This article is written by Pranav Sethi, from SVKM NMIMS School of Law, Navi Mumbai. This article is an exhaustive analysis of blood donation in India.

Introduction 

Blood safety is one of seven prioritized topics designated by the World Health Organization (WHO). ‘Blood Saves Life: Safe Blood Starts with Me,’ was the topic of World Health Day in 2000. The South-East Asia Region’s (SEAR) member countries acknowledged blood safety as a critical concern. It’s one of the 13 areas in which the WHO has been asked to speed up technical cooperation.

WHO has launched a comprehensive attempt to secure blood safety, particularly in the building up of nations, and to boost the accessibility and purity of blood. Health practitioners in SEAR countries were found to be unfamiliar with the principles and practice of providing high-quality blood transfusion services (BTS). As a result, the WHO’s Quality Management Project (QMP) has been in place since 2001 in all of the WHO’s regions to introduce/strengthen quality in all elements of BTS, with the general goal of enhancing blood safety, adequacy, and quality.

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Capacity development in performance monitoring instruction is a crucial element of the QMP since it improves the abilities of BTS personnel in ensuring the quality of medical products and supplies. WHO created a standard programme for this training, which was customized to the requirements of SEAR member countries and field-tested during a regional workshop conducted in Bangkok, Thailand, from March 26 to April 13, 2001. In October 2001, India held a National Quality Management Training (QMT) course. A conference of state blood safety programme officers was held to educate them on the QMP and the value of QMT in ensuring the quality, safety, and adequacy of blood.

Legal considerations

Legal considerations are critical in establishing a foundation for the Indian blood transfusion service (BTS), even as moral concerns help to ensure reliability. Even though all blood banks are licensed, the Drugs and Cosmetics Act has not been updated, putting reliability at risk. The Act does not refer to current procedures like chemiluminescence or nucleic acid testing (NAT). It does not apply to specialized goods such as shared platelet concentrates or customized complete blood, treatments such as erythropheresis, plasma share, stem cell collection, or manufacturing processes such as leukoreduction and irradiation.

An extremely segmented BTS with over 2500 blood banks, combined with a delayed and inefficient dual licensing (state and centre) procedure, is impeding the seamless operation of blood banks. Blood safety is jeopardized by the small size of blood banks. In India, new blood banks are formed by hospitals to suit the needs of insurance companies or by medical colleges to meet the standards of the Medical Council of India (MCI). Because they are prohibited by law from hosting camps, hospital-based blood banks arrange for alternative donations. Blood abuse continues due to a need for new blood, a shortage of components, and a lack of criteria for appropriate transfusions.

Differential retail prices of blood elements are challenging to justify in terms of both science and ethics. Blood safety could be achieved by accrediting blood banks and establishing multilateral testing facilities. The National Aids Control Organization (NACO) and the National Blood Transfusion Council (NBTC) should be more involved in the licensing process. The Food and Drug Administration (FDA) should make it clear that methods or tests aimed at improving blood safety are not prohibited.

Licensing blood donation in India

The Drugs and Cosmetics Act of 1940 and the Drugs and Cosmetics Rules of 1945 classify blood as a “drug.” The drug supervisor became the regulatory framework after blood was classified as a drug. Licensing is just the beginning of the road to excellence. With approximately 2500 blood banks, the Indian BTS is highly fragmented, posing distinct issues.

Eligibility for blood donation

Anyone between the age group of 18 and 75 who matches the donor eligibility requirements can donate blood. The process is generally painless and safe. You will donate approximately 470ml of whole blood during a normal donation. This represents around 8% of the average adult’s blood volume. This volume is replaced in 24 to 48 hours, and red blood cells are replenished in 10 to 12 weeks.

Blood donation types

The most common forms of blood donations are:

  1. Platelets (known as plateletpheresis) – The red cells and plasma are similarly delivered to the donor licensing donation.
  2. Blood – Plasma, red and white blood cells, platelets, antibodies, as well as other elements are included in normal donations.
  3. Plasma (known as apheresis) – During the transfusion, a specific machine separates the plasma from the other elements, and the red blood cells are restored to the donor in cycles.

