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.

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. 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. 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.

5. • “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.

6. Food Technologies Ethical Matrix

7. Framework of Factors influencing in Public Involvement/
Public Participation in S&T Policymaking

8. 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

10. 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

12. 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

13. 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

14. 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

15. 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.

16. Thank you.
http://anupkumardas.blogspot.in