Dr Dilip Pawar - Clinical Research In India 2zg4h
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Clinical Research in India Drivers for changing perceptions Dr Dilip Pawar MD, PhD, MCSEPI, DPBM, DCA, MAST(USA), MASPET(USA), F(USA), MBA
Fellow Of American Society Of Clinical Pharmacology
Director & Chief Scientific Advisor Institute of Clinical Research Education and Research Chief Executive Officer & Global Medical Director Drug Research Laboratory; MUMBAI, INDIA Dr Dilip Pawar
1
WELCOME Dr Dilip Pawar
2
Dr Dilip Pawar
3
INDIA POPULATION LIFE EXPECTANCY 68 YEARS
EXPENDITURE ON HEALTH
URBAN
345 million
Total
1 billion
INDIA URBAN LITERACY
6%OF GDP
(1.2% Government Spend)
MALES
82%
FEMALES
64%
•Fourth largest economy in the world
•Second fastest growing economy in the world
BIRTH RATE
27 per 1000
DEATH RATE
8 per 1000
•Projected GDP growth rate – 8%
INFANT MORTALITY 77 per 1000
•Healthcare, Pharma, Biotech, IT, BPO, telecom are fastest growing sectors
Dr Dilip Pawar
4
Life Span Population >65 years (million)
119
120 100 80
62 58
60
42
Life Expectancy
40
72
32
Dr Dilip Pawar
2025
2020
1998
1991
1980
0
1947
20
5
Population – Pronounced Rural to Urban Migration
218 mn
2000 (1000mn)
1990 (846 mn)
2025 (1400 mn)
340 mn
Prevalence of Illness 10%
• Rapid recruitment (20-30% time advantage if studies are conducted in India – Ernst & Young)
22%
15-60 years
> 60 years URBAN POPULATION PREVALENCE OF ILLNESS
Dr Dilip Pawar
6
PROBLEMS OF REPRODUCTIVE HEALTH
ACUTE INFECTIOUS DISEASES NUTRITIONAL DISEASES
AIDS CHRONIC DISEASES LIFESTYLE-RELATED CARDIO-VASCULAR CANCERS DEGENERATIVE DISEASES
Epidemiologic Transition •Varied Disease Patterns of developing and developed world Dr Dilip Pawar
DISEASES OF DEVELOPED WORLD
DISEASES OF DEVELOPING COUNTRIES
Changing Disease Patterns
7
Diseases and Patients Patient Population
Changing Disease Patterns
8 million Epileptics 40 million Asthmatics
~34 million Diabetics
8-10 million HIV +ve
3 million Cancer patients
> 2 million Cardiac deaths
1.5 million Alzheimer patients
1 million PD patients
15% Hypertensive
1% Schizophrenia patients
Cardiovascular diseases Degenerative neurological diseases Diabetes Cancer Psychiatric illnesses Gastro Intestinal Disorders Infectious Diseases Tropical diseases
India has diseases of the tropical world plus diseases of the developed countries Dr Dilip Pawar
8
India – Ethnic Diversity Successive waves of visitors / invaders from the North – Dravidians driven southwards
Aryans from Central Asian steppes – 1500 BC (pale skinned and light-eyed)
Greeks (Yavanas) Scythians Parthians Iranians (Persians)
Also Turks, Huns, Chinese, Ethopians
Today Caucasians Dravidians
80% 20%
• Ethnic diversity - majority Caucasian
Later Portuguese, Dutch, French, Moghuls (Mongols), English
Dr Dilip Pawar
9
The ‘Language’ Advantage Languages Hindi -
English
Teaching - Medical, Nursing & Pharmacy
-
15 official languages National language Mother tongue of 30% of people Language for communication
• Hospital Management • Source documents
ENGLISH
Communication with Regulatory Authorities
Labeling of Medicines
Dr Dilip Pawar
10
Medical Practice in India
Multiple systems Ayurveda Other traditional Indian systems Homeopathy Western system; most widely practiced
Multiple systems of therapies
Dr Dilip Pawar
11
Pharmaceutical industry- Past Clinical trials not mandatory till 1987 Market of branded generics No incentive for research Innovator companies indifferent Local industry not serious about clinical trials No data exclusivity & patent protection
Dr Dilip Pawar
12
Medical profession Did not question source of references Did not demand local evidence Patient care Ist priority Not familiar with G needs Did government funded research Lack of appreciation of mutual needs
