Transcript Document

Clinical Trials
New Horizon – India
Dr. Surinder Singh
Drugs Controller General (India)
E-mail: [email protected]/ www cdsco.nic.in
CDSCO
PRIORITIES
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Establish Single Window clearance
for approvals
Fix timelines for each application
(2-6 Weeks)
New Drug application status on the
web – Update daily
Subject Experts-reviewers –
Internal / External
Staff & Infrastructure at one site
Training
CDSCO
Clinical Trials in India
“Broad regulatory reforms, a sizable and growing
pharmaceutical market, combined with highly attractive
professional and patient populations, make India a
compelling new region for conducting global clinical
trials.”
CenterWatch (Aug 2003)
“India’s business and regulatory climates have undergone
dramatic change in the past 18 months through passage
of a patent bill, regulations updated to harmonize with
TRIPs and international standards, and plans for a more
US FDA-like regulatory body.”
CenterWatch (July 2007)
The journey towards becoming an attractive
new destination for clinical research
Acceleration
Attraction
1992
1996
Acceptance
2000
2004
2008
2012
61 Companies
100 CROs
80 Hospitals
150 Investigators
registered with US FDA
Overall Country attractiveness index :
India 2nd most preferred destination
China
India
Russia
6.10
5.58
5.55
Brazil
5.26
5.00
5.00
Czec. Rep.
U.K.
Argentina
Poland
Hungary
Germany
South Africa
Taiwan
Israel
Singapore
Ireland
4.90
4.84
4.81
4.69
4.56
4.46
4.28
4.27
Scale : 1-10
3.86
United USA
6.88
Patient pool
Cost efficiency
Regulatory
conditions
Relevant
expertise
Infrastructure &
environment
Notes: Higher scores indicate higher levels of attractiveness.
The 15 countries analyzed were selected based on size, diversity & geographical distribution.
CDSCO
A.T.Keamey
Indian Clinical Research Market
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The Indian pharmaceutical industry is growing at an
annual rate of 11 % while the clinical research industry
is growing an annual rate of whopping 84 %.
*McKinsey estimated that clinical research in the
country would be a $1bn ($1000m or €800,000m)
industry by 2010 whereas Ernest & Young indicates
around $1.5 -2 billion by 2010.
**Market value for clinical trials outsourced to India is
estimated at around $300 million, having increased by
65% in 2006, it is expected to touch $1.5-2 billion by
2010. By 2010, the industry will spend USD 300M+ on
clinical trials in India
*Goldman Sachs, Centre watch, Goldman Sachs and McKinsey (2008)
**Report of the High Level Group on Services Sector, pg. 105, Government of India, Planning Commission, New Delhi,
March 2008.
Growth of Indian Clinical Trial Industry
Growth of Indian Clinical Trial Industry
USD (Million)
1200
1000
1000
800
600
300
400
200
35
120
160
2005 - 06
2006 - 07
0
2002 - 03
2007 - 08
2009 - 2010
Year
As per FICCI - Ernst & Young Survey Report 2008, India can attract between 5 - 10% of the global contract research outsourced market
(all services including chemistry, toxicology and clinical research) over next 5 years
.
Clinical Trials from India
(www.clinicaltrials.gov; 15 Apr08)
No. Trials (Log transformed)
100000
10000
1000
100
10
1
Phase-1
Phase-2
Phase-3
Phase-4
India
32
165
394
63
USA
6324
11305
5683
2474
All
8540
16878
11662
6142
Phase of trial
CLINICAL TRIAL ACTIVITIES IN ASIA
ALL STUDIES
www.clinicaltrials.gov-Snapshot: 7 Feb 2008
Countries with more than 100 studies listed
Country
All Studies
% Industry
Sponosred
Australia
1572
62.72
Chinese Taipei
903
45.29
Japan
732
67.76
Korea
674
72.26
China
643
53.50
India
582
72.16
Singapore
335
68.36
Thailand
327
69.42
Chinese Hong Kong
250
82.00
Philippines
206
93.20
Malaysia
180
93.33
CDSCO
India : Resource advantages
• Large No. of specialists in different therapy
segments
Investigators
• Medical Training In English
• 600,000 Eng. Speaking physicians
• PG training from Europe/US
• Treatment Protocols in line with West
• Large no. of ICH/GCP compliant Investigators / sites
• Large, Diverse, therapy-naïve
Patient
population
• Advantage of having 6 out of 7 genetic varieties
• Large pt. pool in acute/chronic disease segment
• Increasing no. of pts in life style disorders
segment, HIV, Oncology
CDSCO
Sr. No.
