An update on the Pharmacovigilance Programme of India

Abstract

Pharmacovigilance is a pharmacological science related to the detection, assessment, understanding and prevention of adverse effects, particularly long-term and short-term adverse effects of medicines (WHO-Essential Medicines and Health Products, 2002). It has been observed that a medication that is proven efficacious in large patient population often fails to work in some other patients of different ancestry. Ancestral background of the patients are controlled by genetic factors that influence drug response-drug targets, drug-metabolizing enzymes, drug transporters, and genes indirectly affecting drug action can modulate drug toxicity and contribute to its individual variability Thus, adverse drug reactions are highly variable in individuals and are major limiting factor in drug therapy and development. For example people with Asian ancestry are at greater risk for serious cutaneous reactions when starting treatment with carbamazepine. Therefore, even though the drug had already been approved in some other country, clinical trial with robust pharmacovigilance monitoring is needed in the population of different race & ethnicity.