Dr Dilip Pawar
13
IRBs Very few in number Mainly reviewed animal studies & post graduate theses Not US FDA compliant No SOPs Not much attention paid to ICF Patient reimbursement not permitted
Dr Dilip Pawar
14
Why Not India until recently? High importation duty (55%) No provision in drug laws for global studies No incentive for PI’s; academic institutions suspicious of clinicians No Data Exclusivity Long start up times
Dr Dilip Pawar
15
Changing perceptions and a new environment
Drivers: WTO Need to globalize Encourage Private public partnership Intense lobbying by MNCs Shift of focus of the indigenous industry; from process to product Economic sense
Dr Dilip Pawar
16
OUTSOURCING OPPORTUNITIES - INDIA Contract R&D
Bulk Drugs & Formulations Manufacturing
International Clinical Trials
Medicinal Chemistry
Plant Machinery & Pharma Equipment Primary Packaging Materials
Contract Marketing & Sales
Outsourcing Opportunities India
Bioinformatics Biostatistics Software Development
Dr Dilip Pawar
Technical Services
Herbals Neutraceuticals
17
Why India Now? No importation duty Patent act amended; IPR in place Data Exclusivity – Export procedures simplified Drug laws amended to permit global studies
Dr Dilip Pawar
18
Why India….. G compliant IRB’s Untapped patient population English business language G guidelines ICH compliant Start up time reduced to 8-12 weeks CAP certified central labs
Dr Dilip Pawar
19
Clinical Trial Environment Change Drivers Government and Regulatory Environment more conducive to clinical research • G guidelines introduced by ICMR and DGHS • Customs levies on clinical trial drug supplies eliminated Healthcare and Healthcare delivery improvements • Tertiary Hospital Infrastructure • G awareness • Healthcare Industry - Rs.100,000 crores • Growing demand by Middle Class
Patent rules harmonised
Epidemiological Transition of Disease - Patterns changing
Health Insurance expansion - private participation emphasis on preventive care
• Good connectivity • Increasing use of IT and Internet • Transfer of ECGs and Imaging - now routine
Good Courier Systems within India and to other countries Dr Dilip Pawar
20
High quality research
Maintenance of time schedules INDIA
Therapeutic Expertise Dr Dilip Pawar
Skilled workforce with domain expertise
Shortening time to market
Technology 21
Regulatory milestones Mandatory clinical trials for the first applicant – 1987 BE for subsequent applicants – 1987 G committee formed – 1995 Ethical guidelines - 2000 G guidelines released – 2001 Drug laws amended to permit simultaneous phase global trials Dr Dilip Pawar 2005
22
Recipe for success in India MOH approval easy if US IND/ EMEA application Understand PI behavior – financial negotiations Invest in training PIs, IRBs Promote young, enthusiastic PIs
Dr Dilip Pawar
23
Nascent but Fast Growing - India’s Clinical Development Sector
Annual Revenues USD 120 M with 40% growth in past year 240 international studies recruiting subjects = 1.2% of the total studies worldwide 66% of international clinical trials are Phase III 207 sites FDA ed 40,000 subjects participated in clinical trials to date (<0.02% of population)
Dr Dilip Pawar
24
Recent India Regulatory Reform makes Approvals Possible within 6 weeks. Regulatory body Drugs Controller General of India (DCGI)
Approval Regulatory approval for study conduct in India
Time
4 weeks – FAST TRACK, US,UK,CANADA,SWITZERLAND, ,EMEA, AUSTRALIA, JAPAN CTA available 16 weeks, no documentation to successful US/EU CTA
Drugs Controller General of India (DCGI)
Test license to import trial supplies
2 weeks in addition
Ethics Committees
Local Ethics committee approval by sites
6 – 8 weeks (in parallel)
Total (parallel processing)
-
6-8 weeks – FAST TRACK 16 weeks (track B)
