affect these materials' quality also affect the quality of the herbals. In addition, the quality of herbal materials is becoming increasingly a concern due to adulteration. The quality characteristics of the herbal material the herbal pharmaceuticals are assessed using a variety of chemical and phytochemical tests, analytical techniques, and hyphenated analytical techniques. Formulations made from herbs are now widely accepted as effective treatments for many ailments. the creation of reliable analytical techniques, such as quantitative assessments of marker/bioactive chemicals and other techniques, that can accurately profile the phytochemical makeup. For the manufacture and manufacturing of herbal medications, standardisation is a crucial step in establishing a uniform biological...