Regulatory Challenges of Asian Herbal Medicine

Overall the incidence of serious adverse reactions is significantly lower with most herbal medicines when compared with pharmaceutically derived drugs [8]. However, the need still exists to more closely monitor practitioners and formulators of any traditional medicine, including those of Indian origin, so that unethical practices are reduced.

For most herbal products, verification is difficult if not impossible after processing has occurred. In traditional medicines that are prepared in Asian countries and exported, the task of ensuring safety is even more difficult since the incorporation of certain levels of potentially toxic herbs or heavy metals may not be considered harmful in the country of origin [69]. Some Chinese and Indian Ayurvedic medicines have been rejected by US, Canada and other countries on the grounds that they contain high levels of potentially toxic elements, including heavy metals.

In the view of above problem, the authorized body for traditional medicine "Ayush" has adopted strict guidelines for all herbal medicines (Unani, Ayurveda, and Siddha) to be exported from India. Ayush has made it mandatory for all ISM

medicines to be exported to meet the international standards for contamination including heavy metals in 2005. These guidelines can be accessed on the Ayush website (

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