SYLLABUS
GS-2: Issues relating to the development and management of Social Sector/Services relating to Health, Education, Human Resources.
Context: The Supreme Court of India has ruled that Stem Cell Treatment (SCT) cannot be used as a clinical treatment for Autism Spectrum Disorder (ASD) because it is an unproven and experimental therapy.
More on the News
- While deciding a PIL (Yash Charitable Trust & Ors. v. Union of India & Ors.), the Supreme Court recorded serious concern over the aggressive promotion and clinical use of stem cell therapy for ASD despite the absence of robust scientific evidence supporting its safety or efficacy.
- The bench emphasised that simply because stem cells fall under the definition of “drugs” in the Drugs and Cosmetics Act, 1940, their use cannot automatically be justified as a permissible clinical service.
- The Drugs and Cosmetics Act, 1940, regulates the import, manufacture, distribution, and sale of drugs in India.
Key Highlights of the Judgement
- The Court held that stem cell therapy for ASD fails the legal requirement of “adequate information” needed for valid informed consent, because doctors themselves lack reliable data on its risks, benefits, and long-term outcomes.
- Relying on ICMR’s National Guidelines for Stem Cell Research (2017), the “Evidence-Based Status of Stem Cell Therapy for Human Diseases” (2021), and NMC’s 2022 recommendations, the Court found that stem cell therapy for ASD lacks sufficient, high-quality scientific evidence of safety or efficacy.
- The Supreme Court categorically ruled that any use of stem cells in patients outside an approved, monitored clinical trial is unethical and amounts to medical malpractice.
- Stem cell interventions are permissible only within approved, regulated, and closely monitored clinical trials, solely for advancing scientific knowledge, and not as routine therapies offered to patients.
- It further ordered that patients cannot demand unproven treatments as a matter of right, even if they give consent, because valid informed consent requires adequate information about the therapy’s risks and benefits.
Significance of the Judgement
- Reinforcement of Evidence-Based Medicine: The ruling firmly establishes that only scientifically validated treatments can be offered as clinical care, preventing the misuse of experimental therapies like stem cell treatment for autism outside regulated trials.
- Strengthening the Doctrine of Informed Consent: The judgment clarifies that consent without adequate, reliable medical information is not valid, thereby protecting patients, especially vulnerable children, from being subjected to unsafe or misleading medical interventions.
- Curb on Medical Commercialisation and Malpractice: By declaring unapproved stem cell therapy for ASD as unethical and amounting to malpractice, the Court checks exploitative practices, reinforces professional accountability, and safeguards public trust in the healthcare system.
About Autism
- Autism is also referred to as Autism spectrum disorders (ASD), and constitutes a diverse group of conditions related to the development of the brain.
- ASD are a group of conditions characterised by difficulties in social interaction and communication.
- Signs of autism may appear in early childhood, but diagnosis often occurs much later.
- Scientific evidence suggests that both genetic and environmental factors likely contribute to the development of autism.
- As per estimates by the National Institute of Mental Health and Neurosciences (NIMHANS), around 18 million people in India are affected by ASD.
- The Rights of Persons with Disabilities Act, 2016, explicitly recognises ASD as a specified disability, thereby entitling persons with ASD to legal protections, reservations, and welfare benefits.
- World Autism Awareness Day, designated by the United Nations in 2007, is observed annually on April 2 to raise global awareness, promote inclusion, and combat stigma surrounding autism.