Pharmacovigilance practices in South Asian Association for Regional Cooperation countries: the need for collaboration

Abstract

Abstract Objectives One-fifth of the world’s population lives in eight countries that constitute the South Asian Association for Regional Cooperation (SAARC). There is very little coordination among SAARC countries regarding the harmonization of pharmaceutical regulations and medicines safety. Pakistan, India and Bangladesh have experienced medicine-related tragedies where many patients have died. This study aims to examine current pharmacovigilance activity in the SAARC region to improve pharmacovigilance practices and to make recommendations for building a platform for collaboration to improve the safety monitoring of medicines in the region. The current review utilized secondary data. We reviewed the official websites of all SAARC countries’ national regulatory authorities for pharmacovigilance-related information. A data set with eleven pharmacovigilance indicators were gathered and synthesized. Key findings All eight SAARC member countries have pharmacovigilance systems with full membership in the WHO Program for International Drug Monitoring. Out of eleven pharmacovigilance indicators, India met ten; Pakistan, Bangladesh and Bhutan nine; Maldives and Afghanistan seven; Nepal and Sri Lanka five. The SAARC countries do not have a harmonized pharmacovigilance system or centralized database. Due to positioning in different WHO regions, it is proposed to create a consortium on medicine safety among SAARC countries like other regional organizations of the world to strengthen the pharmacovigilance systems and harmonize the pharmacovigilance practices among member countries. Summary To improve the quality of medicines and to strengthen regional medicine safety, the SAARC secretariat should consider forming a technical group of all member countries’ regulatory authorities.