Blood banks get a license to collect, test, process and distribute blood for a fee, however the demand-supply gap has given rise to a multi-billion dollar blood transfusion industry and everyone wants a share. Will this industry forsake its non-profit cloak to have a fair, better regulated, organised and efficient playing field for all stakeholders so that people can have quality blood components, in sufficient quantum, without replacement, whenever, wherever, the need arises, at a reasonable cost? By Neelam M Kachhap
Most people working in the healthcare sector understand that the term ‘blood bank’ is a misnomer. It neither functions as a bank nor stores blood indefinitely. It is more like a manufacturing facility that converts raw materials into finished goods. “A blood bank is halfway between a pharma manufacturing unit and a healthcare service provider. Blood components are manufactured in the blood banks and as with all manufacturing units, so raw material is the key,” explains Dr Gautam Wankhede, Director-Medical Affairs/ Marketing, Alliance Transfusion, Gurgaon.
As blood banking activity happens behind the cloak of philanthropy, people seldom talk about revenues generated by selling blood and its components. As Dr Nabajyoti Choudhury, Secretary General, Asian Association of Transfusion Medicine wrote in an article ‘Management in Indian Blood Banking System: True Reality,’ blood banking in the real sense is a production industry with all the components of a business built into it.
Unlike ‘Matrix’ where machines use humans as a power source, cultivating humans and harvesting power from them; blood banks rely on voluntary blood donation. However, whole blood, as collected from donors, is not used as such. It first needs to be tested for infections like HIV, Hepatitis etc. Then the blood is separated into
useful components. Apheresis is a process by which blood is separated into different components, through centrifugation and membrane separation technology. Blood is collected from volunteers so it is free; but the testing, storing and apheresis cost money. To understand the scope of blood banking one needs to know the market size.
Need for blood
At any given point there is scarcity of blood in India. According to a World Health Organisation (WHO) report, India needs 12 million units of blood annually, whereas annual collections are just nine million units. If we consider a simple scenario where one unit of blood costs around Rs 1500, the probable market size of blood in India (1500×12) would be Rs 18000 million (Rs 18 billion/1800 crores) market. Blood and blood components have generated billions of dollars in revenue for entities that deal in non-profit blood supply even though profiteering is not one of the things associated with blood banking.
There are upwards of 3000 blood banks in India. “There are about 2760 registered blood banks in India as per the records of the Central Drugs Standard Control Organization (CDSCO), the national regulatory body for blood banks in India. However, the number of active blood banks may be lesser than this,” says Dr Wankhede. However, Dr Shanta Ghatak, Director, Public Welfare Trust Organisation and Bhoruka Research Centre for Haematology and Blood Transfusion, Kolkata has a different view. “There are around 3042 blood banks in India, mostly in the public sector,” she informs. “A huge black market for blood operates when epidemic diseases like dengue break-out or when rare blood groups are sought,” she adds.
Other than the government, the Indian Red Cross Society (IRCS) is a well known organisation involved in blood collection and supply. Other blood banks are owned and operated by charitable trusts, NGOs or private players. According to Dr Choudhury, about 55 per cent blood banks are operated by the government, five per cent by the IRCS, about 20-25 per cent are run by the NGOs and the rest 15-20 per cent are run by private players. “There is a huge difference when it comes to the ownership of the blood bank. By far, I am sorry to say, the blood banks run by the government come out to be the worst. The blood banks run by corporate sectors are by far better in maintenance and administration as they are conscious of providing better services and do not wish to get into any legal conundrums. Whereas, NGOs are more budget-friendly and generally stick to all rules,” says Dr Jyotsna Codaty, HOD – Transfusion Medicine, Fortis Malar Hospital, Chennai and NABH Assessor for Blood banks, Quality Council of India.
Understanding blood banks
Currently, most of India’s blood banks are hospitals’ in-house blood banks. However, a full-fledged blood bank is not required to be a part of any hospital. Blood banking can be a self-sustained activity wherein blood is collected, processed and supplied to the hospitals and nursing homes of the area. “Normally, a multi-disciplinary hospital with about 500 beds requires 5000-7000 units of blood per year of blood, split into its components like red cells, platelets and fresh frozen plasma. An economically viable blood bank should have collection of 100,000 units of blood per year,” says Mohatta.
“That means a big blood bank should meet about 15-20 hospitals’ requirement of blood. If each hospital tries to accommodate a blood bank, then their in-house blood banks are bound to be inefficient and a burden on the hospital,” he further observes.
Blood donation paradox
“This is one of the biggest reasons for failure of Indian blood banks,” opines Mohatta. “Indian blood banks ask the patient to replace a unit of blood for every unit one wants. This is a sort of barter where fresh blood is available only against blood donated. By banking mainly on replacement donors, blood banks have become complacent and are not motivated to go out and collect blood from voluntary donors,” he adds.
