Overview
- A bench of Justices J.B. Pardiwala and R. Mahadevan on Jan. 30 held that any use outside approved clinical trials is unethical and not a recognized medical practice.
- The Court said consent for such procedures is invalid without adequate scientific information and warned against exploiting families under “therapeutic misconception”.
- Stem cells were held to fall under the Drugs Act, with NDCT Rules and ICMR guidelines requiring that human use proceed only as regulated clinical trials.
- Practitioners offering these interventions as treatment risk professional misconduct proceedings and penalties under the Clinical Establishments Act.
- Acting on a PIL by Yash Charitable Trust and others, the Court urged consolidation of fragmented rules and recommended reconstituting the NAC-SCRT for national oversight.