National blood policy

The Government of India launched the National Blood Policy (NBP) in 2002. The NBP reaffirms the commitment of the government to safe blood and blood constituents and it has well-documented plans in place to make enough resources, technology, and training sufficient to improve transfusion operations. It also explains how to motivate donors and how to use blood safely in therapeutic settings. It has also taken initiatives to improve research and development in the field of transfusion medicine. It is also tasked with verifying that regulation and education are in place to prevent profiteering in blood banks.

Role of national aids control organization

Most of the developments witnessed in our nation during the last decade and a half have been the consequence of licensing, which established minimum standards in terms of space, people, and equipment, as well as support for blood safety from the National Aids Control Organization (NACO). While the pharmaceuticals controller is the regulatory organization, NACO/NBTC has been the primary technical body for developing transfusion medicine guidelines. The National Aids Control Program has developed the NBP. NACO and NBTC have worked jointly to improve blood safety by developing infrastructure, establishing various components separating units, advocating voluntary blood donation, educating employees, and establishing guidelines for blood facilities in India

Drug controller issues licenses to blood banks

The Drugs and Cosmetics Act of 1940 and the Drugs and Cosmetics Rules of 1945 outline the process for obtaining a license for a blood bank. Over the years, the underlying licensing regulations for blood banks have been essentially constant. Minor amendments to the Drugs and Cosmetics laws include raising the donation age from 60 to 65 years old and recognising transfusion medicine as a specialization. The recommendations for establishing blood storage facilities may be the only significant change.

Qualification to run a blood bank

Any individual or organization can propose to start a blood bank. After submission to the drugs controller, drug control officials from both the state and the federal government undertake a combined inspection and offer a proposal to the Central Licensing Approving Authority (CLAA), which is the final authority for granting licenses. This drug controller examination is preceded by a visit by the SBTC, the advisory panel, which grants the drug controller its approval.

Amount of space required

All blood banks must meet minimum requirements for space, equipment, and staff, which are examined at the time of license grant/renewal. In India, the functioning of a blood bank requires 100 square meters for whole blood, 50 square meters for blood components, and 10 square meters for aphaeresis. 

Staff requirements

A person having an MD (doctor of medicine) in transfusion medicine or pathology, a Diploma in pathology with 6 months experience, or an MBBS with 1-year experience in blood banking could be the medical officer. Additional criteria include technicians with a BSc (MLT) or DMLT and staff nurses.

Regulation charge requirements 

It is debatable whether a blood bank should be compliant with the agency of the requirements that supervises the Food and Drug Administration.

Monitoring the country’s 2500+ blood banks is a tremendous effort for the pharmaceuticals regulator, who is already overburdened with medications, equipment, and clinical trial authorization. Blood banking, aphaeresis, cell biology, molecular biology, and treatments are all part of transfusion medicine’s growing super-specialty. Drugs controllers, who are essentially pharmacologists, have no experience in transfusion medicine but are expected to look into blood component quality control (QC), TTI testing, and immunohaematology.

NACO/NBTC is a specialized organization that is well-equipped to govern and supervise blood banks, but it only serves as a consultant. As a result, while the pharmaceuticals controller efficiently monitors the legal requirements of infrastructure, equipment, spacing, and staff, the medical and quality components of transfusion medicine are disregarded. It will be more relevant to regulate by engaging specially selected specialists in transfusion medicine, who will be supplemented by Drug Controllers.

Dual licensing system

The dual-licensing approach for granting or renewing a license has made the licensing procedure extremely time-consuming and inefficient. Non-administrative elements play an essential role in obtaining a license in some regions, just as they do in certain divisions.

Excessive restrictions (License Raj) relating to the system and minimum standards for blood banks should be eliminated and amended more sensibly; problems in upgrading the Act or establishing a framework to audit blood banks are obstructing India’s blood safety measures.

Drugs and Cosmetics Act

Due to various improvements in transfusion science, this requires it to be revised immediately. It’s critical to have a clear understanding of what blood banks can and cannot perform. The Act, for example, makes no provision for leukoreduced and treated blood constituents without which many cancer patients and thalassaemic youngsters would suffer. The Act does not indicate whether leukoreduction and irradiation require a separate license. However, NACO has established national criteria for leukoreduction and irradiation quality control. In the meantime, while the Act is being revised, the researchers propose issuing a directive clarifying that any further method used to strengthen blood safety, such as leukoreduction, irradiation, or NAT testing, does not require a license.

