Contract research and manufacturing services (CRAMS) in India the business, legal, regulatory and tax environment
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, w...
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| Otros Autores: | |
| Formato: | Libro electrónico |
| Idioma: | Inglés |
| Publicado: |
Cambridge :
Woodhead Pub
2012.
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| Edición: | 1st edition |
| Colección: | Woodhead Publishing series in biomedicine,
no. 19 Woodhead Publishing Series in Biomedicine |
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| Ver en Biblioteca Universitat Ramon Llull: | https://discovery.url.edu/permalink/34CSUC_URL/1im36ta/alma991009628858106719 |
Tabla de Contenidos:
- 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
