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Stem cells and regenerative medicine

Stem cell therapy in India is regulated more tightly than it is advertised. Only a few uses are proven, each replacing a tissue with the same tissue after decades of trials. Two regulators divide the work, one over research and one over products, and the Health Ministry has now added treatment guidelines to that framework. The line regulation has to hold is the one between treatment and experiment.

UPSC has asked

Prelims 2020: germline editing and human induced pluripotent stem cells in a pig embryo
Prelims 2017: what somatic cell nuclear transfer is used for

What is proven, and what is not

Haematopoietic stem cell transplantation, the bone marrow transplant, treats leukaemia, lymphoma, thalassaemia and aplastic anaemia.
Limbal stem cells from the eye restore a cornea scarred by chemical burns.
Cultured skin cells are grafted onto severe burns.
Other conditions, neurological and degenerative disease among them, remain investigational, for an approved clinical trial only.
No whole organ has yet been grown from stem cells for human transplant.

Who regulates what

The National Stem Cell Research Regulation Committee oversees research using minimally manipulated stem cells.
The Central Drugs Standard Control Organisation (CDSCO) regulates stem cell products as drugs, under the New Drugs and Clinical Trials Rules, 2019.

What has happened

11 Aug 2026
The Health Ministry's Centre for Evidence Based Guidelines issued guidelines on stem cell therapy and regenerative medicine for 2025 to 2026.
- They join the National Guidelines for Stem Cell Research 2017, the gene therapy guidelines 2019, the haematopoietic cell transplantation guidelines 2021 and the cord blood banking guidelines 2023.
- India's first in human gene therapy trial was run by the Centre for Stem Cell Research with Christian Medical College, Vellore.
PIB, 11 Aug 2026: Regulation of stem cell therapy and regenerative medicine (opens in a new tab)