Transcript 1. Tracing Pharmaceuticals in South Asia

Tracing Pharmaceuticals
in South Asia
Overview of Project
Nepal, 5 April 2009
Research Problematic
• Gaps in analysis:
– Sociologists/anthropologists study the meanings of illnesses
and treatments
– Political economists study value chains
– Public health researchers study diseases, their epidemiology
and spread
• Need to bring these three together
• Need to study from the ground up:
– start from how drugs are being used;
– follow drugs from cradle to grave
Research Design
To take oxytocin, rifampicin, and fluoxetine as case
studies, because:
– They have significant relationships to poverty
– They play important roles in key health areas,
and they have broad implications for the MDGs
– They offer diverse insights into production,
distribution and prescription of drugs;
– They are off patent, like most medicines
consumed by the poor
Research Questions
•
What is the evidence base for ‘best practice’ for the use of
oxytocin in augmentation of labour, rifampicin in active TB,
and fluoxetine in depression in developing countries?
•
What are the governmental and pharmaceutical companies’
indications for use of these medicines in South Asia, and how
do these compare with the research evidence base and
everyday practice?
•
What are the production and distribution systems of oxytocin,
rifampicin, and fluoxetine in South Asia, and how have these
changed since liberalisation and the arrival of product patent
protection in India?
Research Questions (2)
• What are the marketing, medical training and education strategies
of the pharmaceutical companies for these medicines, and what
roles are played by medical representatives?
• What are the national regulatory standards for production, quality
control, distribution and prescribing of medicines, how are they
developed, and how do the enforcement mechanisms work in
practice?
• How do the relevant health delivery programmes (in Safe
Motherhood, TB control and Mental Health) interact with the
pharmaceutical commodity chains for key medicines?
Research Methods
• Analysis of public documents and clinical
•
guidelines, etc.
Fieldwork in six sites:
– Kolkata and rural West Bengal
– Delhi, Lucknow and rural UP
– Kathmandu and rural East Nepal
• Interviews and observations of everyday
practices of producers, distributors, retailers
and prescribers
Problems of regulation are
compounded by complex
pharmaceutical chains
• Drugs are only sometimes produced by the
originator
• They often travel to final users through many
indirect ways (involving loan licenses, contract
agreements, floating prescriptions, centralised
procurement, resale and removal from packaging)
Large
Pharma
Producer
Small
Pharma
Producer
Counterfeit
Producer
Carriage and
Forwarding Agent or
Company Depot
Super
Stockist
Wholesaler
or Stockist
Hospital
Government or
NGO Agency
Retailer or
Pharmacist
Practitioner
Patient or
Representative
Papers from the project
at this workshop:
1. Trials and evidence in relation to health policy: The
2.
3.
4.
5.
6.
case of Tuberculosis in Nepal and India
Labour Management: Oxytocin in the context of the
Millennium Development Goals
Global Burden of Disease Measures for Depression –
time for a rethink ?
National (non-) regulation in a global pharmaceutical
world
Prozac on the loose: Rethinking the "treatment gap"
for depression in South Asia
Disputing Distribution: Ethics and pharmaceuticals in
Nepal