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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 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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 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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 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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 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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 CLINICAL DATA MANAGEMENT
ADVANTAGE INDIA
Capabilities of Vendors
HR capabilities to support
large work force
well capitalized & willing to
invest
committed to innovation
long term high level
relationship
Opportunity From Deals
Strategic outsourcing of a global
function
Seek more than cost saving
Long term contracts
Board level oversight
Scale & Scope to effect a “Tipping
Point”

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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 CROS CONTRIBUTING FOR OUTSOURCING
CLINICAL RESEARCH
CROs
CROs Can
Can Deliver
Deliver Quicker
Quicker
and
and More
More Efficient
Efficient Trials
Trials
•• Specialized
Specialized in
in clinical
clinical research
research and
and
can generate
can generate economies
economies of of scale
scale

139 140 •• Utilize

Utilize latest
latest data
data management
management tools
tools
89 66 81 97 && technologies
technologies as as well
well as
as other
other
technologies (e.g., patient
technologies (e.g., patient
recruitment)
recruitment)

Phase I Phase II Phase III •• Can

Can conduct
conduct trials
trials in
in lower
lower cost
cost
Sponsor CRO regions
regions

•• Reduce
Reduce time
time to
to complete
complete trials*
trials*
–– CROs
CROscomplete
completetrials
trials30%
30%faster
fasterthan
than
pharma
pharmacompanies*
companies*
–– CROs complete trials in less time
CROs complete trials in less time
across
acrossphases
phases

ADVANTAGE INDIA OVER OTHER COUNTRIES

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 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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 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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 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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 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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 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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 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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 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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 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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