Annotation

Purpose: Analysis of the evolution of the regulation of biolaw and bioethics in India in 1985–2025 (as of early 2026) in the context of socially significant cases of ethical violations (organ trade, abuses in clinical trials, commercial surrogacy), and assessment of the impact of adopted changes on further regulation. Methods: general scientific methods (analysis, synthesis, systematic approach); specific legal methods (comparative legal, formal legal, historical legal, system-structural). Results: legal regulation of bioethics and biolaw in India has developed in a predominantly reactive manner – in response to practical crises, unlike the directive model of planned codification characteristic of the European Union. The historical core of the system combined the judicial constitutional doctrine of Article 21 of the Constitution of India and delegated regulation by specialized agencies, supplemented since 2021 by parliamentary sectoral legislation; a unified bioethics law remains absent. Discussion: the research results may be used in Russian doctrine of biolaw and medical law in developing models of comprehensive regulation of bioethical relations.