‘Stem cell therapy for autism is unethical, medical malpractice,’ says Supreme Court

The Supreme Court of India has held that administering stem cell therapy for the treatment of Autism Spectrum Disorder (ASD) is unethical and amounts to medical malpractice if it is outside an approved and monitored clinical trial. A bench of Justices JB Pardiwala and R Mahadevan ruled that stem cell therapy is not recognised as a sound and relevant medical practice due to the lack of scientific support and empirical evidence on its efficacy.

“Therefore, every use of stem cells in patients outside an approved clinical trial is unethical and shall be considered as malpractice,” the Supreme Court ruled.

The stem cell therapy is permissible only for approved and monitored clinical trials with the intent to advance science, the bench added.

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‘Mere classification of stem cells as drugs not enough’

The court also made it clear that the mere classification of stem cells as “drugs” under the Drugs and Cosmetics Act, 1940, does not make their therapeutic use for autism permissible as a clinical service.

“Although the stem cells administered for therapeutic use in ASD are characterised as drugs under the Drugs Act, 1940, the same by itself is not determinative of the fact that it is permissible to be administered as a clinical service,” the bench said.

If doctors offer such treatment as a routine clinical service, they fail to meet the reasonable standard of care owed to patients.

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‘Every medical practitioner owes a duty to…’

The bench observed that every medical practitioner owes a duty to exercise a reasonable degree of care, skill and knowledge expected of a prudent practitioner in the field.

It further said that this standard is breached when doctors administer interventions that lack credible scientific backing or are expressly discouraged by authoritative medical bodies.

“A medical practitioner cannot be said to meet the standard of reasonable care if he administers an intervention that lacks credible scientific evidence of safety and efficacy or where authoritative medical bodies unequivocally state that such a form of treatment is not recommended,” the judgment said.

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‘Consent invalid if it is not based on…’

After examining the recommendations of the Ethics and Medical Registration Board of the National Medical Commission dated December 6, 2022, read with the Ethical Guidelines for Biomedical and Social Science Research, the National Guidelines for Stem Cell Research, 2017, and the National Ethical Guidelines formulated by the Indian Council of Medical Research, the court noted that these documents clearly state that stem cell therapy for autism is not recognised as a sound or relevant medical practice.

“It is categorically mentioned therein that any stem cell use in patients must only be done within the purview of an approved and monitored clinical trial with the intent to advance science and medicine and not offering it as therapy,” the bench said.

The court also held that consent is invalid if it is not based on adequate and credible scientific information.

The court noted that offering a choice between no treatment and an unproven therapy does not amount to valid consent, especially when families are emotionally vulnerable.