Book description
The field of contract research and manufacturing broadly encompasses those services in the pharmaceutical and biotechnology sectors that require extensive research and development and large-scale manufacturing facilities. The field has great potential for growth in the Indian outsourcing industry, which is world-renowned for its provision of cheap and highly-skilled services. Contract research and manufacturing services (CRAMS) in India provides a detailed account of the current scenario in India and the advantages that the Indian outsourcing industry can offer in the field of CRAMS. Following an overview of the services and their emergence in India, chapters in the book begin by discussing the legal and regulatory scenario and major concerns and issues. In the latter part of the book, topics covered include service agreements, dispute resolution and contract negotiations, followed by a discussion of the outlook for CRAMS in India and some concluding remarks. Several appendices are included, offering a list of major players in the field and various forms for use in licence applications.- Simple and accessible presentation using tables, charts and diagrams
- Practical tips from leading practitioners
- Inclusion of relevant case laws and other legal considerations
Table of contents
- Cover image
- Title page
- Table of Contents
- Copyright
- List of figures, tables and box
- List of abbreviations
- About the authors
- Chapter 1: Introduction
- Chapter 2: Overview of CRAMS
- Chapter 3: Legal and regulatory scenario
- Chapter 4: Issues and concerns
- Chapter 5: Tax environment and related issues
- Chapter 6: Service agreements
- Chapter 7: Negotiating a contract
- Chapter 8: Outlook and conclusion
- Appendix 1: Some important players in contract manufacturing in India
- Appendix 2: Contract research organisations in India
- Appendix 3: Schedule M
- Appendix 4: Schedule Y
- Appendix 5: Various forms for application for licensing
- Index
Product information
- Title: Contract Research and Manufacturing Services (CRAMS) in India
- Author(s):
- Release date: October 2012
- Publisher(s): Woodhead Publishing
- ISBN: 9781908818164
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