Directorate General of Foreign Trade (DGFT)
Permission to export blood samples
Additional 2 to 4 weeks
Dr Dilip Pawar
25
Meticulously Following Prescribed Process Is Key. Regulatory & IRB Approval Process:India CDA signed, Site Selected, Release Protocol
Contract/LOI executed All documents received
Consent Letter from PIs
PI submits application to EC reply to queries
Queries from EC
Approvals from EC to PI
Sponsor / CRO
Regulatory dossier compilation
Internal review of dossier
Approvals from EC
Regulatory submission to DCGI
Regulatory Approval from DCGI
Export License Obtained from DGFT
Dr Dilip Pawar
DGFT Export License Application
Submission to DGFT
26
Don‘t set too ambitious deadlines
Deadline is deadline ! Dr Dilip Pawar
27
India — Gradually Building a Track Record
Dr Dilip Pawar
28
Clinical Trials Outsourced to India Differing Dynamics Clinical Trials on diseases of topics e.g. malaria, TB, leishmaniasis
Locations – usually outside urban areas Benefits to India – likely / immediate
II.
Clinical Trials on diseases/ disorders of a primitive economy e.g. Acute infections Nutrition-related Reproductive health-related AIDS
Sponsors – Industry and Others Locations – urban and perirural Benefits to India – likely / immediate
III.
Clinical Trials on diseases/ disorders of a developed economy e.g. Cardiovascular CNS including neurological degeneration and psychiatry Gastrointestinal Diabetes Cancers Dr Dilip Pawar AIDS
Sponsors – Industry Locations – urban Test molecules – drugs in development Data for regulatory submission Benefits to India – likely / immediate
I.
29
India offers Cost Saving Potential Overall Indexed Clinical Trial Costs India
0.56
China
0.52
Russia
0.4
Australia
0.73 1
US Spain
0.93
1.2
0.71
UK
1.09 0.77
Poland
0
0.2
0.4
0.6
0.8
1
1.2
1.4
Source: FastTrack Systems Global Cost Databases Dr Dilip Pawar
30
Mckinsey Report Indian CR market will grow to US $1.5 billion in value by 2010.
Dr Dilip Pawar
31
Choose Good Investigators Need local understanding and global experience India has experienced Investigators Concern factors :
Using Investigator groups (some will be great, others might not) When inexperienced, assess willingness and motivation to learn and then train and retrain
Dr Dilip Pawar
32
INDIA - Perceptions & Realities Perception
Reality
Many sites in India are trained in G – now mandated by Government Various audits of the study show no adverse finding Data integrity in question In India US FDA has audited sites with no major comments Different languages cause English used for all healthcare-related confusion and escalate costs activities, systems, procedures and drug because of need to translate labels. Only patient-related documents need documents translation Telecommunication facilities good in urban Telecommunication poor areas. Connectivity good – EDC studies Connectivity poor possible – electronic transmission of ECG, imagings frequent. G awareness absent or low
Dr Dilip Pawar
33
Is Clinical Research is an attractive Option for INDIA
Dr Dilip Pawar
34
Key Messages India is well placed to provide solutions for contemporary and future clinical research
Can facilitate affordable drug research Has required patient populations and qualified scientists and clinicians Has the information technology competitive advantage Has a regulatory framework which is moving towards regulatory harmonization The socio-economic transformation in urban India understands contemporary G requirements Rapid urbanisation and exposure to developed world facilitates cross-cultural understanding Product patents fromDrJanuary 1, 2005 Dilip Pawar 35
The Opportunities ahead In Clinical Research Opportunities are many Not Only in India but also internationally GRAB THE OPPORTUNITY…….
