CIOMS cited

India's changing PV regulatory framework has been influenced by the incorporation of international standards, including those from the European Medicines Agency (EMA), the World Health Organization Programme for International Drug Monitoring, the Council for International Organizations of Medical Sciences (CIOMS), and the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). Large-scale public health initiatives, patient populations with a variety of cultural backgrounds, and the existence of ancient medical systems like Ayurveda, Siddha, and Unani are just a few of the distinctive national adaptations that India has made in response to local healthcare circumstances. The convergence of India's PV rules with international norms is examined in this review, which also identifies characteristics specific to India's regulatory framework. Overall, the path towards harmonisation has improved India's standing internationally in the drug-safety ecosystem; but full global equivalency would require continued investment, digital growth, and regulatory modernization.

This review synthesizes global and Indian perspectives on real world evidence (RWE) for signal detection, outlines current frameworks, evaluates available real world data sources, and examines emerging methods including artificial intelligence/machine learning. It also discusses operational, regulatory, and ethical challenges in India and proposes a roadmap for strengthening RWE-based pharmacovigilance (PV) systems. By consolidating insights from open-access scientific literature and regulatory guidance, this review aims to support PV scientists, regulators, and healthcare policymakers in harnessing RWE to enhance drug safety and public health in India

Randomized controlled trials are central to progress in medicine, but trialists commonly struggle to recruit the required number of participants. Offering financial incentives is one proposed solution, but financial incentives may be problematic when they become irresistible and, thus, undermine the autonomy of potential participants. While some have dismissed this worry about undue inducement and argued that we should be paying participants more to avoid exploitation, the authors argue that this line of argument is based on a too narrow conception of undue inducement and does not fully appreciate the distinction between reimbursement, compensation, and financial incentives.

The study conducted by the authors revealed conflicting perspectives on compensation and benefits among research stakeholders in Malawi. While stakeholders involved in conducting research had a shared understanding of compensation as reimbursement for time and costs, some community members viewed it as redress for harm. The disconnect suggests unequal access to information about research ethics among research stakeholders. Varying compensation based on study procedures also raised concerns over perceived inequalities and feelings of being devalued.