Guidelines Without Teeth: A Comparative Study of India's Regulatory Gaps in Neurotechnology and Germline Gene Editing

Abstract

India regulates two of the twenty-first century's most ethically fraught technologies, consumer and clinical neurotechnology, and human germline gene editing, almost entirely through non-binding administrative guidance rather than enforceable statute. This paper examines that pattern through two case studies: the treatment of neural data under the Digital Personal Data Protection Act 2023, which abolished the earlier category of "sensitive personal data" altogether, and the prohibition on human germline editing, which rests on the Indian Council of Medical Research's non-binding 2019 guidelines rather than the 1989 environmental Rules that predate CRISPR by decades. Read together, these cases reveal a recurring legislative strategy: guidance is issued to demonstrate ethical awareness while the underlying statutory architecture is left unamended, producing rights and prohibitions that exist in principle but are difficult to enforce in a court of law. Drawing on the Supreme Court's privacy jurisprudence and comparative developments in the UNESCO neurotechnology framework, Chile's constitutional neurorights amendment, and China's criminalisation of unauthorised germline editing, this paper argues that India's guideline-centric model functions less as a transitional stage toward regulation than as a durable substitute for it, and proposes specific statutory reforms to close the resulting enforcement gap.