Development, of remedies based on traditional medicine

Abstract: In development of drugs from traditional medicine such as Chinese, Ayurveda and Unani medicine we face peculiar problems. Herbal drug preparations are in some countries and some cultural areas well accepted on the basis of local experience but not in other countries. Health authorities are reluctant to accept traditional drug preparations from foreign countries without well documented data on quality, safety and efficacy. Surprisingly, the philosophies of the traditional medicines (Chinese, Indian and European) have some resemblance to each other. In general, the traditional medicines have the advantage to be available to patients in a specific geographical area for long periods of time (decades or centuries). Therefore, safety has been proven for a long period of time in man and the safety requirements in animals are less than for new chemical entities. Nevertheless, also herbal drug preparations have to fulfil the international requirements for quality, safety and efficacy. Quality control by extended pharmacognosy is absolutely necessary. Controlled clinical studies on efficacy and safety are required. Pharmacological analysis as being performed with new chemical entities turns out to be impossible if traditional medicines consisting of a mixture of many herbal drugs are to be analysed. Therefore, a different development procedure has to be considered for traditional medicine than for new chemical entities. Stepwise clinical studies have to be the main basis of development whereby the first steps have to be performed in the country of origin. One has to bear in mind that development of modem Western medicine was also a stepwise procedure.

Keyword(s): Traditional medicine

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