1. INDIA AS AN EMERGING
DESTINATION FOR OUTSOURCING
CLINICAL RESEARCH
Dr. S K Gupta
Dean & Director General
Institute Of Clinical Research, India
New Delhi-110037
REQUIREMENTS FOR GLOBAL RESEARCH
Infrastructure
Regulatory Environment
Patient Pool-Genetic Diversity
I.P Protection
Investigator Availability
Bioethics Regulation
Cost Advantage
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2. LANDMARK YEAR: 2005
CLINICAL RESEARCH
Phase I clinical
trial NCE from
Amended abroad in Phase I trial for
Schedule Y Pipeline NCE developed
in India: Yes
Pharmacovigilance
Clinical Trial launch
Registry
launched
Product patent
regime
ICMR/
Bioethics
ICH-GCP
INFRASTRUCTURE AVAILABLE
• Over 200 Medical Colleges
• Over 22,000 graduates per year
• 15,622 hosp., 903,952 hosp.beds >75% in urban area
Clin. Res. • 14000 diagnostic labs
Infrastructure
• 700,000 scientists and engineering graduates / year
• World class medical / lab facilities at secondary /
tertiary care centers
• Skilled computer savvy biomedical work force
• Highly developed IT / ITES
IT Support
• Motivated & committed personnel
• High quality digital connectivity
Connectivity • Excellent air/surface transport facilities across
country
CDSCO
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3. INDIA : ADVANTAGES
• Large No. of specialists in different therapy segments
• Medical Training In English
Investigators • 600,000 Eng. Speaking physicians
• PG training from Europe/US
• Treatment Protocols in line with West
• Large no. of ICH/GCP compliant Investigators / sites
• Large, Diverse, therapy-naïve
• Advantage of having 6 out of 7 genetic varieties
Patient
population • Large pt. pool in acute/chronic disease segment
• Increasing no. of pts in life style disorders
segment, HIV, Oncology
CDSCO
Demand-Supply Gap of CR Professionals, 2010 in India
4000
Other Site Staff 400
2000
Invigilator
300
Demand
6000 Supply
CRO Staff 1000
1000
Sponsor Staff
200
0 1000 2000 3000 4000 5000 6000 7000
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4. HUMAN RESOURCE DEVELOPMENT
Established in 2004
To meet the challenges 50,000 Professionals
DELHI, MUMBAI, BANGALORE AHEMEDABAD AND HYDERABAD
DRUG DISCOVERY & DEVELOPMENT
R&D investment by Indian Pharma Companies
Before patent protection implementation
Process research NDDS NCE
After patent protection implementation -Expected
Process NDDS NCE
research
Process Research NDDS NCE
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5. WHY INDIA IS BECOMING A HOT DESTINATION
FOR CLINICAL RESEARCH?
Clinical trials in India is growing at a 60% AAGR
• Crossed USD 100 million in 2004.
• By 2010, the industry will spend USD 300M+ on clinical trials in
India.
Estimated market size of clinical trials in India (USD in mn)
More than 150 CRO’s are conducting clinical trials complying
TREATMENT NAIVE PATIENTS (DISEASE WISE)
45 million asthmatics 8 million epileptics
30 million diabetics 3 million cancer
18 million hypertensive 1.5 million Alzheimer's
13 million hepatitis C one million
10 million or more HIV schizophrenics
patients
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6. CLINICAL DATA MANAGEMENT
ADVANTAGE INDIA
Capabilities of Vendors Opportunity From Deals
HR capabilities to support Strategic outsourcing of a global
large work force function
well capitalized & willing to Seek more than cost saving
invest Long term contracts
committed to innovation Board level oversight
Scale & Scope to effect a “Tipping
long term high level
Point”
relationship
CLINICAL TRIALS
Cost of Clinical trials in USA vis-à-vis in India
Study Average US cost (in Indian cost
millions)
Phase I 20 50% less than the average cost in
US
Phase II 50 60%less than the average cost in
US
Phase III 100 60%less than the average cost in
US
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7. CROS CONTRIBUTING FOR OUTSOURCING
CLINICAL RESEARCH
CROs Can Deliver Quicker
CROs Can Deliver Quicker
and More Efficient Trials
and More Efficient Trials
•• Specialized in clinical research and
Specialized in clinical research and
can generate economies of scale
can generate economies of scale
139 140 •• Utilize latest data management tools
Utilize latest data management tools
89 66 81 97 & technologies as well as other
& technologies as well as other
technologies (e.g., patient
technologies (e.g., patient
recruitment)
recruitment)
Phase I Phase II Phase III •• Can conduct trials in lower cost
Can conduct trials in lower cost
Sponsor CRO regions
regions
•• Reduce time to complete trials*
Reduce time to complete trials*
– CROs complete trials 30% faster than
– CROs complete trials 30% faster than
pharma companies*
pharma companies*
– CROs complete trials in less time
– CROs complete trials in less time
across phases
across phases
ADVANTAGE INDIA OVER OTHER COUNTRIES
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8. DISEASE WISE CLINICAL TRIALS DONE IN INDIA
THE PERCENTAGE OF CRO REVENUES FROM BIOTECH
FIRMS IS RAPIDLY INCREASING
CRO R&D Expenditure Forecast
(2000–2007)
100%
% of 23% 26% 30% 32%
Expenditure 34% 36% 38% 40% Biotech
75%
50%
77% 73% 70% 68% 66% 64% 62% 60%
25% Pharma
0%
2000 2001 2002 2003 2004 2005 2006 2007
Source: Frost & Sullivan, 2003.
