Pharmacovigilance of Herbal Medicines

Herbal medicine has been known to be effective in the treatment of various ailments since the beginning of human civilization. Ayurveda is a form of herbal therapy originated in India. Plants, their parts, metabolites and preparations are proven to have enormous therapeutic properties. The importance of herbal medicines has been overlooked with the rise of modern medicine, yet they never ceased to amaze the scientific world with their efficacy. Herbal medicines are known to treat a wide range of diseases and disorders ranging from common cold to most serious chronic conditions and are considered safer than the synthetic drugs.

Though they are obtained from natural sources, it is necessary to test their efficacy, quality and safety in order to minimize adverse drug reactions. Self medication, usage of wrong species of medicinal plants, inappropriate dosage, cross reactivity with other drugs may result in adverse drug reactions. The most common adverse reactions reported from herbal formulations are related to liver and kidney. Herbal medicines that are contaminated with pathogens or those accidentally adulterated with toxic metals or hazardous chemical substances may sometimes lead to fatal health complications. This emphasizes the need to develop a system that tests and reports the safety and adverse reactions of these medicines.

Pharmacovigilance is the science that deals with the testing of drug safety and prevents adverse events. About one third of the conventional medicines in market are either direct or indirect derivatives of plant products whereas herbal medicines are made exclusively from plants. There is negligible information on adverse reactions resulting from the herbal products due to one or more of the following reasons:

  1. Since the practice of treating serious health conditions using plant products dates back to ancient times, most of the information related to the preparation, safety and adverse events of these medicines is not in electronic form and hence remains inaccessible
  2. Pharmacovigilance is majorly applied to conventional medicines and hence the methods that can be applied to herbal medicines are inadequate. Likewise, the terminology pertaining to adverse reaction monitoring is unavailable making accurate identification difficult
  3. There is a firm belief that all herbal products are safe resulting in lack of research and reports regarding its safety and adverse reactions
  4. Identification of causative agent of the adverse reaction is a major challenge since herbal preparations are often a combination of more than one ingredient. It gets even more difficult to assign causality when patients taking herbal medicines simultaneously undergo alternative therapies
  5. Lack of exposure of ayurvedic physicians to the concept and need of pharmacovigilance

It is quite necessary to introduce pharmacovigilance methods to herbal medicine practitioners and students by including these concepts as a part of their curriculum and acquaint ayurvedic experts with performing causality analysis and reporting of adverse events to regulators.  All the information that comes into existence with these implementations should be made easily accessible. In addition to these, patients should be educated about the adverse reactions and the need for rational use of herbal medicines.


At the James Lind Institute we offer multiple pharmacovigilance courses that are suitable for people with a background in Herbal Medicine, Ayurveda, Pharmacy etc. To know more about these programs  jliand how they can help your pharmacovigilance career please see this link: Online Pharmacovigilance Courses

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