Transcript India

India – A Critical Player in
Global Clinical Research
Dr. Anoop K. Agarwal
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
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)
The Players in Clinical Research
Investigator
/ Site
Sponsor
CRO
SMO
Patient
IRB/IEC
Regulators
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)
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
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
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
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
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
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
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.
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
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
Clinical Research Market
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
est McKinsey 2003
Assumption USD = Rs. 45
3-Year Employment Growth
Global Pharmaceutical Industries
Growth rate
8%
6.0%
6%
4.2%
4%
2.0%
2%
0%
Asia
Latin
America
US
1.7%
Canada
1.5%
W.
Europe
Source: PhRMA, CenterWatch Aanalysis
Staff Distribution in Indian CROs
7.9
IT
14.83
Data M gmt
22.68
Lab. Se rv
4.06
Bus.De v
46.39
Clin Ops
18.9
Corporate
0
10
20
30
40
50
Source: Data on File
Key Qualifications Sought
Experience
59%
Organization
al Skills
2%
Computer
Skills
2%
Degree
16%
Communication Skills
4%
Work Ethic
2%
Attitude
11%
Flexibility
4%
Source: CenterWatch Survey
Changes in Roles & Responsibilities During Past 3
Years
0%
20%
40%
60%
Significantly changed
roles & responsibilities
80%
66.7%
48.6%
Changed employer
N = 1771
Received a promotion
Relocation
46.6%
14.4%
Source: ACRP Outlook
100%
Technologies & Clinical Trials
Percent of Total
Currently Use Often
100%
Will Use Often in 2 years
80%
60%
58%
60%
52%
45%
40%
20%
14%
17%
16%
5%
0%
Electronic CRF
RDE
Internet-based Clinical
Data Management
Electronic Medical
Records
Source: ACRP Outlook
Clinical Research-A Regulated Approach
•
•
•
•
ICH-GCP guidelines
Indian GCP
Schedule Y
Biomedical Ethics
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
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
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…
Have you seen geese heading south
for winter
flying along in V formation?
As each bird flaps its wings, it
creates
an uplift for the bird immediately
following.
By flying in V formation the whole
flock adds
at least 77% greater flying range,
than if each bird flew on its own.
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.
THANK YOU FOR YOUR KIND
ATTENTION !