Supreme Court Bars Stem Cell Therapy for Autism

• 09 Feb 2026

Source: TH 

Why in News? 

Recently,  the Supreme Court ruled that stem cell therapy cannot be offered as a clinical service for Autism Spectrum Disorder (ASD) outside approved clinical trials and directed the Union Government to create a dedicated regulatory authority for stem cell research. 

• The Court held that such therapy lacks established evidence on safety and efficacy and therefore fails the reasonable standard of care owed by doctors to patients.

What are Stem Cells? 

• About: Stem cells are unique cells that generate specialized cells like blood, bone, and muscle, playing a vital role in tissue repair and bodily functions. 
• Types:  
  • Embryonic (Pluripotent) Stem Cells: Can become any cell type, sourced from embryos or cord blood. 
  • Tissue-Specific (Multipotent/Unipotent) Stem Cells: Generate cells only for their tissue, e.g., blood stem cells. 
  • Induced Pluripotent Stem Cells (iPSCs): Lab-made cells mimicking embryonic stem cells for research and drug testing. 
• Stem Cell Therapy: It is also called regenerative medicine, aims to repair damaged or diseased tissues by using stem cells or their derivatives. 
  • In India, stem cell-based treatments are permitted only within approved clinical trials, as their safety, efficacy, and long-term effects are not yet fully established for many diseases. 
• Regulations: In India stem cell therapy is governed by the National Guidelines for Stem Cell Research 2025, which were jointly drawn up by the Indian Council of Medical Research (ICMR) and the Department of Biotechnology (DBT). 

Supreme Court Judgement 

• Informed Consent: Valid informed consent requires clear scientific evidence on safety, effectiveness, risks, and alternatives, which is currently lacking for stem cell therapy in autism, making such clinical use ethically and legally impermissible. 
• Ethical Limits on Patient Autonomy: The Court clarified that patient or parental consent cannot justify treatments that are scientifically unproven, ethically impermissible, or outside accepted medical practice. 
• Violation of Legal Framework: Such practices contravene the New Drugs and Clinical Trial Rules, 2019 and the National Guidelines for Stem Cell Research, 2017 issued by the Indian Council of Medical Research (ICMR). 

Autism (ASD) 

• Autism Spectrum Disorder (ASD) is a complex neurodevelopmental condition affecting brain development, marked by difficulties in social interaction, communication, and behaviour, with wide variation in abilities. 
• Around 1 in 100 children worldwide is estimated to have autism, though cases are often underreported in low- and middle-income countries. 
• Autism arises from a combination of genetic and environmental risk factors during early development, and childhood vaccines do not increase the risk of autism. 
• Individuals with autism may have co-occurring conditions such as epilepsy, depression, anxiety, sleep disturbances, or self-injurious behaviour, while intellectual abilities range from severe impairment to above-average levels. 

Frequently Asked Questions (FAQs) 

1. What are stem cells? 
Stem cells are special cells that can develop into different types of cells in the body and have the ability to repair or replace damaged tissues. 

2. What is stem cell therapy? 
Stem cell therapy involves using stem cells to treat or manage diseases by regenerating damaged cells, but most such therapies are still experimental. 

3. Why is stem cell therapy restricted for autism? 
Because there is no proven scientific evidence on its safety or effectiveness for autism, and valid informed consent cannot be ensured. 

UPSC Civil Services Examination, Previous Year Questions (PYQs) 

Prelims

Q. In the context of hereditary diseases, consider the following statements: (2021)

1. Passing on mitochondrial diseases from parent to child can be prevented by mitochondria replacement therapy either before or after in vitro fertilization of the egg.  
2. A child inherits mitochondrial diseases entirely from mother and not from father.  

Which of the statements given above is/are correct?  

(a) 1 only  

(b) 2 only  

(c) Both 1 and 2  

(d) Neither 1 nor 2  

Ans: (c)  

Q. With reference to ‘stem cells’, frequently in the news, which of the following statements is/are correct? (2012)

1. Stem cells can be derived from mammals only  
2. Stem cells can be used for screening new drugs  
3. Stem cells can be used for medical therapies  

Select the correct answer using the codes given below:  

(a) 1 and 2 only  

(b) 2 and 3 only  

(c) 3 only  

(d) 1, 2 and 3  

Ans: (b)