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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. [ABSTRACT FROM AUTHOR]

Abstract: This paper responds to the call for culturally-relevant intervention research by introducing a methodology for identifying community norms and resources in order to more effectively implement sustainable interventions strategies. Results of an analysis of community norms, specifically attitudes toward gender equity, are presented from an HIV/STI research and intervention project in a low-income community in Mumbai, India (2008–2012). Community gender norms were explored because of their relevance to sexual risk in settings characterized by high levels of gender inequity. This paper recommends approaches that interventionists and social scientists can take to incorporate cultural insights into formative assessments and project implementation These approaches include how to (1) examine modal beliefs and norms and any patterned variation within the community; (2) identify and assess variation in cultural beliefs and norms among community members (including leaders, social workers, members of civil society and the religious sector); and (3) identify differential needs among sectors of the community and key types of individuals best suited to help formulate and disseminate culturally-relevant intervention messages. Using a multi-method approach that includes the progressive translation of qualitative interviews into a quantitative survey of cultural norms, along with an analysis of community consensus, we outline a means for measuring variation in cultural expectations and beliefs about gender relations in an urban community in Mumbai. Results illustrate how intervention strategies and implementation can benefit from an organic (versus a priori and/or stereotypical) approach to cultural characteristics and analysis of community resources and vulnerabilities. [Copyright &y& Elsevier]

Stigma contributes greatly to the burden of schizophrenia and is a major obstacle to recovery, yet, little is known about the subjective experiences of those directly affected in low and middle income countries. This paper aims to describe the experiences of stigma and discrimination of people living with schizophrenia (PLS) in three sites in India and to identify factors influencing negative discrimination. The study used mixed methods and was nested in a randomised controlled trial of community care for schizophrenia. Between November 2009 and October 2010, data on four aspects of stigma experienced by PLS and several clinical variables were collected from 282 PLS and 282 caregivers and analysed using multivariate regression. In addition, in-depth-interviews with PLS and caregivers (36 each) were carried out and analysed using thematic analysis. Quantitative findings indicate that experiences of negative discrimination were reported less commonly (42%) than more internalised forms of stigma experience such as a sense of alienation (79%) and significantly less often than in studies carried out elsewhere. Experiences of negative discrimination were independently predicted by higher levels of positive symptoms of schizophrenia, lower levels of negative symptoms of schizophrenia, higher caregiver knowledge about symptomatology, lower PLS age and not having a source of drinking water in the home. Qualitative findings illustrate the major impact of stigma on ‘what matters most’ in the lives of PLS and highlight three key domains influencing the themes of 'negative reactions' and ‘negative views and feelings about the self’, i.e., ‘others finding out’, ‘behaviours and manifestations of the illness’ and ‘reduced ability to meet role expectations’. Findings have implications for conceptualising and measuring stigma and add to the rationale for enhancing psycho-social interventions to support those facing discrimination. Findings also highlight the importance of addressing public stigma and achieving higher level social and political structural change. [ABSTRACT FROM AUTHOR]

Abstract: The MANAS trial evaluated the effectiveness of a lay counselor led collaborative stepped care intervention for Common Mental Disorders (CMD) in public and private sector primary care settings in Goa, India. This paper describes the qualitative findings of the experience of the intervention and its impact on health and psychosocial outcomes. Twenty four primary care facilities (12 public and private each) were randomized to provide either collaborative stepped care (CSC) or enhanced usual care (EUC) to adults who screen positive for CMDs. Participants were sampled purposively based on two criteria: gender and, in the CSC arm, adherence with the intervention. The qualitative study component involved two semi-structured interviews with participants of both arms (N = 115); the first interview within 2 months of recruitment and the second 6–8 months after recruitment. Data were collected between September 2007 and November 2009. More participants in the CSC than EUC arm reported relief from symptoms and an improvement in social functioning and positive impact on work and activities of daily life. The CSC participants attributed their improvement both to medication received from the doctors and the strategies suggested by the lay Health Counselors (HC). However, two key differences were observed in the results for the two types of facilities. First, the CSC participants in the public sector clinics were more likely to consider the HCs to be an important component of providing care who served as a link between patient and the doctor, provided them skills on stress management and helped in adherence to medication. Second, in the private sector, doctors performed roles similar to those of the HCs and participants in both arms placed much faith in the doctor who acted as a confidante and was perceived to understand the participant's health and context intimately. Lay counselors working in a CSC model have a positive effect on symptomatic relief, social functioning and satisfaction with care in patients with CMD attending primary care clinics although the impact, compared with usual care, is greater in the public sector. [Copyright &y& Elsevier]

Abstract: This paper aims to understand the transaction costs implications of two different governance modes for large scale contracting of HIV prevention services to non-governmental organisations (NGOs) in 2 states in India as part of the National AIDS Control Programme between 2001 and 2003. Interviews at purposively selected case study NGOs, contracting agencies and key informants as well as document review were used to compile qualitative data and make comparisons between the states on five themes theoretically proposed to shape transaction costs: institutional environment, informational problems, opportunism, scale of activity and asset specificity (the degree to which investments made specifically for the contract have value elsewhere). The State AIDS Control Society (SACS) in state Y used a management agency to manage the NGO contracts whereas the SACS in state X contracted directly with the NGOs. A high level of uncertainty, endemic corruption and weak information systems served to weaken the contractual relationships in both states. The management agency in state Y enabled the development of a strong NGO network, greater transparency and control over corrupt practises than the contract model in state X. State X’s contractual process was further weakened by inadequate human resources. The application of the transaction cost framework to contracting out public services to NGOs identified the key costs associated with the governance of HIV prevention services through NGO contracts in India. A more successful form of relational contract evolved within the network of the contract management agency and the NGOs. This led to improved flows of information and perceived quality, and limited corrupt practises. It is unlikely that the SACS on its own, with broader responsibilities and limited autonomy can achieve the same ends. The management agency approach therefore appears to be both transaction cost reducing and better able to cope with the large scale of these contracting programmes. [Copyright &y& Elsevier]