Tracing pharmaceuticals in South Asia: Regulation, distribution and consumption

This research aimed to investigate pharmaceutical supply chains and health care delivery systems through three South Asian case studies, and compare actual practices with national regulatory standards and international best practice. We aimed to assess whether (and if so, how far) pharmaceutical misuse hinders efforts to reach key Millennium Development Goals; and what policy changes might improve the situation.
We planned to
(a) develop a new framework for research on the socio-economic dynamics of pharmaceuticals, integrating the insights from the anthropology of global assemblages and the political economy of global commodity chains;
(b) contribute to theories of global interdependency, integrating 'bottom-up' and 'top-down' approaches to local and global contexts through specific case-studies;
(c) develop new approaches to global policy-making.
Our objectives were to:
1. map patterns of production, distribution, marketing and retail of three key generic drugs (oxytocin, rifampicin and fluoxetine) in South Asia
2. assess use of these three drugs in light of current international standards of best practice.
3. relate these processes to public health goals (maternal and child health, infectious diseases, mental health) and the poverty reduction agenda.
4. contribute to theoretical and methodological debates in public health, medical anthropology and political economy.

This research integrated sociological, public health and political economic approaches to analyse the diverse cultural, medical, economic and institutional factors that determine how three pharmaceuticals—oxytocin, rifampicin, fluoxetine—reach their end users in South Asia. The research also aimed to assist the development of effective interventions to improve MDG and other health outcomes and thereby contribute to poverty-reduction strategies, especially in relation to maternal and child health, infectious diseases and mental health. We innovatively combined detailed ethnographic interviews, semi-structured qualitative interviews with key opinion leaders and shapers, organisational analysis and secondary data sources using government statistics and pharmaceutical industry data.
Our main findings show how complex pharmaceuticals’ supply chains in South Asia create continuing difficulties for the Governments of Nepal and India in regulating how pharmaceuticals reach consumers in ways that minimise both high prices and excessive and inappropriate consumption. Our case studies – including disputes over ‘ethical practice’ in Nepal, ‘floating prescriptions’ of psychiatric drugs, and controversies over the accessibility of uterotonic drugs – have illuminated some key areas of concern in governmental failures to regulate producers, suppliers, retailers and prescribers. Further, through analysing the available evidence of ‘best practice’ with respect to our three selected drugs, we have shown how little is reliably known about the ‘global burden of disease’ in respect of depression, about the most appropriate methods of delivering anti-TB drugs, and about the use of uterotonics to augment labour and prevent/arrest post-partum haemorrhage – not only in South Asia but elsewhere as well.

The findings that have had the most scientific impact relate to rigorous questioning of the weak empirical base for the estimates of the global burden of disease by the WHO, especially depression; the inadequate empirical basis for the use of oxytocin in first and second stage labour; the implications of mutual mistrust among patients, government staff and private practitioners for the misuse of rifampicin in TB control; the broadening of policy ideas related to the “private sector” (in the STOP TB strategy, for example, which encourages “public-private mix” in TB control) to include upstream pharmaceutical markets; and the elaboration of the mechanisms through which prescription medicines (especially psychopharmaceuticals) spread in the Indian and Nepali markets. A second set of issues raised relate to the implications for regulation of the mechanisms by which mutual mistrust is increased by key stakeholders in the pharmaceuticals supply chains, including the mistrust of regulatory systems and their poor regulatory capacity.