Contract Research and Manufacturing Services (CRAMS) in India: The Business, Legal, Regulatory and Tax Environment in the Pharmaceutical and Biotechnology Sectors

by Milind Antani (Editor), Gowree Gokhale (Editor)

Overview

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

Product Details

ISBN-13:	9781908818164
Publisher:	Elsevier Science
Publication date:	10/31/2012
Series:	Woodhead Publishing Series in Biomedicine
Sold by:	Barnes & Noble
Format:	eBook
Pages:	248
File size:	3 MB

About the Author

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 is a partner at Nishith Desai Associates.

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