SMA Panel: Production, Distribution and Consumption of Pharmaceuticals–South Asia Focus

In the final SMA session I will summarize, the work of three of the panelists (Roger Jeffery, Ian Harper and Stefan Ecks) adds to a long-term collective project at the Centre for South Asian Studies at the University of Edinburgh. The project is entitled “Tracing Pharmaceuticals in South Asia,” and its aim is to “provide governments and others with a better understanding of the contexts and causes of pharmaceutical use in South Asia… by integrating anthropological, public health, and political economic approaches in an investigation and analysis of the diverse cultural, medical, economic and institutional factors that determine the pathways by which three pharmaceuticals-oxytocin, rifampicin, and fluoxetine-reach their end users” (http://www.health.ed.ac.uk/CIPHP/ourresearch/DFIDESRCtraps.htm).

Having had the privilege of visiting the centre and participating in one of its workshops last June, I can commend the Project’s approach to mapping out the complex pattern of pharmaceuticals dissemination in a region where regulation is in flux, commercial motivations diverse and influential, and medical oversight erratic. (A fourth member of the Project, Patricia Jeffery, presented the previous afternoon at an SMA session entitled ‘Polio Histories, “Geographies of Blame” and Global Health.’) Also at this panel, Murphy Halliburton considered the effects of a 2005 patent law on the production of ayurvedic and biomedical pharmaceuticals in India, and I presented a paper about a company/government controversy over the regulation of the antipsychotic drug, olanzapine, in the far more centralized regulatory environment of Japan. Lawrence Cohen was our discussant.

Jeffery offered an overview of the Project and this panel’s relation to it, and then presented a paper (co-authored by M.R. Santhosh) entitled “The architecture of drug regulation in India: can it be reformed?” Jeffery began by contrasting the circumstances for pharmaceutical regulation in places such as Europe and North America with those of India. The focus on new drug approval and monitoring their effects through assumed channels of distribution is inadequate for India where the “context effects” upon the product life of drugs—how they are formulated, distributed, marketed, prescribed and consumed—are barely understood. It is not that there is no regulation in India; in fact there is plenty. However, the real story lies in the gap between regulations as they exist on paper and everyday practice. Moreover, the local regulatory context is affected by global procurement agencies (such as The Global Fund to Fight AIDS, Tuberculosis and Malaria) and by foreign regulators such as the US FDA. Investigative commissions have identified areas in need of reform, however, their recommendations suffer from (among other things) failures to account for local knowledge of the sort Jeffery and his group has been researching.

Ian Harper’s paper (“Disputing distribution: Ethics and pharmaceutical regulation in Nepal”, co-authors Nabin Rawal and Madhusudan Subedi) considered the effects of the Nepalese government’s 2007 guidelines for the ethical distribution of drugs. As in Jeffery’s paper, here too the thick description of the pharmaceutical trade (pharmacists, marketing reps [MR], physicians, etc.) enables the development of a case surrounding the acceptance and resistance to the guidelines.

The Nepalese trade is dominated by branded generics, which are off-patent formulations sold under brand names by different manufacturers. The unregulated environment and the competition with Indian imports are partly responsible for the growth of this commercial type, which has in turn given rise to a lively gift/bonus economy for prescriptions, as well as opportunities for retailers to game the system. These result in feedback incentives for producers and then distributors that further complicates and makes more difficult efforts at regulatory and ethical control over the trade. It has, from the viewpoint of local ethical discourse, become a system of corruption in which individual actors can rightfully blame external conditions for their behavior. The path to regulatory amelioration may remain unclear, however, the analysis Harper and his colleagues are building is a gateway to disentangling the complexity on the ground.

Stefan Ecks’ paper, “Unseen drug dissemination: Rethinking the ‘treatment gap’ for anti-depressants in India” shows that, contrary to the commonplace understanding that depression is under-detected and undertreated in rural India, there is in fact a “stunning proliferation of psychopharmaceutical drugs” there. The conventional approach has been to measure the availability of medical personnel and institutions. Ecks, inspired by the “social biography of things” approach, looks at the actual availability of fluoxetine (Prozac). His results starkly challenge prior methodologies and conclusions of the WHO’s incipiently influential Mental Health Gap Action Programme.

Ecks identifies the existence of 66 generic brands of the drug available at innumerable retail outlets. Because of Indian patent laws in effect until 2005, generics dominate the market. Eli Lilly’s branded Prozac was never, in fact, sold in India. The line between formal and informal retail of the drugs, Ecks says, is often unclear, and the familiar boundaries “between production, marketing, distribution, retail, and prescription of drugs can be surprisingly porous”. Information about drug brands is widely available in brochures, or “reckoners”, that are sold by street hawkers. Because prescriptions are not surrendered when they are filled, patients/consumers can keep purchasing medicines for years, a phenomenon Ecks calls “floating prescriptions”. What emerges here as from the other Tracing Pharmaceuticals papers is a convincing argument for fieldwork centered upon pharmaceutical biographies, and the triangulation of data among researchers working regionally.

The value of a focus on the ambiguous regulatory environment for drugs was evident also in Murphy Halliburton’s paper about ayurvedic drugs, which are common indigenous medicines. Although ayurvedic medicines are undoubtedly used in conjunction with or as alternatives to biomedical pharmaceuticals, as legal-scientific entities they are often held to be distinct. As such, the new intellectual property regulations (TRIPS) portend a different, potentially threatening environment for the makers and sellers of these compounds, and it is this situation that Halliburton’s research reports upon.

“Ayurvedic science”, he points out, is based on plant use rather than that of chemical agents. While plants contain chemical ingredients, TRIPS only deals with the latter. Ayurveda’s entire treatment epistemology is different and as such is “inherently unpatentable”. This legal contrast implicitly opposes western and nonwestern/noncapitalist forms of innovation and knowledge, even while the mass, standardized manufacture and distribution of ayurvedic medicines suggests quite a bit of overlap between the two. Halliburton has researched the conditions under which innovation is realized in the development of ayurvedic treatments, and how ayurvedic practitioners are responding to the appropriation of their medicines by biomedical pharmaceutical companies, both in relation to the new patent laws.

Lawrence Cohen offered stimulating comments, which I won’t attempt to summarize fully, particularly as he spent the greatest amount of time reflecting upon and adding to individual papers in the panel. He began by identifying the new context for how pharmaceuticals are thought about in global health. Both in the WHO agenda and in the scholarly and practical engagements of at least some medical anthropologists, drugs have taken center stage. Concomitant with this emphasis is the expansion both of uncertainties as to particular pharmacopolitical futures, as well as certitudes or “structurations” that accompany the planning mechanisms of those engaged in strategies to forge solutions (as in the case of regulators) or to diminish their exposure to risk (as in the case of pharmaceutical corporations, the subject of my own paper). The social planner’s engagement with contingency (with its “epistemic and affective conditions”) is itself an uncertain enterprise, and therefore also grist for the analyst.

This compounded intellectual challenge, Cohen observed, was confronted by each of the papers in the panel. In the face of this complexity, the familiar poles of anthropological engagement with pharma—on the one hand noting and constructing models of resistance, and on the other “wresting [moral] clarity from the epistemic murk” in order to mobilize pharmaceutical power in the labor of curing global sickness—are insufficient.

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