Emerging Clinical Trial Locations – India: Market dynamics and the changing healthcare and regulatory environment

Over the last decade pharmaceutical and biotechnology companies have entered a period where they have become confronted by a variety of complex issues affecting their operational efficiency and profitability. It has now become generally acknowledged that the current business models have become both economically unsustainable and operationally unsuited to act quickly enough to produce the types of innovative treatments that will be demanded by global markets. Major issues confronting both the pharmaceutical and biotechnology market are: the requirement to reduce the escalating costs and risks associated with drug development; and reduce clinical trial timelines by improving patient recruitment and improving the efficiency of clinical trial results analysis and reporting. The biopharmaceutical industry has recognized the opportunities and advantages that exist by conducting clinical trials in what are referred to as the emerging markets. This report identifies market dynamics and key regulatory changes, and analyzes the implications and factors which need to be taken into consideration when conducting clinical trials in India.

Report Highlights

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Table of Contents
Emerging clinical trial locations - India
Executive summary 10
Introduction 10
Conducting clinical trials in emerging markets 11
India 12
Chapter 1 Introduction 14
Summary 14
Introduction 15
Generic competition 15
Intellectual property protection 15
Managing regulatory compliance 17
Cost containment and government funding restrictions 18
Obtaining and maintaining competitive advantage 18
Recruitment and retention of a skilled workforce 19
Improvement to R&D productivity 20
High risks and costs associated with drug development 20
Escalating costs of clinical trials 20
Global increase in the number of clinical trials conducted 23
Longer R&D timelines 24
Increased attrition rates during R&D 26
Clinical trial study design and planning 27
Clinical trial study design 27
Clinical trial study protocol 28
Clinical trial sponsors 28
Identifying and recruiting patients 28
Role of CROs 29
Information technology and new technology platforms 29
Drivers of development 30
Advantages associated with EDC 30
Advantages of electronic Clinical Trial Management Systems (CTMS) 30
Cost saving 31
Issues and challenges 31
Electronic records and signatures 31
Integration and linkage of electronic systems 32
Security and confidentiality of patient data 32
Chapter 2 Conducting clinical trials in emerging markets 36
Summary 36
Introduction 37
Market drivers 39
Rapid recruitment of patients and clinical trial investigators 39
Significant cost benefits 41
Improving transparency and efficiency of regulatory systems 42
Harmonization and standardization of regulatory requirements 43
Expansion of CROs 44
Conducive hospital infrastructure and healthcare systems 46
Enhanced clinical site effectiveness 47
Future commercial value 49
Key barriers 50
Concerns over the clinical trial transparency 50
Publication bias 51
Selective reporting 52
Duplicate publication 53
Conflict of interest 53
Availability of demographic and epidemiology data 53
Critical components concerning capacity building 53
Assimilation of individual national regulations and guidelines 56
United States 56
Japan 57
European Union 58
Language translation 59
Ethical challenges 60
Health needs of the population under study 60
Respect for potential and enrolled subjects 61
Ethical oversight 61
Lack of review by institutional review board (IRB) 61
Absence of informed consent 62
Scientific validity 63
Inadequate protection of intellectual property 64
Clinical trial logistics 64
Import licenses and applications 64
Customs regulations 65
Storage, handling and distribution 66
Selecting an appropriate CRO 67
Patient enrolment 70
Site selection 70
Site activation 71
Patient recruitment 71
Chapter 3 India 74
Summary 74
Introduction 75
Geographic 75
Political 75
Economic 75
Market dynamics 76
Vital statistics 76
Population statistics 77
Epidemiology and prevalence of major disease 79
Pharmaceutical market 80
Biotechnology market 83
CRO market 84
Clinical trial market 88
Geographic focus of the Indian clinical research industry 88
Market drivers 91
Population ethnicity and genetic diversity 91
Large complement of trained medical specialists in India 92
Significant cost savings 93
Government incentives 94
Creation of the Clinical Trials Registry – India (CTRI) 95
Sophisticated logistics and clinical research infrastructure 95
Comprehensive IT and IT enabled support (ITES) base 96
Key barriers 97
Ethical issues 97
Lack of experienced investigators 98
Inability to detect and monitor ADRs 98
Bribery and corruption 99
Healthcare 99
Healthcare system 99
National level 99
