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INDIA AS AN EMERGING

DESTINATION FOR OUTSOURCING

CLINICAL RESEARCH

Dr. S K GuptaDean & Director GeneralInstitute 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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Amended

Schedule Y

Phase I clinical

trial NCE from

abroad in

PipelinePhase I trial for

NCE developed

in India: Yes

Pharmacovigilance

launch

ICMR/

Bioethics

Product patent

regime

Clinical Trial

Registry

launched

ICH-GCP

LANDMARK YEAR: 2005CLINICAL RESEARCH

CDSCO

INFRASTRUCTURE AVAILABLE

Over 200 Medical Colleges

Over 22,000 graduates per year

15,622 hosp., 903,952 hosp.beds >75% in urban area

14000 diagnostic labs

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

Motivated & committed personnel

Clin. Res.Infrastructure

IT Support

Connectivity

High quality digital connectivity

Excellent air/surface transport facilities acrosscountry

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CDSCO

Large No. of specialists in different therapy segments

Medical Training In English

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-nave

Advantage of having 6 out of 7 genetic varieties

Large pt. pool in acute/chronic disease segment

Increasing no. of pts in life style disorders

segment, HIV, Oncology

INDIA : ADVANTAGES

Patient

population

Investigators

200

1000

300

400

1000

6000

2000

4000

0 1000 2000 3000 4000 5000 6000 7000

Sponsor Staff

CRO Staff

Invigilator

Other Site Staff

Demand

Supply

Demand-Supply Gap of CR Professionals, 2010 in India

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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

NCENDDSProcess research

After patent protection implementation -Expected

NCENDDSProcess

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.

More than 150 CROs are conducting clinical trials complying

Estimated market size of clinical trials in India (USD in mn)

TREATMENT NAIVE PATIENTS (DISEASE WISE)

45 million asthmatics

30 million diabetics

18 million hypertensive

13 million hepatitis C

10 million or more HIV

patients

8 million epileptics

3 million cancer

1.5 million Alzheimer's

one million

schizophrenics

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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

60%less than the average cost in

US

100Phase III

60%less than the average cost in

US

50Phase II

50% less than the average cost in

US

20Phase I

Indian costAverage US cost (in

millions)

Study

Cost of Clinical trials in USA vis--vis in India

CLINICAL TRIALS

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CROS CONTRIBUTING FOR OUTSOURCINGCLINICAL RESEARCH

CROs Can Deliver Quickerand More Efficient Trials

CROs Can Deliver Quickerand More Efficient Trials

Specialized in clinical research andcan generate economies of scale

Utilize latest data management tools& technologies as well as othertechnologies (e.g., patientrecruitment)

Can conduct trials in lower costregions

Reduce time to complete trials*

CROs complete trials 30% faster thanpharma companies*

CROs complete trials in less timeacross phases

Specialized in clinical research andcan generate economies of scale

Utilize latest data management tools& technologies as well as othertechnologies (e.g., patientrecruitment)

Can conduct trials in lower costregions

Reduce time to complete trials*

CROs complete trials 30% faster thanpharma companies*

CROs complete trials in less timeacross phases

14013989 978166

Phase I Phase II Phase IIISponsor CRO

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

70% 68% 66% 64% 62% 60%

30% 32% 34% 36% 38%

77% 73%

40%

23% 26%

0%

25%

50%

75%

100%

2000 2001 2002 2003 2004 2005 2006 2007

Biotech

Pharma

% of

Expenditure

CRO R&D Expenditure Forecast(20002007)

Sour ce: F rost & Sul li van, 2003.

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PHASE IV TRIAL MARKET INCREASING DUE TO

SAFETY CONCERNS

20.2% 20.6%

23.4% 22.2%

39.3% 37.2% 34.2% 31.1%

15.5% 18.8% 22.2% 26.1%

19.7%19.0%

24.3%26.2%

0%

25%

50%

75%

100%

2001 2003 2005 2007

Phase IV

Phase III

Phase II

Phase I

% of Revenue

CRO Revenues by Clinical Phase (200107)

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-3Jannsen 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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98139Total

1315Sanofi Aventis10

145Roche9

516Pfizer8

69Novartis7

58Merck6

1320J&J5

1422GSK4

1217Eli Lilly3

617BMS2

1010Astra Zeneca1

CLINICAL Trial in ChinaClinical Trial in IndiaCompanySr. No.

GLOBAL CLINICAL TRIALS

COMPARISON INDIA : CHINA

1

10

100

1000

10000

100000

Phase of trial

No.

Trials(Logtransformed)

India 32 165 394 63

USA 6324 11305 5683 2474

All 8540 16878 11662 6142

Phase-1 Phase-2 Phase-3 Phase-4

Clinical Trials from India

(www.clinicaltrials.gov.: 15Apr08)

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CLINICAL TRIAL ACTIVITIES IN ASIA

ALL STUDIES

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 72.16Singapore 335 68.36

Thailand 327 69.42

Chinese Hong Kong 250 82.00

Philippines 206 93.20

Malaysia 180 93.33

www.clinicaltrials.gov-snapshot: 7 Feb 2008

Countries with more than 100 studies listed

YEAR No. of Trials

2003 30

2004 50

2005 1002006 143

2007 264

2008( upto August) 115

Total 702

CDSCO

Global Clinical Trials Permitted

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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)

GOVERNMENTS INITIATIVESINCENTIVES

RECENT INITIATIVES BY CDSCO FOR

PROMOTING ETHICAL CLINICAL RESEARCH

Review of proposal- Time lines

Phase O, Phase-1 and Micro dosing trial-initiatives

Registration CROs

Registration of Clinical Trials

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Establish Single Window clearance forapprovals

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

PRIORITIES SET BY CDSCO

Short Term Goals

Year 2008

Guidelines for Registration of CROs Meeting timelines

Registration of CROs

Mandatory registration of clinical trials incentralized clinical trial registry

Allow Phase 0 (micro dosing) studies andphase 1 studies in the country in controlledmanner

CDSCO

CDSCO GOALS FOR CLINICAL TRIALS

REGULATION

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CDSCO

* 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 INITIATIVES E-GOVERNANCE-DRUG REGULATORY SYSTEM

Indias 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)

CLINICAL TRIALS IN INDIA

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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 YOUwww.icriindia.com