Item
%
1.
Clinical Development
1a.
Phase I
1b
Phase II & II
1c
Phase IV
(Break of Clinical Development %)
2.
Discovery
3.
Non Clinical
4.
Regulatory
5.
Others
5.
Total
Source : Zinnov Annalysis
CDSCO
38.2
18%
67%
16%
26.9
19.5
4.1
11.5
100%
India : Resource advantages
Clin. Res.
Infrastructure
IT Support
•
•
•
•
•
•
Over 200 Medical Colleges
Over 22,000 graduates per year
15,622 hosp., 903,952 hosp.beds >75% in urban area
14000 diagnostic labs
700,000 scientists and engineering graduates / year
World class medical / lab facilities at secondary /
tertiary care centers
• Skilled computer savvy biomedical work force
• Highly developed IT / ITES
• Motivated & committed personnel
• High quality digital connectivity
Connectivity
• Excellent air/surface transport facilities across
country
CDSCO
In conclusion….
Patient pool
Large
Scanty
India
Patient
Recruitment
rate
Speed
Cost
India
Low
High
India
Least expensive
Most expensive
India
Facility &
Investigator pool
Smallest pool
Industry trial
experience
Least experience
Regulatory
Environment
Least Conducive
Quality of
data
Highest rate
Lowest rate
Highest pool
India
Most experience
India
Most Conducive
India
Unacceptable to EU/US
Acceptable to EU/US
India
CDSCO
Mckisney 2008
Facility Type
No. Of Facilities
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Toxicity studies
11
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Mutagenicity studies
9
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Analytical and clinical chemistry testing
8
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Physical-chemical testing
7
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Environmental toxicity studies on aquatic
& terrestrial organisms
4
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Residue studies
3
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Studies on behaviour in water, soil and air; bioaccumulation
2
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Studies on effects on mesocosms and natural ecosystems
1
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Studies on natural enemies and predators
1
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Safety Pharmacology and Pharmacokinetic Studies
1
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Others (drug metabolism & pharmacokinetics
[DMPK] and tissue distribution studies)
TOTAL
1
48
CDSCO
US FDA NEW DRUGS APPLICATION DATA
GENERATED FROM INDIA
Drug Company
Molecules / Brands
Researched
Alcon
Vegamox
AstraZeneca
Merenem
Cangene
Hepatitis B Vaccine
Eli Lilly
Alimta, Gemcitabine
Galaxo
Lamotrigine
Jannsen
Resperidal
Novartis
Tegaserod
Pfizer
Voriconazole
Roche
Peg-Interferon
Santen
Quixin
Wyeth
Influenza A Vaccine
CDSCO
Mckisney 2008
Government’s facilitating initiatives
Fiscal Incentives
 No import duty on clinical trial supplies (2003)
 Exemption from registration requirements for clinical trial
supplies (2003)
 Export of clinical trial related biological specimens allowed,
based on protocol approval (2005)
 Exemption from Service Tax on new Drug testing (2007)
Timelines for Regulatory Approvals
Agency / Institutions
Approval
Time
Drugs Controller General of
India (DCGI)
Regulatory approval for
study conduct in India
• Category A trial is approved
using a fast-track process within 6
weeks after the required
documentation
• Category B within 8 to 12 weeks
Drugs Controller General of
India (DCGI)
Test license to import trial
supplies
2 weeks in addition
Ethics Committees
(Independent body)
Local Ethics committee
approval by sites
6 – 8 weeks (in parallel)
Total (parallel processing)
6-8 weeks – FAST TRACK
(Category A)
16 weeks (Category B)
Directorate General of Foreign
Trade (DGFT)
Permission to export
Biological samples
CDSCO
Did away with this procedure,
Regulatory Approval
Clinical Proposal Review
Timelines
140
120
D
100
A
Y 80
S
Multinational trials
Local Trials
Query resolution
Linear (Multinational trials)
60
Linear (Query resolution)
Linear (Local Trials)
40
20
0
2000-06 2006-07
YEARS
2008
2009-10
S.No. Subject
Applicatins
Applications
Applications
Applications Received
Received in
Received in
Received in
from 2008 to 2009
2007Approx
Approx.