Dr Dilip Pawar
36
Dr Dilip Pawar
37
Fellow Of American Society Of Clinical Pharmacology
Director & Chief Scientific Advisor Institute of Clinical Research Education and Research Chief Executive Officer & Global Medical Director Drug Research Laboratory; MUMBAI, INDIA Dr Dilip Pawar
1
WELCOME Dr Dilip Pawar
2
Dr Dilip Pawar
3
INDIA POPULATION LIFE EXPECTANCY 68 YEARS
EXPENDITURE ON HEALTH
URBAN
345 million
Total
1 billion
INDIA URBAN LITERACY
6%OF GDP
(1.2% Government Spend)
MALES
82%
FEMALES
64%
•Fourth largest economy in the world
•Second fastest growing economy in the world
BIRTH RATE
27 per 1000
DEATH RATE
8 per 1000
•Projected GDP growth rate – 8%
INFANT MORTALITY 77 per 1000
•Healthcare, Pharma, Biotech, IT, BPO, telecom are fastest growing sectors
Dr Dilip Pawar
4
Life Span Population >65 years (million)
119
120 100 80
62 58
60
42
Life Expectancy
40
72
32
Dr Dilip Pawar
2025
2020
1998
1991
1980
0
1947
20
5
Population – Pronounced Rural to Urban Migration
218 mn
2000 (1000mn)
1990 (846 mn)
2025 (1400 mn)
340 mn
Prevalence of Illness 10%
• Rapid recruitment (20-30% time advantage if studies are conducted in India – Ernst & Young)
22%
15-60 years
> 60 years URBAN POPULATION PREVALENCE OF ILLNESS
Dr Dilip Pawar
6
PROBLEMS OF REPRODUCTIVE HEALTH
ACUTE INFECTIOUS DISEASES NUTRITIONAL DISEASES
AIDS CHRONIC DISEASES LIFESTYLE-RELATED CARDIO-VASCULAR CANCERS DEGENERATIVE DISEASES
Epidemiologic Transition •Varied Disease Patterns of developing and developed world Dr Dilip Pawar
DISEASES OF DEVELOPED WORLD
DISEASES OF DEVELOPING COUNTRIES
Changing Disease Patterns
7
Diseases and Patients Patient Population
Changing Disease Patterns
8 million Epileptics 40 million Asthmatics
~34 million Diabetics
8-10 million HIV +ve
3 million Cancer patients
> 2 million Cardiac deaths
1.5 million Alzheimer patients
1 million PD patients
15% Hypertensive
1% Schizophrenia patients
Cardiovascular diseases Degenerative neurological diseases Diabetes Cancer Psychiatric illnesses Gastro Intestinal Disorders Infectious Diseases Tropical diseases
India has diseases of the tropical world plus diseases of the developed countries Dr Dilip Pawar
8
India – Ethnic Diversity Successive waves of visitors / invaders from the North – Dravidians driven southwards
Aryans from Central Asian steppes – 1500 BC (pale skinned and light-eyed)
Greeks (Yavanas) Scythians Parthians Iranians (Persians)
Also Turks, Huns, Chinese, Ethopians
Today Caucasians Dravidians
80% 20%
• Ethnic diversity - majority Caucasian
Later Portuguese, Dutch, French, Moghuls (Mongols), English
Dr Dilip Pawar
9
The ‘Language’ Advantage Languages Hindi -
English
Teaching - Medical, Nursing & Pharmacy
-
15 official languages National language Mother tongue of 30% of people Language for communication
• Hospital Management • Source documents
ENGLISH
Communication with Regulatory Authorities
Labeling of Medicines
Dr Dilip Pawar
10
Medical Practice in India
Multiple systems Ayurveda Other traditional Indian systems Homeopathy Western system; most widely practiced
Multiple systems of therapies
Dr Dilip Pawar
11
Pharmaceutical industry- Past Clinical trials not mandatory till 1987 Market of branded generics No incentive for research Innovator companies indifferent Local industry not serious about clinical trials No data exclusivity & patent protection
Dr Dilip Pawar
12
Medical profession Did not question source of references Did not demand local evidence Patient care Ist priority Not familiar with G needs Did government funded research Lack of appreciation of mutual needs
Dr Dilip Pawar
13
IRBs Very few in number Mainly reviewed animal studies & post graduate theses Not US FDA compliant No SOPs Not much attention paid to ICF Patient reimbursement not permitted
