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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]

Background: Burn injury is one of the major traumas that a child can experience. Parents of burn-injured children experience anxiety, depression, guilt and post traumatic stress disorders as they care for their burn-injured children. Such empirical evidence related to effects of burns on parents and parenting process is unavailable from low and middle income countries like India. Objectives: The aim of the study was to discover the process of parenting burn-injured children in India. The objective of this paper is to present one of the substantive processes ''Enduring the Blame'' that emerged from the data. Design: Constructivist grounded theory methodology was used to explore the experiences of parenting burn-injured children. Setting: The study was conducted through a tertiary hospital that provided advanced paediatric burn care in a town in South India. Setting: The study was conducted through a tertiary hospital that provided advanced paediatric burn care in a town in South India. Methods: Twenty-two semi structured individual or family interviews were conducted in Tamil over a period of one year. The interview started with an overview question and then was followed by trigger questions as the participants shared their experiences. Second interviews were conducted with three participants in three families for theoretical saturation purposes. Results: Mothers and fathers encountered blame from family members, health professionals, strangers, and their burn-injured children along the burn injury trajectory. They suffered double trauma of their child's burn and the blame. Parenting their burn-injured child involved a process of ''Enduring the Blame.'' Enduring the Blame included four stages: internalizing blame, submitting to blame, rising above blame, and avoiding blame. Conclusions: Encouraging and assisting parents in caring for their children instead of blaming is a vital component of paediatric burn care. Parents will benefit from ongoing assessment and psychological interventions that will provide emotional support. Studying the perceptions of health professionals and the burn-injured children will help in further clarification of blame related issues and developing a parenting theory. [ABSTRACT FROM AUTHOR]