1Associate Professor, Himachal Pradesh National Law University, Shimla, India
Email: ruchisapahia@hpnlu.ac.in
2Associate Professor, Faculty of Legal Sciences, Shoolini University, India
Email: renupalsood@shooliniuniversity.com
3Assistant Professor, School of Legal Studies, CGC University, Mohali, 140307, India
Email: bineetsingh86@gmail.com
4Assistant Professor of Law, School of Law, Bahra University, Solan, 173234, Himachal Pradesh, India
Email: daizythakur@yahoo.in
5Associate Professor, University Institute of Legal Studies, Chandigarh University, Mohali, 140413, India
Email: payalsood80.ps@gmail.com
6Senior Associate Professor, School of Law, University of Petroleum and Energy Studies, Dehradun, India
Email: kgupta@ddn.upes.ac.in
Pharmacological studies are important in terms of further development of health care innovation, but the rapid evolution of science has compounded ethical and legal issues that surround clinical trials, protection and safeguarding of participants, and regulatory regulation. This paper discusses the problem of ethics and law in pharmacological research and practice by combining the bioethical theory and regulatory analysis and primary survey data. The study conducts a quantitative cross-sectional research design based on the structured questionnaire survey with the means of Google Form, which results in the collection of 98 valid answers among the participants of the study as healthcare professionals, researchers, and academics. The research assesses the attitudes of ethical awareness, the practice of informed consent, legal adherence, accountability of the pharmaceutical industry, and the challenges brought about by emerging technology.
The results suggest that the respondents are highly ethical as shown by their keenness in participant welfare, ethical inquiry, and the implications of research misconduct on the society. Nevertheless, there was a moderate level of trust in legal and regulatory frameworks, which indicated a discord between the ethical standards and the institutional practice. Another major issue was the question of informed consent which was highlighted by the participants who indicated that continuous communication and not procedural documentation was necessary. Findings also indicate doubtful professional faithfulness to the practice of pharmaceutical industries, raising concerns on transparency and commercial control and firmly advocate on the conduct of post-marketing safety studies. The most agreement was found in the up-and-coming ethical risks associated with artificial intelligence, digital health information, and personalized medicine, and this suggests that adaptive governance frameworks are in demand.
The research makes a contribution to the field of pharmacological ethics scholarship because it empirically proves the relationship between ethical thinking and the perception of legal governance. It suggests a combined ethical-legal system, which urges transparency, constant monitoring, and regulation responsive to technology. The results demonstrate the significance of integrating ethical values, law implementation, and innovation regulation to enhance the confidence of the population and guarantee responsible pharmacological research in the rapidly changing healthcare settings.
KEYWORDS: clinical trial governance, informed consent, pharmacological ethics, regulatory compliance, research ethics governance, pharmaceutical accountability.
How to cite this article: Sapahia R, Sood RP, Singh B, Thakur D, Sood P, Gupta K. Ethical and legal issues in pharmacological research and practice. Int J Drug Deliv Technol. 2026;16(7s): 771-793; DOI: 10.25258/ijddt.16.7s.83
Source of support: None
Conflict of interest: None