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]. Howev-
er, the need still exists to more closely monitor practitioners and formulators of
any traditional medicine, including those of Indian origin, so that unethical prac-
tices are reduced.
For most herbal products, verification is difficult if not impossible after process-
ing 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 medi-
cines 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
3.3 Constraints in Herbal Medicine 71
medicines to be exported to meet the international standards for contamination in-
cluding heavy metals in 2005. These guidelines can be accessed on the Ayush web-
site (http://www.indianmedicine.org).
Overall the incidence of serious adverse reactions is significantly lower with most
herbal medicines when compared with pharmaceutically derived drugs [8]. Howev-
er, the need still exists to more closely monitor practitioners and formulators of
any traditional medicine, including those of Indian origin, so that unethical prac-
tices are reduced.
For most herbal products, verification is difficult if not impossible after process-
ing 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 medi-
cines 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
3.3 Constraints in Herbal Medicine 71
medicines to be exported to meet the international standards for contamination in-
cluding heavy metals in 2005. These guidelines can be accessed on the Ayush web-
site (http://www.indianmedicine.org).
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