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Policy and regulations

Stem cells: minimum manipulation, maximum confusion

Should stem-cell treatment be described as a drug or a therapy? The question, following a health ministry draft note, has perplexed stakeholders of all hues — from the regulatory agency and research body to practising doctors — who are all pulling in different directions.
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16 May 2018 8 Mins Read 0 comment
A network of milk transport ducts which were derived from a single stem cell; The Walter and Eliza Hall Institute of Medical Research via Getty Images
A network of milk transport ducts which were derived from a single stem cell; The Walter and Eliza Hall Institute of Medical Research via Getty Images
Stem cells make for that rare healthcare technology that excited everyone with its possibilities — but then stalled. Stem cells are biological cells that can regenerate into other types of cells and grow more of the same types. They are mostly extracted from bone marrow, adipose tissue, or blood. While regulatory agencies in India do not recognise stem-cell
the rigorous requirements of the regulatory agencies for the approval of a clinical trial. “To have a product based on adequate tests on patients is the safest way to validate a product,” says a research scientist from the company. The most curious part of this draft rule is that no consultative process was followed before its announcement, he adds.
Stem cells make for that rare healthcare technology that excited everyone with its possibilities — but then stalled. Stem cells are biological cells that can regenerate into other types of cells and grow more of the same types. They are mostly extracted from bone marrow, adipose tissue, or blood. While regulatory agencies in India do not recognise stem-cell the rigorous requirements of the regulatory agencies for the approval of a clinical trial. “To have a product based on adequate tests on patients is the safest way to validate a product,” says a research scientist from the company. The most curious part of this draft rule is that no consultative process was followed before its announcement, he adds.

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