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Ethical Dimensions in the Biomedical 
Innovations in India: An Analysis 
Anup Kumar Das 
CSSP, SSS 
Jawaharlal Nehru Unive...
National Guidelines and Ethical Frameworks in Biomedical Research 
• Conforming to: 
– UNESCO Universal Declaration on Bio...
GEST: Global Ethics in Science and Technology, 2011 - 2014 
GEST is a 3 year Collaborative Project, funded by the European...
• “GEST represents the first concerted effort to explore the global dynamics 
of ethics in Science & Technology policy.” 
...
Food Technologies Ethical Matrix
Framework of Factors influencing in Public Involvement/ 
Public Participation in S&T Policymaking
Clinical Trials Registry India 
• The Clinical Trials Registry - India (CTRI.NIC.IN) 
• A free and online system for regis...
A CTRI Record 
CTRI 
No. 
Public 
Title 
Type of 
Trial 
Recruit 
ment 
Status 
Health 
Condition 
Interven 
tion 
Name 
L...
Top Cited papers on India AND Bioethics (Results: 34, from All Databases, 
Source: Web of Science) 
1. The Commodification...
Top Cited papers on ICMR AND Guidelines (Results: 15, from All Databases, 
Source: Web of Science) 
1. The Indian Genome V...
Some Recent Policy Moves, as saw in newspapers 
• India Outlines Plans for Upgrading Clinical Trial Procedures, Wall Stree...
Some Observations 
• Amount of biomedical research being undertaken in India with transnational 
participation is signific...
Thank you. 
http://anupkumardas.blogspot.in
Ethical Dimensions in the Biomedical Innovations in India: An Analysis
Ethical Dimensions in the Biomedical Innovations in India: An Analysis
Ethical Dimensions in the Biomedical Innovations in India: An Analysis
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Ethical Dimensions in the Biomedical Innovations in India: An Analysis

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Presentation titled "Ethical Dimensions in the Biomedical Innovations in India: An Analysis" was presented in the Second International Convention on Ethics in Research on Human Participants: Evolving Norms and Guidelines for the Indian Context, 2-4 September 2014, at JNU Convention Centre, New Delhi; Organized by Institutional Ethics Review Board, JNU, India.

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Ethical Dimensions in the Biomedical Innovations in India: An Analysis