Apheresis licensing

Blood banks must apply for specialized authorization and establish that they have the necessary equipment, space, and personnel to perform apheresis. The Act only specifies plateletpheresis, plasmapheresis, and leukapheresis on donors, but only the products, such as single donor (apheresis) platelets (SDP), plasma, and leukocytes (granulocytes/mononuclear cells), require a license. Many more particular goods must be supplied, such as processed whole blood (whole blood minus platelets or cryoprecipitate).  While it is permissible to administer six randomized donor platelets one after the other, they cannot be aggregated in a closed facility, processed, and administered as a pooled platelet concentration. In Europe, pooled platelet concentrates are utilized as a cost-effective alternative to SDP.

Therapeutic procedures

Numerous blood bankers now are capable of performing specific operations such as therapeutic plateletpheresis, plasmapheresis, leukapheresis, PBSC collection, and red cell exchange. Blood bankers, in collaboration with clinicians, are the best-qualified personnel to execute these operations. On therapeutic operations, the Act needs to be clarified. Using PBSC for classic treatments such as leukemia, lymphomas, aplastic anaemia, myelomas, and hemoglobinopathies, without a doubt, does not require approval. Appendicectomy, hysterectomy, and cataract surgery would all require a license if such were the case. Wherever licensure is lacking but national guidelines are available, accreditation, or a peer-review procedure, could be a viable substitute

Fragmented blood transfusion service

In India, blood banks are established for a variety of purposes. Because they are unable to establish holding facilities, some hospitals open blood banks. Only Regional Blood Transfusion Centers (RBTCs) are allowed to open storage centres, and only a small number of blood banks are RBTCs. Some hospitals establish blood banks because their insurance companies enable them to charge more for their services when they employ a blood bank. To fulfill the requirements of the Medical Council of India, medical colleges open blood banks. Due to mandates from political officials, the government establishes blood banks in several areas. When blood banks are formed for no reason other than to fill a need, and there aren’t enough qualified individuals to run them or enough work to keep them running, quality suffers. The solution is additional blood storage centres, not more blood banks.

Size of blood banks and the methods used to screen donors

Small labs have greater rates of false-negative for human immunodeficiency virus and hepatitis B surface antigen than medium and large labs, according to studies. Rapid tests, which have a delay of almost a week in antibody detection, are used by blood banks with tiny workloads (5-10 donors/day), jeopardizing safety. Except in a few blood banks, QC (Quality control) measures to ensure safety in TTI testing, such as the Levy Jennings chart for ELISA, are essentially non-existent.

Absence of standards for safe transfusion

The National Aids Control Organization/NBTC guidelines only address safe donor and blood concerns, not a safe transfusion, which is the third element of blood safety. Transfusion triggers are only used by a few institutions at most. Furthermore, there are no audits conducted by a qualified technical organization to check that standards are being followed.

Restrictions on holding blood donation camps

According to the Drugs and Cosmetics Act, only licensed RBTCs, government blood banks, the Indian Red Cross Society, and licensed blood banks managed by volunteer or charity organizations are allowed to host blood donation camps. Withholding approval for camps harms many good blood banks and may be a barrier to voluntary blood donation. If we want to reach 100% voluntary blood donation, we need to revisit this law.

Incorporation of new technology and the use of centralized testing

The Drugs and Cosmetics Act makes no description of recent testing technologies like NAT (Nucleic acid amplification testing)/CLIA (chemiluminescence immunoassay) /ELFA (Enzyme-Linked Fluorescent Assay), and some regulatory bodies are likewise unaware of these new approaches. While closing tiny blood banks in a segmented BTS is more challenging than it appears, regulations to centralize TTI (transfusion transmitted infections) testing are not difficult to implement. One of the measures to improve blood safety, according to the WHO, is centralized/regionalized testing. As the first move towards consolidating the Indian BTS, standardized ELISA/NAT testing centres supported by professionals in transfusion medicine, along with an efficient courier system, may be established.

Excessive reliance on testing methods

TTI testing alone isn’t enough to ensure safe blood. The world has progressed from testing to processing techniques, but the Act does not refer to processing technology. While the NACO/NBTC established recommendations for leukoreduction and irradiation as early as 2007, many blood bankers and drug inspectors are unaware of them.

