STEM CELL THERAPY FOR AUTISM SPECTRUM DISORDER [PRELIMS BITS]

18 Sep 2026

Tags: Prelims   Current events of national and international importance

Source: The Hindu

Context: Union Health Ministry directed States/UTs to restrict stem cell therapy for Autism Spectrum Disorder (ASD) to duly approved clinical trials.

  • Regulatory framework: Based on the National Guidelines for Stem Cell Research, 2017, issued by the Indian Council of Medical Research (ICMR) and Department of Biotechnology (DBT).
  • Routine use: Stem-cell interventions not approved for routine clinical use cannot be offered as standard or commercial treatment.
  • ASD: Any stem-cell therapy for autism must remain within duly approved clinical trials.
  • ICMR review: Available evidence does not establish stem-cell therapy as superior to behavioural and supportive therapies for ASD.
  • Supreme Court linkage: Advisory follows the January 30, 2026 judgment in Yash Charitable Trust & Ors. v. Union of India & Ors.
  • Clinical Establishments Act: Advisory applies to States/UTs that have adopted the Clinical Establishments (Registration and Regulation) Act, 2010.
  • Stem cells: Undifferentiated cells capable of self-renewal and differentiation into specialised cell types.
  • Clinical trial: Systematic research involving human participants to evaluate the safety, efficacy and/or effects of an intervention before wider clinical use.

Prelims Question

Q1. With reference to stem-cell interventions and clinical trials in India, consider the following statements:

  1. Stem cells are characterised by their capacity for self-renewal and potential differentiation into specialised cell types.
  2. An intervention being investigated in a clinical trial automatically permits its commercial use as standard clinical treatment.
  3. Clinical trials involving human participants may be undertaken to evaluate the safety and efficacy or effects of an intervention.
  4. The National Guidelines for Stem Cell Research, 2017 were issued jointly by the Indian Council of Medical Research (ICMR) and the Department of Biotechnology (DBT).

Which of the statements given above are correct?

(a) 1 and 3 only
(b) 1, 3 and 4 only
(c) 2 and 4 only
(d) 1, 2, 3 and 4

Answer: (b) 1, 3 and 4 only

Explanation:

  • Statement 1 is Correct: Self-renewal and differentiation are defining properties of stem cells.
  • Statement 2 is Incorrect: Being under clinical investigation does not automatically make an intervention approved for routine or commercial clinical use.
  • Statement 3 is Correct: Clinical trials systematically assess interventions in human participants, including their safety and efficacy/effects.
  • Statement 4 is Correct: The 2017 National Guidelines for Stem Cell Research were issued by ICMR and DBT.