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Reportlinker Adds Emerging Clinical Trial Locations - India: Market Dynamics and the Changing Healthcare and Regulatory Environment
Date:12/1/2009

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 int
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