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9. PHASE IV TRIAL MARKET INCREASING DUE TO
SAFETY CONCERNS
% of Revenue
100%
15.5% 18.8% 22.2% 26.1% Phase IV
75%
39.3% 37.2% Phase III
34.2% 31.1%
50%
Phase II
26.2% 24.3% 23.4% 22.2%
25%
19.0% 19.7% 20.2% 20.6% Phase I
0%
2001 2003 2005 2007
CRO Revenues by Clinical Phase (2001–07)
Source: Frost & Sullivan, 2003.
INDIA BUILDING A TRACK RECORD
Clinical Trial Data From India to Achieve an FDA NDA
Drug Company Compound Researched Indication US Launch
Canagene Hepagam Hepatitis B Jan 06
Eli Lilly Alimta Cancer Feb-04
Eli Lilly Cialis Erectile dysfunction Nov-3
Jannsen Risperidal Psychosis Oct-03
Wyeth Flumist Influenza May-03
Alcon Vigamox Ophthalmic Infections Jan-03
Glaxo Lamictal Epilepsy Jan-03
Novrtis Zelcorm Irritable Bowel Syndrome Jul-02
Pfizer Vfend Fungal Infection May-02
Eli Lilly Xigris Septicemia Nov-01
Santen Quixin Ophthalmic Infections Oct-00
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10. GLOBAL CLINICAL TRIALS
COMPARISON INDIA : CHINA
Sr. No. Company Clinical Trial in India CLINICAL Trial in China
1 Astra Zeneca 10 10
2 BMS 17 6
3 Eli Lilly 17 12
4 GSK 22 14
5 J&J 20 13
6 Merck 8 5
7 Novartis 9 6
8 Pfizer 16 5
9 Roche 5 14
10 Sanofi Aventis 15 13
Total 139 98
Clinical Trials from India
(www.clinicaltrials.gov.: 15Apr08)
100000
No. Trials (Log transformed)
10000
1000
100
10
1
Phase-1 Phase-2 Phase-3 Phase-4
India 32 165 394 63
USA 6324 11305 5683 2474
All 8540 16878 11662 6142
Phase of trial
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11. CLINICAL TRIAL ACTIVITIES IN ASIA
ALL STUDIES
www.clinicaltrials.gov-snapshot: 7 Feb 2008
Countries with more than 100 studies listed
Country All Studies % Industry
Sponosred
Australia 1572 62.72
Chinese Taipei 903 45.29
Japan 732 67.76
Korea 674 72.26
China 643 53.50
India 582 72.16
Singapore 335 68.36
Thailand 327 69.42
Chinese Hong Kong 250 82.00
Philippines 206 93.20
Malaysia 180 93.33
Global Clinical Trials Permitted
YEAR No. of Trials
2003 30
2004 50
2005 100
2006 143
2007 264
2008( upto August) 115
Total 702
CDSCO
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12. GOVERNMENT’S INITIATIVES
INCENTIVES
No import duty on clinical trial supplies (2003)
Exemption from registration requirements for clinical trial
supplies (2003)
Export of clinical trial related biological specimens
allowed, based on protocol approval (2005)
Exemption from Service Tax on new Drug testing (2007)
RECENT INITIATIVES BY CDSCO FOR
PROMOTING ETHICAL CLINICAL RESEARCH
• Review of proposal- Time lines
• Phase O, Phase-1 and Micro dosing trial-
initiatives
• Registration CRO’s
• Registration of Clinical Trials
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13. PRIORITIES SET BY CDSCO
Establish Single Window clearance for
approvals
Fix timelines for each application (2-6 Weeks)
New Drug application status on the web –
Update fortnightly
Subject Experts-reviewers – Internal / External
Staff & Infrastructure at one site
Training
CDSCO GOALS FOR CLINICAL TRIALS
REGULATION
Short Term Goals
Year – 2008
• Guidelines for Registration of CROs
• Meeting timelines
• Registration of CROs
• Mandatory registration of clinical trials in
centralized clinical trial registry
• Allow Phase 0 (micro dosing) studies and
phase 1 studies in the country in controlled
manner
CDSCO
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14. CDSCO INITIATIVES E-GOVERNANCE-
DRUG REGULATORY SYSTEM
• * LAN / WAN connectivity of CDSCO
campus
• * Online submission of all the forms
• * Digitalized interactive portal
• * Digitalization of records
• * Online approvals with Digital signature
• * Inbuilt feature would administer
spontaneous and random
• * Checks to ensure quality ethical standards.
• Vision : Paperless CDSCO office
CDSCO
CLINICAL TRIALS IN INDIA
“India’s business and regulatory climates have
undergone dramatic change in the past 18
months through passage of a patent bill,
regulations updated to harmonize with TRIPs
and international standards, and plans for a
more US FDA-like regulatory body.”
CenterWatch (July 2007)
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15. CHALLENGES AHEAD
• Improvement in Regulatory Framework
• Expanding Investigators Pool
• Moving from Metro to Mini Cities
• Scale up Competence Building
• Making India a Vibrant Destination
THANK YOU
www.icriindia.com
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