Tracing Pharmaceuticals in South Asia Overview of Project Nepal, 5 April 2009

Research Problematic Gaps in analysis: 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 bring these three together Need to study from the ground up: 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 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 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? 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 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? 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? 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. Analysis of public documents and clinical guidelines, etc. Fieldwork in six sites: 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 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 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) 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 Carriage and Forwarding Agent or Company Depot Super Stockist Hospital Government or NGO Agency Retailer or Pharmacist Practitioner Patient or Representative Wholesaler or Stockist Counterfeit Producer Key Main channels Other channels Channels for counterfeit drugs

1. Trials and evidence in relation to health policy: The case of Tuberculosis in Nepal and India 2. Labour Management: Oxytocin in the context of the Millennium Development Goals 3. Global Burden of Disease Measures for Depression – time for a rethink ? 4. National (non-) regulation in a global pharmaceutical world 5. Prozac on the loose: Rethinking the "treatment gap" for depression in South Asia 6. Disputing Distribution: Ethics and pharmaceuticals in Nepal Papers from the project at this workshop: