The Supreme Court has held that administering stem cell therapy for the treatment of Autism Spectrum Disorder outside an approved and monitored clinical trial is unethical and amounts to medical malpractice.
A Bench of Justices JB Pardiwala and R Mahadevan ruled that such treatment is not recognized as a sound and relevant medical practice due to the lack of scientific support and empirical evidence regarding its efficacy.
"Therefore, every use of stem cells in patients outside an approved clinical trial is unethical and shall be considered as malpractice,” the Court ruled.
The same is permissible only for approved and monitored clinical trial with the intent to advance science, the Court added.
The Court 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 characterized 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 Court held.
Thus, doctors offering such treatment as a routine clinical service fail to meet the reasonable standard of care owed to patients.
The Bench stated that every medical practitioner owes a duty to exercise a reasonable degree of care, skill and knowledge expected of a prudent practitioner in the same field. It held 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 form of treatment is not recommended,” the judgment said.
On the regulatory framework, the Bench examined 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, citing the absence of scientific support and empirical evidence regarding its efficacy.
“A perusal of the EMRB, NMC recommendations dated 6.12.2022, read with the EBSSCT 2021, the NGSCR 2017, and the National Ethical Guidelines formulated by the ICMR, indicates that the therapeutic use of stem cells for treatment of ASD is not recommended as routine clinical treatment. These documents indicate that the therapeutic use of stem cells for the treatment of ASD is not recognized as a sound and relevant medical practice due to the lack of scientific support and empirical evidence regarding its efficacy. 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 made it clear.
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