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Mahaveer Sharma* and S. S. Agrawal


Pharmacovigilance helps in detection, assessment, understanding and prevention of adverse effects or any other drug related problem.[1] A large number of reports of the adverse events come every year from different countries. And herbal drugs are also the contributor these events.[2] Every country has been following the rules to collect the side effects of herbal medicines as per their regulatory authorities’ rule. In India for the adverse events collection of herbal medicines, a three-tier network of National Pharmacovigilance Centre (NPvCC), Intermediary Pharmacovigilance Centres (IPvCCs) and Peripheral Pharmacovigilance Centres (PPvCC) has been established. These centres will collect the adverse events reporting, will process the reports and will send them to the regulatory authority of the country.[3] As per WHO various national pharmacovigilance program established in various countries to collect, process, understand and report adverse events of the medicines including the herbal medicines.[4] The European medicine agency (EMA) has provided its rule for pharmacovigilance of herbal medicines and provided its reviews of various herbal medicines as per the available data.[7] In India for the pharmacovigilance of herbal drugs the rules of Drugs and Cosmetic Act and Rules (1940 & 1945) and AYUSH pharmacovigilance program are followed.[3,9] Though every possible step is being followed by the regulatory authorities to assess the causality of the events occurred by the use of herbal medicines use yet it is difficult to proper assess the single constituent as causing agent of the adverse effects. New ways can be followed up by the regulatory authorities to access the exact causality assessment of the adverse events occurring by the use of herbal medicines.

Keywords: Pharmacovigilance (PPvCC) herbal medicines.

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