The Supreme Court directed the Union Health Ministry to clarify the regulatory framework for stem cell therapy for autism spectrum disorder (ASD) within six weeks.
The court reiterated that no new patients should receive stem cell therapy for ASD outside duly approved and monitored research or clinical trials.
- The Supreme Court gave states four months to complete the ground-truthing of wetlands and other waterbodies under the Wetlands (Conservation and Management) Rules, 2017.
- The court noted that even nine years after the rules were introduced, states had failed to complete the exercise, including the identification and protection of smaller wetlands.
The Supreme Court on October 13, 2026, directed the Union Ministry of Health and Family Welfare (MoHFW) to take steps within six weeks to clearly explain the existing regulatory framework governing research and clinical trials involving different levels of stem cell manipulation for autism spectrum disorder (ASD).
The court said this would help curb the malpractice of illegally administering a prohibited medical intervention as a clinical service.
The ministry was directed to issue a comprehensive protocol explaining the regulatory framework governing the use of stem cells in research and clinical trials relating to ASD.
The protocol must set out, step by step, the procedure for obtaining the necessary permissions and approvals, the timelines applicable at each stage, and the duties and obligations of all stakeholders.
The statutory or regulatory basis for each compliance requirement, along with the competent authority responsible for granting the necessary approval or authorisation, must also be clearly identified and explained.
Wherever practicable, the protocol should include a flowchart to help medical practitioners, institutions and members of the public identify the regulatory pathway applicable to a proposed intervention.
The ministry was also directed to raise awareness and widely disseminate information about the existing regulatory framework, making it clear that stem cell therapy for ASD is not permissible as a clinical service outside a duly approved and monitored research or clinical trial setting.
The Union government had proposed a multicentre randomised controlled trial (RCT) across two tertiary care centres. However, the Supreme Court raised concerns about the eligibility criteria for participation in such research or clinical trials.
The court directed the Union government to clarify the proposed eligibility criteria for the RCT, particularly whether randomisation could result in some participants, including those already undergoing the therapy, being excluded from the intervention under study and consequently being unable to access its potential benefits.
If the proposed trial design could result in eligible participants, including those already receiving the therapy, being excluded from the intervention, the government must consider the implications and submit a comprehensive plan to the court.
The plan should provide for continued monitoring and medical supervision of such participants, including appropriate follow-up, assessment of their clinical condition and any further measures necessary to safeguard their health and well-being.
All these measures must comply with applicable scientific, ethical and regulatory standards, said the bench of Justices J B Pardiwala and R Mahadevan.
The court reiterated that no new patients should be enrolled for stem cell therapy for ASD outside a duly approved and monitored research or clinical trial setting.
The Supreme Court on October 12, 2026, directed states to expedite the ground-truthing of wetlands, as required under the Wetlands (Conservation and Management) Rules, 2017.
The court granted states four months to complete the exercise.
It emphasised that the ground-truthing exercise must cover not only wetlands but also other waterbodies. These waterbodies must be identified, specified and marked in the reports.
The Supreme Court referred to its August 19, 2025, order, which stated that wetlands smaller than 2.25 hectares must also be identified in accordance with the existing rules.
The court had directed state governments and wetland authorities to explain, through affidavits, the measures taken or being taken to protect these smaller wetlands, estimated to number around 555,557 according to the Wetland Atlas.
The court also pointed out that Rule 7(1)(a) of the Wetlands (Conservation and Management) Rules, 2017, requires the concerned department of a state government or Union Territory administration to prepare a brief document for each wetland identified for notification within one year of the rules being published.
These documents must include the details specified under clauses (a) to (g) of Rule 7(1). However, the court noted that states had failed to complete this exercise.
It was for this reason that the Supreme Court had issued directions and orders on December 11, 2024; August 19, 2025; October 7, 2025; October 28, 2025; and July 28, 2026.
The court observed that even nine years after the rules were published, the exercise had not been completed.
It directed states to file affidavits within four weeks, detailing the status of the ground-truthing exercise, including the identification and assessment of other waterbodies.