dr dilip pawar - clinical research in india

8/2/2019 Dr Dilip Pawar - Clinical Research in India

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Dr Dilip Pawar 1

Clinical Research in India

Drivers for changing perceptions

Dr Dilip Pawar

MD, PhD, MCSEPI, DPBM, DCA, MASCPT(USA),

MASPET(USA), FCP(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


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WELCOME


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INDIA

LIFE EXPECTANCY

68 YEARS

EXPENDITURE ON HEALTH

6%OF GDP(1.2% Government Spend)

POPULATION

URBAN 345 millionTotal 1 billion

BIRTH RATE 27 per 1000

DEATH RATE 8 per 1000

INFANT MORTALITY 77 per 1000

Fourth largest economy in the

world

Second fastest growing economy in

the world

Projected GDP growth rate 8%

Healthcare, Pharma, Biotech, IT,

BPO, telecom are fastest growingsectors

URBAN LITERACY

MALES 82%

FEMALES 64%

INDIA


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58

0

20

40

60

80

100

120

1947

32

1998

62

1980

2020

72

Life Expectancy

Life Span

42

1991

119

2025 P

opulation>65years(million)


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218 mn1990(846 mn) 2000 (1000mn)

340 mn

2025 (1400 mn)

URBAN POPULATION

PREVALENCE OF ILLNESS

Prevalence of Illness

10% 22%

15-60 years > 60 yearsRapid recruitment

(20-30% time advantage ifstudies are conducted in India Ernst & Young)

Population PronouncedRural to Urban Migration


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DISEASESO

FDEVELOPING

COUNTRIES

PROBLEMS OF

REPRODUCTIVE

HEALTH

ACUTE

INFECTIOUS

DISEASES

NUTRITIONAL

DISEASES

Varied Disease Patterns

of developing and

developed world

Epidemiologic Transition DISE

ASESOFDEVEL

OPEDWORLD

AIDS

CHRONIC DISEASES

LIFESTYLE-RELATED

CARDIO-VASCULAR

CANCERS

DEGENERATIVE DISEASES

Changing Disease Patterns


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Changing Disease

PatternsCardiovascular diseases

Degenerative neurologicaldiseases

Diabetes Cancer

Psychiatric illnesses

Gastro Intestinal Disorders

Infectious Diseases

Tropical diseases

Patient Population

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

India has diseases of the tropical world plus diseases ofthe developed countries

Diseases and Patients


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Successive waves of visitors / invaders from the NorthDravidians 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

Later Portuguese, Dutch, French, Moghuls (Mongols), English

TodayCaucasians 80%Dravidians 20%

Ethnic diversity

- majority Caucasian

India Ethnic Diversity


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The Language Advantage

Teaching - Medical, Nursing

& Pharmacy

Communication withRegulatory Authorities

Hospital Management

Source documents

Labeling of Medicines

ENGLISH

Languages - 15 official languages

Hindi - National language- Mother tongue of 30% ofpeople

English - Language for communication


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Medical Practice in India

Multiple systems

Ayurveda

Other traditional Indian systems Homeopathy

Western system; most widely practiced

Multiple systems of therapies


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Medical profession

Did not question source of references

Did not demand local evidence

Patient care Ist priority Not familiar with GCP needs

Did government funded research

Lack of appreciation of mutual needs


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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


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Why Not India until recently?

High importation duty (55%)

No provision in drug laws for global

studies No incentive for PIs; academic

institutions suspicious of clinicians

No Data Exclusivity Long start up times


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Changing perceptionsand 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


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OUTSOURCING OPPORTUNITIES- INDIA

OutsourcingOpportunities -

India

Bulk Drugs&

FormulationsManufacturing

BioinformaticsBiostatistics

SoftwareDevelopment

ContractMarketing &

Sales

InternationalClinical

Trials

TechnicalServices

HerbalsNeutraceuticals

ContractR&D

MedicinalChemistry

PlantMachinery

&Pharma

Equipment

PrimaryPackagingMaterials


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Why India Now?

No importation duty

Patent act amended; IPR in place

Data Exclusivity Export procedures simplified

Drug laws amended to permit global

studies


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Why India..

GCP compliant IRBs

Untapped patient population

English business language GCP guidelines ICH compliant

Start up time reduced to 8-12 weeks

CAP certified central labs


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Government and Regulatory Environment more conducive to clinical research

GCP guidelines introduced by ICMR and DGHS

Customs levies on clinical trial drug supplies eliminated

Patent rules harmonised Healthcare and Healthcare delivery

improvements Tertiary Hospital Infrastructure

GCP awareness

Healthcare Industry - Rs.100,000 crores

Growing demand by Middle ClassEpidemiological Transition of

Disease - Patterns changing

Good connectivity

Increasing use of IT and Internet Transfer of ECGs and Imaging - now routineHealth Insurance expansion