Deficiencies in bedside transfusion controlling and processing

Transfusion indications

Another provision of the Drugs and Cosmetics Act that is rarely followed, probably due to the lack of common guidelines.

Form for requesting blood

“Blood and/or its components shall be distributed on the prescription of a Registered Medical Practitioner,” according to the Act. This guideline, however, is rarely maintained due to realistic constraints. The Act needs to be updated to substitute doctors’ manual signatures with electronic signatures.

Notified consent for transfusion

This provision is an outgrowth of the National Consumer Redressal Forum’s legal mandate. In the case of M. Chinnaiyan vs Sri Gokulam Hospital and Anr., the court ruled that “patient intervention is necessary for blood transfusion surgery entails hazards, but blood transfusion entails even more. Affirmative consent has to be a written document detailing the risks, advantages, and substitutes to transfusion taken after a discourse between the medical practitioner and the transfusion beneficiary. For children and unconscious patients, an informed consent form should be signed by the next family member. In times of extreme transfusions, such as autoimmune haemolytic anaemia, the authors believe it is also preferable to have a neutral witness.

Different viewpoints by various hematologists

Fragmented services

In India, there are more than 900 government-sponsored blood banks, 360 maintained by charitable organizations, 680 affiliated with private hospitals, and roughly 500 controlled by commercial organizations. Some hospitals will only allow blood from their banks to be given to patients. Because hospitals and blood banks do not have well-developed networks, medical personnel may not know where to get blood in an emergency. A helpline was recently established in Mumbai to arrange blood for patients at a predetermined price of Rs450 (£4.60; €5.90; $7.30) per bag.

Harsh Vardhan’s idea, according to N K Naidu, blood bank director at the Indian Red Cross Societies Maharashtra state branch in Mumbai, is “excellent” as individuals will now be familiar with the notion of blood donation. She told The BMJ that “blood is never imported” from other nations since the transportation and storage networks are inadequate. The gap is filled by pressuring family or acquaintances of the sufferers to donate blood. 

According to Samiran Nundy, dean of the Ganga Ram Institute for Postgraduate Medical Education and Research in New Delhi, complicated surgeries are not done at many institutions if there is a blood shortage.

The importance of need is undervalued

According to Amit Sengupta, the associate global organizer in Delhi for the worldwide advocacy network the People’s Health Movement, India has a 31 percent blood shortage, and more voluntary blood donation is required. This amount is significantly higher than the Indian Red Cross Society’s estimate of 25% and is unconfirmed.

“However, this figure [31%] that is constantly quoted is a  possible gross underestimate,” he added. “It is based on present demand, which in turn is based on the present level of treatment access. Treatment access is very low in India, especially in  remote and poorer areas, and hence this cannot be the basis for  calculating actual requirement for blood.”

“There can be no quick fix solutions,” Sengupta says. “The minister’s call for voluntary donations is welcome but does not  adequately attend to a range of issues that need to be addressed.”

Additional blood banks should be established in India, especially in villages, according to Sengupta. He also suggests that new devices and equipment be created to allow for proper blood collection and processing.

Many people, including Sengupta, are advocating for reform in the legislation to require the transfusion of unbanked blood, which, he claims, would make a tremendous impact in rural areas where there are no blood banks. Due to the paucity of donors, blood that has beyond its expiration date is an issue. In January 2012, the All India Institute of Medical Sciences in Delhi disposed of 140 units of packed red blood cells that had reached the end of their shelf life. During 2008 and 2009, the Lord Mahavir Civil Hospital in Ludhiana reportedly squandered 458 units of blood.

Identification of the patient

It is critical to have a documented method/protocol ensuring affirmative (right) patient recognition. Failure to do so could result in incorrect transfusions, which could be interpreted as doctor carelessness. Wrist bands are one technique to accomplish this. The majority of potential severe transfusion responses are caused by clerical errors.

Transfusion monitoring

Following medical supervision, transfusions must be recommended and given. Regular monitoring during transfusion is recommended by national (NACO) guidelines. For delaying responses, many worldwide standards propose monitoring critical indicators well before the commencement of the transfusion (time 0), 15 minutes after the transfusion, the finalization of the transfusion, and 1 hour after the transfusion.

