Legal Non-Est Status of Administrative Instructions Supplanting Statutory Frameworks

It is a settled constitutional and administrative principle that executive instructions, orders, or departmental notifications can only operate to supplement statutory rules by filling existing administrative gaps, but cannot supplant, amend, contradict, or whittle down the express provisions of statutory enactments. Under Rules 17 and 18 of the New Drugs and Clinical Trials Rules, 2019, the Department of Health Research (DHR) is vested with overarching statutory authority to register, monitor, and regulate institutional Ethics Committees overseeing biomedical and health research. Accordingly, Clause 2(vi) of the Executive Order dated 03.03.2024 issued by the DHR, which purported to disclaim and renounce any regulatory oversight over stem cell research following the dissolution of the NAC-SCRT, runs directly contrary to the statutory mandate of Rules 17 and 18. Such an administrative renunciation cannot defeat or override delegated legislation, rendering the purported exclusion of DHR regulatory oversight non-est and legally invalid. (Yash Charitable Trust & Ors. Vs Union of India & Ors. | 2026 INSC 96).