Book description
The trend of outsourcing to India for research and development is catching on fast. Over the last decade, worldwide pharmaceutical and biotechnology companies have made India their choice for a research destination. Initially R&D was inclined more towards developing products for the Indian market within the country. This led to several multinational companies opening up production plants in India, primarily due to the globalization of the Indian economy and offshoring jobs to India. Alongside, several global pharma-biotech majors ascertained large market requirements within the country and capitalized on the advantage of serving Indian customers. Strategies were devised to optimize operational expenses with the setting up of on-site R&D to develop products for local requirements. In view of this, this book seeks to explore various nuances of the outsourcing sector with respect to biopharma in India.- Constitutes the first ever comprehensive insight on the Indian biopharma sector
- Provides a perspective based on practical hands-on legal experience
- Simply structured, clearly presented and free from excessive legal jargon
Table of contents
- Cover image
- Title page
- Table of Contents
- Copyright
- Acknowledgements
- About the author
-
Chapter 1: Biopharma outsourcing in India: its evolution
- Abstract:
- 1.1 What is outsourcing?
- 1.2 What is R&D?
- 1.3 Organisational patterns in R&D outsourcing
- 1.4 R&D outsourcing in the pharmaceutical industry
- 1.5 India as the emerging hub of R&D outsourcing in the pharmaceutical industry
- 1.6 Outsourcing models prevalent in India: cooperation models for outsourced services
- 1.7 Key issues involved in outsourcing
- Chapter 2: India’s core competitive advantage in R&D in the biopharma sector: the impetus for outsourcing
-
Chapter 3: Different modes of outsourcing biopharma R&D to India
- Abstract:
- 3.1 Indian companies involved in outsourcing activities6
- 3.2 Contract research services
- 3.3 Contract manufacturing organisations
- 3.4 Drug substance manufacturing
- 3.5 Drug product manufacturing
- 3.6 Process development
- 3.7 Analytical methods and characterisation
- 3.8 Business models for contract manufacturing organisations
- 3.9 Insights into outsourcing of product development and manufacture
- 3.10 Clinical trials
- 3.11 Advantages and disadvantages of doing clinical trials in India
- 3.12 Active pharmaceutical ingredient and technology transfer
- 3.13 Conclusions and implications
- Chapter 4: The Indian regulatory environment: a historical perspective
- Chapter 5: Implications of the changing regulatory environment in India
- Chapter 6: Creating contracts for outsourcing in the biopharma industry
- Chapter 7: Environmental, health and safety guidelines and biopharma outsourcing: an Indian perspective
-
Chapter 8: Certifications
- Abstract:
- 8.1 Introduction
- 8.2 Certifications
- 8.3 Manufacturing licence
- 8.4 Good Manufacturing Practices
- 8.5 No-Objection Certificate and Certificate of Origin
- 8.6 Certificate of a Pharmaceutical Product
- 8.7 Certifications for clinical trials
- 8.8 International regulatory certifications
- 8.9 Conclusion
- Chapter 9: The need for due diligence of service providers
- Index
Product information
- Title: Outsourcing Biopharma R&D to India
- Author(s):
- Release date: May 2011
- Publisher(s): Woodhead Publishing
- ISBN: 9781908818010
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