Around the world, most countries encourage voluntary blood donation. Blood is a life-saving medicine and should be available in-stock whenever required. Moreover, a country with a large adult population like India should have no dearth of blood, if collected pro-actively. However, there is little effort to educate and popularise the culture of blood donation in India. “It is the blood bank’s responsibility to collect blood sufficient for their area’s requirement. By asking for replacement they indirectly encourage professional blood donors,” laments Mohatta. Most of the developed nations like Europe and US have more than 95 per cent voluntary blood donors and the rest are direct or autologous donors. No patient is ever asked to organise for the replacement.
Thinking outside the blood
Blood as collected from donors is whole blood. Advancement in the field of transfusion medicine has led to processing of this whole blood to make different lifesaving therapeutic components. About 10 different life saving products can be made from one unit of blood. “The most common components made from blood is packed red blood cells, platelet and fresh frozen plasma; cryoprecipiate and platelet rich plasma (PRP) are also prepared,” informs Dr Wankhede. Plasma can be further fractionated into proteins and immunogloblins. “Cryo-poor plasma can be fractionated into about five main plasma fractions in a complex plasma fractionation factory,” says Mohatta. “The main plasma fractionation products are Albumin, Immunoglobulin, Factor 8, Factor 9, Fibrinogen and some other life-saving products as well,” adds Mohatta.
It is now a well known scientific fact that there is no need for whole blood transfusion in medical science. Still an estimated 50 per cent of blood in India is used as whole blood. It is a waste of precious resource which otherwise can go in making plasma fractions and making India self-sufficient in plasma products. “It is world wide accepted fact, also recognised and strongly recommended by National Blood Transfusion Council (NBTC), that the practice of usage of whole blood should be abolished. Yet, there are no concrete steps to eliminate usage of whole blood. Government should have put a five-year ultimatum to switch to the practice of blood components to all blood banks,” opines Mohatta.
Investing in safety
Infectious diseases continue to be transmitted through blood transfusion and remain one of the main concerns in transfusion medicine today. According to National Aids Control Organisation (NACO), around 1,000 people contracted HIV infection in Maharashtra in 2014 due to blood transfusion and on account of violation of blood donation guidelines during voluntary blood donation camps. Another report said that in the same year a state-run hospital had to throw away 717 units of whole blood due to lack of proper storage facility. “The blood donation drives are usually held on holidays, Saturdays, Sundays and during Republic days and Independence days etc., mostly for politicians to gain mileage; but too much and too many blood bags are wasted due to this utter atrocious practice and mismanagement across the blood banking segments in India,” says Dr Ghatak. In practice, two per cent of the collected blood is discarded annually. “The figures may vary in different blood banks, but it may range from three to ten per cent depending on the screening tests carried out for infectious markers. The most common cause of discarding donated blood remains positivity of infectious markers. However, there are other reasons for discarding the blood components, especially platelets, because of expiry of utilisation date. At times, some units show signs of haemolysis, or fail to meet quality criteria in terms of volume and functionality. These have to be discarded too,” says Dr Wankhede.
Traditionally employed enzyme linked immunosorbent assay (ELISA) techniques and chemiluminescence (CLIA)/ enzyme-linked fluorescence assay (ELFA) are used by blood banks to screen donors. However, the onus of providing safe blood lies with the blood bank, and knowingly or unknowingly, the testing is not 100 per cent accurate. Quality control is unheard of in most blood banks and the lapse in safety is only talked about when a patient contracts infection after the transfusion. Novel methods of screening are expensive but can further guarantee safety. In addition to transfusion transmitted infections (TTI) testing, red cell antibodies screening, nucleic acid testing (NAT) and the newer gel/ bead techniques are being adopted by blood banks. Experts believe that blood processing techniques like leukoreduction, irradiation and pathogen inactivation are expected to play an increasingly important role in enhancing blood safety in future.
Ground realities
It is clear that blood banks need to upgrade and have a stringent quality process, more in terms of GMP to be able to provide blood. “Blood banking system in India is decentralised, while in Western countries it is centralised. Therefore, we see that blood banks have varied practices of blood manufacturing and using different technology. As the technology advances, the cost of blood components go high,” explains Dr Annapurna Ramesh, HOD, Department of Transfusion Medicine and Blood Bank, Fortis Bengaluru.
Investments in this regard have been almost non-existing. Capital cost of setting up a blood bank is very high. “It depends to a large extent on the type of tests and procedures that are to be implemented in a blood bank. The most basic set up would cost anything in the range of Rs 75 lakhs to a crore, whereas the more advanced blood banks with NAT tests and automatic blood grouping and infectious disease testing instruments can cost in excess of Rs four crores to set up,” shares Dr Wankhede. Along with this, there is huge operational cost. “A major expenditure is on the blood banks staff which includes doctors, counselors, camp organisers, lab technicians, phlebotomists, IT personnel, drivers and other workers who need to be well-trained and available 24 hours. Multiple teams are required to carry out simultaneous blood donation camps and run the blood bank at the same time. The heavy machinery requires annual maintenance, regular calibration and breakdown support, besides the electricity and water bill. Most expensive equipment such as refrigerated centrifuge, refrigerators, automated equipment, apheresis machines, etc. have a life of four to five years and have to replaced after this period,” shares Dr Wankhede. Apart from these, there are recurring costs of blood bags, apheresis kits, haemoglobin testing kits, kits for testing infections, blood grouping reagents, glassware, disposables, red cell antibody screening reagents, leucodepletion kits and QC testing reagents. Refreshments for donors are also a part of the recurring cost. “We spend about Rs 1000/ unit of collected blood in fixed cost and Rs, 600/ unit in direct variable cost,” reveals Mohatta.
