1) The document summarizes the state of clinical research in India, including the growth of the domestic and global clinical trials market in India, drivers of industry change, and India's strengths that make it an attractive location for outsourcing clinical research. 2) Key points discussed include India having a large, diverse population and strong technical skills that help accelerate patient recruitment for clinical trials compared to other countries. Costs of conducting clinical research in India are also much lower. 3) Challenges discussed include the need to further streamline regulatory processes, improve site infrastructure and staff training, and ensure strong data privacy protections to gain client confidence in outsourcing to India.

1. New Delhi
Clinical Research
in India
DIA – Training Course
Mumbai
Surya Chitra, Savio Group Inc
Sunder Venkatraman, Asian Clinical Trials
Bangalore
Chennai
1

2. Outline
About India
Global Scenario
Domestic market
Industry drivers for Change
Clinical Research In India
Going Forward
2

3. India Fact File
Multicultural , multi-linguistic and pluralistic country
Second most culturally, linguistically and genetically
diverse geographical entity after the African continent
70% of population is rural
Literacy rate is 64.8% (53.7% for females and
75.3% for males). Independence in 1947
Second Largest democracy
Seventh largest Country
Most populous democracy in World
3

4. Indian Economy Today…
Optimistic Scenario
Fastest growing economy in the world
India's GDP in terms of USD EX exchange
transfer factor for 2007-08 is US$ 1.089 Trillion .
Purchasing power parity (PPP), India has the
world's third largest GDP at US$4.726 trillion.
World's second largest labor force
GDP growth rate of 8-9% in 2006-07
Liberalization in 1991
Multiparty democracy
Free enterprise
Vibrant media
4

5. Government Support …….
Government would provide necessary
environment to help the country emerge
as an attractive destination for
outsourcing in drug discovery and
clinical research
Indian Finance Minister- P. Chidambaram
Budget 2005-2006
5

6. Big Pharma Partnering In India
Collaborative Research
Contract Research
Big Pharma
Contract Manufacturing
Distribution in India
6

7. Global Industry Scenario
Network Pharma
…..is the emerging
model for global
pharma industry
7

8. Global CRO Market
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.
25
20
15
G lo b a l C R O
m a r k e t in m ilio n
10
5
0
2006 2007 2008 2009 2010
Source :Frost and Sullivan 2003
8

9. 9

10. Global Growth Of Indian Market
Outsourced Clinical Drug trials
growth more than 170%
Annual Revenues USD 120 M
with 40% growth in past year
240 international studies
recruiting subjects = 1.2% of
the total studies worldwide
66% of international clinical
trials are Phase III
40,000 subjects participated in
clinical trials to date (<0.02%
of population)
10

11. Indian Pharma Market: Low Value,
Large Volume & Growth Potential
Pharmaceutical / Biotech Sales in USD Billion
India’s pharmaceutical
5 market ranks 4th in unit sales
but 15th in value
Growth 8% per year
4
Indian companies control
70% of the market &
3 multinationals the rest
Fragmented market: leading
company has a 7% market
2
share
Biotech sales growth driven
1 by exports and vaccines,
accounts for 2% of global
market, 25% growth expected
0
over next 5 yrs compared to
1996 1998 2000 2002 2004 2006
15% market average
11

12. India’s Record
12

13. Pressurized Pharma industry ….
Shortage of new drug in the pipeline
Imminent Expiry of the patents on numerous
blockbusters
Intense competition among the pharmaceutical
companies
Stringent FDA and Regulatory Authority
demands
Reduction of marketing opportunity for
innovators
Pressures from Government Agencies for
reduction of cost
Increase in scientific knowledgebase and
understanding for innovators
13

14. Changing India
Increasing Education Changing lifestyle and aspirations
Increasing Income- Changing demands and
expectations
Growing middle class
Changing disease pattern
Improving Healthcare
14

15. Changing Disease Patterns
CNS
CVS
Problems of Reproductive
Cancers
Health
Diabetes
Acute Infectious Disease
Others
Nutritional Disease
15

16. Scope of Outsourcing to India
Function Current Expertise Evolving Towards
Program Design & Mgmt
CR Ops Monitoring
Full Statistical Management
Data Ops Data Mgmt
CP Ops Bioequivalence Phase I, Pharmacodynamics
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17. Can India deliver on these?
Increase commitment to uphold & enforce
Data privacy International Property Protection as per
international standards
Regulatory approval process more streamlined
Regulatory Study start up 12 wks from regulatory submission
Government initiatives to strengthen ethics
committee approval process
Ethics
Recognition of critical importance of informed consent
Overall benefit to healthcare delivery in India
17

18. Can India deliver on these?
Data of Pivotal studies accepted by FDA/ EMEA
Quality Successful FDA audit in 2005 – no findings
Investment in education & training: state & private
Logistics More labs been setup
Training Investment in education & training: state & private
18

19. India’s Strength
Heterogeneous Population >1.2
1.5 lac sub-centres,
Different Ethnic Groups
23,000 primary health centres,
billon
4000 community health centres
Endogamous tribal population
1,600 urban family welfare centres
(conserved gene pool)
New Delhi
3 million graduates,
700,000 post – graduates Mumbai 200 Medical Colleges
1500 PhDs in biosciences and Research Institutes
engineering Bangalore Universities
Employment for 15,000 scientists Chennai 11,500 hospitals and 14,000 diagnostic
exists in Indian Biotech itself. laboratories
5000 harnessed 50 R&D labs in the public sector & 200
Potential for hiring 50,000 in Govt. Sector
professionals
over 5 years in the Contract Research
19