A transfusion card, similar to a medicine card, will aid in accurate and thorough documentation by documenting patient demographic data and vital signs, as well as specifics about the unit provided. 

Inability to combine strong research and development and clinical practices

When established, the Clinical Establishment (Registration and Regulatory) Act, 2010 will help to merge excellent manufacturing processes with good clinical practice guidelines, bringing blood bankers closer to physicians and assisting in the implementation of safer transfusion practices. Admittedly, this is only partially adopted in a few states.

Conditions are, fortunately, improving in India. With NACO’s help, non-governmental institutions have been recognized for increasing voluntary blood donation. Through concentrating on developing technologies, private clinics are attempting to improve quality.

Better testing, such as NAT, antibody screening, antigen typing, better blood bags, leukoreduction, and bacterial detection technologies, must be attributed to the industry.

Transfusion medicine organizations such as the Indian Society of Transfusion Medicine and the Asian Association of Transfusion Medicine deserve recognition for the blood utilization improvements that have occurred.

Whole blood is no longer used, which in several major health facilities technology such as leukoreduction and irradiation are now standard procedure. The Quality Council of India (QCI) runs a National Accreditation Board for Hospitals and Healthcare Providers (NABH) accreditation scheme specifically for blood banks. We also have an Indian National Haemovigilance Program that monitors adverse transfusion reactions in recipients, although participation is limited because these are volunteer programmes.

Hospital-based blood banks are forced to practice substitute donations because they are unable to hold camps. Managed donations are medically opposed, yet they are frequently requested by recipients and clinicians, providing an ethical problem for blood bankers. All blood bankers want to use blood as a blood ingredient sparingly, but the need for whole blood leads to the opposite. At the turn of the century, the transfusion triggers for red cells were set at 10 g/dl, which left little opportunity for anaesthesia errors.

This has altered dramatically over time. Some anaesthetists, on the other hand, refused to deliver anaesthesia unless the haemoglobin level met their expectations, resulting in needless treatments. A blood bank that performs life-saving operations such as erythropheresis and plasma exchange that are not covered by the Act is biologically and ethically proper, but it could be legally improper. Differential tariffs for various blood constituents are prescribed by NBTC primarily on commercial rather than ethical grounds.

If the payment is simply being used for execution, all elements must be charged the same. The community expects blood banks to offer the greatest quality blood for free or at a minimal cost, which is morally correct but financially unfeasible. The administration and staff of blood banks must follow ethical guidelines. To guarantee ethical practices, conflicts of interests affecting blood bank administration and staff must be prevented, particularly concerning manufacturers/suppliers of kits and reagents.

To eliminate bias and ensure that research and morality take precedence over the business in the practice of transfusion medicine, a monitoring structure with checks and balances must be explicitly defined.

The lack of transfusion triggering presents a moral dilemma for blood bankers, as the treating physician’s instincts will always be correct. Blood bankers are seen in the community as business people who sell blood to make a living. In actuality, comparable to other clinical specializations, blood bankers are among the lowest rewarded professions. Drug inspectors, like blood bankers, must have a minimum level of qualification to operate a blood bank.

When examining blood banks, narcotics examiners must get at least a year of training in the fundamentals of blood banking, apheresis, and molecular biology. The medicines controllers should be included in the inspections team which should be chosen from a list of professionals with blood management experience and led by a technical expert.

Conclusion 

The Drugs and Cosmetics Act should be examined in two years to keep up with developing circumstances, and it should be amended to indicate that any element or operation not covered by the Act may be conducted by the blood bank according to NACO/NABH standards. The NBTC should take a more active role in the licensing process. The dual licensing system between the state and the central government must be eliminated, and the licensing process should be streamlined so that permits can be granted or renewed in as little as three months. SBTCs must operate one major, jurisdictional blood bank in each state to gain a sense of how much blood costs and use that information to set service charges for other blood donations.

To assure testing reliability and save costs, commercial players or public-private collaborations must be expected to promote certified provincial testing sites. To make this possible, certain revisions to the Act are required. The focus of inspections and audits should be on improving quality through adherence to standards and protocols, as well as facilitating the efficient operation of blood banks. The adoption of safe transfusion methods should not be hampered by licensing.

References

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