- private participation

emphasis on preventive care

Good Courier Systems within India

and to other countries

Clinical Trial EnvironmentChange Drivers


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Skilled workforcewith

domain expertiseHigh quality research

Therapeutic Expertise Technology support

Maintenance oftime schedules

Shortening timeto market

INDIA


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Regulatory milestones

Mandatory clinical trials for the firstapplicant 1987

BE for subsequent applicants 1987 GCP committee formed 1995

Ethical guidelines - 2000

GCP guidelines released 2001 Drug laws amended to permit

simultaneous phase global trials -

2005


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Recipe for success in India

MOH approval easy if US IND/ EMEAapplication

Understand PI behavior financialnegotiations

Invest in training PIs, IRBs

Promote young, enthusiastic PIs


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Nascent but Fast Growing

- Indias Clinical Development Sector-

Annual Revenues USD 120 M with 40% growth inpast year

240 international studies recruiting subjects =1.2% of the total studies worldwide

66% of international clinical trials are Phase III

207 sites FDA registered

40,000 subjects participated in clinical trials to date(


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Regulatory body Approval Time

Drugs Controller Generalof India (DCGI)

Regulatory approval forstudy conduct in India

4 weeks FAST TRACK,US,UK,CANADA,SWITZERLAND,GERMANY,EMEA, AUSTRALIA,JAPAN CTA available

16 weeks, no documentation tosupport successful US/EU CTA

Drugs Controller Generalof India (DCGI)

Test license to importtrial supplies

2 weeks in addition

Ethics Committees Local Ethics committeeapproval by sites

6 8 weeks (in parallel)

Total (parallel processing) - 6-8 weeks FAST TRACK

16 weeks (track B)

Directorate General ofForeign Trade (DGFT)

Permission to exportblood samples

Additional 2 to 4 weeks

Recent India Regulatory Reform makesApprovals Possible within 6 weeks.


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Meticulously Following Prescribed

Process Is Key.

Contract/LOI

executedAll documents

received

Regulatory

dossier

compilation

CDA signed,

Site Selected,

Release Protocol

Consent Letter

from PIs

Internal review

of dossier

PI submits

application

to EC

reply to queries

Approvals

from EC

Regulatory

submission

to DCGI

Sponsor / CRO

Queries

from EC

Approvals

from ECto PI

Regulatory

Approval

from DCGI

DGFT

Export License

Application

Submission

to DGFT

Export License

Obtained

from DGFT

Regulatory & IRB Approval Process:India


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Deadline is deadline !

Dont set too ambitiousdeadlines

I di G d ll B ildi


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India Gradually Building aTrack Record

Cli i l T i

l O t d t


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Differing Dynamics

I. 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 periruralBenefits to India likely / immediate

III. Clinical Trials on diseases/ disorders of adeveloped economy e.g.

Cardiovascular

CNS including neurological degeneration andpsychiatry

Gastrointestinal

Diabetes

Cancers

AIDS

Sponsors Industry

Locations urbanTest molecules drugs in development

Data for regulatory submission

Benefits to India likely / immediate

Clinical Trials Outsourced toIndia

I di ff C t S i


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India offers Cost SavingPotential

Overall Indexed Clinical Trial Costs

0.77

1.09

0.71

1.2

0.93

1

0.73

0.4

0.52

0.56

0 0.2 0.4 0.6 0.8 1 1.2 1.4

Poland

UK

France

Germany

Spain

USAustralia

Russia

China

India

Source: FastTrack Systems Global Cost Databases


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Mckinsey Report

Indian CR market will grow to US $1.5billion in value by 2010.

Choose Good Investigators


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India has experiencedInvestigators

Concern factors : Using Investigator groups (some will be

great, others might not)

When inexperienced, assess willingness

and motivation to learn and then trainand retrain

Choose Good InvestigatorsNeed local understanding and global

experience


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Perception Reality

GCP awareness absent or lowMany sites in India are trained in GCP nowmandated by Government

Data integrity in question

Various audits of the study show no adversefinding

In India US FDA has audited sites with no majorcomments

Different languages causeconfusion and escalate costsbecause of need to translatedocuments

English used for all healthcare-relatedactivities, systems, procedures and druglabels. Only patient-related documents needtranslation

Telecommunication poorConnectivity poor

Telecommunication facilities good in urbanareas. Connectivity good EDC studiespossible electronic transmission of ECG,imagings frequent.

INDIA - Perceptions & Realities


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Is Clinical Research is anattractive Option for INDIA


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Key MessagesIndia is well placed to provide solutions forcontemporary and future clinical research

Can facilitate affordable drug research

Has required patient populations and qualified scientistsand clinicians

Has the information technology competitive advantage

Has a regulatory framework which is moving towardsregulatory harmonization

The socio-economic transformation in urban India

understands contemporary GCP requirements

Rapid urbanisation and exposure to developed worldfacilitates cross-cultural understanding

Product patents from January 1, 2005


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The Opportunities ahead In Clinical Research Opportunities are many

Not Only in India but also internationally

GRAB THE OPPORTUNITY.


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dr dilip pawar - clinical research in india

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