Dr Dilip Pawar
14
Why Not India until recently? High importation duty (55%) No provision in drug laws for global studies No incentive for PI’s; academic institutions suspicious of clinicians No Data Exclusivity Long start up times
Dr Dilip Pawar
15
Changing perceptions and a new environment
Drivers: WTO Need to globalize Encourage Private public partnership Intense lobbying by MNCs Shift of focus of the indigenous industry; from process to product Economic sense
Dr Dilip Pawar
16
OUTSOURCING OPPORTUNITIES - INDIA Contract R&D
Bulk Drugs & Formulations Manufacturing
International Clinical Trials
Medicinal Chemistry
Plant Machinery & Pharma Equipment Primary Packaging Materials
Contract Marketing & Sales
Outsourcing Opportunities India
Bioinformatics Biostatistics Software Development
Dr Dilip Pawar
Technical Services
Herbals Neutraceuticals
17
Why India Now? No importation duty Patent act amended; IPR in place Data Exclusivity – Export procedures simplified Drug laws amended to permit global studies
Dr Dilip Pawar
18
Why India….. G compliant IRB’s Untapped patient population English business language G guidelines ICH compliant Start up time reduced to 8-12 weeks CAP certified central labs
Dr Dilip Pawar
19
Clinical Trial Environment Change Drivers Government and Regulatory Environment more conducive to clinical research • G guidelines introduced by ICMR and DGHS • Customs levies on clinical trial drug supplies eliminated Healthcare and Healthcare delivery improvements • Tertiary Hospital Infrastructure • G awareness • Healthcare Industry - Rs.100,000 crores • Growing demand by Middle Class
Patent rules harmonised
Epidemiological Transition of Disease - Patterns changing
Health Insurance expansion - private participation emphasis on preventive care
• Good connectivity • Increasing use of IT and Internet • Transfer of ECGs and Imaging - now routine
Good Courier Systems within India and to other countries Dr Dilip Pawar
20
High quality research
Maintenance of time schedules INDIA
Therapeutic Expertise Dr Dilip Pawar
Skilled workforce with domain expertise
Shortening time to market
Technology 21
Regulatory milestones Mandatory clinical trials for the first applicant – 1987 BE for subsequent applicants – 1987 G committee formed – 1995 Ethical guidelines - 2000 G guidelines released – 2001 Drug laws amended to permit simultaneous phase global trials Dr Dilip Pawar 2005
22
Recipe for success in India MOH approval easy if US IND/ EMEA application Understand PI behavior – financial negotiations Invest in training PIs, IRBs Promote young, enthusiastic PIs
Dr Dilip Pawar
23
Nascent but Fast Growing - India’s Clinical Development Sector
Annual Revenues USD 120 M with 40% growth in past year 240 international studies recruiting subjects = 1.2% of the total studies worldwide 66% of international clinical trials are Phase III 207 sites FDA ed 40,000 subjects participated in clinical trials to date (<0.02% of population)
Dr Dilip Pawar
24
Recent India Regulatory Reform makes Approvals Possible within 6 weeks. Regulatory body Drugs Controller General of India (DCGI)
Approval Regulatory approval for study conduct in India
Time
4 weeks – FAST TRACK, US,UK,CANADA,SWITZERLAND, ,EMEA, AUSTRALIA, JAPAN CTA available 16 weeks, no documentation to successful US/EU CTA
Drugs Controller General of India (DCGI)
Test license to import trial supplies
2 weeks in addition
Ethics Committees
Local Ethics committee approval by sites
6 – 8 weeks (in parallel)
Total (parallel processing)
-
6-8 weeks – FAST TRACK 16 weeks (track B)
Directorate General of Foreign Trade (DGFT)
Permission to export blood samples
Additional 2 to 4 weeks
Dr Dilip Pawar
25
