The Supreme Court of India.
Credit: iStock Photo
New Delhi: The Supreme Court on Friday said every use of stem cells in patients of Autism Spectrum Disorder outside an approved clinical trial is unethical and would be considered as malpractice.
A bench of Justices J B Pardiwala and R Mahadevan said, 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 court found that the legal framework pertaining to stem-cell research was "fragmented" and spread out across legislations with little harmony, which makes both compliance and enforcement an uphill task.
It said the obscurity in the legal regime also enabled manipulation of patients' vulnerabilities by errant medical practitioners.
"Such obscurity, whether conscious or unintended, has arisen directly from legislative shortsightedness," the bench said.
The court urged the Union government to consolidate and clarify the position of law for enabling better implementation of it in this regard at the earliest and insist on the creation of a dedicated authority for the regulatory oversight of stem cell research all across the country.
It suggested the enactment of a legislation that may clarify several issues that plague the research in stem cells.
"It is unfortunate that the Union has let the matter worsen without any suitable and timely intervention. Such inaction has led to several parents/guardians seeking an unproven method of treatment for their children suffering from ASD incurring huge financial cost and in alternative to other approved treatments,'' the bench said.
It cannot be denied that various clinics, in flagrant violation of the aforesaid statutory mandate, continued to recommend and perform stem cell therapy as a routine clinical treatment for ASD because there was lack of executive action against it, the court added.
The court rendered its judgment on a PIL filed by Yash Charitable Trust and others, which raised certain concerns relating to the rampant promotion, prescription and administration of stem cell “therapy” for the treatment of Autism Spectrum Disorder (hereinafter, “ASD”) by several clinics across the country.
"Since therapeutic use of stem cells in ASD is not recognised as ‘a sound and relevant medical practice’ as per the knowledge available at present, the medical practitioners who offer the same as a clinical service, outside of an approved and monitored research/clinical trial, fail to meet the reasonable standard of care owed by them towards their patients,'' the bench said.
Hence, until there is further research which establishes this as a sound and relevant medical practice, stem cell ‘therapies’ for ASD cannot be offered by medical practitioners as a clinical service, outside an approved and monitored clinical trial/research setting, the court added.
The bench also pointed out, if the available information itself is not adequate, there cannot logically be a disclosure of such a nature that could enable a patient to give their consent.
As the court held that the stem cell therapy for ASD cannot continue as a commercial endeavour in the form of routine clinical treatment, it directed the Secretary, Ministry of Health and Family Welfare in consultation with the officials of AIIMS and the National Medical Council, to provide the best possible solution to those patients undergoing the therapy.