Contract Research and Manufacturing Services (CRAMS) in India: The Business, Legal, Regulatory and Tax Environment in the Pharmaceutical and Biotechnology SectorsMilind Antani, Gowree Gokhale Elsevier, 2012 M10 31 - 248 páginas 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.
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Contenido
1 | |
5 | |
17 | |
4 Issues and concerns | 35 |
5 Tax environment and related issues | 41 |
6 Service agreements | 65 |
7 Negotiating a contract | 77 |
8 Outlook and conclusion | 81 |
Some important players in contract manufacturing in India | 83 |
Contract research organisations in India | 87 |
Schedule M | 89 |
Schedule Y | 121 |
Various forms for application for licensing | 191 |
227 | |
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Contract Research and Manufacturing Services (CRAMS) in India: The Business ... Milind Antani,Gowree Gokhale Sin vista previa disponible - 2012 |
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agreement and/or animals APIs Appendix application appropriate approval areas arm’s length price biotechnology bulk drug substance capital gains Carcinogenicity cent clinical research contract manufacturing contract research Cosmetics Rules CRAMS CROs DCGI documents dosage form drug development Drugs and Cosmetics ensure equipment Ethics Committee evaluation first-in-man studies fixed dose combination foreign enterprise formulation human income Indian CRO/CMO Indian Tax Treaties informed consent investigational investigational product Investigator’s issues label laboratory Licensing Authority Manufacturing Practices marketing outsourcing packaging paediatric parameters participation patients permission personnel pharmaceutical companies pharmacovigilance Phase premises prescribed product recall proposed protocol Quality Control raw material records Registration Certificate regulatory relevant research and manufacturing rodent route of administration safety pharmacology studies samples service provider service tax specific specified in Schedules Sponsor Standard Operating Procedures systemic toxicity studies test substance therapeutic transaction transfer pricing trials in India valid