1. Clinical Research in India
Drivers for changing perceptions
Dr Dilip Pawar
MD, PhD, MCSEPI, DPBM, DCA, MASCPT(USA),
MASPET(USA), FCP(USA), MBA
Fellow Of American Society Of Clinical Pharmacology
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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4. INDIA
POPULATION
URBAN 345 million
LIFE EXPECTANCY
Total 1 billion
68 YEARS
INDIA
EXPENDITUR ON HEALTH
E
URBAN LITERACY
6%OF GDP
MALES 82%
(1.2% Government Spend)
FEMALES 64%
•Fourth largest economy in the
world
•Second fastest growing economy in BIRTH RATE 27 per 1000
the world DEATH RATE 8 per 1000
•Projected GDP growth rate – 8% INFANT MORTALITY 77 per 1000
•Healthcare, Pharma, Biotech, IT,
BPO, telecom are fastest growing
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sectors
5. Life Span
119
120
Population >65 years (million)
100
80 72
62
58
60
Life Expectancy 42
32
40
20
0
1947
1980
1998
2020
2025
1991
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6. Population – Pronounced
Rural to Urban Migration
2000 (1000mn) 2025 (1400 mn)
218 mn
1990 (846 mn)
340 mn
Prevalence of Illness
10% 22%
• Rapid recruitment 15-60 years > 60 years
(20-30% time advantage if
studies are conducted in India URBAN POPULATION
– Ernst & Young)
PREVALENCE OF ILLNESS
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7. Changing Disease
Patterns
DISEASES OF DEVELOPED WORLD
DISEASES OF DEVELOPING COUNTRIES
PROBLEMS OF
REPRODUCTIVE AIDS
HEALTH
CHRONIC DISEASES
ACUTE LIFESTYLE-RELATED
INFECTIOUS
DISEASES CARDIO-VASCULAR
NUTRITIONAL CANCERS
DISEASES DEGENERATIVE DISEASES
Epidemiologic Transition
•Varied Disease Patterns
of developing and
developed world
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8. Diseases and Patients
Changing Disease Patient Population
8 million Epileptics
Patterns
40 million Asthmatics
Cardiovascular diseases
~34 million Diabetics
Degenerative neurological
diseases 8-10 million HIV +ve
Diabetes 3 million Cancer patients
Cancer > 2 million Cardiac deaths
Psychiatric illnesses 1.5 million Alzheimer
Gastro Intestinal Disorders patients
Infectious Diseases 1 million PD patients
Tropical diseases 15% Hypertensive
1% Schizophrenia patients
India has diseases of the tropical world plus diseases of
the developed countries
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9. India – Ethnic Diversity
Successive waves of visitors / invaders from the North – Dravidians
driven southwards
Aryans from Central Asian steppes – 1500 BC
(pale skinned and light-eyed)
Greeks (Yavanas) Today
Scythians Caucasians 80%
Parthians Dravidians 20%
Iranians (Persians)
Also Turks, Huns, Chinese, Ethopians • Ethnic diversity
- majority Caucasian
Later Portuguese, Dutch, French, Moghuls (Mongols), English
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10. The ‘Language’ Advantage
Languages - 15 official languages
Hindi - National language
- Mother tongue of 30% of
people
English - Language for communication
• Hospital Management
Teaching - Medical,
Nursing & Pharmacy • Source documents
ENGLISH
Communication with
Regulatory Authorities Labeling of Medicines
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11. Medical Practice in
India
Multiple systems
Ayurveda
Other traditional Indian systems
Homeopathy
Western system; most widely practiced
Multiple systems of therapies
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12. Pharmaceutical industry-
Past
Clinical trials not mandatory till 1987
Market of branded generics
No incentive for research
Innovator companies indifferent
Local industry not serious about
clinical trials
No data exclusivity & patent
protection
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13. 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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14. 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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15. Why Not India until recently?
High importation duty (55%)
No provision in drug laws for global
studies
No incentive for PI’s; academic
institutions suspicious of clinicians
No Data Exclusivity
Long start up times
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16. Changing perceptions
and a new environment
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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17. OUTSOURCING OPPORTUNITIES
- INDIA
Bulk Drugs Contract
Contract & Marketing &
R&D Formulations Sales
Manufacturing
Medicinal International
Chemistry Clinical
Trials
Plant Outsourcing
Machinery Opportunities - Technical
& India Services
Pharma
Equipment
Primary Herbals
Packaging Neutraceuticals
Bioinformatics
Materials Biostatistics
Software
Development
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18. Why India Now?
