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ICMR guideline spurs debate on regulation of stem cell banking

ICMR seeks to prevent commercialisation of unproven stem cell therapies; industry says move is detrimental as it will impede research in this sphere

Gireesh Babu  |  Chennai 

Stem cell treatment. Representative image. Photo: Reuters
Stem cell treatment. Representative image. Photo: Reuters

The Indian Council of Medical Research (ICMR) guideline on research has spurred the banking industry to discuss the need for regulations and guidelines on the storage of stem cells other than umbilical cord blood (UCB) cells. Currently, in general do not have substantial clinical benefits, but could be useful in future.

Major industry players in the segment say that at present there is lack of clarity about the collection and storage of these stem cells, which could be misused by some companies.

The National Guidelines for Research (NGSCR), 2017, which seeks to ensure standards on various processes related to Stemcell treatment, has been prepared with the aim of preventing commercialisation of unproven therapies and generating new knowledge, based on sound scientific rationale while addressing all ethical concerns, says the

The document details that at present there is no scientific evidence to substantiate clinical benefits with the use of stem cells derived from cord tissue, placenta, tooth extract, adipose tissue, dental pulp, menstrual blood and olfactory ensheating cells. Yet their procurement and banking is increasingly becoming a commercial activity and care needs to be taken so that there is no exploitation and commoditisation of the resources.

"As of now, only UCB banking is permitted and licensed by (Central Drug Standard Control Organisation). Accordingly, commercial banking of all other biological material is not permitted until further notification," it said.

Mayur Abhaya, president, Association of Banks of India (ASBI) and CEO of LifeCell, the largest umbilical cord bank today has questioned the guideline, saying that the observation will have consequences in the longer term. This is because the preservation of biological material would be beneficial since there are hundreds of research works taking place across the globe on various sources of and at least some of them may be proved successful. Once that happens these samples could be used by the customers for treatment.

He added that the has already granted approval for the commercialse Stempeucel, a mesenchymal derived from bone marrow for treatment, to Stempeutics Research (a group company of Manipal Education and Medical Group, and a joint venture with Cipla). In this case, the observation is inconsistent with the decision of the CDSCO, he said. The industry is seeking clarification with the officials on its stand on the observation.

At present, the companies are preserving some of the samples, apart from the UCB These are preserved by attaining no objection certificate from the drug control authority, which is regulating the segment. While the guideline may not directly impact the industry at present, it could have a bearing on the decisions by the drug control authority which is the approving authority for products, he said.

C V Nerikar, chief executive of Pvt Ltd, another player in the segment, said that the company would like to get some clarity on the remarks of He said that the company is stopping collection of materials other than Umbilical Cord Blood and would look forward for approval. He said that so far there has been no guideline related to preservation of other biological materials.

Satyen Sanghavi, of another baking firm BabyCell said that the ICMR's obervation is appreciable, since it would be helpful in curbing the malpractices in the industry and support the genuine players in the field. He said that proper regulation related to banking of stem cells from sources other than Umbilical Cord Blood Stem Cells are in place, it would help the industry to grow better. India was the pioneer in commencing storage of other stem cells also, he added.

First Published: Sat, October 14 2017. 17:24 IST