lexgenLex GeneticaLex Genetica3034-16393034-1647МГЮА10.17803/lexgen-2026-5-2-91-120lexgen-107Research ArticleLex Genetica: сравнительно-правовые исследованияLex Genetica: Comparative Legal AnalysisГенетическая конфиденциальность и защита данных в Индии: новые правовые вызовы в эпоху геномных исследованийGenetic Privacy and Data Protection in India: Emerging Legal Challenges in the Age of Genomic ResearchМехраН.MehraN.

Нитеш Мехра, адвокат, член исполнительного комитета Ассоциации адвокатов Высокого суда Дели (DHCBA), юридическая фирма NMA

Нью-Дели

Nitesh Mehra, Advocate Member Executive, Delhi High Court Bar Association (DHCBA)NMA Law Offices

New Delhi

advniteshmehra@gmail.comЮридическая фирма NMA; Ассоциации адвокатов Высокого суда ДелиИндияNMA Law Offices; Delhi High Court Bar AssociationIndia2026080820265291120Copyright © Мехра Н., 20262026Мехра Н.Mehra N.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://lexgen.msal.ru/jour/article/view/107

Генетические данные представляют собой особый тип персональных данных, поскольку они неизменяемы, носят по своей природе «семейный» характер, могут использоваться для прогнозирования будущего состояния здоровья и не могут быть полностью анонимизированы. В условиях значительного прогресса, которого Индия достигает в реализации своих геномных целей в рамках проекта Genome India, а также развития персонализированной медицины, существующая правовая архитектура регулирования геномных данных становится актуальной конституционной, законодательной и этической проблемой. В статье проводится доктринальный и сравнительно-правовой анализ действующей нормативной базы регулирования геномных данных в Индии, а именно: решения по делу Justice K.S. Puttaswamy (Retd.) v Union of India (2017), Закона о защите цифровых персональных данных 2023 г. (Digital Personal Data Protection Act, DPDP, 2023), Правил к Закону о защите цифровых персональных данных 2025 г. (Digital Personal Data Protection Rules, DPDPR, 2025), а также Национальных этических руководящих принципов Индийского совета медицинских исследований (ICMR) 2017 г.

При сравнении индийской правовой системы автор опирается на Общий регламент по защите данных Европейского союза (GDPR), Закон США о недискриминации генетической информации (Genetic Information Nondiscrimination Act, GINA), а также институциональные модели управления, такие как UK Biobank и Genomics England. В исследовании выявляются шесть ключевых пробелов в индийском регулировании: отсутствие особой категории sui generis для генетических данных, недостаточность модели информированного согласия, не приспособленной для долгосрочных геномных исследований, отсутствие установленных законом сроков хранения и удаления данных, отсутствие закона о недопустимости генетической дискриминации, структурные уязвимости в регулировании трансграничной передачи данных, а также полное отсутствие нормативной базы для предиктивной геномики, основанной на искусственном интеллекте. В заключение предлагаются основанные на эмпирических данных рекомендации по принятию специального Закона о защите генетических данных, Закона о недискриминации по генетическому признаку и создания Национального регулятора геномных данных.

Genetic data is a highly specific type of personal data, being inalterable, inherently family-like, capable of being used to predict future health states, and incapable of being completely anonymized. With the growing strides India is making towards its genomic goals defined under the Genome India project and the general push for precision medicine, the current legal architecture to regulate genomic data has become a pressing constitutional, statutory, and ethical concern. This article engages in a doctrinal analysis and comparative legal analysis of the existingregulatory framework of genomic data in India, namely the Justice K.S. Puttaswamy (Retd.) v Union of India (2017) case, the Digital Personal Data Protection Act, 2023, the Digital Personal Data Protection Rules, 2025, and the Indian Council of Medical Research (ICMR) National Ethical Guidelines, 2017.

The analysis places India’s framework in a comparative perspective, which is based on the General Data Protection Regulation of the European Union, the Genetic Information Nondiscrimination Act of the United States, as well as institutional governance models of the United Kingdom Biobank and Genomics England. The study points out six key regulatory gaps in the Indian regulatory landscape: the absence of a sui generis special category for genetic data, the absence of an adequate informed consent architecture suitable for longitudinal genomic research, the lack of statutory storage and retention limits, the lack of an anti-genetic discrimination statute, structural vulnerabilities in cross-border data transfer governance, and the total absence of any statutory frameworks for AI-driven predictive genomics. The article concludes with evidence-based recommendations for the enactment of a dedicated Genetic Data Protection Act, a Genetic Non-Discrimination Act, and a National Genomic Data Regulatory Authority.

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The authors declare that there are no conflicts of interest present.