Evaluation of National Quality Control Capacity for Herbal Medicines in West Africa: the Case of Benin and Burkina Faso (original) (raw)
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Quality assurance and quality control for African natural plant products
2002
BACKGROUND Development of a quality assurance system for new botanicals, which are not internationally well-known for health and nutrition, is challenging. Consumer awareness and acceptance of new products must be developed before real markets can be successfully established. Producers must understand consumer demands and develop methods of production that meet those demands of product quality and efficacy, which exceeds or corresponds to international standards. Producers, marketers and scientists must work together to develop and introduce a product that will bring a reasonable return to the producer, while the consumer will receive a high quality, healthy, and safe product. The USAID co-funded "Agribusiness in Sustainable Natural African Plant Products" (ASNAPP) project (www.asnapp.org) was initiated in 1999 to help develop the natural products sector in sub-Sahara Africa in a socially and environmentally sensitive manner. ASNAPP uses a market-driven, commodity-systems approach, which minimizes the risk to growers, and is focused on crop clusters such as teas, dyes, spices, and aromatic plants. A sub-focus of the project is the commercialization of traditional medicinal plants that can assist in primary health care. ASNAPP uses ongoing training programs to promote organic and sustainable production methods, business development skills and education. The main services that ASNAPP provides are: Local Capacity Building-Farmer and Producer Associations; New Crop Development and Technology Transfer; and Quality Control (QC) and Quality Assurance (QC) of Plant Sourcing through Processing and Market Development. One of the major objectives of the quality control component of the ASNAPP program was to establish a product-tracking system for the cultivation, sustainable harvesting, shipping, quality control, and quality assurance of plant products, either nationally or internationally, such as was proposed in the WHO Guidelines for the Assessment of Herbal Medicine. The detailed objectives of the product tracking system are to: (1) provide farmers with avenues to develop sustainable collection and cultivation methods; (2) provide a system to track the flow of products through the ASNAPP organization; (3) provide an internal interactive feedback system; (4) ensure authenticity of African botanical products; and (5) ensure quality control for internal and external purposes. ASNAPP had to establish standard procedures for the tracking system of African plant products produced and harvested from cultivated plots or collected from the wild by rural African farmers, while maintaining the genetic diversity of the wild species and utilizing sustainable agriculture and collecting methods. Once these procedures were developed, we needed to educate ourselves to utilize them routinely and properly. Together, these steps also provide the foundation for the monitoring and assurance that Good Sourcing Practices (GSP) and Good Agricultural Practices (GAP) were adhered to in the commercialization of the botanical products. The current manuscript describes how we established and institutionalized procedures for natural African plant products for proper species (botanical) identification, methods of cultivation, and introduction or domestication. The paper also describes how we developed sustainable collection and processing methods, seeds and product sourcing, monitor and improved chemical and agronomic traits, harvesting and drying methods, packaging and sample forwarding methods, and quality control and assurance for African natural plant products developed through ASNAPP, bound to local, regional, and international markets.
Phytothérapie, 2021
Introduction: Traditional medicine has become an important component in the care system of African populations. Many products derived from it are increasingly used in the therapeutic arsenal. This work is an inventory of the production of these drugs in two countries of West Africa, Burkina Faso and Benin. Methods: A cross-sectional descriptive study that listed the drug manufacturing units producing medicines derived from the traditional pharmacopoeia (MDTP) identified by the health ministries in the two countries was carried out. Results: Thirty-three production facilities, including 10 in Burkina Faso and 23 in Benin, were surveyed. Seven units surveyed in Burkina Faso and 16 in Benin were illegally installed. Only 16 of the 33 units obtain their raw materials from botanical gardens. The rest obtain theirs through picking which is not favorable to the perpetuation of the plant resource. In addition, among the 1041 MDTPs manufactured by the units surveyed, only 1.44% are registere...
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.
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With the global increase in the use of traditional and complementary remedies for the prevention and treatment of illness, the quality and safety of these medicines have become a significant concern for all regulatory authorities. Herbal medicines are the most commonly used form of traditional and complementary medicines in the world and the efficacy and safety of herbal medicines, like conventional medicines, largely depends on their quality from planting to harvesting, preprocessing and final processing. Due to the inherent complexity of herbal medicines, often containing an array of active compounds, the primary processing of herbal medicines has a direct influence on their quality. Quality concerns are the reason why the medicines regulatory agencies insist that manufacturers of medicines strictly follow Good Manufacturing Practices since it is an essential tool to prevent instances of contamination, mix-ups, deviations, failures and errors. However, a strict application of GMP ...
Application of Quality Control Principles to Herbal Drugs
International Journal of Phytomedicine, 2009
Quality is conformance to requirement and meeting stated as well as implied needs of customer. The word quality is derived from Latin 'qualis' means 'of what kind' and encompasses composition and properties of object. Quality is of paramount importance when it is specifically related with drugs. And when it comes to herbal drugs, because of several reasons is a herculean task. The quality of pharmaceuticals has been a concern of the World Health Organization (WHO) since its inception. The setting of global standards is requested in Article 2 of the WHO Constitution, which cites as one of the Organization's functions that it should "develop, establish and promote international standards with respect to food, biological, pharmaceutical and similar products". The World Health Assembly-in resolutions WHA31.33 (1978), WHA40.33 (1987) and WHA42.43 (1989)-has emphasized the need to ensure the quality of medicinal plant products by using modern control techniques and applying suitable standards. This manual describes a series of tests for assessing the quality of medicinal plant materials. The tests are designed primarily for use in national drug quality control laboratories in developing countries, and complement those described in 'The international pharmacopoeia' which provides quality specifications only for the few plant materials that are included in the WHO 'Model List of Essential Drugs'. In this review, we have addressed some important issues related to quality of botanicals and discussed possible application of total quality management for herbal drugs.
