• Dr.Jeevan.E.P

What does safety mean in the context of the THMPD?

Updated: Jun 1, 2019

What is THMPD?

The Traditional Herbal Medicinal Products Directive (THMPD) 2004/24/EC is a regulatory process established to provide a mechanism whereby manufacturers of good- quality herbal medicines can register their products as medicines, rather than classifying them as food supplements, and thus allow them to make (restricted) medicinal claims on the packaging and the patient information leaflet (PIL).

The Traditional Herbal Medicines Registration Scheme (THMRS) is designed for manufactured traditional herbal medicines that are suitable for use without medical supervision (EC Directive, 2004). It provides an assurance that the patient is receiving not only a good- quality product, but also more reliable advice on its use. Previous legislation provided very little in the way of safeguards and meant that the products could be sold with little regard to safety, quality or the provision of useful patient information.

The EU was prompted to act because of the rising popularity and regular usage of herbal medicines, the mounting number of reports of adverse drug reactions and the increased understanding about the possibilities for side-effects and interactions between herbal and other medicines. There has also been growing concern about the safety and quality of some unlicensed products and about the lack of reliable information, as well as concerns about the professionalism of some practitioners. Recent reports have highlighted adverse, sometimes life-threatening, incidents, which have resulted from use of poor-quality herbal medicinal products. In some cases, these have been tainted with other toxic plant species, microbial contaminants or heavy metals, and even adulterated with pharmaceutical drugs such as warfarin, dexamethasone and sildenafil.

Although many unlicensed herbal medicines on the market are already manufactured to reasonable and even good manufacturing practice (GMP) standards, without some form of approval by a regulatory body it is impossible for consumers to identify which unlicensed products are made to acceptable standards. There are 1000 ́s of herbal preparation in the sector of Healthy products. This makes a lot of confusion


What does safety mean in the context of the THMPD?

The concept of safety, whether applied to a conventional drug or herbal medicine, covers many facets, but these may be roughly divided into two main categories which can be described as medical and pharmaceutical.
Drug interactions with herbal medicines are an in- creasing focus for re- search, although they are difficult to characterize and predict. The main problems may occur because the practitioner is not informed that the patient is taking a herbal medicine alongside a prescribed drug (patients fear dis- approval); herbs may not be considered to be 'drugs' at all; an interaction may not be recognized as such, or only reported if it is considered serious;
Finally, the safety of a particular product is only one aspect of the pharmaco vigilance of herbals, and the problem of unqualified or unregistered practitioners of herbal medicine must also be addressed. When the Traditional Herbal Medicinal Products Directive comes fully into force, many herbal products from all around the world (including Eastern and Western herbal traditions and South America) – and food supplements containing herbs will be illegal across the 
Availability will be restricted to herbal medicinal products registered under the scheme. For a broad range of herbal formulae, the requirements of the scheme are either impossible to meet or impossibly ex- pensive. This applies especially to herbal products from non-European traditions, such as Ayurveda and Traditional Chinese Medicine (TCM). Criteria designed to apply to pharmaceutical drugs cannot be applied in any meaningful way to the complex plants that are herbs, or to the traditions that mix and use them with expertise. Fur- the rmore, each herb has to be registered individually, at great cost. The current esti- mate is €50,000 to €100,000 per herb.

In many cases, both constraints apply. Consequently, very few herbal medicines from Ayurveda or TCM have been registered. Many Western herbal blends are also on the blacklist.



Are we aware of this?

What is medicine and what are food supplements are clearly defined. A plant or plant product is to be sold, at least the people should have been using this for a period of minimum thirty years. In India we accept every thing. Either it is from the classical texts Charaka, Susrutha, vagbhata or from the manuscripts or from the family tradition or just a Kshara thailam or Aswa thailam from the haven - all are welcome! No question at all. No studies are needed. Anything under the umbrella of Ayurveda is safe! Remember It is

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