The Level of Cadmium Impurities in Traditional Herbal Medicinal Products with Plantago lanceolata L., folium (Ribwort Plantain Leaves) Available in Polish Pharmacies — Comprehensive Toxicological Risk Assessment Including Regulatory Point of View and ICH Q3D Elemental Impurities Guideline

Plantago lanceolata L., folium (ribwort plantain) is an active pharmaceutical ingredient in traditional herbal medicinal products (THMP) available in pharmacies as a demulcent for the symptomatic treatment of oral or pharyngeal irritations and associated dry cough. This kind of THMP is widely applied among the European population; however, recently, voices have been heard in the public about alleged cadmium impurities. The idea of our study was a comprehensive risk assessment of the Cd impurity exposure and its effect on human health. Our assessment strategy was based on regulatory aspects (raw results versus limits set by FAO/WHO for herbal medicines) and toxicological risk assessment approach based on ICH Q3D guideline for elemental impurities in final pharmaceutical products. The cadmium was determined by electrothermal atomization atomic absorption spectrometry based on our previously described methodology. Obtained results show that all analysed THMP with P. lanceolata L., folium available in the Polish pharmacies contain cadmium impurities, but at a very low level (ranged 0.73 – 20.6 μg/L). The content of Cd in a single dose (ng/single dose) is also very low and is not a threat to patients. The estimated maximum daily exposure (ng/day) of Cd based on the ‘worst-case scenario’ (maximum concentrations by oral administration) meets the standards of ICH Q3D guideline (all results were below oral permitted daily exposure; PDE for Cd, i.e. < 5.0 µg/day). It can be concluded that all analysed samples of THMP with P. lanceolata L., folium should not represent any health hazard to the patients due to cadmium levels. To the best of our knowledge, this is the first study about Cd impurity level in THMP with P. lanceolata L., folium (ribwort plantain leaves) available in European pharmacies.

A Comprehensive Study on Regulation of Herbal Drugs in India, US and European Union

The current investigation surveys the guidelines of natural medications in the India US and Europe and illuminates issues identified with their clinical preliminaries. Natural medications have been utilized for quite a while in various frameworks of wellbeing like Ayurveda, Yunani, Sidha and Homeopathy for treating number of infections. It is an exceptionally hard to perform clinical investigation on Hm’s medications in light of the fact that these medications are an unpredictable mix of dynamic fixings. It is subsequently hard to distinguish the fixing which is answerable for the remedial impact among different elements of Hm’s medications. The normalization of Hm’s medications is likewise a troublesome assignment. Notwithstanding every one of these issues are existing public interest has expanded towards natural medications in last two thirty years in light of their long history of treating the illness securely. The laws and guidelines for natural medications are distinctive in various nations. The WHO has expressed that every nation ought to have a framework to control Hm’s medications in their region. In Europe, the Committee on Herbal Medicinal Products (HMPC) was established in accordance with Regulation (EC) No 726/2004 and Directive 2004/24/EC, which introduced a simplified registration procedure for traditional herbal medicinal products in EU Member States. The primary obligation of HMPC is to assess and give approval for natural medications based on their wellbeing and adequacy. In US spices are delegated dietary enhancements after the presentation of the Dietary Supplement Health and Education Act (DSHEA) in1994. In US natural medications are sorted into two kinds, first is OTC Hm’s medications and medications which required NDA endorsement. In India the Department of AYUSH has made rules for quality improvement of natural substances. The current investigation audits the guidelines of herbal medications (Hm’s) in the India US and Europe illuminates issues identified with their clinical preliminaries.

Sceletium for Managing Anxiety, Depression and Cognitive Impairment: a Traditional Herbal Medicine in Modern-Day Regulatory Systems

: Modern-day regulatory systems governing conditions for how health products enter national markets constitute a barrier of access for traditional herbal medicines on an international level. Regulatory intentions are focused on ensuring consumers are being provided with safe, efficacious and high-quality products that, however, collaterally limit opportunities for traditional herbal medicinal products, especially those that do not already have a long-standing tradition of use established in the respective national marketplaces. This case study investigates and compares how a Southern African herbal medicine with great potential as an anxiolytic and mild antidepressant – Mesembryanthemum tortuosum L. [syn. Sceletium tortuosum (L.) N.E.Br.] aerial parts – fares internationally in today’s regulatory environments. It is argued that inadvertent regulatory favoritism combined with the lack of means for adequate protection of intellectual property may obstruct innovation by creating an almost insurmountable economical hurdle for successful product development and introduction of botanicals from developing countries into most of the world’s health product markets.

Should Anthroposophic Medicinal Products Be Regulated in Europe?

European Commission’s reports suggest that the European Union should address the status of anthroposophic products, i.e. products that are developed, manufactured and prescribed in accordance with the holistic approach on which anthroposophic medicine is based. Anthroposophic products cannot be placed as such on the European market because they cannot meet the marketing authorisation or even registration requirements set out by European or national pharmaceutical law. Yet, the 95-year European tradition and good safety profile of anthroposophic products justify giving them an easier access to market. Such access can result from specific rules on anthroposophic products, but can be more efficiently achieved by encouraging the Member States to better apply the existing rules on marketing authorisation procedures or on registration of homeopathic and traditional herbal medicinal products, or by including anthroposophic substances, manufacturing methods or uses in monographs.