Contract Research and Manufacturing Services (CRAMS) in India: The Business, Legal, Regulatory and Tax Environment in the Pharmaceutical and Biotechnology Sectors

Portada
Milind 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.
  • Simple and accessible presentation using tables, charts and diagrams
  • Practical tips from leading practitioners
  • Inclusion of relevant case laws and other legal considerations
 

Contenido

1 Introduction
1
2 Overview of CRAMS
5
3 Legal and regulatory scenario
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
Index
227
Derechos de autor

Otras ediciones - Ver todas

Términos y frases comunes

Acerca del autor (2012)

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 a partner at Nishith Desai Associates.

Información bibliográfica