The following points are to be considered:

1. In many products, mainly cosmetic items and medicines for external application, one or two herbal extracts are added with some chemicals or Allopathic medicines and branded as herbal products to increase sale. Use of such mixtures may bring dangerous outcome due to drug interactions.

2. Many formulations are available (mainly liquid mixtures) in the market with printed name of some plants on it. Those are alcohol or sugar based mixtures. Leave about the actual addition of such herbal medicine, the so called mixtures may be dangerous due to contamination of any fungus with them.

3. The herbal medicines with certificate of the concerned authorities of the concerned countries should only be sold.

4. Product of only very reputed companies are to be considered for sale.

5. Like all other types of medicines, plant derived medicines may show toxic effects, if not formulated after proper laboratory based studies.

The phytochemicals and secondary metabolites of plants can vary depending on the geography and environmental conditions where the plants grew. This might change the efficacy and safety of herbal products. It is best to get from sources that are studies to be safe. There is also a need to consider the ecological aspect of herbal drug use. There are some medicinal plants that can only be found in the forest and are actually classified as endangered species, I think this is something that should also be taken into account

(1) Evidence that the botanical ingredients of the product were produced according to suitable Good Agricultural and Collection Practices (GACPs) for medicinal plants; (2) evidence that the botanicals were specified, tested and released for use in the product in conformance with a pharmacopoeial quality standards monograph; (3) evidence that finished herbal medicinal product was manufactured according to suitable Good Manufacturing Practices (GMPs); and (4) (depending on the regulatory framework of the country where the product is marketed) evidence that the herbal medicinal product has been granted marketing authorization by the competent authorities, demonstrating that quality, safety and efficacy evidence was submitted and reviewed in order to license or register the herbal medicinal product for marketing in that country.

The three main parameters and under them many sub parameters are important for Herbal Products. The suggested by JA Brinckmann are quite sufficient and suitable.

Quality, Safety and Efficacy are the main parameters

Thank you all!

1. Origin of the raw material; 2. Standardization of the extract, and 3. Safety and efficacy.

My first criterion for recommendation is the research data behind the product - for extracts, this means to look at clinical data, and any other (animal, in vitro, analytical) research that has been published. For those herbal ingredients where clinical data is lacking (many of the botanicals used as teas do not have clinical studies but rely on years of traditional use to support the efficacy), I may base recommendation on my own experience with the plant/product, and based on the manufacturers reputation. During my undergraduate study in pharmacy, we went to visit all the major manufacturers of herbal products in Switzerland, so we got a good idea about the quality control systems of these companies. We also get visits from sales representatives of the major players, so this is another opportunity to ask questions about ongoing/past research, quality control, sustainability of the harvest, and other questions that may be of interest ahead of recommending a product.

Dear Mostafa Elsersy

According to WHO (1996a and b, 1992), standardization and quality control of herbals is the process involved in the physicochemical evaluation of crude drug covering aspects, such as selection and handling of crude material, safety, efficacy and stability assessment of finished product, documentation of safety and risk based on experience, provision of product information to consumer and product promotion. Attention is normally paid to such quality indices such as: Macro and microscopic examination: Foreign organic matter: Ash values: Moisture content: Extractive values: Crude fibre: Qualitative chemical evaluation: Chromatographic examination: Quantitative chemical evaluation: Toxicological studies: This helps to determine the pesticide residues, potentially toxic elements, safety studies in animals like LD50 and Microbial assay to establish the absence or presence of potentially harmful microorganisms.

Also toxicity, standardization, microbial contamination

To ensure that a phytoceutical product can be offered as an alternative therapeutic agent it must conform to quality standards prescribed and have efficacy/toxicity evidence. The product must be produced using BIOTOPE plants ( since traditional medicine is based on ethnobotanical geographical data, the herbs from geographies described in traditional books have developed unique biochemistry that has been the basis for the medicinal properties discovered. Using plants from alien geographies raises several questions. Secondly the ingredients must be produced according to GMP norms, FULL SPECTRUM STANDARDIZED EXTRACTS is the only format acceptable , any manipulation, or irrational concentration of naturally occurring compounds removes all traditional claims. Microbial contamination, heavy metal analysis, agro-chemical residues are necessary. However one of the most important issues often overlooked is the rational dose of each ingredient. Many products have less than effective doses, some containing over 30 ingredients at below pharmacologically active doses.

Stability data is necessary and batch to batch conformity is crucial.

Degradation studies of the botanical product may also be helpful.

If it is autherized by the ministry of health and thus relatively safe!

Should follow the quality parameters as prescribed by WHO for Botanical-Herbal products and most of the country authorities are following the same.

quality, safety and efficacy as per govt guidelines

WHO guidelines for QC, GACP, cGMP

ICH guidelines, GMP requirements, Stability guidelines

and Research guidelines for evaluation of safety and efiicacy