Supreme Court: Stem Cell Therapy for Autism Outside Trials Is Malpractice

KEY TAKEAWAYS:

SC says stem cell therapy for autism outside approved trials is unethical and malpractice.
Therapy permitted only within duly monitored clinical research frameworks.
Court cites NMC, ICMR, and national stem cell guidelines against routine clinical use.

The Supreme Court has ruled that stem cell therapy for autism malpractice applies when the treatment is offered outside an approved and monitored clinical trial. The Bench held that, in the absence of credible scientific evidence on safety and efficacy, administering such therapy as a routine service is unethical.

The judgment clarified that stem cell interventions for Autism Spectrum Disorder (ASD) are permissible only within sanctioned clinical research aimed at advancing scientific knowledge.

Bench Cites Lack of Scientific Evidence

A Bench of Justice J.B. Pardiwala and Justice R. Mahadevan delivered the ruling in Yash Charitable Trust v. Union of India. The Court observed that stem cell therapy for autism is not a recognised medical practice due to insufficient empirical support.

“Every use of stem cells in patients outside an approved clinical trial is unethical and shall be considered as malpractice,” the Bench held.

‘Drug’ Classification Does Not Permit Routine Use

The Court rejected the argument that because stem cells are classified as “drugs” under the Drugs and Cosmetics Act, 1940, they can be offered as treatment.

It said this classification does not automatically legitimise their therapeutic use for ASD in regular clinical settings.

Duty of Care and Medical Standards

Emphasising medical ethics, the Court noted that doctors must adhere to standards expected of prudent practitioners. Administering treatments discouraged by authoritative bodies or lacking credible evidence violates this duty of care.

“A practitioner cannot meet reasonable care standards by using interventions without proven safety and efficacy,” the judgment said.

Court Relies on National Medical and Ethical Guidelines

The Bench referred to:

Recommendations of the Ethics and Medical Registration Board of the National Medical Commission (Dec 6, 2022)
National Guidelines for Stem Cell Research, 2017
Ethical Guidelines issued by the Indian Council of Medical Research (ICMR)

All these frameworks clearly state that stem cell therapy for autism is not recommended as routine treatment and may be conducted only under approved clinical trials.

The ruling sets a strong precedent on medical accountability and the limits of experimental therapies in clinical practice.