Cord blood banking: Ambiguous policy

In the interim Union Budget 2014, then finance minister P Chidambaram had announced exemption of service tax on cord blood banking services. In his budget speech, he had said that “(the) Ministry of Health and Family Welfare has requested that services provided by cord blood banks are also healthcare services and should be exempt from service tax. I propose to accept the request.”

The request from the ministry is a clear indication of conflict between biomedical agencies in India at the level of policy formulation. Given that, in the revised 2013 stem cell research guidelines, the Indian Council of Medical Research (ICMR) has raised concerns over the commercialisation of private cord blood banking in India. It is worth mentioning here that the newly elected BJP-led government also did not indicate rolling back of that decision.

Cord blood banking is a process of collecting and storing a new born cord blood for harvesting stem cell. Cord blood is one of the richest sources of stem cell which is widely seen as a potential to treat many incurable diseases such as spinal injury, muscular dystrophy, Parkinson’s disease, Alzheimer’s disease, multiple sclerosis, diabetes, retinal pigmentosa etc. 

There are two types of cord blood banking as per their nature: a) public, and b) private cord blood banking. In the former, expectant parents pay a fee to preserve their child’s cord blood while in the latter, the nature is altruism. There are more than 15 private cord blood banks in India. The private cord blood banking is seen as a commercial venture which is largely based on hope and hype and raises many ethical, social and governance concerns.

The ICMR, jointly with the Department of Biotechnology, updated the 2007 stem cell guidelines in December 2013. In Section 12.1 of stem cell guidelines, it is stated that “procurement and banking of various biological tissues such as umbilical cord blood, placenta, extracted tooth, adipose tissue and other sources of stem cells, with the specific objective of their isolation and/or ex vivo expansion, is increasingly becoming a commercial activity”.

Further, Section 12.2.2 emphasises that “there are ethical concerns about the promotional advertisements by private banks offering storage of cord blood for possible future use. Such advertisements are often misleading for the public and lack comprehensive and accurate information. It may be mentioned that there is no scientific basis for preservation of cord blood for future self-use and this practice is not recommended.”

However, despite these concerns, one of the departments of the Ministry and Family Welfare requested the government for service tax exemption on cord blood banking services.

Self use of cord blood
The legitimate question arises whether the ICMR has acknowledged that there is not enough scientific evidence in favour of future self-use of the preserved cord blood. It is worth highlighting that for biomedical governance, there are two key agencies in India working under the Ministry of Health and Family Welfare – ICMR and Central Drugs Standard Control Organisation (CDSCO).

The ICMR works as an advisory body while CDSCO is a regulatory body that primarily oversees manufacturing, sale and distribution of drugs. The CDSCO also approves new drugs and monitors clinical trials. It is the licensing authority for cord blood banks in the country.  Given the ICMR position in 2013 stem cell research guidelines, it appears that CDSCO has requested government for the service tax exemption on cord blood banking services. 

With the contradictory statement of the former FM  and the 2013 stem cell research guidelines, one can infer a serious policy conflict between biomedical agencies in India. This needs to be addressed soon as the proliferation of private cord blood banking leads to possible economic exploitation of expectant parents in the name of ‘biological insurance’. 

However, the chances that a particular child will develop a condition requiring cord blood transplantation are very slim. It has been observed that 0.04 per cent (1/2,500) of cord blood units stored would ever be used for autologous transplantation. The reason is that the occurrence of diseases currently treated with cord blood is small, and many patients would not be eligible for autologous cord blood, including those with genetic disorders and leukaemia.

In addition, no one knows, whether CDSCO ensures storage conditions and quality control especially while shipping the stored cord blood from hospitals to banking firms. Since Union health minister Harsh Vardhan is a clinician by profession, one can expect a robust policy regime and an effective monitoring mechanism for cord blood banking in India.

(The writer, a scholar of Science and Technology Studies, is based in the USA)

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