2005Approx. 2006Approx.
1
New Drug
1200
1500
1600
2000
Applications
2
Global Clinical Trials
100
170
200
300
3
Vaccines and Biotech
10
50
40
50
4
Medical Device
0
300
450
500
5
Diagnostic Kit
250
350
400
1000
including Test licence
for Dignostics
6
Export NOCs
2000
2100
1800
2500
7
Test License
3700
5000
5500
7500
8
Blood Bank License
200
225
250
275
9
Import Registration
300
450
400
500
10
Import Licence
2300
2400
2000
2000
Total
10060
12545
12640
16625
CDSCO
TEST LICENSE
347
PROTOCOL AMENDMENT
397
CT NOC
223
NO. OF FRESH APPLICATION
RECEIVED
322
TOTAL CORRESPONDENCE
LETTERS ISSUED
1328
CDSCO
Global Clinical Trials Permitted
YEAR
No. of Trials
2003
30
2004
50
2005
100
2006
143
2007
273
2008
223
2009 (Till January 2009)
25
CDSCO
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Draft guidelines and requirements for registration of
such organisation in the country have been
developed.
Proposed to be incorporated as new schedule Y1 to
drugs and cosmetics rules,1945.
Also proposed to incorporate Rule 122DAB for the
proposed new schedule Y1. Said guidelines and Rule
will be placed before forthcoming DTAB meeting
scheduled to be held on 23/02/09 for consideration.
CDSCO
At the time of granting permission for conducting
clinical trial, applicants are now being advised to
get clinical trial registered at ICMR’s web based
clinical trial registry (www.ctri.in) and will be
made mandatory
CDSCO
GOALS FOR CLINICAL TRIALS
REGULATION
Short Term Goals
Year - 2008
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Training for Clinical Trials site
inspections
Robust review process for clinical trial
proposals
Meeting timelines
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CDSCO
Medium Term Goals
Year - 2009
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Registration of CROs
Inspection of Clinical trial sites in the
country.
Guidelines for Registration of Ethics
Committees/IRBs
Mandatory registration of clinical trials
in centralized clinical trial registry
CDSCO
Long Term Goals
Year 2010 – 2015
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Ensuring penal provisions for fraud &
misconduct in clinical research
Registration of Clinical trial sites
Registration of Ethics Committees/IRBs
Creation of environment for Phase 0 and
micro dosing studies.
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CDSCO
 WHO
 USA
FDA
 Health Canada
 ANVISA, Brazil
 South Africa
CDSCO
With USFDA :
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Training on GCP and clinical Research Inspection
workshops on clinical trial oversight for vaccines
advanced workshops on GCP / Clinical Research
Inspection
workshops on Pharmacovigilance
workshops on medical devices
1 Technical Officer was nominated for training in
medical devices at USFDA
1 ADC and 1 Technical officer nominated for
training at CDER and CBER (USFDA)
CDSCO
Following are the workshops & Trainings
organized in association with WHO WR
office,New Delhi:
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Clinical Trials Inspection
Regulatory Affairs
HR Development
Pharmacovigilance
CDSCO
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LAN / WAN connectivity of CDSCO
campus
Digitalization of records
Linking of all CDSCO Zonal/Sub Zonal, Port
offices.
Office Automatization
Vision : Paperless CDSCO office
CDSCO
CDSCO
“Let us not follow a
path set by others
Let us set a path for
others to follow”
CDSCO