Regulatory Inefficacy of Internal Deliberations and Advisory Body Recommendations

Deliberations, minutes, and unadopted recommendations emerging from statutory advisory bodies do not possess the force of law or create enforceable legal rights unless formally accepted, ratified, and published by the appropriate government through gazetted statutory notifications. The internal recommendations formulated during the 84th meeting of the Drugs Technical Advisory Board (DTAB), which suggested that stem cell therapies administered by clinicians to their own patients without outside commercialization fall beyond the purview of the Drugs and Cosmetics Act, 1940, were never incorporated into statutory directions under Section 33P or otherwise promulgated. Such minutes remain non-binding internal records that cannot establish legal exemptions. Furthermore, an arbitrary distinction exempting commercialized cellular practices conducted within a clinic's own walls from statutory oversight is irrational, legally unsustainable, and wholly incapable of legitimizing unapproved stem cell administrations. (Yash Charitable Trust & Ors. Vs Union of India & Ors. | 2026 INSC 96).