Diverse approaches to off-label drug regulation: A global regulatory perspective

Diddi, Sudha and Miryala, Raghu Chandra and Md, Aqib Ahmed and Kavilikatta, Krupa Parimala and Singam, Sankeerthana (2025) Diverse approaches to off-label drug regulation: A global regulatory perspective. World Journal of Biology Pharmacy and Health Sciences, 22 (2). pp. 254-258. ISSN 2582-5542

This retrospective study probes Off-label drug use, or prescribing drugs for unapproved patient groups, dosages, or purposes, is a common but continuous practice around the world. In contrast to other regions with well-defined rules, India lacks comprehensive and unambiguous guidelines for off-label prescribing and promotion, even though many other regions have developed legal structures to do so. The legal implications of off-label drug usage and promotion are examined in this comparative study in a number of nations, including the US, the EU, Australia vs India. It considers important regulatory variations, moral dilemmas and enforcement strategies and examining how many regions strike a balance between patient safety, medical innovation and pharmaceutical marketing laws. The legal environment in India is given special attention, as the lack of official regulations leaves medical personnel in the dark and uncertainty for healthcare professionals and potential risks for patients. The study provides insights into effective practices for ethical pharmaceutical promotion and responsible off-label prescribing by comparing global regulatory models. The results highlight the necessity that India must set up organized legislative frameworks to guarantee patient-centered, ethical and evidence-based off-label medication use while halting abuse and uncontrolled marketing tactics.