Navigating Adverse Drug Reactions: Extent of Pharmacovigilance in India

    Introduction

    Pharmacovigilance, as defined by the World Health Organization (WHO), is the science and practice of detecting, assessing, understanding, and preventing adverse effects or any other drug-related problems. Pharmacovigilance in essence aims to enhance patient safety by monitoring and evaluating the risks associated with pharmaceutical products. It is interesting to note that the significance of pharmacovigilance has grown over the years, especially with the increasing global integration of pharmaceutical supply chains and concerns over drug safety. With India being commonly referred to as the ‘pharmacy of the world’ due to it being a global supplier of affordable medicines, ensuring drug safety is critical for public health at large. This blog post outlines the pharmacovigilance system in India, including the existing framework, current challenges, and the future roadmap.Continue Reading Navigating Adverse Drug Reactions: Extent of Pharmacovigilance in India

    Linking Patents to Pills: Unravelling the Patent Linkage Framework for Pharmaceutical Products in India

    A patent grants the patentee exclusive rights, title, and interest in an invention. This creates a right in rem – a right to restrict a third party from making, using, offering for sale, selling, or in any manner commercializing the invention (as claimed in the patent)[1] for a period of 20 years[2]. In case of drugs, grant of patent, does not give the patent owner an automatic right to market the product. Such additional right in the form of a marketing approval/ license/ registration is granted by the concerned drug regulatory body acting under the auspices of the relevant legislation that regulates the import/ manufacture/ sale/ marketing of the drug in the relevant jurisdiction. Continue Reading Linking Patents to Pills: Unravelling the Patent Linkage Framework for Pharmaceutical Products in India