  1. 1. Ethical Dimensions in the Biomedical Innovations in India: An Analysis Anup Kumar Das CSSP, SSS Jawaharlal Nehru University, India Presented in Second International Convention on Ethics in Research on Human Participants: Evolving Norms and Guidelines for the Indian Context, 2-4 September 2014, at JNU Convention Centre, New Delhi; Organized by Institutional Ethics Review Board, JNU, India
  2. 2. National Guidelines and Ethical Frameworks in Biomedical Research • Conforming to: – UNESCO Universal Declaration on Bioethics and Human Rights, 2005 – WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects (Revised 2013, 1st adopted in 1964) • Guidelines for Stem Cell Research, 2013 • The Assisted Reproductive Technologies (Regulation) Bill - 2010 • The Assisted Reproductive Technologies (Regulation) Rules - 2010 • Ethical Guidelines for Biomedical Research on Human Participants, 2006 • National Guidelines for Accreditation, Supervision & Regulation of ART Clinics in India, 2005 • Guidelines on Code of Conduct for Research Scientists engaged in field of Life Sciences, N.D.
  3. 3. GEST: Global Ethics in Science and Technology, 2011 - 2014 GEST is a 3 year Collaborative Project, funded by the European Community's Seventh Framework Programme, 1 February 2011 - 31 May 2014. GEST Aims to: •Explore the state-of-the-art in the debates on ethics in S&T in the three regions with a focus on interdependent scientific developments in the areas of Nanotechnologies, Food Technologies, and Synthetic Biology. •Explore the social determinants of policymaking in the three regions in terms of public perceptions of risks and benefits, and lay morality. •Instigate a best practice system of ethics analysis that can be applied equally well in each of the three regions. •Promote and support a global debate on the issue of the ethical and social implications of scientific and technological developments with a view to in forming national policies. •Create a high-level policy advisory network of experts from Europe, China and India in order to promote concrete collaboration in the area amongst the three regions.
  4. 4. • “GEST represents the first concerted effort to explore the global dynamics of ethics in Science & Technology policy.” • Communication Flows: Informing, Expressing, and Public Participation – Established forms of public consultation or expression, which means communication flows from the general public – e.g. Eurobarometer and other surveys or focus groups organized by research organisations, and – From affected parts of the public or civil society organisations (CSOs) – e.g. inviting CSOs to meetings of policy advisory bodies, to stakeholder discourses or other participatory activities as well – to science policy institutions. – Modes and forms of bidirectional communication or public participation.
  5. 5. Food Technologies Ethical Matrix
  6. 6. Framework of Factors influencing in Public Involvement/ Public Participation in S&T Policymaking
  7. 7. Clinical Trials Registry India • The Clinical Trials Registry - India (CTRI.NIC.IN) • A free and online system for registration all clinical trials being conducted in India • Set up at the National Institute of Medical Statistics, ICMR, New Delhi • Registration of clinical trials in the CTRI is now mandatory, as per notification of the Drugs Controller General (India). • Trials registered in the CTRI are freely searchable, both from the CTRI site as well as the International Clinical Trials Registry Platform (ICTRP). • International Committee for Medical Journals Editors (ICMJE) released an editorial statement on compulsory registration of clinical trials in 2004. • ICJME member journals now require, as a consideration for publication, registration in a public trials registration. • About 1650 journals from across the world are listed with ICJME.org • About 50+ Indian journals are listed with ICJME
  8. 8. A CTRI Record CTRI No. Public Title Type of Trial Recruit ment Status Health Condition Interven tion Name Location Details CTRI/201 4/06/00 4699 Outcome of patients treated with chemoth erapy and Radiatio n in Cervical Cancer. Observat ional Total: Not Applicabl e Indian: Open to Recruitm ent Cancer of Cervix NIL Tata Memori al Hospita l, Mahara shtra View
  9. 9. Top Cited papers on India AND Bioethics (Results: 34, from All Databases, Source: Web of Science) 1. The Commodification of the Body and Its Parts; Sharp, LA; Annual Review Of Anthropology, 29), 287-328, 2000. Times Cited: 95 2. Millions of Missing Girls: From Fetal Sexing to High Technology Sex Selection in India; George, Sabut M.; Prenatal Diagnosis, 26(7), 604-609, 2006. Times Cited: 26. 3. Public Good, Ethics, and Everyday Life: Beyond the Boundaries of Bioethics; Das, V; Daedalus, 128(4), 99-133, 1999. Times Cited: 25 4. East Meets West: Cross-cultural Perspective in End-of-life Decision Making from Indian and German Viewpoints; Chattopadhyay, Subrata; Simon, Alfred; Medicine Health Care And Philosophy, 11(2), 165-174, 2008. Times Cited: 13 5. Good Gifts for the Common Good: Blood and Bioethics in the Market of Genetic Research; Reddy, Deepa S.; Cultural Anthropology, 22(3), 429-472, 2007. Times Cited: 12 6. Where It Hurts: Indian Material for an Ethics of Organ Transplantation; Cohen, L; ZYGON, 38(3), 663-688, 2003. Times Cited: 12 7. Stem Cell Tourism and Future Stem Cell Tourists: Policy and Ethical Implications; Einsiedel, Edna F.; Adamson, Hannah; Developing World Bioethics, 12(1), 35-44, 2012. Times Cited: 11 8. Localized Past, Globalized Future: Towards an Effective Bioethical Framework Using Examples from Population Genetics and Medical Tourism; Widdows, Heather; Bioethics, 25(2), 83-91, 2011. Times Cited: 9 9. Substance and Relationality: Blood in Contexts; Carsten, Janet; Annual Review Of Anthropology, 40, 19-35, 2011. Times Cited: 9 10. Clinical Research in India: Great Expectations; Thatte, U. M.; Bavdekar, S. B.; Journal Of Postgraduate Medicine, 54(4), 318-323, 2008. Times Cited: 9
  10. 10. Top Cited papers on ICMR AND Guidelines (Results: 15, from All Databases, Source: Web of Science) 1. The Indian Genome Variation database (IGVdb): a project overview; Brahmachari, SK; Singh, L; Sharma, A; et al. Human Genetics, 118(1), 1-11, 2005. Times Cited: 52 2. High prevalence of low dietary calcium and low vitamin D status in healthy south Indians; Harinarayan, CV; Ramalakshmi, T; Venkataprasad, U, Asia Pacific Journal Of Clinical Nutrition, 13(4), 359-364, 2004. Times Cited: 34 3. ICMR-DBT Guidelines for Evaluation of Probiotics in Food; Ganguly, N. K.; Bhattacharya, S. K.; Sesikeran, B.; et al. Indian Journal Of Medical Research, 134 (1), 22-25, 2011. Times Cited: 10 4. Age Profile of Neonatal Deaths; Rasaily, Reeta; Indian Pediatrics, 45(12), 991-994, 2008. Times Cited: 6 5. Physico-chemical and Heavy Metals Evaluation of Polluted Urban Wetlands of Bangalore; Aboud, Jumbe S.; Nandini, N.; Research Journal Of Chemistry And Environment 14(2), 22-35, 2010. Times Cited: 3 6. Regulating stem cell research in India: Wedding the public to the policy; Basu, S; Current Science, 90 (11), 1476-1479, 2006. Times Cited: 3 7. Prevalence of low dietary calcium intake in patients with epilepsy: A study from South India; Menon, Bindu; Harinarayan, Chittari Venkata; Raj, Marella Neelima; et al.; Neurology India, 58(2), 209-212, 2010. Times Cited: 2
  11. 11. Some Recent Policy Moves, as saw in newspapers • India Outlines Plans for Upgrading Clinical Trial Procedures, Wall Street Journal Blog, Aug 27, 2014. • Government may exempt critical drugs from local clinical trials, The Economic Times, Sep 02, 2014. • 'Clinical Trial Norms Should Change', Indian Express News Service, Aug 14, 2014. • Health ministry considering clinical trial waiver for cancer drugs Aflibercept & Trastuzumab emtansine, PharmaBiz.com, September 02, 2014. • Stem Cell Research In India Surges Ahead, Business Insider India, Aug 14, 2014 • Stringent Regulations Halt Research on Ayurvedic Drug, Financial Chronicle, Sep 01, 2014
  12. 12. Some Observations • Amount of biomedical research being undertaken in India with transnational participation is significant. • Global accessibility, visibility and collaborative research are increased due to increased contributions to: – Open Access (OA) Journals – OA Institutional Repositories • However Indian biomedical research institutions need to establish: – OA Institutional Repositories – Open Data Repositories – Contents Produced with Creative Common (CC) Licenses • Need to strengthen – Interfaces of Science, Technology and Society – Interfaces of Risks Communication – Bidirectional Information Flows – Voices from affected parts of the public or civil society (e.g. patients, displaced people, victims of hazards or toxicity) – Civil Society Participation in Policy Debates – Knowledge Networking amongst Biomedical Research Institutions – Advocacy, Capacity Building & Awareness Raising on Ethical Principles & Best Practices.
  13. 13. Thank you. http://anupkumardas.blogspot.in

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