Herbal Pharmacovigilance

Pharmacovigilance (drug safety monitoring) is mandatory for acquiring information on the safety of drugs and herbal medicines are no exception to the rule. South-Asian countries like India, China, Thailand highly believe in and propagate traditional medicines however there is no coherence regarding regulation and monitoring of these herbal products. Stringent guidelines for herbal medicines should be followed worldwide just as conventional pharmaceutical drugs.

It is a myth conceived by everyone that natural or herbal products are safe and hence a large number of herbal products available in the market do not undergo toxicology and pharmacology screening. Apart from vigilance what escapes is the adulteration and incomplete knowledge of the herbal products by pharmaceutical companies resulting in contaminated products. Herbal medicines are self prescribed primarily and are available over the counter and most consumers neither report the usage of these medicines to their general practitioner and hence any adverse reaction relative to the herbal product is not reported. Thus underreporting of adverse reaction is a drawback faced by the pharmacovigilance sector.  It is necessary that both consumers, herbal industries keep in mind that even herbal medicines can cause toxic effects and reactions especially when an individual is on prescription. Suspected interactions between herbs and drugs is an increasing concern arising from the same reasons of under-reporting.

The issues faced by herbal industry for standardization of herbs are dependent on geographical origin, the part of the plant used, method of storage and processing thus creating a large number of variables. Thus, it not only becomes extensive as same herbs are at times used as herbal medicines (Treatment usage) and at times as food supplements thus difficult to classify them in a standardized category like pharmacological drugs. Hence, the present pharmacovigilance structure needs changes and additions to accommodate the differences and variations of medicinal herbs.

an article of James Lind Institute (JLI)