Need for involving the pharmaceutical industry in the national pharmacovigilance program of Nepal

Abstract

Introduction: Adverse drug reactions (ADRs) have high morbidity and mortality and can cause a significant burden on patients. Most of the data on ADRs are generated from the developed world, and these data cannot be generalized to developing nations due to the variation in prescribing patterns, regulatory policies, and varied effects of drugs. Implementing a successful pharmacovigilance program in many developing countries faces several challenges including under-reporting, human resource shortage, financial challenges as well as poor policy and legal framework. Method: In this commentary, we aim to explore the situation of Pharmacovigilance in Nepal through a close comparison with India and suggest ways to strengthen the same. Results: Nepal is still in the beginning stage of Pharmacovigilance and ADR reporting is quite low. The Pharmacovigilance System in Nepal is limited to regional centers which report ADRs to the national center. There is no involvement of pharmaceutical industries in the system which may be a major reason for underreporting and suboptimal functioning of the pharmacovigilance system. Discussion: Nepal must mandatorily involve pharmaceutical industries in pharmacovigilance. The new drug policy is under revision and addresses aspects of pharmacovigilance in terms of patient safety and the role of pharmaceutical companies.