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Chapter 1: Biopharma outsourcing in India: its evolution
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
2.2 Cost competitiveness
2.3 Resources and skill
2.4 The role of the government
Chapter 3: Different modes of outsourcing biopharma R&D to India
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
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
5.2 Capacity Building Programme: recent development5
5.3 Clinical Trials Registry – India11
5.4 The Indian Society for Clinical Research12
Chapter 6: Creating contracts for outsourcing in the biopharma industry
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
Chapter 7: Environmental, health and safety guidelines and biopharma outsourcing: an Indian perspective
7.2 The environmental, health and safety guidelines
7.3 EHS guidelines and India
7.4 Challenges faced by Indian companies in EHS compliance
Chapter 8: 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
Chapter 9: The need for due diligence of service providers
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
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
The pharmaceutical and biotechnology industries
- No. of pages:
- © Woodhead Publishing 2011
- 5th May 2011
- Woodhead Publishing
- eBook ISBN:
- Hardcover ISBN:
- Paperback ISBN:
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.
J. Sagar Associates, India
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