Outsourcing Biopharma R&D to India
- 1st Edition - May 5, 2011
- Imprint: Woodhead Publishing
- Author: P R Chowdhury
- Language: English
- Paperback ISBN:9 7 8 - 0 - 0 8 - 1 0 1 7 3 4 - 0
- Hardback ISBN:9 7 8 - 1 - 9 0 7 5 6 8 - 0 8 - 4
- eBook ISBN:9 7 8 - 1 - 9 0 8 8 1 8 - 0 1 - 0
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… Read more
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Request a sales quoteThe 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
The pharmaceutical and biotechnology industries
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
Abstract:
2.1 Introduction
2.2 Cost competitiveness
2.3 Resources and skill
2.4 The role of the government
2.5 Conclusion
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
Abstract:
4.1 Indian Council for Medical Research
4.2 Central Drugs Standard Control Organisation
4.3 Department of Biotechnology
4.4 National Pharmaceutical Pricing Authority
4.5 Overview of the industry
Chapter 5: Implications of the changing regulatory environment in India
Abstract:
5.1 Introduction
5.2 Capacity Building Programme: recent development5
5.3 Clinical Trials Registry – India11
5.4 The Indian Society for Clinical Research12
5.6 Conclusion
Chapter 6: Creating contracts for outsourcing in the biopharma industry
Abstract:
6.1 Biopharma outsourcing
6.2 Preliminary documentation
6.3 Drafting of the biopharma outsourcing agreement
6.4 Specific considerations in different types of agreements
6.5 Conclusion
Chapter 7: Environmental, health and safety guidelines and biopharma outsourcing: an Indian perspective
Abstract:
7.1 Introduction
7.2 The environmental, health and safety guidelines
7.3 EHS guidelines and India
7.4 Challenges faced by Indian companies in EHS compliance
7.5 Conclusion
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
Abstract:
9.1 Introduction
9.2 Sources utilised prior to due diligence
9.3 Areas of due diligence
9.4 Due diligence process
9.5 Contents of the due diligence report6
9.6 Conclusion
Index
- Edition: 1
- Published: May 5, 2011
- Imprint: Woodhead Publishing
- No. of pages: 130
- Language: English
- Paperback ISBN: 9780081017340
- Hardback ISBN: 9781907568084
- eBook ISBN: 9781908818010
PC
P R Chowdhury
Probir Roy Chowdhury is Senior Associate of J. Sagar Associates, and is part of the firm's Technology Practice Group. He advises on Information Technology Law in areas including outsourcing, data protection, and e-commerce issues, and his transactional practice includes advice on venture capital fund structuring, transaction structuring, legal due diligence exercises, investment in the education sector, entry strategies and foreign exchange regulations. He writes on several technology-related subjects, and has contributed to the United Nations WSIS Summit project on Technology Surveillance as well as chapters in Advances in Biopharmaceutical Technology in India published by BioPlan Associates Inc. He is a regular contributor to the Computer Law Review International.
Affiliations and expertise
J. Sagar Associates, IndiaRead Outsourcing Biopharma R&D to India on ScienceDirect