Clinical Trials New Horizon – India Dr. Surinder Singh Drugs Controller General (India) E-mail: [email protected]/ www cdsco.nic.in CDSCO.

Clinical TrialsNew Horizon – India

Dr. Surinder Singh

Drugs Controller General (India)

E-mail: [email protected]/ www cdsco.nic.in

CDSCO

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

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

Acceptance

Attraction

1992 1996 2000 2004 2008 2012

61 Companies

100 CROs

80 Hospitals

150 Investigators registered with US FDA

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.

ChinaIndia

Russia

Brazil

Argentina

Poland HungaryGermany

TaiwanIsrael

SingaporeIreland

South Africa

United USA

6.105.58

5.55

5.265.005.00

4.904.84

4.814.69

4.46

4.284.27

3.86

4.56

6.88

Patient pool Cost efficiency Regulatoryconditions

Relevantexpertise

Infrastructure &environment

Scale : 1-10

A.T.Keamey

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

Growth of Indian Clinical Trial Industry

Growth of Indian Clinical Trial Industry

35120 160

300

1000

0

200

400

600

800

1000

1200

2002 - 03 2005 - 06 2006 - 07 2007 - 08 2009 - 2010

Year

US

D (

Mil

lio

n)

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)

1

10

100

1000

10000

100000

Phase of trial

No

. T

rial

s (L

og

tra

nsf

orm

ed)

India 32 165 394 63

USA 6324 11305 5683 2474

All 8540 16878 11662 6142

Phase-1 Phase-2 Phase-3 Phase-4

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

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

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

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. Infrastructur

e

IT Support

Connectivity• High quality digital connectivity

• Excellent air/surface transport facilities across country

CDSCO Mckisney 2008

In conclusion….Scanty Large

IndiaPatient pool

Lowest rate Highest rate

India

Patient Recruitment rate

Low High

IndiaSpeed

Most expensive Least expensive

IndiaCost

Smallest pool Highest pool

India

Facility & Investigator pool

Unacceptable to EU/US Acceptable to EU/US

IndiaQuality of data

Least Conducive Most Conducive

India

Regulatory Environment

Least experience Most experience

India

Industry trialexperience

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

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

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

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

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

DAYS

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 16625CDSCO

CDSCO

TEST LICENSE 347

PROTOCOL AMENDMENT 397

CT NOC 223

NO. OF FRESH APPLICATION RECEIVED

322

TOTAL CORRESPONDENCE LETTERS ISSUED

1328

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

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.

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

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

Medium Term GoalsYear - 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

Long Term GoalsYear 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

CDSCO

WHOUSA FDAHealth CanadaANVISA, BrazilSouth Africa

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)

CDSCO

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

Clinical Trials Inspection Regulatory Affairs HR Development Pharmacovigilance

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

CDSCO

“Let us not follow a path set

by othersLet us set a path

for others to follow”CDSCO