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Contract Research and Manufacturing Services (CRAMS) in India

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

  1. Cover image
  2. Title page
  3. Table of Contents
  4. Copyright
  5. List of figures, tables and box
  6. List of abbreviations
  7. About the authors
  8. Chapter 1: Introduction
    1. Abstract:
  9. Chapter 2: Overview of CRAMS
    1. Abstract:
    2. 2.1 What are contract research and manufacturing services (CRAMS)?
    3. 2.2 Emergence of CRAMS in India
    4. 2.3 Contract manufacturing organisations (CMOs)
    5. 2.4 Contract research organisations (CROs)
  10. Chapter 3: Legal and regulatory scenario
    1. Abstract:
    2. 3.1 Drugs legislation
    3. 3.2 Regulatory authorities in India
    4. 3.3 Drugs and Cosmetics Act and Rules
    5. 3.4 Clinical trials
    6. 3.5 Regulatory procedure
    7. 3.6 Recent regulatory developments
    8. 3.7 Information on updates
  11. Chapter 4: Issues and concerns
    1. Abstract:
    2. 4.1 Clinical research
    3. 4.2 Contract manufacturing
  12. Chapter 5: Tax environment and related issues
    1. Abstract:
    2. 5.1 Direct taxes
    3. 5.2 Indirect taxes
    4. 5.3 Synopsis of benefits available to units set up in Special Economic Zones
  13. Chapter 6: Service agreements
    1. Abstract:
    2. 6.1 Contract research/contract manufacturing agreements
    3. 6.2 Intellectual property (IP)
    4. 6.3 Other issues
    5. 6.4 Term and termination
    6. 6.5 Governing law and jurisdiction
    7. 6.6 Alternate dispute resolution (ADR)
  14. Chapter 7: Negotiating a contract
    1. Abstract:
    2. 7.1 Separate negotiation team
    3. 7.2 Approach
    4. 7.3 Negotiation process
    5. 7.4 Issues management
  15. Chapter 8: Outlook and conclusion
  16. Appendix 1: Some important players in contract manufacturing in India
  17. Appendix 2: Contract research organisations in India
  18. Appendix 3: Schedule M
  19. Appendix 4: Schedule Y
  20. Appendix 5: Various forms for application for licensing
  21. Index