India – A Critical Player in Global Clinical Research Dr. Anoop K. Agarwal
Mar 26, 2015
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)
SponsorInvestigator
/ SitePatient
CRO
SMO
IRB/IEC
The Players in Clinical Research
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
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
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
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
Key Qualifications Sought
Experience59%
Flexibility4%Attitude
11%
Degree16%
Communication Skills4% Work Ethic
2%
Computer Skills2%
Organizational Skills
2%
Source: CenterWatch Survey
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
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
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
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.
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 THANK YOU FOR YOUR KIND ATTENTION !KIND ATTENTION !