1 32nd who south-east asia advisory committee on health research bangkok, thailand, 11-13 october...

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32nd WHO South-East Asia Advisory Committee on Health Research

Bangkok, Thailand, 11-13 October 2011

Review of work carried out by Subcommittee on Vaccines and Drug

Development

By

Professor Ranjit Roy Chaudhury

and

Professor N. K. Ganguly WHO-SEA ACHR

Bangkok

11 October 2011

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32nd WHO South-East Asia Advisory Committee on Health Research

Bangkok, Thailand, 11-13 October 2011

Members of Subcommittee

Professor Ranjit Roy Chaudhury

Professor N. K. Ganguly

Dr. Nyoman Kandun

Dr. Somsak Chunharus

Dr. Harun Ar. Rashid

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32nd WHO South-East Asia Advisory Committee on Health Research

Bangkok, Thailand, 11-13 October 2011

Presentation

Review of Regional Policy on Research

aspect of Immunization – separate

presentation

Status of Vaccine production in region

Development of Vaccines in the region

Mapping of National Centres and Institutes

of Tropical Diseases Research in India –

An example

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32nd WHO South-East Asia Advisory Committee on Health Research

Bangkok, Thailand, 11-13 October 2011

Drugs

Centres of Drug Discovery in Region

Centres of Clinical Trials in Region

Pharmacovigilance Centres

Drug Development from Traditional Medicine

Harmonization of Regulations

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32nd WHO South-East Asia Advisory Committee on Health Research

Bangkok, Thailand, 11-13 October 2011

Centres of Drug Discovery

India – New Molecules

Thailand – Limited Research

Bangladesh – New Formulations

Indonesia – New Formulations

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32nd WHO South-East Asia Advisory Committee on Health Research

Bangkok, Thailand, 11-13 October 2011

India

Government Sector

e.g. Central Drug Research Institute, Lucknow

Private Sector

about 13 Pharmaceuticals

Higher Education Centres

National Institute of Immunology, New Delhi

2007-2008 - 30 New Chemical Entities developed

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32nd WHO South-East Asia Advisory Committee on Health Research

Bangkok, Thailand, 11-13 October 2011

Weakness in Drug Development

Lack of Human Resources to develop Drug

from Chemistry to Pharmacovigilance

Lack of facilities

- Toxicology studies- Good centres for Clinical Trial

Tendency to license out to foreign company

as soon as interesting lead is discovered

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32nd WHO South-East Asia Advisory Committee on Health Research

Bangkok, Thailand, 11-13 October 2011

Drug Discovery

Much cheaper to do this in countries in the

region

Opportunity not being availed of

Need of government support to industry to

develop new drugs in SEAR countries

Partnership between Indian centres and

other centres

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32nd WHO South-East Asia Advisory Committee on Health Research

Bangkok, Thailand, 11-13 October 2011

One Important Discovery

Piperine – A plant used in Ayurvedic Medicine when administered with

Rifampicin – Increases availability of Rifampicin

Reduced dose of Rifampicin from 450 mgm. to 200 mgm. – Reduced cost

- Reduced side effects

- Marketed

CSIR – RRL – JAMMU - CADILA

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32nd WHO South-East Asia Advisory Committee on Health Research

Bangkok, Thailand, 11-13 October 2011

Issues

Can specific centres in countries in region be

linked together for drug discovery rather than

trying to develop all expertise needed in all

countries

Can WHO have a larger role in this at regional

level

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32nd WHO South-East Asia Advisory Committee on Health Research

Bangkok, Thailand, 11-13 October 2011

Clinical Trials in the Region Registered

Bangladesh – 97

India – 1674

Indonesia – 140

Myanmar – 5

Nepal – 20

Sri Lanka – 65

Thailand - 920

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32nd WHO South-East Asia Advisory Committee on Health Research

Bangkok, Thailand, 11-13 October 2011

Other Background Information

Generally Phase II and Phase III studied

India and Sri Lanka have primary Clinical

Trials Registry linked to International Clinical

Registry at WHO

Thailand has a Registry

Indonesia to begin Registry

Phase I studies only in India

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32nd WHO South-East Asia Advisory Committee on Health Research

