Regulation Stem Cell Therapy

Medical Standard of Care and Prohibition of Experimental Interventions as Routine Clinical Services
Legal Classification of Stem Cells as Drugs Under the Drugs and Cosmetics Act
Statutory Distinction Between New Drugs, Stem Cell Derived Products, and Autologous Procedures
Evidentiary Weight and Interpretative Authority of National Guidelines and ICMR Publications
Limitations of Patient Autonomy and the Doctrinal Invalidation of Consent Without Adequate Information
Mandatory Statutory Force of National Ethical Guidelines via Delegated Legislation
Legal Non-Est Status of Administrative Instructions Supplanting Statutory Frameworks
Continuation of Disciplinary Liability for Professional Misconduct Under Transitory Provisions
Strict Statutory Limits on Non-Cord Blood Stem Cell Banking and Processing
Regulatory Inefficacy of Internal Deliberations and Advisory Body Recommendations
State Power to Sanction Errant Establishments and the Equitable Protection of Ongoing Patients