Judicial Medicine: How the Ivermectin Ruling Redefined Doctors’ Responsibilities in Drug Governance

Abstract

INTRODUCTION: Ivermectin, a tropical medicine recognised with the 2015 Nobel Prize, is safe at approved doses but in Malaysia remains registered solely for veterinary use under the Poisons Act, raising complex legal and regulatory issues when dispensed to humans. This paper critically analyses the Federal Court decision in Dr Vijaendreh a/l Subramaniam, situating it within Malaysia’s drug dispensing framework and assessing implications for medication safety and patient protection. MATERIALS & METHODS: Using  a doctrinal legal research approach, statutory interpretation and case law analysis were applied to the Poisons Act, Sale of Drugs Act, Control of Drugs and Cosmetics Regulations, and appellate decisions, highlighting tensions between medical practice and pharmaceutical governance. RESULTS: The Federal Court affirmed that section 19 of the Poisons Act grants registered doctors’ statutory authority to dispense Group B poisons, including ivermectin, regardless of whether products are registered for human or veterinary use, and that this right cannot be curtailed by subsidiary legislation under the Sale of Drugs Act. The Poisons Act was deemed a complete code for practitioners, while the Sale of Drugs Act governs commercial trade. This interpretation exposes regulatory gaps: the Poisons List lacks human–veterinary distinction, NPRA’s product control may be undermined, and safeguards remain reactive, leaving no proactive mechanism to prevent unsafe prescribing. CONCLUSION: Legislative reform is urgently needed to distinguish human and veterinary medicines, ensuring safe prescribing, protecting patients, and modernising Malaysia’s regulatory framework for public trust.