Cargando…
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...
| Clasificación: | Libro Electrónico |
|---|---|
| Autor principal: | |
| Otros Autores: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Cambridge :
Woodhead Pub.,
2012.
|
| Colección: | Woodhead Publishing series in biomedicine ;
no. 19. |
| Temas: | |
| Acceso en línea: | Texto completo |
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.