India – A Critical Player in Global Clinical Research
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India – A Critical Player in Global Clinical Research
Dr. Anoop K. Agarwal
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What is Outsourcing?
• Transfer in full or part of the business activities to an outside entity.
• This may include transfer of – Business Processes – Procedures– Responsibilities
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WATERSHED YEAR 2005
Several major events occurred in 2005 making it watershed year.
Amendment to Schedule Y Passage of IPR bill Launch of CDSCO/ WHO- GCP training programmes. First USFDA inspection of a global trial Launch of Pharmacovigilance programme Ministry of
Health & World Bank (6 centres)
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SponsorInvestigator
/ SitePatient
CRO
SMO
IRB/IEC
The Players in Clinical Research
Regulators
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India - Natural choice for CR services
Easy Access of patient recruitment
Well-trained medical community to global
standards
Rapidly increasing awareness of GCP
English as a primary language of education and
communication
100 million English speaking people (Largest outside US)
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India - Natural choice for CR services
“Right” patient pool Genetically & culturally diverse population
Treatment- naïve patients from multiethnic and multiracial
backgrounds
Wide spectrum of diseases
Speed of patient recruitment
IPR / WTO, GATT on board
Cost effective operations
Presence of all Pharma majors
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Facts & Figures
40 million patients with cardiovascular diseases
35 million with Type 2 diabetes
10 million with psychiatric disorders
2 million cases of cancer with 5,00,000 cases
detected every year
Recruits for genetic studies
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Facts & Figures
600,000 practicing physicians
14,000 hospitals
7,00,000 beds
17,000 medical graduates per year
Estimated no. of GCP trials conducted in 2010: 300 – 350
Estimated no. of GCP trained PIs in 2010: 3000 - 3500
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India – Favorable destination for Clinical Trials
• CR industry will witness a business of Rs 10,000 crore creating a demand of 50,000 professionals in the next 5 yrs (McKinsey Report)
• By 2012 up to 5% of global trials will take place outside USA & Western Europe
• 2003-04, not > 20,000 patients participated in global trials, estimated that 20% of all patients in global trials could be from India
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Projected Growth of Indian CR Industry
Resources 2012
CR market $1.5 Billion
GCP Studies 1500-2000
GCP Trained Drs. 10000-15000
Subjects reqd. 200000-300000
CR Professionals 50000
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In preparation for this role…
• ICMR improving facilities for CT & drug development research -10 yrs– Advanced centers in toxicology, clinical pharmacology,
reproductive toxicology, CTs of medicinal plants & herbs .
• No trial can be conducted in India without the approval of the DCGI
• Ministry of Environment & Forests to approve genetically modified drugs, before DCGI
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Widening Operations of CROs
• No. of companies participating in CR is increasing
• Large Indian pharma companies (Wockhardt, Sun
Pharma, Lupin) working on NCEs. They have established their own CR units to conduct trials for their new molecules.
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Widening Operations of CROs
• Central / Referral Labs (Dr. Lal’s Lab, Metropolis Health
Services, SRL Ranbaxy) are offering CT services• IT Companies (Cognizant, Eassar, HCL, IBM, Infosys & TCS),
making investments in Data Management
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CROs in India
• > 250 CROs in India• Many pharma Cos. have their own CR Units
conducting trials in 250-300 government & private hospitals.
• E.g. Eli Lilly is conducting 17 global & local CTs in 65 locations
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Clinical Research Market
est McKinsey 2003 Assumption USD = Rs. 45
Year Indian market
(Rs. in cr.)
Indian Market (million $)
[% of global]
Global Market
(million $)
2003 315 70 [1.16 %] 5000 - 6000
2004 450 100 [1.11 %] 9,000
2005 810 180 [1.80 %] 10,000
2007 2700 600 [2.26% of US] 26,500 US + Rest
2010 3000 700 [2 %] 50,000
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3-Year Employment GrowthGlobal Pharmaceutical Industries
6.0%
4.2%
2.0%1.7% 1.5%
0%
2%
4%
6%
8%
Asia LatinAmerica
US Canada W.Europe
Source: PhRMA, CenterWatch Aanalysis
Growth rate
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Staff Distribution in Indian CROs
18.9
46.39
4.06
22.68
14.83
7.9
0 10 20 30 40 50
Corporate
Clin Ops
Bus.Dev
Lab. Serv
Data Mgmt
IT
Source: Data on File
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Key Qualifications Sought
Experience59%
Flexibility4%Attitude
11%
Degree16%
Communication Skills4% Work Ethic
2%
Computer Skills2%
Organizational Skills
2%
Source: CenterWatch Survey
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Changes in Roles & Responsibilities During Past 3 Years
66.7%
48.6%
46.6%
14.4%
0% 20% 40% 60% 80% 100%
Significantly changedroles & responsibilities
Changed employer
Received a promotion
Relocation
N = 1771
Source: ACRP Outlook
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Technologies & Clinical Trials
14% 16%
5%
17%
45%
58%60%
52%
0%
20%
40%
60%
80%
100%
Electronic CRF RDE Internet-based ClinicalData Management
Electronic MedicalRecords
Currently Use Often Will Use Often in 2 yearsPercent of Total
Source: ACRP Outlook
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Clinical Research-A Regulated Approach
• ICH-GCP guidelines• Indian GCP• Schedule Y• Biomedical Ethics
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New “Drug” - Indian Regulations
• New device, Any intervention, Vaccine• A drug discovered abroad must be evaluated
in India• Mandatory clinical trials
e.g: HIV vaccine trials
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Patent Act opens up vast business opportunities for Indian Companies
• Positive transformation, will improve nation’s image in the world
• Product patents • Boost R&D & will help to bring in foreign direct
investment in the industry & contribute to healthcare• Major opportunity for MNC pharma by launching
patented new products• “India will get an estimated revenue of US $10 billion
thru’ the new patent regime”. » Dr. William Haseltine
Head - MSAB
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There is no second chance !
• Clinical research is not a BPO• Whether done in Delhi or Dallas, needs the
same scientific scrutiny & ethics• No short cuts & half measures • Because…
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Have you seen geese heading south for winter
flying along in V formation? As each bird flaps its wings, it
createsan uplift for the bird immediately
following.By flying in V formation the whole
flock addsat least 77% greater flying range, than if each bird flew on its own.
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People who share a common direction
and sense of community can get
where they are going more quickly
and easily because they are travelling
on the thrust of one another.
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THANK YOU FOR YOUR THANK YOU FOR YOUR KIND ATTENTION !KIND ATTENTION !