Pharmacovigilance (PV) is a scientific discipline that significantly impacts public health. It involves several stakeholders such as the pharmaceutical industry, academia, healthcare professionals, consumers, and drug regulatory agencies. There was a time when investing in national PV systems was considered a luxury by underdeveloped and developing countries, as access to medicines was generally limited and the safety monitoring of products that were not available to most of their populace was considered unimportant. But global initiatives by the World Health Organization(WHO) and some other organizations subsequently improved access to medicines on a large scale in many of the low and middle-income countries which in chorus triggered the demand for PV systems to ensure patient safety, given the pharmacological rationale for the need for PV in every country. PV in India dates to its milestones in 1986, 1989, and 1997 when unsuccessful attempts were made to establish a PV system in the country. The National Pharmacovigilance Programme (NPP) launched in 2004 was better than its predecessors but did not make any noteworthy progression. This apparently led to the re-conceptualization of the NPP and its rechristening as the Pharmacovigilance Programme of India (PvPI) in 2010. Despite being a resourceful country with diverse skills and expertise in pharmaceuticals, India is still considered a resource-limited country striving hard to achieve excellence in PV. Of course, Indian PV has evolved compared to how it used to be in the past and a lot more headway may be expected based on the current trends. Considering the scale of the Indian population and the size of the Indian pharmaceutical industry, Indian PV has a compelling need to create and leverage opportunities for all its stakeholders to engage with each other and adopt globally validated approaches with appropriate customization. The complexity of the Indian healthcare scenario is by itself a challenge to implementation of a common single PV system for the country, which warrants a more inclusive cross-functional review by experts to facilitate the identification of a long-term solution. For a sustainable PV system to be built, regulatory reinforcement, synchronization of PV obligations of all stakeholders, maximization of human resource utilization, encouragement of public/consumer involvement and deployment of state-of-the-art technological tools are the needs of the hour. This chapter describes the status quo, challenges, and concerns in PV, especially in the post-marketing scenario in India—a country in which the erstwhile buzzword is now an area of growing interest.