The historical sociology of medicine in India: Introduction to the special section.

This introduction to a special section brings together three papers first presented at a panel, 'Medical Professions in South Asia: Historical and Contemporary Analyses', at the 26th European Conference on South Asian Studies, held in Vienna, Austria and online, in July 2021. All three papers deal with aspects of the professionalisation of biomedical doctors in India since its independence in 1947. The authors bring together historical and sociological approaches to illuminate the growth of specialisms, patterns of practitioner-patient interactions and efforts to maintain occupational closure and maintain status in the face of growing challenges. The introduction concludes with a discussion of the relevance of these papers for the sociology of health and illness in India and beyond.

Current challenges for doctors in India: Deprofessionalisation, reprofessionalisation or fragmentation?

Western-trained doctors in India struggled to establish themselves as a medical 'profession' in the 1920s and 1930s and these struggles continued into the post-colonial period. The direction of travel is, however, no longer clear. Increasing evidence of a crisis in doctors' collective ability to provide a form of self-regulation since 2000 is highlighted. India's Supreme Court suspended the operations of their country's medical councils in the face of a proliferation of poorly regulated private medical colleges. Practitioners of alternative systems of medicine and unqualified medical practice continue, while new 'short-course' doctors take over tasks previously restricted to fully fledged MBBS doctors. The diversification of the social origins of medical students, with rising numbers of doctors from a wider range of social backgrounds, threatens their aspirations to high status. There is little diminution of the earnings of elite doctors, yet their conditions of work are increasingly constrained by financial targets. Young doctors face uncertain futures. This article analyses the increasingly diverse occupational positions of doctors in India using a Bourdieusian lens and asks whether an alternative, stable form of institutional arrangements is emerging, as some have claimed, or if fragmentation is a more apt description.

How Civil Society Organisations Changed the Regulation of Clinical Trials in India.

In 2005 India changed its pharmaceutical and innovation policy that facilitated a dramatic increase in international clinical trials involving study sites in India. This policy shift was surrounded by controversies; civil society organisations (CSOs) criticised the Indian government for promoting the commercialisation of pharmaceutical research and development. Health social movements in India fought for social justice through collective action, and engaged in normative reasoning of the benefits, burdens and equality of research. They lobbied to protect trial participants from structural violence that occurred especially in the first 5-6 years of the new policy. CSOs played a major role in the introduction of new regulations in 2013, which accelerated a decline in the number of global trials carried out in India. This activism applied interpretations of global social justice as key ideas in mobilisation, eventually helping to institutionalise stricter ethical regulation on a national level. Like government and industry, activists believed in randomised controlled trials and comparison as key methods for scientific knowledge production. However, they had significant concerns about the global hierarchies of commercial pharmaceutical research, and their impact on the rights of participants and on benefits for India overall. Pointing to ethical malpractices and lobbying for stricter ethical regulations, they aimed to ensure justice for research participants, and developed effective strategies to increase controls over the business side of clinical research.

Atomic force microscopy with integrated on-chip interferometric readout.

The most common readout technique used in atomic force microscopy (AFM) is based on optical beam deflection (OBD), which relies on monitoring deflection of the cantilever probe by measuring the position of the laser beam reflected from the free end of the AFM cantilever. Although systems using the OBD readout can achieve subnanometre displacement resolution and video rate imaging speeds, its main limitation is size, which is difficult to minimise, thus limiting multiprobe imaging capability. Currently, system miniaturisation has been accommodated by adopting on-chip electrical readout solutions, often at the expense of measurement sensitivity. To date, no cost-effective AFM readout solution exists without sacrificing either measurement sensitivity, system miniaturisation, or multiprobe array scalability. In this paper we present an AFM probe with integrated on-chip optical interferometric readout based on silicon photonics. Our AFM probe combines the advantages of subnanometre resolution of optical readouts with on-chip miniaturisation. The adopted approach determines deflection of the cantilever using an integrated on-chip photonics waveguide by monitoring the separation between the sensing cantilever and an interrogating grating. The implemented methodology provides ultimate interferometric resolution and sensitivity, on-chip miniaturisation, and array scalability, which makes possible ultrafast multiprobe-array AFM imaging. Using a Digital Instruments D3000 AFM retrofitted with our cantilever probe and integrated readout, we report sub-nanometre AFM topography images obtained on reference samples. We demonstrate RMS static AFM noise level of 19 pm, outperforming the operation of this system in its standard, optical beam deflection configuration (51 pm). The noise spectrum measurements of our probe indicate that the integrated readout is shot noise limited, achieving a deflection noise density (DND) of 36fm/Hz.

Correcting India's Chronic Shortage of Drug Inspectors to Ensure the Production and Distribution of Safe, High-Quality Medicines.

