The present day world has been experiencing rapid technological advancement on the one hand and increasing number of diseases afflicting the human beings on the other. To deal with the later, medical devices are innovated and introduced in to the market (making use of the technological advancements), on a continuous basis across the world. However, taking an innovated medical device to the market poses innumerable challenges and therefore, these have to be clinically trialled before its launch to ensure safety and efficacy. Of late, India has emerged as one of the preferred destinations to carry out clinical studies due to numerous advantages, primarily its diverse human gene pool and cost-competitiveness. However, there is very little understanding on the landscape of medical devices clinically trialled in India. It is to throw light on this critical issue with respect to the selection of participants in the clinical trial process, selection of locations and determination of trial duration that the present study has been carried out. In addition, the role of patents associated with the introduction of new medical devices in relation to the key challenges is examined. Furthermore, we studied the characteristics of clinical trials by industry and non-industry sponsors and between cardiovascular and other disease related trials. The present study has been carried out based on secondary data covering 108 medical device clinical trial registrations accessed from Clinical Trial Registry of India (CTRI) database pertaining to the period 2008-2014. At the outset, the pattern of trials related to the most prominent diseases such as cardiology and cardiovascular diseases and those which are invasive and non-invasive are examined. Our findings indicate that almost 50% of the trials are related to diseases of cardiology, cardiovascular diseases and those which are invasive in nature. For studying the patenting aspect, we proposed a conceptual grouping of sponsors as Incumbent, Potential Entrant and Supporter, based on their patent holdings in the domestic market and in PCT (Patent Cooperation Treaty) filings. Patents owned by Primary Sponsor (PS) showed significant variations in their clinical trial characteristics particularly the invasiveness of device, disease type, locations and participants. Three quantitative models are developed to identify the factors that influence the selection of number of participants, locations and time taken to execute medical device clinical trials using multivariate statistical techniques. The results of the three conceptual models on number of participants, locations and trial duration showed invasiveness of device and disease type playing significant roles in all the three models. The number of PCTs owned by PS was found to be influential in selecting the number of locations and participants but not the patents owned in IPO (Indian Patent Office). We also observed significant differences between industry and non-industry sponsors in terms of their clinical trial characteristics. The findings of the study formed the basis to understand the medical device clinical trial landscape and other pertinent issues in the Indian context, which enabled us to derive appropriate inferences and policy implications.

Made available in DSpace on 2015-04-11T13:40:56Z (GMT). No. of bitstreams: 1 Esron Soares Carvalho Rocha.pdf: 1656624 bytes, checksum: 9da4d4e6670ca378c18430e36df82a61 (MD5) Previous issue date: 2008-10-02 / CAPES - Coordenação de Aperfeiçoamento de Pessoal de Nível Superior / This study is characterised as ethnography of the sanitary practices developed at the Rio Negro Indian Sanitary Special District (DSEI), highlighting the work organization of nursing professionals, such as, nurses, nursing technicians and the Indian health-care agent. Its aims comprise the sanitary practices employed by the Indian Health-Care Multidisciplinary Team (EMSI) nursing corps regarding the provision of differentiated attention to health-care as it interacts with the Baniwa Indian health-care agent (AIS), his forming process and sociodemographic profile; social representations and sanitary practices, seeking to grasp his compatibility and/or incompatibility with the policy of differentiated attention to the Indian health-care subsystem. The present research entails a prospective, descriptive, qualitative type study, directed by the interpretative model of the social representation theory and health evaluative survey. The findings here obtained show that the Baniwa AIS, faces problems regarding his low schooling, along with the fact that his professional forming process has advanced very little since the DSEI was implemented six years ago. The EMSI acting profile is marked by the care treatment model to the spontaneous demand, even though the professionals provide care for diseases of the infectious, chronic-degenerative type to specific population groups (mother-child group), with detriment to health surveillance components presupposed on the design of the National health programs. Among the set of essential activities developed in the DSEI, the travelling logistics consumes a large part of the EMSI time and energy, with negative implications on the health-care agent overseeing and followup as well as on the implementation of the differentiated attention principle presupposed by the National Indian Health-Care Policy. The areas are still greatly patched and the differentiated attention gets mixed up with the extension of the coverage provided by the DSEI Implantation. / O estudo se caracteriza como uma etnografia das práticas sanitárias desenvolvidas no DSEI Rio Negro, com ênfase na organização do trabalho dos profissionais de enfermagem, aí compreendidos o enfermeiro, o técnico de enfermagem e o agente indígena de saúde. Os objetivos compreendem a análise das práticas sanitárias do corpo de enfermagem da Equipe Multidisciplinar de Saúde na oferta de atenção diferenciada à saúde e em interação com o agente indígena de saúde; do perfil-sócio-demográfico e o processo de formação dos Agentes Indígenas de Saúde (AIS) Baniwa; das representações sociais e práticas sanitárias dos AIS, buscando apreender sua compatibilidade e/ou incompatibilidade com a política de atenção diferenciada do subsistema de saúde indígena. A pesquisa é um estudo exploratório, descritivo, do tipo qualitativo, orientado pelo modelo interpretativo da teoria das representações sociais e da pesquisa avaliativa em saúde. Os resultados obtidos mostram que os AIS Baniwa enfrentam problemas ligados à baixa escolaridade, e que seu processo de formação profissional pouco avançou após 6 anos de implantação do DSEI. O perfil de atuação da EMSI é marcado pelo modelo assistencial curativo à demanda espontânea, ainda que os profissionais efetuem assistência a agravos de tipo infeccioso, crônico-degenerativo e de grupos populacionais específicos (grupo materno-infantil), com prejuízo dos componentes de vigilância a saúde previstos na organização dos programas nacionais de saúde. Dentre o conjunto de atividades essenciais desenvolvidas no DSEI, a logística de deslocamento consome grande parte do tempo e energia da EMSI, com implicações negativas na supervisão e acompanhamento dos agentes de saúde e na implementação do princípio da atenção diferenciada previsto na Política Nacional de Saúde Indígena. As áreas são ainda bastante fragmentadas e a atenção diferenciada se confunde com a extensão de cobertura provida pela implantação do DSEI.

In this Master’s thesis, I attempt to illuminate the historical relationship between Classical Indian medical practice and Buddhist monastic law codes, vinaya, in India around the turn of the Common Era. Popular scholarly conceptions of this relationship contend that the adoption of the Indian medical tradition into the Buddhist monastic institution is directly traceable to the Pāli canon. The Mūlasarvastivāda-vinaya (MSV) does not appear to take issue with physicians or medical knowledge, yet the condemnation of physicians in ancient Indian literature strongly suggests that the relationship between monks and medicine is more complex than the Pāli canon illustrates. Similar to other vinaya traditions, the MSV includes detailed information about permitted medicaments, as well as allowances for monastics to provide medical care to other monastics and even, in particular cases, the laity. I argue that the incentives for monastics to maintain a positive relationship with the medical world were driven by the economic benefits of monastic medical knowledge, as well as associations with wealthy physicians. Using a variety of extant Sanskrit materials, as well as epigraphic evidence, I aim to present a nuanced picture of the history of the relationship between Indian Buddhist monasticism and medicine around the turn of the Common Era. / Thesis / Master of Arts (MA)