State level 100
Regional level 100
District level 101
Sub-divisional/Taluka level 101
Community level 101
Primary health centre (PHC) level 101
Sub health centre (SHC) level 102
Hospital resources 102
Regulation and legislation 103
Regulatory authorities 103
The Ministry of Health and Family Welfare 103
Central Drug Standard Control Organization (CDSCO) 107
Drug Controller General of India (DCGI) 108
Indian Council of Medical Research (ICMR) 108
Clinical trial regulation 109
Harmonization of the clinical trial approval process 111
Legislation 112
Patent law and WTO TRIPS 112
Schedule Y Drugs and Cosmetics Act and Rule 114
Summary of the recent regulatory and legislative changes 115
Evolution of the regulatory environment 116
Expected improved collaboration: DCGI with international agencies 118
Anticipation of approval for early phase studies in India 118
Registration and regulation of CROs in India 119
Future reform and emphasis on improved pharmacovigilance in
India 120
India to implement an electronic management system 120
Outlook 122
Chapter 4 Appendix 124
Introduction to clinical trials 124
Clinical trial phases 124
Phase I 124
Phase II 124
Phase III 125
Phase IV 125
What is a clinical trial 125
Clinical trials of pharmaceutical agents 126
Types of clinical trial 127
Pilot studies 127
Proof of concept (PoC) trials 127
Randomized clinical studies 127
Controlled clinical trials 127
Parallel studies 128
Parallel group trials 128
Cohort studies 128
Case control studies 128
Role of the chief investigator 129
Clinical trial protocol and procedure 129
Determination of the clinical trial size 130
Role of the coordinating centre and trials unit 130
Role of the trial coordinator 130
The trial principle investigator 131
Forms and data management 131
Trial data analysis and evaluation 132
Ethical issues and conduct of clinical trial research 132
Interpretation and publication of clinical trial results 133
Principle regulatory agencies 133
The European Agency for the Evaluation of Medicinal Products (EMEA) 133
The United States Food and Drug Administration (US FDA) 133
Japanese Ministry of Health, Labor and Welfare (MHLW) 134
Methodology statement 135
Primary Data and Information Gathering 135
Secondary data and information gathering 136
Definitions of Product-Life Cycle stages 138
Glossary of abbreviations and acronyms 139
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List of Tables
Table 2.1: Demographics of selected emerging markets, 2007 40
Table 2.2: Ethical principles & their application for research 62
Table 3.3: Statistical healthcare data India 78
Table 3.4: Ten leading causes of death (%) in India, 2002 79
Table 3.5: Diseases of the developed world in India 80
Table 3.6: Top 10 pharmaceutical companies ($m) in India, 2008 82
Table 3.7: Major biotechnology products in India and their companies 84
Table 3.8: Major CROs operating in India 86
Table 3.9: Major specialty hospital groups operating in Northern India 89
Table 3.10: Regulatory authorities based in Northern India 90
Table 3.11: Snapshot of hospitals in India 102
List of Figures
Figure 1.1: Key issues facing Pharma and Biotech companies 16
Figure 1.2: Cost of bringing a drug to market ($m), 1975-2008 21
Figure 1.3: Pharmaceutical R&D expenditure ($bn), 2004-2009e 22
Figure 1.4: Biotechnology R&D expenditure ($bn), 2004-2009e 22
Figure 1.5: Cost of clinical trials in the US ($bn), 2005-2011e 23
Figure 2.6: Comparison of locations across selected countries 38
Figure 2.7: Korean Food and Drug Administration (KFDA) Approval Process 43
Figure 2.8: CRO Segment Leaders 45
Figure 2.9: Enhanced clinical site effectiveness (patients per site) in the emerging countries 48
Figure 2.10: Fewer ineffective sites in the emerging countries 48
Figure 2.11: Critical components for capacity building/conducting clinical trials 54
Figure 2.12: Assessing clinical trial location feasibility 55
Figure 2.13: CRO selection criteria 70
Figure 3.14: GDP in India (%) by sector 76
Figure 3.15: Projected growth of healthcare industry in India ($bn), 2008-2022 77
Figure 3.16: Population projection (millions) in India, 2000-2020 78
Figure 3.17: Pharma industry in India ($bn), 2007-2010 81
Figure 3.18: Market share (%) between MNCs and local pharmaceutical companies in India, 2003- 2007 82
Figure 3.19: Outsourced clinical trial market in India (US$), 2002-2010 87
Figure 3.20: Clinical trials in India (by phase), 2009 88
Figure 3.21: Types of disease and types of hospitals in India 91
Figure 3.22: Cost of clinical trials (%) in India vs US 94
Figure 3.23: Structure of healthcare system in India 100
Figure 3.24: Current organogram of the Ministry of Health and Family Welfare 105
Figure 3.25: Proposed organogram of the Ministry of Health and Family Welfare 106
Figure 3.26: Approval categories of global clinical trials in India 111
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