BACKGROUND: Good drug regulation requires an effective system for monitoring and inspection of manufacturing and sales units. In India, despite widespread agreement on this principle, ongoing shortages of drug inspectors have been identified by national committees since 1975. The growth of India's pharmaceutical industry and its large export market makes the problem more acute. METHODS: The focus of this study is a case study of Maharashtra, which has 29% of India's manufacturing units and 38% of its medicines exports. India's regulations were reviewed, comparing international, national and state inspection norms with the actual number of inspectors and inspections. Twenty-six key informant interviews were conducted to ascertain the causes of the shortfall. RESULTS: In 2009-2010, 55% of the sanctioned posts of drug inspectors in Maharashtra were vacant. This resulted in a shortfall of 83%, based on the Mashelkar Committee's recommendations. Less than a quarter of the required inspections of manufacturing and sales units were undertaken. The Indian Drugs and Cosmetics Act and its Rules and Regulations make no provisions for drug inspectors and workforce planning norms, despite the growth and increasing complexity of India's pharmaceutical industry. CONCLUSION: The Maharashtra Food and Drug Administration (FDA) falls short of the Mashelkar Committee's recommended workforce planning norms. Legislation and political and operational support are required to produce needed changes.

Community perceptions of health and chronic disease in South Indian rural transitional communities: a qualitative study.

BACKGROUND: Chronic diseases are now the leading cause of death and disability worldwide; this epidemic has been linked to rapid economic growth and urbanisation in developing countries. Understanding how characteristics of the physical, social, and economic environment affect behaviour in the light of these changes is key to identifying successful interventions to mitigate chronic disease risk. DESIGN: We undertook a qualitative study consisting of nine focus group discussions (FGDs) (n=57) in five villages in rural Andhra Pradesh, South India, to understand people's perceptions of community development and urbanisation in relation to chronic disease in rural transitional communities. Specifically, we sought to understand perceptions of change linked to diet, physical activity, and pollution (because these exposures are most relevant to chronic diseases), with the aim of defining future interventions. The transcripts were analysed thematically. RESULTS: Participants believed their communities were currently less healthy, more polluted, less physically active, and had poorer access to nutritious food and shorter life expectancies than previously. There were contradictory perceptions of the effects of urbanisation on health within and between individuals; several of the participants felt their quality of life had been reduced. CONCLUSIONS: In the present study, residents viewed change and development within their villages as an inevitable and largely positive process but with some negative health consequences. Understanding how these changes are affecting populations in transitional rural areas and how people relate to their environment may be useful to guide community planning for health. Measures to educate and empower people to make healthy choices within their community may help reduce the spread of chronic disease risk factors in future years.

Big-pharmaceuticalisation: clinical trials and Contract Research Organisations in India.

The World Trade Organisation's Trade Related Intellectual Property Rights [TRIPS] agreement aimed to harmonise intellectual property rights and patent protection globally. In India, the signing of this agreement resulted in a sharp increase in clinical trials since 2005. The Indian government, along with larger Indian pharmaceutical companies, believed that they could change existing commercial research cultures through the promotion of basic research as well as attracting international clinical trials, and thus create an international level, innovation-based drug industry. The effects of the growth of these outsourced and off-shored clinical trials on local commercial knowledge production in India are still unclear. What has been the impact of the increasing scale and commercialisation of clinical research on corporate science in India? In this paper we describe Big-pharmaceuticalisation in India, whereby the local pharmaceutical industry is moving from generic manufacturing to innovative research. Using conceptual frameworks of pharmaceuticalisation and innovation, this paper analyses data from research conducted in 2010-2012 and describes how Contract Research Organisations (CROs) enable outsourcing of randomised control trials to India. Focussing on twenty-five semi-structured interviews CRO staff, we chart the changes in Indian pharmaceutical industry, and implications for local research cultures. We use Big-pharmaceuticalisation to extend the notion of pharmaceuticalisation to describe the spread of pharmaceutical research globally and illustrate how TRIPS has encouraged a concentration of capital in India, with large companies gaining increasing market share and using their market power to rewrite regulations and introduce new regulatory practices in their own interest. Contract Research Organisations, with relevant, new, epistemic skills and capacities, are both manifestations of the changes in commercial research cultures, as well as the vehicles to achieve them. These changes have reinvigorated public concerns that stress not only access to new medicines but also the 'price' of innovation on research participants.

Frontline health workers as brokers: provider perceptions, experiences and mitigating strategies to improve access to essential medicines in South Africa.

