Table of Contents
List of figures, tables and box
List of abbreviations
About the authors
Chapter 1: Introduction
Abstract:
Chapter 2: Overview of CRAMS
Abstract:
2.1 What are contract research and manufacturing services (CRAMS)?
2.2 Emergence of CRAMS in India
2.3 Contract manufacturing organisations (CMOs)
2.4 Contract research organisations (CROs)
Chapter 3: Legal and regulatory scenario
Abstract:
3.1 Drugs legislation
3.2 Regulatory authorities in India
3.3 Drugs and Cosmetics Act and Rules
3.4 Clinical trials
3.5 Regulatory procedure
3.6 Recent regulatory developments
3.7 Information on updates
Chapter 4: Issues and concerns
Abstract:
4.1 Clinical research
4.2 Contract manufacturing
Chapter 5: Tax environment and related issues
Abstract:
5.1 Direct taxes
5.2 Indirect taxes
5.3 Synopsis of benefits available to units set up in Special Economic Zones
Chapter 6: Service agreements
Abstract:
6.1 Contract research/contract manufacturing agreements
6.2 Intellectual property (IP)
6.3 Other issues
6.4 Term and termination
6.5 Governing law and jurisdiction
6.6 Alternate dispute resolution (ADR)
Chapter 7: Negotiating a contract
Abstract:
7.1 Separate negotiation team
7.2 Approach
7.3 Negotiation process
7.4 Issues management
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