Dr. Surinder Singh
Drugs Controller General (India)
E-mail: dci@nb.nic.in/ www cdsco.nic.in
CDSCO

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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

“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 FDAlike regulatory body.”
CenterWatch (July 2007)

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

China
India
Russia
Brazil
Czec. Rep.
Poland
Hungary
Germany
South Africa
Taiwan
Israel
Singapore
Ireland
Overall Country attractiveness index :
India 2 nd most preferred destination
3.86
4.90
4.84
4.81
4.69
4.56
4.46
4.28
4.27
5.00
5.00
5.26
5.58
5.55
6.10
Scale : 1-10
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

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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
1200
1000
800
600
400
200
0
120
35
2002 - 03 2005 - 06
160
300
1000
2006 - 07 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
.

(www.clinicaltrials.gov; 15 Apr08)
100000
10000
1000
100
10
1
India
USA
All
Phase-1
32
6324
8540
Phase-2 Phase-3
165
11305
394
5683
16878 11662
Phase of trial
Phase-4
63
2474
6142

www.clinicaltrials.gov-Snapshot: 7 Feb 2008
Countries with more than 100 studies listed
Country All Studies
Australia
Chinese Taipei
Japan
Korea
China
India
Singapore
Thailand
Chinese Hong Kong
Philippines
Malaysia
335
327
250
206
180
1572
903
732
674
643
582
% Industry
Sponosred
62.72
45.29
67.76
72.26
53.50
72.16
68.36
69.42
82.00
93.20
93.33
CDSCO

Investigators
Patient population
India : Resource advantages
• 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
CDSCO

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

India : Resource advantages
Clin. Res.
Infrastructure
• 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
IT Support
• Highly developed IT / ITES
• Motivated & committed personnel
• High quality digital connectivity
Connectivity
• Excellent air/surface transport facilities across country
CDSCO

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

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

US FDA NEW DRUGS APPLICATION DATA
GENERATED FROM INDIA
Drug Company
Alcon
AstraZeneca
Cangene
Eli Lilly
Galaxo
Jannsen
Novartis
Pfizer
Roche
Santen
Wyeth
Molecules / Brands
Researched
Vegamox
Merenem
Hepatitis B Vaccine
Alimta, Gemcitabine
Lamotrigine
Resperidal
Tegaserod
Voriconazole
Peg-Interferon
Quixin
Influenza A Vaccine
CDSCO Mckisney 2008

 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
Drugs Controller General of
India (DCGI)
Drugs Controller General of
India (DCGI)
Ethics Committees
(Independent body)
Approval
Regulatory approval for study conduct in India
Time
• Category A trial is approved using a fast-track process within 6 weeks after the required documentation
• Category B within 8 to 12 weeks
2 weeks in addition Test license to import trial supplies
Local Ethics committee approval by sites
6 – 8 weeks (in parallel)
Directorate General of Foreign
Trade (DGFT)
Permission to export
Biological samples
Total (parallel processing)
6-8 weeks – FAST TRACK
(Category A)
16 weeks (Category B)
Did away with this procedure,
CDSCO
Regulatory Approval

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

3
4
5
8
9
6
7
S.No.
1
2
Subject
New Drug
Applications
Global Clinical Trials
Applicatins
Received in
Applications
Received in
2005Approx.
2006Approx.
1200 1500
100 170
10
Vaccines and Biotech
Medical Device
Diagnostic Kit including Test licence for Dignostics
Export NOCs
Test License
Blood Bank License
Import Registration
Import Licence
Total
10
0
250
2000
3700
200
300
2300
10060
50
300
350
2100
5000
225
450
2400
12545
CDSCO
Applications Applications Received
Received in
2007Approx
1600 from 2008 to 2009
Approx.
2000
200
40
450
400
1800
5500
250
400
2000
12640
300
50
500
1000
2500
7500
275
500
2000
16625

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

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

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Draft guidelines and requirements for registration of such organisation in the country have been developed.
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Proposed to be incorporated as new schedule Y1 to drugs and cosmetics rules,1945.
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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

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

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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

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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

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WHO
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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

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Following are the workshops & Trainings organized in association with WHO WR office,New Delhi:
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

CDSCO