BACKGROUND: Front-line health providers have a unique role as brokers (patient advocates) between the health system and patients in ensuring access to medicines (ATM). ATM is a fundamental component of health systems. This paper examines in a South African context supply- and demand- ATM barriers from the provider perspective using a five dimensional framework: availability (fit between existing resources and clients' needs); accessibility (fit between physical location of healthcare and location of clients); accommodation (fit between the organisation of services and clients' practical circumstances); acceptability (fit between clients' and providers' mutual expectations and appropriateness of care) and affordability (fit between cost of care and ability to pay). METHODS: This cross-sectional, qualitative study uses semi-structured interviews with nurses, pharmacy personnel and doctors. Thirty-six providers were purposively recruited from six public sector Community Health Centres in two districts in the Eastern Cape Province representing both rural and urban settings. Content analysis combined structured coding and grounded theory approaches. Finally, the five dimensional framework was applied to illustrate the interconnected facets of the issue. RESULTS: Factors perceived to affect ATM were identified. Availability of medicines was hampered by logistical bottlenecks in the medicines supply chain; poor public transport networks affected accessibility. Organization of disease programmes meshed poorly with the needs of patients with comorbidities and circular migrants who move between provinces searching for economic opportunities, proximity to services such as social grants and shopping centres influenced where patients obtain medicines. Acceptability was affected by, for example, HIV related stigma leading patients to seek distant services. Travel costs exacerbated by the interplay of several ATM barriers influenced affordability. Providers play a brokerage role by adopting flexible prescribing and dispensing for 'stable' patients and aligning clinic and social grant appointments to minimise clients' routine costs. Occasionally they reported assisting patients with transport money. CONCLUSION: All five ATM barriers are important and they interact in complex ways. Context-sensitive responses which minimise treatment interruption are needed. While broad-based changes encompassing all disease programmes to improve ATM are needed, a beginning could be to assess the appropriateness, feasibility and sustainability of existing brokerage mechanisms.

Trust and the regulation of pharmaceuticals: South Asia in a globalised world.

BACKGROUND: Building appropriate levels of trust in pharmaceuticals is a painstaking and challenging task, involving participants from different spheres of life, including producers, distributors, retailers, prescribers, patients and the mass media. Increasingly, however, trust is not just a national matter, but involves cross-border flows of knowledge, threats and promises. METHODS: Data for this paper comes from the project 'Tracing Pharmaceuticals in South Asia', which used ethnographic fieldwork and qualitative interviews to compared the trajectories of three pharmaceuticals (Rifampicin, Oxytocin and Fluoxetine) from producer to patient in three sites (north India, West Bengal and Nepal) between 2005-08. RESULTS: We argue that issues of trust are crucial in reducing the likelihood of appropriate use of medicines. Unlike earlier discussions of trust, we suggest that trust contexts beyond the patient-practitioner relationship are important. We illustrate these arguments through three case studies: (i) a conflict over ethics in Nepal, involving a suggested revised ethical code for retailers, medical representatives, producers and prescribers; (ii) disputes over counterfeit, fake, substandard and spurious medicines, and quality standards in Indian generic companies, looking particularly at the role played by the US FDA; and (iii) the implications of lack of trust in the DOTS programmes in India and Nepal for the relationships among patients, government and the private sector. CONCLUSIONS: We conclude that the building of trust is a necessary but always vulnerable and contingent process. While it might be desirable to outline steps that can be taken to build trust, the range of conflicting interests in the pharmaceutical field make feasible solutions hard to implement.

Only when the boat has started sinking: a maternal death in rural north India.

This paper uses a close reading of villagers' responses to the death in childbirth of a Muslim woman to raise questions about India's current policy emphasis on institutional delivery as a means of reducing maternal mortality. After introducing the context and methods of our research, we describe recent policy interventions related to maternal health, including the National Rural Health Mission established in 2005. We then outline villagers' commentaries on the specific maternal death, focusing on the costs to women's health (and sometimes life) of high fertility; the lack of care available from rural government facilities and staff and the preference for delivering at home with the aid of local practitioners; the financial constraints that make people hesitate to seek medical treatment; and the high costs of private treatment and the poor treatment experienced in government facilities. Our core argument is that government health care provision in rural Uttar Pradesh is embedded in a moral universe characterised by widespread and long-term mistrust of state services and that encouraging institutional deliveries without addressing the perceptions of potential service users is a seriously flawed approach to reducing maternal mortality. The paper draws primarily on ethnographic research funded by the Wellcome Trust during 2002-2005, in a Muslim village in rural Bijnor district (in north-western Uttar Pradesh).

Unmonitored intrapartum oxytocin use in home deliveries: evidence from Uttar Pradesh, India.

Intrapartum use of oxytocin should entail controlled dosages administered through infusion, continual monitoring of mother and fetus and surgical back-up, since several adverse outcomes have been reported. However, in Uttar Pradesh, north India, small-scale ethnographic studies as well as a large-scale retrospective survey have established that unmonitored intramuscular oxytocin injections are commonly given to birthing mothers to augment labour by unregistered local male practitioners and auxiliary nurse-midwives employed by government during home deliveries. India's reproductive and child health policy needs to address the inappropriate use of oxytocin. Under a new 2007 policy, female government health workers at peripheral institutions are to be supplied with oxytocin to inject during the third stage of labour to prevent post-partum haemorrhage. The practice of injecting oxytocin intrapartum could readily be reinforced by this policy shift. There is an urgent need to ensure that home births are safer for mothers and babies alike, since India's current policy goals of raising the numbers of institutional deliveries, ensuring skilled attendance at birth and improving referrals for emergency obstetric care cannot be met in the foreseeable future. In a context of enduringly high infant and maternal mortality, especially in Uttar Pradesh and other large northern states, the question of whether or not inappropriate use of oxytocin is contributing to maternal and newborn morbidity and mortality deserves further research.