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Abstract: Herbal formulations have reached
widespread acceptability as therapeutic agents for
diabetics, arthritics, liver diseases, cough and cold,
memory enhancement and immunostimulation throughout the
world. Herbals are traditionally considered harmless and
increasingly being consumed by people without
prescription. Systematic data on the incidence of
traditional medicine-associated adverse effects are not
available due to many complex issues including; products
with multiple ingredients, poor standardization, lack of
clinical trials, variation in manufacturing processes,
contamination, adulteration and misidentification of
herbs etc.
The purpose of pharmacovigilance is to detect, assess
and understand, and to prevent the adverse effects or
any other possible drug-related problems, related to
herbal, traditional and complementary medicines.
Pharmacovigilance for herbal medicines is in its infancy
and monitoring the safety of herbal medicines presents
unique challenges as such preparations are available
from a wide range of outlets where no healthcare
professionals are available. The legal status and
approval mechanism of herbal medicine also vary from
country to country.
World Health Organization has set specific guidelines
for the assessment of the safety, efficacy and quality
of herbal medicines as a prerequisite for global
harmonization. The Medicines and Healthcare Products
Regulatory Agency’s, UK has launched ‘yellow card’
scheme for ADR reporting for monitoring the safety of
herbal medicines. Indian drug regulation has not yet
fully integrated traditional herbal medicine into all
aspects of health care system. Herbal pharmacovigilance
should be implemented in Indian herbal regulatory system
to access various aspects of ADR, delayed or acute
toxicities, allergies etc associated with single herb
and/or polyherbal formulation. Modified spontaneous
reporting forms are to be designed following WHO
template to collect information on suspected ADRs of
herbal medicines aiming to achieve the ultimate goal of
safer and more effective treatment available to
patients. This review aims to provide a comprehensive
and critical overview of the current state of
pharmacovigilance for herbal medicines at national and
global levels. This article explores the in depth
challenges associated with herbal pharmacovigilance
considering emerging issues and recommendations to
improve safety monitoring for herbal medicines in the
future.
Introduction
From prehistoric times, herbal medicine are being used
by various communities and civilizations throughout the
world. For the past several decades, herbal medicines
have been increasingly consumed by people without
prescription. Herbal formulations have reached
widespread acceptability as therapeutic agents like
anti-diabetics, anti-arthritics, aphrodisiacs,
hepatoprotective, cough remedies, memory enhancers and
adaptogens. Herbals are traditionally considered as
harmless since they belong to natural sources. Most
over-the-counter herbal products like ginseng have drawn
great public attention but there are several case
reports of adverse reactions of herbal drugs mentioned
in the literature which are generally considered safe.
The accurate scientific assessment of herbal medicine is
a prerequisite for global harmonization of herbal health
claims. In this regard the World Health Organization
(WHO) has set specific guidelines for the assessment of
the safety, efficacy and quality of herbal medicines.
The purpose of pharmacovigilance is to detect, assess
and understand, and to prevent the adverse effects or
any other possible drug-related problems, which is not
only confined to chemical drugs, but extended to herbal,
traditional and complementary medicines, biologicals,
vaccines, blood products and medical devices.
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