Meticulously Following Prescribed Process Is Key. Regulatory & IRB Approval Process:India CDA signed, Site Selected, Release Protocol
Contract/LOI executed All documents received
Consent Letter from PIs
PI submits application to EC reply to queries
Queries from EC
Approvals from EC to PI
Sponsor / CRO
Regulatory dossier compilation
Internal review of dossier
Approvals from EC
Regulatory submission to DCGI
Regulatory Approval from DCGI
Export License Obtained from DGFT
Dr Dilip Pawar
DGFT Export License Application
Submission to DGFT
26
Don‘t set too ambitious deadlines
Deadline is deadline ! Dr Dilip Pawar
27
India — Gradually Building a Track Record
Dr Dilip Pawar
28
Clinical Trials Outsourced to India Differing Dynamics Clinical Trials on diseases of topics e.g. malaria, TB, leishmaniasis
Locations – usually outside urban areas Benefits to India – likely / immediate
II.
Clinical Trials on diseases/ disorders of a primitive economy e.g. Acute infections Nutrition-related Reproductive health-related AIDS
Sponsors – Industry and Others Locations – urban and perirural Benefits to India – likely / immediate
III.
Clinical Trials on diseases/ disorders of a developed economy e.g. Cardiovascular CNS including neurological degeneration and psychiatry Gastrointestinal Diabetes Cancers Dr Dilip Pawar AIDS
Sponsors – Industry Locations – urban Test molecules – drugs in development Data for regulatory submission Benefits to India – likely / immediate
I.
29
India offers Cost Saving Potential Overall Indexed Clinical Trial Costs India
0.56
China
0.52
Russia
0.4
Australia
0.73 1
US Spain
0.93
1.2
0.71
UK
1.09 0.77
Poland
0
0.2
0.4
0.6
0.8
1
1.2
1.4
Source: FastTrack Systems Global Cost Databases Dr Dilip Pawar
30
Mckinsey Report Indian CR market will grow to US $1.5 billion in value by 2010.
Dr Dilip Pawar
31
Choose Good Investigators Need local understanding and global experience India has experienced Investigators Concern factors :
Using Investigator groups (some will be great, others might not) When inexperienced, assess willingness and motivation to learn and then train and retrain
Dr Dilip Pawar
32
INDIA - Perceptions & Realities Perception
Reality
Many sites in India are trained in G – now mandated by Government Various audits of the study show no adverse finding Data integrity in question In India US FDA has audited sites with no major comments Different languages cause English used for all healthcare-related confusion and escalate costs activities, systems, procedures and drug because of need to translate labels. Only patient-related documents need documents translation Telecommunication facilities good in urban Telecommunication poor areas. Connectivity good – EDC studies Connectivity poor possible – electronic transmission of ECG, imagings frequent. G awareness absent or low
Dr Dilip Pawar
33
Is Clinical Research is an attractive Option for INDIA
Dr Dilip Pawar
34
Key Messages India is well placed to provide solutions for contemporary and future clinical research
Can facilitate affordable drug research Has required patient populations and qualified scientists and clinicians Has the information technology competitive advantage Has a regulatory framework which is moving towards regulatory harmonization The socio-economic transformation in urban India understands contemporary G requirements Rapid urbanisation and exposure to developed world facilitates cross-cultural understanding Product patents fromDrJanuary 1, 2005 Dilip Pawar 35
The Opportunities ahead In Clinical Research Opportunities are many Not Only in India but also internationally GRAB THE OPPORTUNITY…….
Dr Dilip Pawar
36
Dr Dilip Pawar
37
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