Regulation And Regulatory Process In India

Federal regulations affect nearly every area of our lives and interest in them is increasing. However, many people have no idea how regulations are developed or how they have an impact on our lives. Regulation: A Primer by Susan Dudley and Jerry Brito provides an accessible overview of regulatory theory, analysis, and practice. The Primer examines the constitutional underpinnings of federal regulation and discusses who writes and enforces regulation and how they do it. Published by the Mercatus Center at George Mason University, it also provides insights into the different varieties of regulation and how to analyze whether a regulatory proposal makes citizens better or worse off. Each chapter discusses key aspects of regulation and provides further readings for those interested in exploring these topics in more detail.

Regulation is often thought of as an activity that restricts behaviour and prevents the occurrence of certain undesirable activities, but the influence of regulation can also be enabling or facilitative, as when a market could potentially be chaotic if uncontrolled. This Handbook provides a clear and authoritative discussion of the major trends and issues in regulation over the last thirty years, together with an outline of prospective developments. It brings together contributions from leading scholars from a range of disciplines and countries. Each chapter offers a broad overview of key current issues and provides an analysis of different perspectives on those issues. Experiences in different jurisdictions and insights from various disciplines are drawn upon, and particular attention is paid to the challenges that are encountered when specific approaches are applied in practice. Contributors develop their own distinctive arguments relating to the central issues in regulation and apply scholarly rigour and clear writing to matters of high policy-relevance. The essays are original, accessible, and agenda-setting, and the Handbook will be essential reading both to students and researchers and to with regulatory and regulated professionals.

Globalization is rapidly changing lives and industries around the world. Drug development, authorization, and regulatory supervision have become international endeavors, with most medicines becoming global commodities. Drug companies utilize global supply chains that often include facilities in countries with inconsistent regulations from those of the United States, perform pivotal trials in multiple countries to support registration submissions in various jurisdictions, and subsequently market their medicines throughout most of the world. These companies operate across borders and require individual national regulators to ensure that drugs authorized for use in their countries are safe and effective, and appropriate for their health care system and their population. This process involves significant resources and often duplicative work. It is important to consider how this process can be improved in order to better allocate resources, time, and efforts to improve public health. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators considers the role of mutual recognition and other reliance activities among regulators in contributing to enhancing public health. This report identifies opportunities for leveraging reliance activities more broadly in order to potentially impact public health globally. Key topics in this report include the job of medicines regulators in today's world, what policy makers need to know about today's regulatory environment, stakeholder views of recognition and reliance, as well as removing impediments and facilitating action for greater recognition and reliance among regulatory authorities.

The rise of the regulatory state has been a major feature of modern constitutional democracies. India, the world's largest democracy, is no exception to this trend. This book is the first major study of regulation in India. It considers how the development of regulation in India has altered the nature and functions of the state; how it is reshaping the relationship between business and the state; how it has called for the refashioning of established legal principles; and how it has raised new questions about the relationship between technical expertise and the rule of law. The chapters cover topics ranging from the foundations of the Indian regulatory state to the form of regulation across different sectors to regulation in practice. Together, the chapters reveal the challenges, promise, and limitations offered by contemporary regulatory practices, and they capture the close if sometimes fraught relationship that regulation must inevitably share with the political economy and constitutional schema within which it operates.

This Book Assesses Th Eimpact Of Regulatory Reform In The Electricity And Telecom Sectors In This Context. This Book Will Be Useful For Those Who Shall Have To Comply With Reformed Statutes. It Will Be Particularly Useful To Policy-Makers, Regulators, Executives, Academicians, Researchers, Donors, Consultants And All Those Involved In The Design And Implementation Of Reform Programmes.

"The rise of the regulatory state has been a major feature of modern constitutional democracies. India, the world's largest democracy, is no exception to this trend. This book is the first major study of regulation in India. It considers how the development of regulation in India has altered the nature and functions of the state; how it is reshaping the relationship between business and the state; how it has called for the refashioning of established legal principles; and how it has raised new questions about the relationship between technical expertise and the rule of law. The chapters cover topics ranging from the foundations of the Indian regulatory state to the form of regulation across different sectors to regulation in practice. Together, the chapters reveal the challenges, promise, and limitations offered by contemporary regulatory practices, and they capture the close if sometimes fraught relationship that regulation must inevitably share with the political economy and constitutional schema within which it operates"--Bloomsbury Publishing.

Regulatory Affairs in the Pharmaceutical Industry is a comprehensive reference that compiles all the information available pertaining to regulatory procedures currently followed by the pharmaceutical industry. Designed to impart advanced knowledge and skills required to learn the various concepts of regulatory affairs, the content covers new drugs, generic drugs and their development, regulatory filings in different countries, different phases of clinical trials, and the submission of regulatory documents like IND (Investigational New Drug), NDA (New Drug Application) and ANDA (Abbreviated New Drug Application). Chapters cover documentation in the pharmaceutical industry, generic drug development, code of Federal Regulation (CFR), the ANDA regulatory approval process, the process and documentation for US registration of foreign drugs, the regulation of combination products and medical devices, the CTD and ECTD formats, and much more. Updated reference on drug approval processes in key global markets Provides comprehensive coverage of concepts and regulatory affairs Presents a concise compilation of the regulatory requirements of different countries Introduces the fundamentals of manufacturing controls and their regulatory importance

On its Surface, this book is aimed at the topical issue of regulatory reform. But underneath it strives to go beyond the topical, seeking to analyze regulation as a distinct discipline and to help teach it as a separate subject.

These changes, together with the general advance in the study of regulation, undoubtedly demand a re-evaluation of the theory of regulation, its methodologies and scope of application. This book is a perceptive investigation of recent evolutions in the manner and extent of governance through regulation. Scholars and students of comparative politics, public policy, regulation theory, institutional economics and political sociology will find it to be essential reading. It will also prove a valuable source of reference for those working or dealing with regulatory authorities and for business managers in private industries and services operating under a regulatory framework.