With such overheads, it’s very difficult to operate blood banks without investors stepping in. “A reasonably modern blood bank might cost Rs nine to ten crores without the cost of land and building. Only self sustaining blood banks which can recover the cost can dream of such an investment,” says Mohatta. “Internationally, a blood bank collecting, processing and distributing about 100,000 units of blood per year is considered economically viable. World’s biggest blood bank, New York Blood Centre (NYBC) collects, processes and distributes more than 600,000 units of blood per year. There are more than 100 blood banks in the world, collecting, and processing above 100,000 units of blood per year. In contrast to international blood banks which collects 100,000 units of blood per year, India’s biggest blood bank collects about 25,000 units/year. At a low level of operations, it is difficult to sustain and afford modern equipment,” laments Mohatta. For blood banks to be self – sustainable and be able to provide affordable and safe blood it is important to increase the number of units processed. “Internationally, blood banks are mainly run by ‘not-for-profit’ organisations. The initial investment comes from grants and loans, then they continue to grow with their own income. Blood banks can go for forward with integration and start plasma fractionation. Higher level of activity at a given fixed cost can make it possible for them to distribute very high quality blood components at a service charge of about Rs 400-500 per component in India, without asking for replacement,” shares Mohatta.
Regulatory woes
In India, blood is categorised as a life-saving ‘drug’ and comes under the purview of the Drugs and Cosmetic Act (D and C Act), 1940 and Drugs and Cosmetics Rules, 1945. CDSCO is the national regulatory body for blood banks in India. However, NACO/ NBTC play the advisory role and are main technical body to frame guidelines for the practice of transfusion medicine. “CDSCO, headed by the Drugs Controller General (India), is the authority that enforces regulations at the central level, while every state has a regulatory body to oversee the blood banks in their territory. NABH has a set of standards for granting accreditation basis which they award a certificate to a blood bank,” informs Dr Ramesh.
The National Blood Policy (NBP) was published by the Government of India in consultation of NACO in 2002. Many experts feel that CDSCO may need more partners to regulate and monitor blood banks as it is only equipped to look at legal aspects pertaining to infrastructure, equipment, spacing and staff neglecting the medical and quality aspects of transfusion medicine.
Accreditation for blood banks is a new and voluntary step taken to assure quality. Talking about NABH’s involvement in accreditation of blood banks, Dr Codaty says, “NABH monitors all quality systems. Though its primary concern is that all government regulations are abided in letter and spirit and it further adds checks and balances, working on their set of standards to plug any loopholes where an error is likely to happen. Presently, there are only about 60 NABH accredited blood banks in the country but they are doing sterling work.”
Making way for centralised banking
Centralised blood testing is the norm internationally, as they successfully ensured quality, economy and bulk processing of blood samples. “Central blood testing centres should have highly automated environment of bar-code, ERP, NABH/ NABL accreditation and ability to collect blood samples from across the country and electronically transfer the results in the shortest possible time. Central blood testing centre should again be a ‘not-for-profit’ centre, preferably a part of RBTC with a permission to accept blood samples from any blood centre,” opines Mahatta. In fact, the government was also in favour of centralised blood banking.
“At one time, the centre had mooted a high-tech, fully component, central blood bank for each state with licenses only for storage centres. These storage centres could give blood to people who need it. Later, these storage centres can submit their requisition and draw from the central blood bank. This is an international system and has been functioning well in most advanced countries,” shares Dr Codaty. “Having mooted it and allocated space for infrastructure, it came to naught and a good idea was wasted. Today, the government issues licences for whole blood even after knowing that the need of the hour is its components,” she laments.
Change is inevitable
There are winds of change in the blood banking and transfusion medicine sector. With the help of associations like Indian Society of Transfusion Medicine and Asian Association of Transfusion Medicine along with federation of Indian, non-government blood banks, the industry must push for reform, mostly in improved testing.
Increased participation in National Haemovigilance Program of India, which seeks to monitor recipient adverse transfusion reactions, should be encouraged by peers. All the stakeholders must join hands to advocate uniform pricing and highest safety standards for blood and components along with safe transfusion practices. The emphasis should be on adopting IT in blood banking. And lastly, pre-operative autologous blood donation (PABD) in elective surgeries should be popularised.
mneelam.kachhap@expressindia.com