This item is in: Biomedicine > Management and business

Contract research and manufacturing services (CRAMS) in India: The business, legal, regulatory and tax environment in the pharmaceutical and biotechnology sectors

Edited by M Antani and G Gokhale, Nishith Desai Associates, India

Woodhead Publishing Series in Biomedicine No. 19

 - simple and accessible presentation using tables, charts and diagrams
 - practical tips from leading practitioners
 - inclusion of relevant case laws and other legal considerations
 - research and practice-driven approach

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.

ISBN 1 907568 19 0
ISBN-13: 978 1 907568 19 0
October 2012
248 pages  234 x 156mm  hardback  
£125.00 / US$210.00 / €150.00

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About the editors

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 also a partner at Nishith Desai Associates.

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Contents

Introduction
 - Notes

Overview of CRAMS
 - What are contract research and manufacturing services (CRAMS)?
 - Emergence of CRAMS in India
 - Contract manufacturing organisations (CMOs)
 - Contract research organisations (CROs)

Legal and regulatory scenario
 - Drugs legislation
 - Regulatory authorities in India
 - Drugs and Cosmetics Act and Rules
 - Clinical trials
 - Regulatory procedure
 - Recent regulatory developments
 - Information on updates

Issues and concerns
 - Clinical research
 - Contract manufacturing

Tax environment and related issues
 - Direct taxes
 - Indirect taxes
 - Synopsis of benefits available to units set up in Special Economic Zones

Service agreements
 - Contract research/contract manufacturing agreements
 - Intellectual property (IP)
 - Other issues
 - Term and termination
 - Governing law and jurisdiction
 - Alternate dispute resolution (ADR)

Negotiating a contract
 - Separate negotiation team
 - Approach
 - Negotiation process
 - Issues management

Outlook and conclusion

Appendix
 - 1: Some important players in contract manufacturing in India
 - 2: Contract research organisations in India
 - 3: Schedule M
 - 4: Schedule Y
 - 5: Various forms for application for licensing