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
  • 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.

    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

    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

    Details

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