India has regulations in place for human stem cell therapy, primarily governed by the Indian Council of Medical Research (ICMR) and Department of Biotechnology (DBT). These guidelines aim to ensure safe and ethical use of stem cells.

Key Regulations:

• Permitted Use: Hematopoietic stem cell transplantation (HSCT) for hematological disorders like blood cancers and sickle cell disease is approved.
• Clinical Trials: Stem cell therapy for other conditions can only be conducted as clinical trials after obtaining necessary regulatory approvals from the Central Drugs Standard Control Organisation (CDSCO).
• Guidelines: The National Guidelines for Stem Cell Research (2017) categorize stem cell research into permissible, restrictive, and prohibited areas, ensuring scientific progress while prioritizing patient safety and ethical considerations ¹ ².

Regulatory Bodies:

• ICMR and DBT: Jointly formulate guidelines for stem cell research and therapy.
• CDSCO: Approves clinical trials and ensures compliance with regulations.
• National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT): Oversees stem cell research and therapy, providing approvals and monitoring compliance ² ³.

Challenges:

• Unproven Therapies: There’s a risk of unproven stem cell therapies being offered to patients, highlighting the need for stricter regulations and enforcement.
• Deceptive Advertising: Clinics may make false claims or use deceptive advertising practices, emphasizing the need for regulatory oversight ⁴.