Transcript UN Reform - World Health Organization

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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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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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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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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Centres of Drug Discovery
India – New Molecules
Thailand – Limited Research
Bangladesh – New Formulations
Indonesia – New Formulations
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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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Harmonization of Drug Regulation in
South East Asia Region
ASEAN Group
Thailand
Indonesia
Myanmar
SAARC Countries
India
Nepal
Bhutan
Sri Lanka
Bangladesh
Maldives
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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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Areas Not Covered
Rational Use of Drugs – Antibiotic
Resistance
Public – Private Partnership
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