Study Reports : 2008-09

Ethical concerns in clinical trials in India: an investigation. Sandhya Srinivasan, and Sachin Nikarge 

This report is the product of a journalistic investigation on clinical trials. It set out to identify ethical concerns in clinical trials that were conducted in India and used for approval of new drugs in the European Union (EU). It was initiated after discussions with the health advocacy organisation Wemos and the research organisation Centre for Research on Multinational Corporations (SOMO), both based in Amsterdam. Wemos has been campaigning with EU regulatory authorities to prevent the use of unethically conducted clinical trials towards marketing approval in the EU. The plan was to document available information on up to three trials and the ethical concerns that they raised.

Published: February 2009.

Clinical Trials and Healthcare Regulation in India : Third K.R. Memorial Seminar on Contemporary Issues in Health and Social Sciences Instituted by Anusandhan Trust. CSER 

Clinical research is an important aspect of universalising healthcare, enabling the development of better drugs, tests, vaccines, devices, surgical procedures and other medical interventions and protocols for their safer and more rational use. However, today it is viewed merely as a business investment with high returns. This view has been strengthened by the global trend to marginalise public sector involvement in drug development, a trend that has reduced the potential for non-profit use of the gains of research. Moreover, the growth of clinical research as a global industry has not been matched by an increase in expertise in regulating the complex arrangements that have emerged through the process of outsourcing and off-shoring clinical trials.

Published: January 2009. ISBN : 978-81-909452-0-2

Response of health system to sexual violence: study of six health facilities in two districts of Maharashtra
Amita Pitre and Meenu Pandey

This study focuses on the response of the public health system to sexual violence. This exploratory study is done in six health facilities at various levels of the public health system in two districts of Maharashtra, India it describes the procedures followed in the public health system for women and children who have been subject to sexual assault, and analyses them from a gender perspective. It also attempts a comparative analysis of the procedures, the quality of medico-legal examination and health care, organsiation of services, examination facilities, equipment, medical supplies and medicines in these facilities with the prescribed International and National norms.

Published: 2009. ISBN : 978-81-89042-49

स्त्रियांच्या माहितीकरिता पत्रक : गर्भापताविषयी सर्वकाही
पटेल, दिव्या; चौधरी, लेनी

हे माहिती पत्रक स्त्रियांच्या मनात असलेल्या गर्भापाता विषयीच्या अनेक प्रश्नांना चालना देते. या पत्रकात गर्भपात म्हणजे काय, संबंधित कायदा, परवानगीची गरज, गोपनीयता, सेवा केंद्र, माहिती केंद्र, उपलब्ध पर्याय, सुरक्षितता, अश्या अनेक प्रश्नांची उत्तर आणि योग्य माहिती या पत्रिकेद्वारे मिळते.

Published: 2009.