Pharmacovigilance of Herbal Products in India

Abstract

Herbal formulations being widely accepted therapeutic agents as antidiabetics, antiarthritics, hepatoprotectives, cough remedies, memory enhancers, and adaptogens. The commonest myth regarding herbal medicines is that these medicines are completely safe, and can therefore be safely consumed by the patient on his/her own, without a physician's prescription. This belief has led to large-scale self-medication by people all over the world, often leading to disappointing end-results, side-effects, or unwanted after-effects. There is an increasing awareness at several levels of the need to develop pharmacovigilance practices for herbal medicines. The current model of pharmacovigilance and its associated tools have been developed in relation to synthetic drugs, and applying these methods to monitoring the safety of herbal medicines presents unique challenges in addition to those described for conventional medicines. Several problems relate to the ways in which herbal medicines are named, perceived, sourced, and utilized. This may be because of differences in the use of nonorthodox drugs (e.g., herbal remedies) which may pose special toxicological problems, when used alone or in combination with other drugs. 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 in Phytophamaceuticals

“…However, reports have been received by drug safety monitoring agencies of prolonged prothrombin time, increased coagulation time, subcutaneous hematomas, and intracranial hemorrhage that are associated with the use of Ginkgo biloba. WHO sponsored pharmacovigilance program in 2008 at Gujarat Ayurveda University to evaluate all ayurvedic products.The WHO, under DFC program, had sponsored four capacity building training programs in India for the coordinators of regional and peripheral centers of pharmacovigilance of Ayurvedic system of medicine in 2010 and 2011 [10]. StandardPharmacological Program guidelines have to be followed along with the local drug regulations/ international norms for all phyto-pharmaceuticals.…”

Untitled

“…Products: Therapeutic products containing substances which are natural in origin or derived from plants are called herbal products. These formulations are increasingly being used as antidiabetics, hepatoprotectives, anti-arthritics, memory enhancers and adaptogens 85 .…”

“…Ayurvedic remedies also emerged from the relation between nature and man 86 . Since these products are natural in origin, it is commonly believed that they are safe, which actually inculcates a false sense of security 85 . These products have varying compositions and chemical properties 87 , which not only cause different degrees of efficacy, but also harmful effects when used over prolonged periods.…”

Gebelik ve emzirme döneminde kozmesötik kullanımı

“…Unutulmamalıdır ki zehirli mantar da doğal bir bitkidir fakat insanları öldürebilir. Bunun gibi doğada, alındığında insanlarda birçok yan etki, alerji ve hatta ölüme neden olabilen zararlı bitki bulunmaktadır 12,13 .…”

“…Yüzlerce yıldır kullanılmaktadırlar, fakat güvenlikleri konusunda bilimsel kanıt bulunmamaktadır 12,13 .…”