Md. Al-Mustansir, Dibyajyoti Saha, Swati Paul, Zahed Bin Rahim, S.M. Zahid Hosen
An increase in drug safety concerns in recent years with some high profile drug withdrawals have led to raising the block by various stakeholders, more importantly by the regulatory authorities. The number of Adverse Drug Reactions (ADRs) reported, have also resulted in an increase in the volume of data handled. To understand pharmacovigilance a high level of capability is required to rapidly detect drug risks as well as to defend the product against an inappropriate removal. Positive pharmacovigilance throughout the product life cycle is the way forward and the future direction for drug safety. It is a challenge to arrange and regiment the act of signal detection and risk management in the context of clinical trials and post- marketing pharmacovigilance. While major advancements of the discipline of pharmacovigilance have taken place in the West, not much has been achieved in Bangladesh. However, with more clinical trials and clinical research activity being conducted in Bangladesh, there is an immense need to understand and implement pharmacovigilance. For this to happen in Bangladesh, the mind set of people working in regulatory agency and the Bangladesh Pharmaceutical companies need to change. The article highlights the various strategies and proposals to build, maintain and implement a robust pharmacovigilance system for various stakeholders and eventually make it happen in Bangladesh.
