Correspondence Address:
Aikaj Jindal
SPS Hospitals, Ludhiana, Punjab
India

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The Indian Blood transfusion Services in 2019 had 3108 blood banks which collected nearly 12.4 million blood units and separated approximately 50% of them into components.[1] Despite such a vast network of blood banks, now called blood centers, there is wide inequity in the distribution of such blood banks, with denser concentrations in urban areas than in rural. This holds true for most Asian countries that have a fragmented and hybrid blood transfusion service.

The Indian Blood Transfusion Services which are governed by the Drugs and Cosmetics (D&C) Act of 1940 have seen several amendments in the recent past[2] and have come a long way. The Act governs and regulates the conditions of licensing of the blood centers, storage, processing, and distribution of the blood. Through this Act, the Central Drugs Standard Control Organisation (CDSCO) working under the Director General of Health Services has been the regulatory body responsible for implementing the provisions of this act and granting, renewal and suspension of licenses through a mechanism of dual authority, i.e., at the level of center and state Food and Drug Administration (FDA). The State Drug Controller/FDA grants the blood bank license with approval of the CDSCO to the blood center after a joint inspection.[3]

In 1996, The Supreme Court of India directed the formation of the National Blood Transfusion Council (NBTC) to regulate the functioning of the blood transfusion services in the country. The National and State Blood Transfusion Councils (SBTCs) carved within the National AIDS Control Organization, and SACS, respectively, play an advisory and technical role only with no stake in licensing regulations.

In addition to these regulatory authorities, the blood transfusion services are also open for liability under the various sections of the Indian Penal Code with respect to medical negligence, the Consumer Disputes Redressal Commission of India, the provisions of the state and district health legislations like any other health system setup. The state legislature, along with district administration, also can regulate certain aspects of the functioning of blood transfusion services coming under its jurisdiction, as seen in the recent times of the COVID-19 pandemic.

The regulations serve an important role in ensuring that the lowest common denominator must be present in all the functional blood centers in terms of quality standards, area, infrastructure, and workforce. The D&C Act sets a minimum criterion required that a blood center must fulfill for it to be granted a license. With dual inspection (center and state), verification is done at the ground level to ensure compliance. This not only ensures uniformity in establishment but also a minimum standard of quality that must be present in the blood transfusion services in a country as diverse as ours.[4] While licensing ensures minimum criteria, accreditation surpasses these minimum criteria. Only a small fraction of the licensed blood centers in India is accredited, which demonstrates that accreditation is more difficult than licensing. Have we reached a point in time where accreditation can replace licensing or at least accredited blood centers be liberated from the process of repeated cycles of licensing?

With subsequent amendments of the D&C Act from time to time supported by the NBTC, the blood transfusion services have been able to prohibit professional blood donors and promote voluntary nonremunerated blood donations. In order to tackle the disparity of stock in the blood banks, bulk transfer of blood within blood centers has been allowed to reduce both wastage and shortage.

In 2014, the NBTC has notified the processing charges of the blood to ensure the standardization of charges in both government and private sectors. This has been an important step in discouraging unethical profiteering in blood centers. However, despite this clear regulation, does not the financial audit of the blood centers by the SBTCs amount to regulatory overreach and act as a deterrent for the growth of blood centers?

With multiple regulatory bodies and guiding councils/laws, the amendments and revisions to our regulations have been reactive rather than proactive. In the absence of clearly defined jurisdictions, multiple regulatory bodies can add unnecessary paperwork and red tape that can cause the impediment to progress by exhausting precious resources and workforce. For instance, amendments were made to the D&C Act permitting all private hospital blood centers to hold blood donation drives after several representations to the Drugs Controller and NBTC.[5] The state authorities, the SBTCs wanted blood centers to seek permission from them for holding blood donation drives (camps) in some states. Such duplication of permissions, which led to another cycle of applications and requests, could have been avoided by a process of self-executing and reflexive percolation of such information from NBTC to SBTC.

Thus, what we need is a unified, integrated and a centralized regulatory body with licensing, technical and financial authority which will adhere to the D&C Act in both letter and its true spirit. This is likely to cure the ills in our current Indian blood transfusion service, which faces fragmentation and inequity.[6] Such a unified regulatory authority, in addition to Drug Controllers, must be led by a Transfusion and Cell Therapy expert. If there are minimum requirements for heading a blood center, should we not be having minimum requirements for the head of the NBTC/SBTC/Regulatory body that monitors the whole country?

There is a need for more representative inclusion in the decision-making groups to be sensitive to regional or local requirements. We need to be able to evolve swiftly and more comprehensively to respond to the fast-paced and ever-growing field of transfusion medicine and to ensure the best patient care possible for all the patients who may require it.

Having too many regulatory agencies is a drain on the exchequer and serves no useful purpose. This is in keeping with the mantra (chant) of Minimum Government, Maximum governance! This is important to ensure that too much regulation/advisory bodies do not become an impediment to blood transfusion services in a country and instead, they give impetus for the growth of transfusion services.

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