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Chairman’s Welcome & Opening Remarks
Mumbai, India – 24th July 2007
Education Issues
IP Issues
“In our judgment, arguing that IP issues constrain you fromhaving aggressing China & India strategies is a cop out”
“It is also important to note that governments in both China &India are becoming increasingly serious about enforcementOf laws on IP”
Source: Wall Street Journal, May 03, 2007
CRAMS Issues
71%
16%
13%
CRAMS market in India
71% contract manufacturing16% clinical research - $143 m13% contract research - $116 m
-$0.9 b in 2006, +43% growth- Forecast to reach $6.6 b in 2013
Source: Frost & Sullivan Business Today, 20th May 2007
Clinical Research Issues
-100,000 patients
-3000 sites
-50,000 clinical research professionals
-400 CT applications by regulatory authorities
Source: Ernst & Young
Market size > $ 1b by 2010 Source: McKinsey
Source: Business Standard, 9th May 2007
Regulatory Issues
Pharmacovigilance-Sweden 250/300 regulators-India 25 regulators Source: Pharma Market Letter, 23rd April’ 2007
On Site Inspection & real time audits of CT-30 investigators -First inspection to start in July Source: MINT, 6th June’ 2007
On line clinical registry-Share data with 26 ICMR institutes on line-Pilot scale to start in July-Only primary date to be held Source: Business Standard, 9th March’ 2007
Medical Tourism Issues
-Tourists from UK, RSA, Canada, Malaysia
-Market size estimated to be $ 1.5b by 2010
Questions for today’s session
Is the current mood towards India sustainable?
How can India improve?
How to keep India clinical trials ethical?
How to address safety concerns?
How to measure ROI in outsourcing?
Thank You
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