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Author:   P R Chowdhury (J. Sagar Associates, India) ,  P R Chowdhury
Publisher:   Elsevier Science & Technology
Imprint:   Woodhead Publishing Ltd
Dimensions:   Width: 15.60cm , Height: 0.70cm , Length: 23.40cm
Weight:   0.200kg
ISBN:  

9780081017340

ISBN 10:   0081017340
Pages:   130
Publication Date:   19 August 2016
Audience:   Professional and scholarly ,  Professional & Vocational
Format:   Paperback
Publisher's Status:   Active
Availability:   Manufactured on demand  
We will order this item for you from a manufactured on demand supplier.

Table of Contents

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

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Author Information

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.

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