Abstract

Traditional medicines are widely used in developing countries with fast gaining popularity all over the world. Traditional medicine practices has long historical background that passes on from generation to generation. The quantity and quality, safety and efficacy of traditional medicine has became a worldwide concern emphasizing the need to develop harmonized international standards. The global market for herbal remedies is about $83 billion and growing at 10 to 20 percent yearly with the top global players like Germany, Asia, Japan, Europe and North America. Traditional therapies have a popular perception lower adverse effects rate as consumers perceive that natural sourced products are less likely to cause problems. The common causes of herbal product related adverse reaction occurrence are use toxic herbs, overdose, drug–herb interactions and idiosyncratic reactions. Herbal are mostly used over the counter without knowledge or advice of practitioner rising safety concern. Quality issues of traditional products are due to improper processing, adulteration, misidentification, missing of one or more herbs in a product, substitution, inclusion of prescription drugs, contamination and variability in active ingredient. Scientific study to assess safety and efficacy, composition, dosage form requirements are need of the time. Regulations governing the safety, quality and efficacy of traditional and complementary therapies vary widely from country to country and many countries do not have formal system for traditional and complementary medicine registration. Implementation of good manufacturing practice in cultivation, harvesting and processing along with chromatographic fingerprinting will greatly contribute to quality control of traditional medicines. Rigorous research is required for preclinical safety-efficacy, toxicology and clinical trials of traditional and complementary medicine. Boosting research with availability of funds are a major issue. Credibility of traditional and complementary will depend on development of evidence base approval system by encouraging spontaneous reporting, implementing active pharmacovigilance and clinical safety monitoring system.

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