Human Organoids And The Legal Vacuum: Property, Personhood And The Regulatory Crisis India Cannot Afford To Ignore
- IJLLR Journal
- Jul 19
- 1 min read
Saswati Mekap, National Forensic Sciences University
ABSTRACT
Human organoids is miniaturised, three-dimensional organ-like structures grown from human stem cells which represent one of the most consequential scientific developments of the twenty-first century. Their applications span disease modelling, drug discovery, personalised medicine, and transplantation research. Yet, beneath this remarkable scientific promise lies a profound and largely unaddressed legal crisis: the law does not know what a human organoid is. Is it human tissue? Is it a laboratory product? Is it a person? Or is it something entirely novel that existing legal categories cannot contain? In India, this question is particularly urgent. The “Patents Act, 1970”, “the Drugs and Cosmetics Act, 1940”, “the ICMR-DBT National Guidelines for Stem Cell Research” and “the DPDPA, 2023:” collectively form a patchwork that neither defines nor governs organoids in any meaningful way. No Indian court has ruled on their legal status. No Indian statute directly addresses their patentability, ownership, or ethical use. This article examines the legal vacuum surrounding human organoids in India, analyses the inadequacy of the existing regulatory framework, draws on international jurisprudence particularly the most paramount American case of “Moore v. Regents of the University of California (1990)” and at the same time, it also examines China's leading “Human Organoid Research Ethical Guidelines (2025)” and proposes a sui generis legal framework tailored to the Indian context. The article argues that India's silence on this question is not merely a regulatory gap but a ticking legal time bomb whose detonation could harm scientific innovation, patient rights, and constitutional dignity simultaneously.
