Outsourcing biopharma R&D to India

130 Pages·2011·0.69 MB·English

by  Probir Roy Chowdhury

Outsourcing Biopharma
R&D to India
Biohealthcare Publishing Series on Pharma, Biotech and
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1. Clinical Research in Asia. U. Sahoo 13. Patently Innovative: How
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Outsourcing Biopharma
R&D to India
Probir Roy Chowdhury
Biohealthcare Publishing (Oxford) Limited
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First published in 2011 by Biohealthcare Publishing (Oxford) Limited
ISBNs: 978 1 907568 08 4 (print) and 978 1 908818 01 0 (e-book)
© P. R. Chowdhury, 2011
The right of P. R. Chowdhury to be identifi ed as author of this Work has been asserted by him in
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Contents
Acknowledgements xi
About the author xiii
1 Biopharma outsourcing in India: its evolution 1
1.1 What is outsourcing? 1
1.2 What is R&D? 2
1.3 Organisational patterns in R&D outsourcing 3
1.4 R&D outsourcing in the pharmaceutical industry 3
1.5 India as the emerging hub of R&D outsourcing
in the pharmaceutical industry 4
1.6 Outsourcing models prevalent in India 4
1.7 Key issues involved in outsourcing 8
2 India’s core competitive advantage in
R&D in the biopharma sector: the impetus
for outsourcing 17
2.1 Introduction 17
2.2 Cost competitiveness 18
2.3 Resources and skill 20
2.4 The role of the government 22
2.5 Conclusion 25
viii Contents
3 Different modes of outsourcing biopharma
R&D to India 29
3.1 Indian companies involved in outsourcing
activities 31
3.2 Contract research services 32
3.3 Contract manufacturing organisations 33
3.4 Drug substance manufacturing 34
3.5 Drug product manufacturing 35
3.6 Process development 35
3.7 Analytical methods and characterisation 35
3.8 Business models for contract manufacturing organisations 35
3.9 Insights into outsourcing of product development
and manufacture 37
3.10 Clinical trials 39
3.11 Advantages and disadvantages of doing
clinical trials in India 40
3.12 Active pharmaceutical ingredient and
technology transfer 41
3.13 Conclusions and implications 41

4 The Indian regulatory environment:
a historical perspective 45
4.1 Indian Council for Medical Research 48
4.2 Central Drugs Standard Control Organisation 49
4.3 Department of Biotechnology 49
4.4 National Pharmaceutical Pricing Authority 50
4.5 Overview of the industry 51
5 Implications of the changing regulatory
environment in India 57
5.1 Introduction 57
5.2 Capacity Building Programme: recent development 62
5.3 Clinical Trials Registry – India 65
Contents ix
5.4 The Indian Society for Clinical Research 67
5.5 Conclusion 67
6 Creating contracts for outsourcing in the
biopharma industry 69
6.1 Biopharma outsourcing 69
6.2 Preliminary documentation 70
6.3 Drafting of the biopharma outsourcing agreement 72
6.4 Specifi c considerations in different types
of agreements 73
6.5 Conclusion 79
7 Environmental, health and safety
guidelines and biopharma outsourcing:
an Indian perspective 81
7.1 Introduction 81
7.2 The EHS guidelines 82
7.3 EHS guidelines and India 83
7.4 Challenges faced by In dian companies in
EHS compliance 86
7.5 Conclusion 87
8 Certifi cations 89
8.1 Introduction 89
8.2 Certifi cations 91
8.3 Manufacturing licence 91
8.4 Good Manufacturing Practices 92
8.5 No-Objection Certifi cate and Certifi cate of Origin 93
8.6 Certifi cate of a Pharmaceutical Product 93
8.7 Certifi cations for clinical trials 94
8.8 International regulatory certifi cations 96
8.9 Conclusion 97
x Contents
9 The need for due diligence of service providers 99
9.1 Introduction 99
9.2 Sources utilised prior to due diligence 100
9.3 Areas of due diligence 101
9.4 Due diligence process 103
9.5 Contents of the due diligence report 105
9.6 Conclusion 106
Index 109