The impact of traditional medicines, in both the economic and health sectors, has resulted in a public demand for increased accountability in the traditional medicines marketplace. Consumers want to know that their products meet acceptable criteria to be considered both safe and effective. This has led to an increased interest among health authorities in research, regulation, international trade and marketing of traditional medicines .
Despite the many challenges, considerable progress has been made in recent years at the national, regional and international levels to create the institutional frameworks and regulatory environments necessary to support the registration, research and production of traditional medicines. Many countries continue, however, to seek technical assistance for producing and distributing quality traditional medicines that meet acceptable levels of efficacy and safety. To this end, WHO has produced several documents designed to assist national governments, including guidelines on methodologies for research and evaluation, good agricultural and collection practice (GACP), good manufacturing practice (GMP), and on the role of the pharmacist in traditional medicine . GACP serves to ensure that the raw materials selected for medicinal products are of assured quality, while GMP provides guidance on how to convert these components into assured quality traditional medicines. Some WHO Regional Offices, including those in the African, Eastern Mediterranean, and South-East Asian regions, have also produced more localized guidelines for regulation and registration of traditional medicines, as well as suggestions for marketing requirements .
The World Medicines Situation Report 2011 Traditional Medicines is summarized below:
1. Traditional medicines, including herbal medicines, have been, and continue to be, used in every country around the world in some capacity. In much of the developing world, 70–95% of the population rely on these traditional medicines for primary care;
2. The global market for traditional medicines was estimated at US$ 83 billion annually in 2008, with a rate of increase that has been exponential;
3. Regulatory status and the associated terminology varies widely. Traditional medicines are used as prescription or over-the-counter (OTC) medications, as self-medication or self-care, as home remedies, or as dietary supplements, health foods, functional foods, phytoprotectants, and under any of many other titles in different jurisdictions, with only minimal consistency between the definitions of these terms from country to country and significant communication issues as a result;
4. To control quality and to ensure safety and efficacy in production of traditional medicines is difficult. WHO, in cooperation with the WHO Regional Offices and Member States, has produced a series of technical documents in this field, including publications on Good Agricultural and Collection Practices (GACP) and Good Manufacturing Practices (GMP), along with other technical support, to assist with standardization and creation of high quality products;
5. Regulation of traditional medicines is a complicated and challenging issue as it is highly dependent upon experience with use of these products. Model countries such as China, India, and South Africa present usable templates, as do the guidelines on regulation and registration of traditional or herbal medicines produced in the WHO African, Eastern Mediterranean, and South-East Asian regions and in the European Union;
6. Evaluation of quality, safety and efficacy based on research is needed to improve approaches to assessment of traditional medicines, a situation made difficult to remedy in light of historically inadequate public and private funding to address this growing concern;
7. World Health Assembly resolution 62.13, passed in May 2009 by the WHO Member States urges national governments to respect, preserve and widely communicate traditional medicine knowledge while formulating national policies and regulations to promote appropriate, safe, and effective use; to further develop traditional medicine based on research and innovation, and to consider the inclusion of traditional medicine into their national health systems. WHA 62.13 also urges Member States to cooperate with each other and to share knowledge while working to strengthen communication between conventional and traditional practitioners.