Traditional Herbal Drugs and Botanical Dietary Supplements: The Italian Experience

Multicomponent phytotherapic medicines are widely used in the European clinical practice and their registration is nowadays regulated by two distinct registration schemes, based on „well established use“ and „traditional use for herbal medicines“, now both codified in Dir. 2001/83/EC.

In this scenario, also in Italy it is today crucial that the preparation of botanical „Active Pharmaceutical Ingredients“ (API) has to fulfil both GAP and GMP guidelines for what harvesting and cultivation of plants and industrial production is respectively concerned.

The combination of these two guidelines is essential in order to guarantee quality and reproducibility of the API and also it allows to avoid the following risks: use of inappropriate classified material, pesticides or other harmful agent contamination, API degradation.

Botanical derivatives (mostly multicomponent products such as extracts) are widely used in Europe also as ingredients for non-pharmaceutical products which are sold as food supplements in relation to the different national legislations. In Italy, the Ministry of Health has recently (March, 2011) initiated a procedure to transpose into law (as Annex 1 of a draft decree which regulates the use of dietary supplements different from vitamins and minerals) a list of admitted plants which can be utilized for the preparation of food supplements.

The quality criteria for the preparation of these products are those requested by the European regulations on food derivatives. Nevertheless some Italian companies, such as Indena are strictly committed to keep the challenge for quality criteria of botanicals used for food supplements as close as possible to „phytotherapic medicines“.