Survey on the Pharmaceutical Quality of Herbal Medicines Sold in Nigeria
Journal of Applied Pharmaceutical Science, 2015
In recent times the apparent upsurge in the popularity and use of herbal medicines can be related to the success in their use for the management of certain important diseases, empirical proof of efficacy and safety, enhanced dosage form design and better tolerance among others. In this study the quality of some herbal medicines sold in Nigeria were evaluated for basic pharmaceutical quality and compliance to regulatory guidelines. Samples of sixteen frequently used herbal products were collected from Pharmacy stores (Ps) and Patent Medicine stores (PMs) across two states and the Federal Capital Territory. The dosage form, organoleptic properties, moisture content, weight/volume uniformity as well as compliance to regulatory guidelines were evaluated. Sixty percent of the samples were liquids, thirty percent were oral bulk powders and ten percent were capsules. None of the products complied completely with the regulatory requirement stipulated for finished herbal products in Nigeria while only ten percent of the products samples complied with the basic physicochemical properties required for pharmaceutical quality. Consequently, there is a compelling need for the regulatory authorities to ensure stringent quality surveillance and enforcement of guidelines to ensure that herbal medicines are of standard quality.
Fitoterapia, 2016
Herbal medicines are the most globally used type of medical drugs. Their high cultural acceptability is due to the experienced safety and efficiency over centuries of use. Many of them are still phytochemically less-investigated, and are used without standardization nor quality control. Choosing SIROP KILMA, an authorized Congolese antimalarial phytomedicine, as a model case, our study describes an interdisciplinary approach for a rational quality assessment of herbal drugs in general. It combines an authentication step of the herbal remedy prior to any fingerprinting, the isolation of the major constituents, the development and validation of an HPLC-DAD analytical method with internal markers, and the application of the method to several batches of the herbal medicine (here KILMA) thus permitting the establishment of a quantitative fingerprint. From the constitutive plants of KILMA, acteoside, isoacteoside, stachannin A, and pectolinarigenin-7-O-glucoside were isolated, and acteoside was used as the prime marker for the validation of an analytical method. This study contributes to the efforts of the WHO for the establishment of standards enabling the analytical evaluation of herbal materials. Moreover, the paper describes the first phytochemical and analytical report on a marketed Congolese phytomedicine.
Quality Assessment Of Aqueous Herbal/Medicinal Products Sold On The Ghanaian Market
2016
The microbial quality of sixteen (16) decoctions sold on the Ghanaian market were investigated and the isolated microbes characterized to the species level. The results indicated that, almost all the decoctions were contaminated with aerobic bacteria and/or fungi. The highest microbial counts greater than 1.0x109 cfu/ml were found in three of the samples with only one out of the sixteen samples having the lowest aerobic bacterial count of 1.0x102 cfu/ml. Fungal contaminations were found in thirteen (81.3%) of the samples with only three found to be free from fungal contamination. The highest fungal contamination of 3.2x105 cfu/ml was found in only one sample. The characterization of the isolates revealed six bacterial genera and eight fungal genera with Bacillus subtilis (50.0%) and Cladosporium herbarum (34.5%) being the predominant bacterial and fungal isolates respectively. The analysis of the samples after three months storage showed that the microbial load of the decoctions wer...
Herbal medicines and products derived from are a diverse group of products for which different (and often limited) levels of evidence are available. As importantly, such products generally vary in their composition and are at the end of an often poorly understood value chain, which often links producers in biodiversity rich countries with the large markets in the North. This paper discusses the current regulatory framework of such herbal medical products (with a focus on the UK) and using examples from our own metabolomic research on Curcumal longa L. (turmeric, Zingiberaceae) how value chains impact on the composition and quality (and thus the safety) of such products. Overall, our recent research demonstrates the need for studying the links between producers and consumers of commodities produced in provider countries and that plant metabolomics offer a novel way of assessing the chemical variability along a value chain.
Quality Control and Evaluation of Herbal Product
International Journal for Research in Applied Science & Engineering Technology (IJRASET), 2023
Standardization of herbal formulation is important in order to assess of quality drug. The quality of herbal drug is the considerate all the factor which contribute directly or indirectly to the safety, effectiveness of the product Medicinal plant have been used to improve human health , increasing popularity global as drug , complementary and alternative medicines, food supplement, cosmetic as medical devices. The complexity of herbs and extracts supplied to such a wide range of markets and in different requlatory environment, raise major quality issues, increasing the need for appropriate analytical method for their identification, standardization &also for the detection of adulterants and contamination. Major limitation factors, such as herbal product naming, sampling and sample preparation are also discussed. The use of products of natural origin has remarkably increased in the global market, because of consumer becoming more health-conscious herbal medicines are considered safe by consumers and these product are generally less expensive than allopathic medicines.