No importation duty
Patent act amended; IPR in place
Data Exclusivity –
Export procedures simplified
Drug laws amended to permit global
studies
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19. Why India…..
GCP compliant IRB’s
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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20. Clinical Trial Environment
Change Drivers
Government and Regulatory Environment more conducive to clinical research
• GCP guidelines introduced by ICMR and DGHS
• Customs levies on clinical trial drug supplies eliminated
Patent rules harmonised Healthcare and Healthcare delivery
improvements
• Tertiary Hospital Infrastructure
• GCP awareness
• Healthcare Industry - Rs.100,000 crores
Epidemiological Transition of • Growing demand by Middle Class
Disease - Patterns changing
• Good connectivity
• Increasing use of IT and Internet
Health Insurance expansion • Transfer of ECGs and Imaging - now routine
- private participation
emphasis on preventive care
Good Courier Systems within India
and to other countries
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21. Skilled workforce
High quality research with
domain expertise
Maintenance of
time schedules
INDIA Shortening time
to market
Therapeutic Expertise Technology support
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22. 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 -
2005 Dr Dilip Pawar 22
23. Recipe for success in India
MOH approval easy if US IND/ EMEA
application
Understand PI behavior – financial
negotiations
Invest in training PIs, IRBs
Promote young, enthusiastic PIs
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24. Nascent but Fast Growing
- India’s Clinical Development Sector -
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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25. Recent India Regulatory Reform makes
Approvals Possible within 6 weeks.
Regulatory body Approval Time
Drugs Controller Regulatory approval for 4 weeks – FAST TRACK,
General of India (DCGI) study conduct in India US,UK,CANADA,SWITZERLA
ND,GERMANY,EMEA,
AUSTRALIA, JAPAN CTA
available
16 weeks, no documentation to
support successful US/EU CTA
Drugs Controller Test license to import 2 weeks in addition
General of India (DCGI) trial supplies
Ethics Committees Local Ethics committee 6 – 8 weeks (in parallel)
approval by sites
Total (parallel processing) - 6-8 weeks – FAST TRACK
16 weeks (track B)
Directorate General of Permission to export Additional 2 to 4 weeks
Foreign Trade (DGFT) blood samples
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26. Meticulously Following Prescribed
Process Is Key.
Regulatory & IRB Approval Process:India
PI submits
CDA signed,
Consent Letter application Queries Approvals
Site Selected,
from PIs to EC from EC from EC
Release Protocol
reply to queries
Contract/LOI Approvals
executed from EC
All documents Sponsor / CRO
to PI
received
Regulatory Regulatory Regulatory DGFT
Internal review
dossier submission Approval Export License
of dossier
compilation to DCGI from DCGI Application
Export License
Submission
Obtained
to DGFT
from DGFT
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27. Don‘t set too ambitious
deadlines
Deadline is deadline !
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29. Clinical Trials Outsourced
to India
Differing Dynamics
I. Clinical Trials on diseases of topics e.g. Locations – usually outside urban areas
malaria, TB, leishmaniasis Benefits to India – likely / immediate
II. Clinical Trials on diseases/ disorders of a Sponsors – Industry and Others
primitive economy e.g. Locations – urban and perirural
Acute infections Benefits to India – likely / immediate
Nutrition-related
Reproductive health-related
AIDS
III. Clinical Trials on diseases/ disorders of a Sponsors – Industry
developed economy e.g. Locations – urban
Cardiovascular Test molecules – drugs in development
CNS including neurological degeneration and Data for regulatory submission
psychiatry Benefits to India – likely / immediate
Gastrointestinal
Diabetes
Cancers Dr Dilip Pawar 29
AIDS
30. India offers Cost Saving
Potential
Overall Indexed Clinical Trial Costs
India 0.56
China 0.52
Russia 0.4
Australia 0.73
US 1
Spain 0.93
Germany 1.2
France 0.71
UK 1.09
Poland 0.77
0 0.2 0.4 0.6 0.8 1 1.2 1.4
Source: FastTrack Systems Global Cost Databases
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32. 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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33. INDIA - Perceptions & Realities
Perception Reality
Many sites in India are trained in GCP – now
GCP awareness absent or low
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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35. 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 from January 1, 2005
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36. The Opportunities ahead
In Clinical Research Opportunities are many
Not Only in India but also internationally
GRAB THE OPPORTUNITY…….
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