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Director & Chief Scientific Advisor Institute of Clinical Research Education and Research Chief Executive Officer & Global Medical Director Drug Research Laboratory; MUMBAI, INDIA
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WELCOME
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Dr Dilip Pawar
INDIA
POPULATION URBAN
LIFE EXPECTANCY
68 YEARS
Total
EXPENDITURE ON HEALTH
INDIA
URBAN LITERACY MALES FEMALES 82% 64%
6%OF GDP
BIRTH RATE
27 per 1000
DEATH RATE
8 per 1000
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Life Span
Population >65 years (million)
2025
5
120 100 80 60
Life Expectancy
119
62 58 42
72
40 20
32
1947
1980
1998
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1991
2020
218 mn
Prevalence of Illness
10% 22%
Rapid recruitment
(20-30% time advantage if studies are conducted in India Ernst & Young)
15-60 years
URBAN POPULATION
> 60 years
Epidemiologic Transition
Varied Disease Patterns of developing and developed world Dr Dilip Pawar
Patient Population
Cardiovascular diseases Degenerative neurological diseases Diabetes Cancer Psychiatric illnesses Gastro Intestinal Disorders Infectious Diseases Tropical diseases
India has diseases of the tropical world plus diseases of the developed countries
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Aryans from Central Asian steppes 1500 BC (pale skinned and light-eyed) Greeks (Yavanas) Scythians Parthians Iranians (Persians) Also Turks, Huns, Chinese, Ethopians
Today Caucasians Dravidians 80% 20%
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English
15 official languages National language Mother tongue of 30% of people Language for communication
ENGLISH
Labeling of Medicines
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Multiple systems
Ayurveda Other traditional Indian systems Homeopathy Western system; most widely practiced
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Medical profession
Did not question source of references Did not demand local evidence Patient care Ist priority Not familiar with GCP needs Did government funded research Lack of appreciation of mutual needs
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IRBs
Very few in number Mainly reviewed animal studies & post graduate theses Not US FDA compliant No SOPs Not much attention paid to ICF Patient reimbursement not permitted
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Drivers:
WTO Need to globalize Encourage Private public partnership Intense lobbying by MNCs Shift of focus of the indigenous industry; from process to product Economic sense
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Herbals Neutraceuticals
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Why India..
GCP compliant IRBs Untapped patient population English business language GCP guidelines ICH compliant Start up time reduced to 8-12 weeks CAP certified central labs
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Good Courier Systems within India and to other countries Dr Dilip Pawar 20
Therapeutic Expertise
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Technology support
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Regulatory milestones
Mandatory clinical trials for the first applicant 1987 BE for subsequent applicants 1987 GCP committee formed 1995 Ethical guidelines - 2000 GCP guidelines released 2001 Drug laws amended to permit simultaneous phase global trials Dr Dilip Pawar 2005
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Annual Revenues USD 120 M with 40% growth in past year 240 international studies recruiting subjects = 1.2% of the total studies worldwide 66% of international clinical trials are Phase III 207 sites FDA registered 40,000 subjects participated in clinical trials to date (<0.02% of population)
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Time 4 weeks FAST TRACK, US,UK,CANADA,SWITZERLAND, GERMANY,EMEA, AUSTRALIA, JAPAN CTA available 16 weeks, no documentation to support successful US/EU CTA
Drugs Controller General of India (DCGI) Ethics Committees Total (parallel processing) Directorate General of Foreign Trade (DGFT)
Test license to import trial supplies Local Ethics committee approval by sites Permission to export blood samples
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Sponsor / CRO
Approvals from EC to PI
Submission to DGFT
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Deadline is deadline !
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Clinical Trials on diseases of topics e.g. malaria, TB, leishmaniasis Clinical Trials on diseases/ disorders of a primitive economy e.g. Acute infections Nutrition-related Reproductive health-related AIDS Clinical Trials on diseases/ disorders of a developed economy e.g. Cardiovascular CNS including neurological degeneration and psychiatry Gastrointestinal Diabetes Cancers Dr Dilip Pawar AIDS
Locations usually outside urban areas Benefits to India likely / immediate Sponsors Industry and Others Locations urban and perirural Benefits to India likely / immediate
II.
III.
Sponsors Industry Locations urban Test molecules drugs in development Data for regulatory submission Benefits to India likely / immediate
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0.2
0.4
0.6
0.8
1.2
1.4
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Mckinsey Report
Indian CR market will grow to US $1.5 billion in value by 2010.
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Choose Good Investigators Need local understanding and global experience India has experienced Investigators Concern factors :
Using Investigator groups (some will be great, others might not) When inexperienced, assess willingness and motivation to learn and then train and retrain
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Reality
Many sites in India are trained in GCP now mandated by Government Various audits of the study show no adverse finding Data integrity in question In India US FDA has audited sites with no major comments Different languages cause English used for all healthcare-related confusion and escalate costs activities, systems, procedures and drug because of need to translate labels. Only patient-related documents need documents translation Telecommunication facilities good in urban Telecommunication poor areas. Connectivity good EDC studies Connectivity poor possible electronic transmission of ECG, imagings frequent.
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Key Messages
India is well placed to provide solutions for contemporary and future clinical research
Can facilitate affordable drug research Has required patient populations and qualified scientists and clinicians Has the information technology competitive advantage Has a regulatory framework which is moving towards regulatory harmonization The socio-economic transformation in urban India understands contemporary GCP requirements Rapid urbanisation and exposure to developed world facilitates cross-cultural understanding Product patents fromDr Dilip Pawar 1, 2005 January 35
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