Contract Research and Manufacturing Services (CRAMS) in India - 1st Edition - ISBN: 9781907568190, 9781908818164

Contract Research and Manufacturing Services (CRAMS) in India

1st Edition

The Business, Legal, Regulatory and Tax Environment in the Pharmaceutical and Biotechnology Sectors

Editors: Milind Antani Gowree Gokhale
Hardcover ISBN: 9781907568190
eBook ISBN: 9781908818164
Imprint: Woodhead Publishing
Published Date: 31st October 2012
Page Count: 248
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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


Description

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

Key Features

  • Simple and accessible presentation using tables, charts and diagrams
  • Practical tips from leading practitioners
  • Inclusion of relevant case laws and other legal considerations

Readership

Lawyers specializing in international contract law; Upper level managers at companies which outsource services, specifically to India; M&A specialists


Details

No. of pages:
248
Language:
English
Copyright:
© Woodhead Publishing 2012
Published:
Imprint:
Woodhead Publishing
eBook ISBN:
9781908818164
Hardcover ISBN:
9781907568190

About the Editors

Milind Antani Editor

Milind Antani is head of the international Pharma and Life Sciences practice at Nishith Desai Associates, and represents clients in matters including corporate mergers and acquisitions, regulatory and transactional matters, intellectual property prosecution and litigation, joint ventures and formation of new companies.

Gowree Gokhale Editor

Gowree Gokhale is a partner at Nishith Desai Associates.

Affiliations and Expertise

Nishith Desai Associates, India