ICMR issues guidelines for Umbilical Cord Blood Banking

It represents the current thinking of scientists and clinicians on the available evidence and will be updated as the evidence grows in future.

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ICMR

Last Updated on January 25, 2023 by The Health Master

Download guidelines issued by ICMR, the link is given below: The Indian Council of Medical Research (ICMR) has issued Guidelines for Umbilical Cord Blood Banking: Collection, Processing, Testing, Storage, Banking, and Release for Clinical Application (2023).

These guidelines have been prepared with the primary aim of providing information on the scientific basis behind umbilical cord blood storage, the status of its therapeutic use, and guidance for various associated issues.

Further, it elaborates on both the quality and ethical considerations of umbilical cord blood banking. It has been prepared through stakeholder consultation, opinion of experts and through intensive debate on current scientific evidence.

Guidelines for Umbilical Cord Blood Banking 2023″ is being widely referred to to ensure quality standards and safety of umbilical cord blood for clinical applications.

“This statement corroborates the existing regulatory requirements of umbilical cord blood banking as given in the Drugs & Cosmetic Act 1940 & Rules 1945 (Amendments 2016) and further provides advice and guidance on the therapeutic use of umbilical cord-derived hematopoietic stem cells,” according to Dr. Rajiv Bahl, Secretary, Department of Health Research, Union Health Ministry, and Director General, ICMR.

The use of hematopoietic stem cells obtained from umbilical cord blood has gained tremendous popularity in the field of bone marrow transplantation or hematopoietic stem cell transplantation owing to its distinct advantages over bone marrow-derived or peripheral stem cells.

Dr. Rajiv Bahl further explained that this brings us the challenge of ensuring the safe and ethical collection, processing, and storage of umbilical cord blood by umbilical cord blood banks.

In view of the establishment of several umbilical cord blood banks in recent years, we felt that it is imperative to educate all stakeholders on various aspects of umbilical cord blood collection and storage for therapeutic purposes.

The document is adapted from the Drugs & Cosmetic Act 1940 and Rules 1945 (Amendments 2016) and has been influenced by various international documents available in public domain like the NetCord FACT Standards and AABB Standards for Cellular Therapies [4,5,6].

It represents the current thinking of scientists and clinicians on the available evidence and will be updated as the evidence grows in future.

It may be stated that these guidelines are not meant to be construed to replace or overrule but to substantiate the existing regulatory requirements as described in Drugs & Cosmetic Act 1940 and Rules 1945 (Amendments 2016) that are already in place for Umbilical Cord Blood Banking.

“The Guidelines for Umbilical Cord Blood Banking 2023 is the culmination of years of deliberation and the relentless efforts of stakeholders, including experts, government agencies, clinicians, scientists, the cord blood banking industry, parents, and NGOs, who contributed to shaping the document in its present form through either their inputs, communication, or queries,” Dr Rajiv Bahl informed.

There has also been a debate over whether it is appropriate at all for expectant parents to store their new-born baby’s cord blood in private banks for future therapeutic use.

This is based on the registry data, whereby the utilization of cord blood as a source for HSCT is declining in the USA, Europe, and Australia.

The Indian Society of Blood and Marrow Transplantation registry data shows that only 60 unrelated cord blood transplants have been done in India from 2012 to 2020 with a further trend for decreasing utilization in recent years.

Presently, the cord blood stored in private cord blood banks remains under-utilized, is expensive and has not been fully compliant with the required regulatory guidelines.

It was brought to the notice of Government of India & ICMR through various grievances and complaints that private cord blood banks are circulating persuasive literature projecting UCB banking as a ‘once in a lifetime opportunity’ for treating a variety of diseases in future by offering mothers the option to store their own baby’s cord HSCs on long-term basis.

The advertisements claim that UCB banking is a biological insurance for stem cell therapy of the child or his/her siblings in case of future need, not only for conditions with SCT are indicated but also where the use is unjustified or at best experimental.

The information is widely circulated through leaflets distributed at antenatal clinics, assisted conception units, women’s magazines and on the internet.

These issues have been deliberated upon in a series of inter-agency and inter-ministerial meetings of the Government of India whereby it was felt that it is imperative to spread awareness about the correct utility of umbilical cord blood storage among all stakeholders and thus curtail misleading advertisements for profit making.

Parents who are offered cord blood banking must have accurate information on the exact utility of cord blood storage for self-directed use, the functioning of private versus public cord blood banks, their international status, and the likelihood of private banking resulting in benefit vis- a-vis the possibility of contributing to a lifesaving therapy for someone else by offering the stored cord blood to a public cord blood bank.

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