Unani Medicine and Law in India: Emerging Regulatory Challenges and the Way Forward

Unani medicine constitutes one of the recognised systems of Indian medicine and occupies an important position within India’s pluralistic healthcare landscape. Its institutionalisation has been accompanied by the development of a progressively elaborate legal and regulatory framework governing education, professional practice, medicines, manufacturing, quality control, advertising and ethical conduct. The enactment of the National Commission for Indian System of Medicine Act, 2020 marks an important transition in the governance of Indian systems of medicine by replacing the earlier regulatory architecture with a framework centred upon national standards, professional registration, ethical regulation and institutional assessment. At the same time, Unani drugs remain subject to a distinct regulatory regime under Chapter IVA of the Drugs and Cosmetics Act, 1940 and the rules framed thereunder. Despite these developments, the contemporary expansion of Unani medicine raises several unresolved legal questions. These include ensuring uniform quality standards, regulating misleading health claims, protecting patients and consumers, strengthening professional accountability, protecting traditional knowledge against misappropriation, addressing digital and e-commerce marketing, and reconciling traditional therapeutic knowledge with contemporary evidence-based healthcare expectations. The paper critically examines the existing legal framework governing Unani medicine in India and identifies gaps that may undermine effective regulation and public confidence. The paper argues that the future regulation of Unani medicine should not be premised either upon unquestioning acceptance of traditional practices or upon the exclusion of traditional systems from mainstream healthcare. Instead, regulation should adopt a balanced approach founded upon patient safety, scientific integrity, constitutional values, professional accountability, preservation of traditional knowledge and equitable access to healthcare. The paper concludes by proposing reforms aimed at strengthening regulatory coordination, quality assurance, consumer protection, digital regulation and protection of Unani traditional knowledge.