Bangkok, Thailand, 11-13 October 2011

Potential

Tremendous potential to become Global

Centre for Clinical Trials

Would result in putting countries in frontiers

of Drug Development

Earn tremendous resources for countries

Provide a very large number of jobs

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32nd WHO South-East Asia Advisory Committee on Health Research

Bangkok, Thailand, 11-13 October 2011

Cautions

Trials should be Ethical

Not exploit poor and illiterate in countries to

participate in trials

Need for strong regulatory authorities

Need for strong Ethics Committees at every

institute

•

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32nd WHO South-East Asia Advisory Committee on Health Research

Bangkok, Thailand, 11-13 October 2011

Need

Need for training of Clinical Investigators in good Clinical

Trials conduct

Need for more training programs in Ethics. Already ongoing

programme of WHO and in several countries

- India - ICMR

- Thailand

- Sri Lanka

- Bangladesh

- Nepal

Centres carrying out trials on 5-6 patients in pharmaceutical multicentred trial improves conduct of trial but not much use to country

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32nd WHO South-East Asia Advisory Committee on Health Research

Bangkok, Thailand, 11-13 October 2011

Growth of CROs (Contract Research Organizations)

Growth of CROs recently

They carry out clinical trials for

pharmaceutical house

Quality of CROs varies tremendously

Need - Accreditation of CROs

Careful Monitoring

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32nd WHO South-East Asia Advisory Committee on Health Research

Bangkok, Thailand, 11-13 October 2011

Clinical Trials in Region

SEA Countries appear favoured destination for

clinical trials with China and USSR

Between 40 to 50 percent of new drugs application

to EU and US FDA are tested in these countries

Assocham estimates that clinical trial industry in

India alone is worth one billion dollars

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32nd WHO South-East Asia Advisory Committee on Health Research

Bangkok, Thailand, 11-13 October 2011

Pharmacovigilance Centres in Region

India – Coordinated by Indian

Pharmacopoeia Commission

- 22 Coordinating Centres

Indonesia – National Agency of Drug and Food Control

Bhutan – Run by Pharmacy Department

JWINNR Hospital, Thimpu

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32nd WHO South-East Asia Advisory Committee on Health Research

Bangkok, Thailand, 11-13 October 2011

Pharmacovigilance Centres in Region

Maldives – Maldives FDA is centre

- Reporting low at present

Nepal – Centred at Department of Drug Administration

- Regional Centres - 4

Sri Lanka – Centre at Department of Pharmacology.

Faculty of Medicine, Colombo and Ministry of Health

- Provides Drug Information

Thailand - Centred at Thai Food and Drug Administration

1992 – 18 Regional Centres established

2011 – Community Based Monitoring

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32nd WHO South-East Asia Advisory Committee on Health Research

Bangkok, Thailand, 11-13 October 2011

Drug Development from Traditional Medicine – An Example

Myanmar requested SEARO for help to conduct

Clinical Trials with a plant which is effective in

treatment multi-drug resistant TB (MDR-TB).

Support provided by SEARO- Study tour of Indian Centres for Research on Medicinal

Plants- Consultant visit to Myanmar to prepare programme of

Standardization and Clinical Evaluation - Studies in progress- Continuous technical support from SEARO and consultant

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32nd WHO South-East Asia Advisory Committee on Health Research

Bangkok, Thailand, 11-13 October 2011

Harmonization of Drug Regulation in South East Asia Region

ASEAN Group Thailand

Indonesia

Myanmar

SAARC Countries

India Sri Lanka

Nepal Bangladesh

Bhutan Maldives

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32nd WHO South-East Asia Advisory Committee on Health Research

Bangkok, Thailand, 11-13 October 2011

Harmonization of Drug Regulation in South East Asia Region

Some activity has begun in these two groups

Asean Group has planned protocol for joint

use

Training programme in Brunei in November

2011

Both SEARO and WPRO involved

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32nd WHO South-East Asia Advisory Committee on Health Research

Bangkok, Thailand, 11-13 October 2011

Areas Not Covered

Rational Use of Drugs – Antibiotic Resistance

Public – Private Partnership