Clinical trials in India –

current scenario

C S Pramesh MS, FRCS

Associate Professor, Thoracic Surgery
Officer in charge, Clinical Research Secretariat
cspramesh@gmail.com
 TATA MEMORIAL CENTRE
• Tata Memorial Hospital (TMH)
• Advanced Centre for Treatment, Research
& Education in Cancer (ACTREC)
 Cancer burden in the
developing world
NEW CASES OF CANCER

YEAR GLOBAL DEVELOPING WORLD % OF

NO. IN MILLIONS NO. IN MILLIONS GLOBAL

1985 7.6 3.9 52%

1990 8.1 4.1 51%
2000 10.1 5.4 53%

2020* 20.0 14.0 70%

* WHO Projection
 Cancer burden in India
• 2 - 2.5 Million cases of cancer in India
• 800,000 new cases are detected each year
• Tobacco related cancers account for 250,000 new
cases per year
• Cervix Cancer accounts for 126,000 new cases per
year
• Breast cancer accounts for 80,000 new cases per
year
• 550,000 deaths occur due to cancers each year
 India – a snapshot
• Over 1 billion people
• 14,000 hospitals
• 700,000 beds
• Half a million doctors
• Heterogeneous population
• Diverse ethnic mix of people

Applied Clinical Trials Journal Jan 2009

 TATA MEMORIAL HOSPITAL - REGISTRATIONS

Total No. of New Registrations = 38790

J&K Case file registrations = 23430
PUNJAB
78 Referrals/Supportive services = 10423
97 HP
17 Preventive Oncology registrations = 4937
HAR
47 SIKKIM
DELHI 10
126
ARUNACHAL
RAJASTHAN ASSAM
UP PRADESH (12)
468 532
2489
BIHAR NAGALAND (84)
TRIPURA
MP 2014
GUJ WB 42
1584 MANIPUR (84)
468 1619
MEGHALAYA
ORISSA 39
MIZORAM (50)
MAHARASHTRA 483
(excl Mumbai)
MUMBAI
6939
5017 Oth.Western 35%
A.P
204 Mumbai 22%
GOA
204 KAR
Eastern 18%
290 Northern 12%
TN Central 7%
KERALA
125
51 North East 3%
Southern 3%
Collaborations
 Cancer prevention and early detection
studies
Title Sponsor Status
Cervical Cancer Prevention IARC, Lyon with Ongoing
Program (CCPP) Bill & Melinda Gates
Osmanabad Study Foundation
Started in June 2000
Cervical Neoplasia Early IARC, Lyon with Ongoing
Detection Study (CEDS) Bill & Melinda Gates
Mumbai Study Foundation
Started in August 2001
Early Detection of common National Institutes of Ongoing
Cancers in India Health, Washington
NIH Study D.C.
Started in May 1998
Global Clinical Trials - Destinations
• India 49%
• China 20%
• CEE 9%
• South America 8%
• Africa 6%
• Japan 5%
• South Korea 4%
• Australia 0%

website of Applied Clinical Trials Journal 2005

 Clinical research in India
• Central and state governments thrust
• Tax breaks, investment incentives
• Biotechnology research spending has
increased from $ 175 million to 350 million
– past 5 years
• The CRO and manufacturing services
market generates $ 900 million annually –
projected to $ 6.6 billion by 2013 (Frost
and Sullivan)
 Clinical research in India -
landmarks
• 1995 Signed the Trade Related Aspects
of Intellectual Property Rights
(TRIPS) agreement
• 2000 Ethical Guidelines for Biomedical
Research on Human Subjects
• 2002 Good Clinical Practices for Clinical
Research in India
100% direct foreign ownership of
pharma companies.
 Clinical research in India -
landmarks
• 2005 Indian govt cut import duties for
investigational drugs
Schedule Y: Phase lag eliminated
• 2007 Indian govt cut 12% tax on
conduct of clinical research
Online clinical trials registry
• 2008 FDA inspections – no citations on
violations
• 2009 Clinical trials registration
mandatory
 Clinical trials in India
• Economics: 30% cost saving
• Patient accrual: Targets met with accrual
ahead of deadlines
• Structured approval process
– DCGI, IRBs
• Trained, qualified, English speaking
physicians
 International Pivotal Phase III
Randomized Trial for Ca Breast
• Ongoing for 2 yrs
• 127 sites in 32 countries
• less than 50% accrual

• INDIA brought in as an afterthought

• 100% enrollment in 7 weeks
• no GCP violation
• documentation better than 27 other
countries!
 Concerns – regulatory approvals
• Regulatory approval process more
streamlined & predictable
• Study start-up 12 weeks from regulatory
submission
• Regulatory approval possible within 6 wks
(c US FDA/ EU CTA)
 DCGI Regulatory Approval
Parallels Ethics Committee Approval
Regulatory & IRB Approval Process: India
Undertaking by PI submits
CDA signed,
the Investigator application Queries Approvals
Site Selected,
(all PIs) to EC from EC from EC
Release Protocol
reply to queries

Contract/LOI Approvals
executed from EC
All documents Sponsor / CRO
to PI
received

Regulatory
Regulatory Regulatory DGFT
Internal review Approval &
dossier submission Export License
of dossier T License
compilation to DCGI Application
from DCGI

The DCGI (Drug Controller General of India) is responsible for the

approval of manufacturing & marketing of new pharmaceutical
products and the control & regulation of clinical trials for new Export License
Submission
drugs. Obtained
to DGFT
DGFT is the Directorate General of Foreign Trade which provides from DGFT
permission for the export of patient samples.
 Strengths
• Skilled workforce
• Large treatment-naïve patient pool
• Competitive labor and material costs
• Well-established infrastructure for local
and international regulatory approvals
• Largest number of FDA approved
manufacturing plants outside the United
States
 Opportunities
 Access to patients with
diseases of both the tropical
& industrialized world Chandigarh

 Motivated, English speaking Jaipur

New Delhi

investigators
 Urban centric, cost-effective Indore Kolkata

health care system Mumbai Pune

 Robust IT infrastructure & Hyderabad

resources Bangalore

 Stable regulatory Chennai

environment Trivandrum
• More than three quarters of the top 50
Western biopharmaceutical companies are
currently conducting clinical research in
India
• Estimated that by 2010 there could be two
million research patients in India
caBIG and cancer research in India
• Huge potential for clinical research
material
• Regional cancer centers in India
• All conducting various levels of clinical
research
• Trained researchers with quality data
• Large population with increasing cancer
incidence
caBIG in India – the challenges
• Resistance to change
• Reluctance to present raw data in public
domain
• Perceived threat of data plagiarism
• Patient confidentiality
• Ethical issues – patient consent
 caBIG in India – the way forward
• Dispel myths about data sharing in
researchers’ minds
• Incentives for researchers to share data
• Involve researchers actively in the process
• caBIG ‘belongs’ to all researchers,
including from India!
• Widespread dissemination from end-users
• Benefits of a worldwide data consortium
 caBIG in India – the way forward
• Initiate ‘model’ sites
– Catalysts for other sites
– Dispel myths about data sharing
• Support model sites with knowledge
centres
• Provide a one-stop solution for all
bioinformatics needs
– Integrate OpenClinica with caBIG modules