Prelims: Current events of national and international importance | Science & Technology | Health
Why in News?
Recently, the Union Ministry of Health & Family Welfare issued an advisory to regulate the use of stem cell therapy, particularly stressing that unproven stem cell interventions.
- Autism Spectrum Disorder (ASD) – This advisory specifically addresses the application of stem cells in the treatment of autism.
- Current position
- Stem cell therapy is not approved as a routine standard of care.
- Use of stem cell therapy is permitted only within duly approved clinical trials.
- All applications must comply with the National Guidelines for Stem Cell Research, 2017.
It is important to note that this restriction applies to the therapeutic use of all types of stem cells in the context of autism.
- National Guidelines for Stem Cell Research, 2017 – The guidelines were jointly issued by the following organizations:
- Indian Council of Medical Research (ICMR)
- Department of Biotechnology (DBT)
- These guidelines establish the framework for stem cell research and its translation into clinical applications.
- Supreme Court's Role – The Ministry's 2026 advisory is issued pursuant to the Supreme Court judgment in Yash Charitable Trust & Ors. v. Union of India & Ors.
- The Court underscored the necessity of adhering to the statutory framework regulating stem cell therapy.
- Consequences of Non-Compliance – The Supreme Court has held that violations of statutory requirements may result in the following consequences:
- Professional misconduct – This is addressed under Regulation 7.22 of the Indian Medical Council (IMC) Regulations, 2002.
- Clinical Establishments Act, 2010 – Sections 32 and 40 of the Act specify the following consequences:
- Cancellation of registration
- Imposition of penalties
- Advisory from the National Medical Commission (NMC) – It reaffirmed the following points:
- Stem cell therapy is permitted as standard clinical care exclusively for indications that have received official approval.
- The following actions, when conducted without proper authorization, are prohibited:
- Administration
- Prescription
- Promotion
- Advertisement of stem cell therapy for unapproved indications may constitute professional misconduct.
- Role of State Medical Councils – State Medical Councils have been instructed to investigate alleged violations, adhere to due process, determine the presence of professional misconduct, and implement appropriate disciplinary measures.
Reference
PIB | Advisory on Regulation of Stem Cell Therapy
