Regulating clinical trials in India: The economics of ethics.

Publisher: John Wiley & Sons Ltd Country of Publication: England NLM ID: 101120122 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1471-8847 (Electronic) Linking ISSN: 14718731 NLM ISO Abbreviation: Dev World Bioeth Subsets: MEDLINE

Publication: 2014- : Abingdon : John Wiley & Sons Ltd.
Original Publication: Oxford ; Malden, MA : Blackwell, c2001-

Economic Development* ; Government Regulation* ; Human Rights* ; Research Subjects*; Biomedical Research/*legislation & jurisprudence ; Drug Industry/*ethics; Biomedical Research/ethics ; Ethics, Research ; Humans ; India ; Internationality ; Policy

The relationship between the ethical standards for the governance of clinical trials and market forces can be complex and problematic. This article uses India as a case study to explore this nexus. From the mid-2000s, India became a popular destination for foreign-sponsored clinical trials. The Indian government had sought to both attract clinical trials and ensure these would be run in line with internationally accepted ethical norms. Reports of controversial medical research, however, triggered debate about the robustness and suitability of India's regulatory system. In response to civil society pressure and interventions by the Supreme Court, the Indian government proposed additional measures aimed at strengthening protections for clinical trial participants. Whilst the reforms can be seen as a victory for human rights activists, they have also been criticised as being overly burdensome for sponsors. Indeed, their announcement prompted an exodus of clinical trials from India. Fearful of losing business to 'rival' countries, the Indian government is revisiting some of its proposals. The Indian example suggests that research ethics frameworks and national policies for economic development are increasingly intertwined. Host countries are in theory free to improve the lot of research participants, but doing so may make them appear less attractive to foreign sponsors, who can simply shift their activities to more industry-friendly jurisdictions. Although these economic pressures are unlikely to lead to a regulatory 'race to the bottom', they may limit host countries' ability to enact socially desirable reforms.
(© 2017 John Wiley & Sons Ltd.)

Keywords: India; clinical trials; regulation; research ethics; the race to the bottom

Date Created: 20170711 Date Completed: 20190607 Latest Revision: 20190607

20240104

10.1111/dewb.12156

28691185