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Pharmaceutical regulation in India is often treated as a matter of statutory compliance. In practice, regulatory outcomes are shaped as much by governance structures, institutional accountability, and decision-making systems as by legal rules themselves.
Pharmaceutical Law and Regulatory Governance in India examines compliance, enforcement, and accountability across the pharmaceutical and healthcare sectors through a governance lens. Integrating technical insight, legal analysis, and governance experience, the book moves beyond rule-based explanations to analyse how regulatory obligations are interpreted, implemented, and defended within organisations and institutions.
Drawing on statutory frameworks, enforcement practices, and adjudication patterns, the book identifies recurring regulatory failures and the governance weaknesses that underpin them. It emphasises preventive compliance, documentation discipline, and board-level oversight as essential to defensible regulatory conduct, and situates compliance within the broader objectives of public health protection and institutional trust.
Designed for regulators, industry professionals, legal practitioners, board members, policymakers, and advanced students, this book serves both as a reference work and a governance manual, offering a long-term perspective on compliance as an institutional responsibility rather than a procedural burden.
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Anbarasan Subramanian
Anbarasan Subramanian
Pharmaceutical Engineer | Lawyer | Regulatory Governance Specialist | Independent Director
Anbarasan Subramanian is a professional working at the intersection of pharmaceutical engineering, law, and regulatory governance. He holds a B.Tech. in Pharmaceutical Engineering and Technology (First Class) from Anna University (2004–2008) and an LL.B. (Honours) in Intellectual Property Rights from the Indian Institute of Technology Kharagpur (2011–2014).
He brings over fifteen years of multidisciplinary experience spanning pharmaceutical and chemical industrial operations, legal and contracts compliance, and governance, risk, and compliance (GRC) functions. His work focuses on preventive compliance, institutional accountability, and risk mitigation, informed by statutory frameworks and regulatory adjudication patterns.
This is his first book, written with the objective of equipping regulators, industry professionals, legal practitioners, and policymakers with practical governance frameworks for navigating pharmaceutical and healthcare regulation.
