Başlık:
Contract research and manufacturing services (CRAMS) in India : the business, legal, regulatory and tax environment
Yazar:
Antani, Milind.
ISBN:
9781908818164
Ek Yazar:
Yayın Bilgisi:
Cambridge : Woodhead Pub., 2012.
Fiziksel Tanım:
1 online resource (xx, 229 pages :) : illustrations.
Seriler:
Woodhead Publishing series in biomedicine, no. 19
Woodhead Publishing series in biomedicine ; no. 19.
Contents:
Cover; Contract research and manufacturing services (CRAMS) in India: The business, legal, regulatory andtax environment in the pharmaceuticaland biotechnology sectors; Copyright; Contents; List of figures, tables and box; List of abbreviations; About the authors; 1 Introduction; Notes; 2 Overview of CRAMS; 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); Notes; 3 Legal and regulatory scenario; 3.1 Drugs legislation.
3.2 Regulatory authorities in India3.3 Drugs and Cosmetics Act and Rules; 3.4 Clinical trials; 3.5 Regulatory procedure; 3.6 Recent regulatory developments; 3.7 Information on updates; Notes; 4 Issues and concerns; 4.1 Clinical research; 4.2 Contract manufacturing; 5 Tax environment and related issues; 5.1 Direct taxes; 5.2 Indirect taxes; 5.3 Synopsis of benefits available to units set up in Special Economic Zones; 6 Service agreements; 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 jurisdiction6.6 Alternate dispute resolution (ADR); Note; 7 Negotiating a contract; 7.1 Separate negotiation team; 7.2 Approach; 7.3 Negotiation process; 7.4 Issues management; 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.
Özet:
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 diagramsPractical tips from leading practitionersInclusion of relevant case laws and other legal considerations.
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Elektronik Erişim:
ScienceDirect http://www.sciencedirect.com/science/book/9781907568190Mevcut:*
Library | Materyal Türü | Barkod | Yer Numarası | Durumu/İade Tarihi |
|---|---|---|---|---|
Arıyor... | E-Book | 199528-1001 | HD9672 .I4 A58 2012 eb | Arıyor... |