Clinical trials for Research purposes

1. Clinical Trials
New Horizon – India
Dr. Surinder Singh
Drugs Controller General (India)
E-mail: dci@nb.nic.in/ www cdsco.nic.in
CDSCO

2.  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
PRIORITIES

3. 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)

4. The journey towards becoming an attractive
new destination for clinical research
Acceleration
Acceptance
Attraction
1992 1996 2000 2004 2008 2012
61 Companies
100 CROs
80 Hospitals
150 Investigators
registered with US FDA

5. CDSCO
Overall Country attractiveness index :
India 2nd most preferred destination
Notes: Higher scores indicate higher levels of attractiveness.
The 15 countries analyzed were selected based on size, diversity & geographical distribution.
Czec. Rep.
U.K.
China
India
Russia
Brazil
Argentina
Poland
Hungary
Germany
Taiwan
Israel
Singapore
Ireland
South Africa
United USA
6.10
5.58
5.55
5.26
5.00
5.00
4.90
4.84
4.81
4.69
4.46
4.28
4.27
3.86
4.56
6.88
Patient pool Cost efficiency Regulatory
conditions
Relevant
expertise
Infrastructure &
environment
Scale : 1-10
A.T.Keamey

6. Indian Clinical Research Market
*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.
 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

7. Growth of Indian Clinical Trial Industry
Growth of Indian Clinical Trial Industry
35
120 160
300
1000
0
200
400
600
800
1000
1200
2002 - 03 2005 - 06 2006 - 07 2007 - 08 2009 - 2010
Year
USD
(Million)
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.

8. Clinical Trials from India
(www.clinicaltrials.gov; 15 Apr08)
1
10
100
1000
10000
100000
Phase of trial
No.
Trials
(Log
transformed)
India 32 165 394 63
USA 6324 11305 5683 2474
All 8540 16878 11662 6142
Phase-1 Phase-2 Phase-3 Phase-4

9. www.clinicaltrials.gov-Snapshot: 7 Feb 2008
Countries with more than 100 studies listed
CDSCO
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
CLINICAL TRIAL ACTIVITIES IN ASIA
ALL STUDIES

10. CDSCO
• Large No. of specialists in different therapy
segments
• 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
• 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
India : Resource advantages
Patient
population
Investigators

11. Sr. No. Item %
1. Clinical Development 38.2
1a. Phase I 18%
1b Phase II & II 67%
1c Phase IV 16%
(Break of Clinical Development %)
2. Discovery 26.9
3. Non Clinical 19.5
4. Regulatory 4.1
5. Others 11.5
5. Total 100%
Source : Zinnov Annalysis
CDSCO

12. CDSCO
India : Resource advantages
• 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
Clin. Res.
Infrastructure
IT Support
Connectivity
• High quality digital connectivity
• Excellent air/surface transport facilities across
country

13. CDSCO Mckisney 2008
In conclusion….
Scanty Large
India
Patient pool
Lowest rate Highest rate
India
Patient
Recruitment
rate
Low High
India
Speed
Most expensive Least expensive
India
Cost
Smallest pool Highest pool
India
Facility &
Investigator pool
Unacceptable to EU/US Acceptable to EU/US
India
Quality of
data
Least Conducive Most Conducive
India
Regulatory
Environment
Least experience Most experience
India
Industry trial
experience

14. Facility Type No. Of Facilities
 Toxicity studies 11
 Mutagenicity studies 9
 Analytical and clinical chemistry testing 8
 Physical-chemical testing 7
 Environmental toxicity studies on aquatic
& terrestrial organisms 4
 Residue studies 3
 Studies on behaviour in water, soil and air; bioaccumulation 2
 Studies on effects on mesocosms and natural ecosystems 1
 Studies on natural enemies and predators 1
 Safety Pharmacology and Pharmacokinetic Studies 1
 Others (drug metabolism & pharmacokinetics
[DMPK] and tissue distribution studies) 1
TOTAL 48
CDSCO

15. CDSCO Mckisney 2008
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
US FDA NEW DRUGS APPLICATION DATA
GENERATED FROM INDIA

16. 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)
Government’s facilitating initiatives
Fiscal Incentives

17. CDSCO
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
Did away with this procedure,
Timelines for Regulatory Approvals
Regulatory Approval

18. Clinical Proposal Review
Timelines
0
20
40
60
80
100
120
140
2000-06 2006-07 2008 2009-10
Multinational trials
Local Trials
Query resolution
Linear (Multinational trials)
Linear (Query resolution)
Linear (Local Trials)
YEARS
D
A
Y
S

19. S.No. Subject Applicatins
Received in
2005Approx.
Applications
Received in
2006Approx.
Applications
Received in
2007Approx
Applications Received
from 2008 to 2009
Approx.
1 New Drug
Applications
1200 1500 1600 2000
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
including Test licence
for Dignostics
250 350 400 1000
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

20. CDSCO
TEST LICENSE 347
PROTOCOL AMENDMENT 397
CT NOC 223
NO. OF FRESH APPLICATION
RECEIVED
322
TOTAL CORRESPONDENCE
LETTERS ISSUED
1328

21. YEAR No. of Trials
2003 30
2004 50
2005 100
2006 143
2007 273
2008 223
2009 (Till January 2009) 25
CDSCO
Global Clinical Trials Permitted

22. CDSCO
 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.

23. 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

24. Short Term Goals
Year - 2008
 Training for Clinical Trials site
inspections
 Robust review process for clinical trial
proposals
 Meeting timelines

CDSCO
GOALS FOR CLINICAL TRIALS
REGULATION

25. Medium Term Goals
Year - 2009
 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

26. Long Term Goals
Year 2010 – 2015
 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.

CDSCO

27. CDSCO
WHO
USA FDA
Health Canada
ANVISA, Brazil
South Africa

28. CDSCO
With USFDA :
 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)

29. CDSCO
Following are the workshops & Trainings
organized in association with WHO WR
office,New Delhi:
 Clinical Trials Inspection
 Regulatory Affairs
 HR Development
 Pharmacovigilance

30. CDSCO
 LAN / WAN connectivity of CDSCO
campus
 Digitalization of records
 Linking of all CDSCO Zonal/Sub Zonal, Port
offices.
 Office Automatization
Vision : Paperless CDSCO office

31. CDSCO

32. “Let us not follow a
path set by others
Let us set a path for
others to follow”
CDSCO