Medical Devices Rules, 2017 alongwith New Drugs & Clinical Trials Rules, 2019 and Drugs & Cosmetics Act, 1941

The Medical Devices Rules, 2017 along with New Drugs & Clinical Trials Rules, 2019 and Drugs & Cosmetics Act, 1941 is an indispensable resource for understanding the comprehensive regulatory framework governing drugs, medical devices, and clinical research in India. This book covers all relevant provisions of the Acts and Rules, providing detailed explanations on licensing, registration, manufacturing, import, export, and sale of medical devices and drugs. It also includes guidance on clinical trials, ethical considerations, safety requirements, and compliance with regulatory authorities. The book bridges the gap between legal text and practical application, offering annotations, procedural insights, and interpretations essential for professionals navigating healthcare compliance. It emphasizes regulatory enforcement, penalties for non-compliance, and best practices for ensuring adherence to Indian laws. The structured content makes it accessible to students, practitioners, and corporate professionals alike. Its Unique Selling Point (USP) lies in consolidating multiple critical healthcare regulations in a single volume, saving time and providing clarity for decision-making and compliance management. This makes it a must-have reference for pharmaceutical companies, medical device manufacturers, legal advisors, healthcare consultants, and regulatory affairs professionals.