Regulatory Situation of Herbal Medicines A worldwide Review

WHO/TRM/98.1page 23The requirements of the licensing system in the United Kingdom are set out in Part II of the Medicines Act1968. Without the appropriate licence it is an offence to manufacture, sell, supply, export or import a medicineinto the United Kingdom, unless some exemption is provided in the Act or regulations [105].Exemptions from licensing for certain herbal remedies are contained in Section 12 of the Medicines Act,namely:- the plant has been subjected only to the processes of drying, crushing or comminuting in producingthe remedy;- it is sold or supplied by its botanical name with reference to the process of manufacture; and- it is sold or supplied without any written therapeutic recommendation [105].The review of herbal medicines was completed in 1990. An information sheet on the review for licence holderswas published in October 1985 by the Medicines Control Agency [106]. Herbal medicines indicated forconditions capable of self-diagnosis were granted a licence when sufficient evidence of efficacy wasestablished, and the authority required the product label to include the statements "a herbal remedytraditionally used for the symptomatic relief of..." and "if symptoms persist consult your doctor". Combinationproducts containing a large number of herbal ingredients or mixtures of herbal and other ingredients were notaccepted, and licence holders were invited to consider to which ingredients the therapeutic claim related andto adjust the formulations [106].Medicines which can, with reasonable safety, be sold or supplied otherwise than by or under the supervisionof a pharmacist are listed in the General Sales List. The exemption from licensing for certain herbal remediesdescribed above is modified by the Retail Sale or Supply of Herbal Remedies Order [107], the purpose ofwhich is to control the use of toxic plants by removing them from the general sale list category of medicinesand making them "pharmacy only", or by limiting the dose or route of administration for use outside apharmacy setting. The plants listed in Part I of the schedule may only be sold or supplied in a registeredpharmacy; those listed in Part II and Part III may be used by practitioners who sell or supply herbal remedieswhere they are for administration to a particular person following a personal consultation (after beingrequested by or on behalf of that person to use his own judgement as to treatment required), but are not forretail in circumstances other than through a pharmacy.In December 1995, "A guide to what is a medicinal product" was published by the Medicines Control Agency. Inaccordance with Directive 65/65/EEC it tries to give examples for clarification where the borderline liesbetween medicinal products and products such as cosmetics and foodstuffs, taking into consideration theclaims for the product, the properties of its ingredients, the labelling, promotional literature, product form andwhether there are similar licensed products on the market. The new guideline does not intend to affect thestatus of products legally sold without a licence, nor does it affect the current exemptions for herbal remedies[108].South East AsiaIndiaMarket Importance and Use of Herbal MedicinesIn India, a great deal of folk knowledge exists among ordinary people about the traditional use of herbalmedicines. It is difficult to quantify the market size of the traditional Indian systems since most practitionersformulate and dispense their own recipes. The present annual turnover of products manufactured by largecompanies is estimated at approximately US $ 300 million, compared to a turnover of approximately US $ 2.5billion for modern drugs. According to a study on the attitude of modern medicine practitioners towardsAyurvedic products, general practitioners are relatively unfamiliar with Ayurvedic products even though someare prescribed. They are willing to try an Ayurvedic product if its efficacy is scientifically proven, and would tryAyurvedic products if no modern medicinal remedies were available. People use self-medication for minorailments such as cough, cold, diarrhoea and stomach problems. Patent and proprietary Ayurvedic medicinesare sold over the counter in pharmacies. These products appear to represent a major share of brandedtraditional products in India. Nevertheless, systems like Ayurveda still need to gain an empirical support ofmodern medical science to make them credible and acceptable for all. An innovative research effort to definethe advantages of traditional systems of medicine with respect to their safety and efficacy could result in abetter utilization of these complementary systems of medicine [109].