20. India’s Strength
Strong IT prowess
English is main language
of communication
New Delhi
Mumbai
Increased investment
Net connectivity Bangalore
Beneficial tax environment
Chennai
20

21. Growth Of Collaborative Models
Within the local industry CR has evolved as an integral part of the
product development cycle
The top 20 Indian companies now have active NCE development
programs that require clinical development capabilities
Several have set up collaborative projects with global big
pharmaceutical companies
Collaboration along all segments of the discovery & development
cycle is emerging as a viable model
Collaborating partners share costs of research as well as
revenues and/or market geographies
Other therapeutic area and segment specific models may emerge
in future
21

22. Relative Overheads Cost In CR
Cost of CR Operations
400 $ '000 per m onitoring resource
300
200
100
0
Lithuania
Taiwan
Canada
Russia
India
B razil
UK
China
Source: Personal Communications 22

23. In
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23

24. Clinical Research Staff Costs
Are Lower
2001 Annual India, 2005
Position Percent
Gross Salary* Annual Gross
US$ Salary US$
52,000 5,555 11%
CRA
68,000 11%
7,750
Senior CRA
74,000 24%
17,500
Project Manager
73,000 24%
17,500
Regulatory
24

25. Subject & Recruitment Rates & Quality
Average patient
recruitment rates in 1080
clinical trials 3-4 times
faster than traditional
geographies in the west
Quality of data is
equivalent to those in
19
traditional locations
Europe India
25

26. Vendor & Service Providers
Central Labs
Ethical Oversight for fee
Drug packaging and distribution services
Data Management
Document translators
Document Archiving facilities
Specialist Clinical trial material suppliers
Education and training facilities
26

27. Vendor & Service Providers
Increasing number of knowledgeable vendors
who are sensitive to clinical research business
At par with international providers
Accreditation and certification to prove their
competency and commitment
27

28. Sites
Types of Diseases
Disease disorder of Disease Disorder of
Diseases of Tropics
Primitive economy Developed Economy
Cardiovascular,
Acute infection,
Malaria, Tuberculosis,
Gastrointestinal,
Nutritional–related,
Leishmaniasis
Cancer, CNS,
Health-Related
Diabetes, etc.
Types of Hospitals
Public funded Hospitals Tertiary Hospitals
Private Hospitals
e.g. Government Hospitals e.g. Super specialized
&
Hospitals
Private Clinics
28

29. Sites
Choice of sites is critical
Patient load
Research orientation, training
and experience of investigators
Infrastructure:
Staffing, Documentation,
Laboratory,
Hardware, Equipment,
IEC/IRBs
29

30. Ethics and Related issues
In India ICMR is the main body for formulation, coordination
and promotion of biomedical research
Setting of FER-CAP
Schedule Y authorizes use of Central Ethics Committee which do
have their own Ethics Committee
Requirement of SOP for each Ethics Committee
Currently working on improvement of Ethics Committee training
Planning Accreditation Of Ethics Committee
30

31. Regulatory Issues
Regulatory Body – Office of the
Drugs Controller General India (DCGI)
Directorate General of Health Services (DGHS)
Schedule Y updated
Review of submission – average 3 months
GCP guidelines issued
Ethics Committee approvals concurrent
Import License for clinical trial drug supplies to DCGI –
concurrent with main submission
Export License for blood and blood products to DGFT
after clinical trial approval
Genetically engineered drugs (live organisms in end
product) to GEAC
Categorization of Global trial to help streamline approval
31

32. Data Privacy
Legislation to enforce protection of product patents in accordance with
WTO standards passed in January 2005
Tension between wide access to low cost medicines
and aspiration to develop an international life science sector
India to adopt a patent regime favorable to inexpensive access
to medicines by prohibiting patent “evergreening” - in spirit with WTO
India has demonstrated an effective legal process for patent grant,
review & challenge
32

33. Concerns & Challenges- I
Regulatory
Need for regulatory liaison staff
Face to face meeting with officials helps
Lead times longer for local NCEs
Additional approvals required for exports
33

34. Concerns & Challenges- II
Site-specific
Orientation of investigators and site staff
Source documentation at trial sites
Ethics committee working practices
ICH E6 compliance
Operating procedures
Workload and staffing
34

35. Concerns & Challenges- III
People-related
Staff turnover at sponsor and sites
Training and experience of CR professionals
Salary inflation and quality of staffing
Rapid growth of training facilities
Low threshold for admission
Variable quality of training
Unreliable output and need for re-training
35

36. Concerns & Challenges- IV
Medical & therapeutic
Medical practice and standard of care
Use of indigenous medicines
Resistance levels to anti-infectives
Strain-specific variations in microbes
36

37. Glo-Local CRO Advantage
Local application of Global process and
systems
Knowledge of local requirements and constrain
Better management of vendor and service
provider
Understand local and country specific
challenges
37

38. Going Forward…..
Plans to establish Central Drug Authority on the lines of FDA
Need to develop capabilities remains
improved training and uniform
Need for Regulatory guidelines for remaining area and effective
implementation of those guidelines
Data privacy laws to be diligently enforced to win confidence
Site infrastructure to be developed in perirural areas to bridge
urban rural of physician and subjects
Improve and ongoing investigator training
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