INDIA AS AN EMERGING DESTINATION FOR CLINICAL TRIALS

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INDIA AS AN EMERGING DESTINATION FOR CLINICAL
TRIALS
Dr. S K Gupta Dean Director General
Institute Of Clinical Research, India New
Delhi-110037
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REQUIREMENTS FOR GLOBAL RESEARCH

• Infrastructure
• Regulatory Environment
• Patient Pool-Genetic Diversity
• I.P Protection
• Investigator Availability
• Bioethics Regulation
• Cost Advantage

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INFRASTRUCTURE AVAILABLE

• Over 200 Medical Colleges
• Over 22,000 graduates per year
• 15,622 hosp., 903,952 hosp.beds gt75 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

Clin. Res. Infrastructure

• Highly developed IT / ITES
• Motivated committed personnel

IT Support

• High quality digital connectivity
• Excellent air/surface transport facilities
  across country

Connectivity
CDSCO
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INDIA ADVANTAGES

• 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

Investigators

• Large, Diverse, therapy-naïve
• 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

Patient population
CDSCO
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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
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DRUG DISCOVERY DEVELOPMENT
RD investment by Indian Pharma Companies Before
patent protection implementation
After patent protection implementation -Expected
Process Research
NDDS
NCE
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LANDMARK YEAR 2005 CLINICAL RESEARCH
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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.
WHY INDIA IS BECOMING A HOT DESTINATION FOR
CLINICAL RESEARCH?
Estimated market size of clinical trials in India
(USD in mn)
More than 150 CROs are conducting clinical
trials complying
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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

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Cost of Clinical trials in USA vis-à-vis in India
CLINICAL TRIALS
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CROS CONTRIBUTING FOR OUTSOURCING CLINICAL
RESEARCH
CROs Can Deliver Quicker and More Efficient Trials

• Specialized in clinical research and can generate
  economies of scale
• Utilize latest data management tools
  technologies as well as other technologies (e.g.,
  patient recruitment)
• Can conduct trials in lower cost regions
• Reduce time to complete trials
• CROs complete trials 30 faster than pharma
  companies
• CROs complete trials in less time across phases

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ADVANTAGE INDIA OVER OTHER COUNTRIES
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DISEASE WISE CLINICAL TRIALS DONE IN INDIA
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THE PERCENTAGE OF CRO REVENUES FROM BIOTECH FIRMS
IS RAPIDLY INCREASING
CRO RD Expenditure Forecast (20002007)
of Expenditure
Source Frost Sullivan, 2003.
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PHASE IV TRIAL MARKET INCREASING DUE TO SAFETY
CONCERNS
of Revenue
CRO Revenues by Clinical Phase (200107)
Source Frost Sullivan, 2003.
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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
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Clinical Trials from India (www.clinicaltrials.go
v. 15Apr08)
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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
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Global Clinical Trials Permitted
CDSCO
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GOVERNMENTS 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)

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RECENT INITIATIVES BY CDSCO FORPROMOTING 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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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

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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
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CLINICAL TRIALS IN INDIA

• 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)

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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

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• THANK YOU
• www.icriindia.com