Blood components in India: collections, processing and safety

A recent Clearstate study found nascent but growing demand for platelet aphaeresis in India, driven by disease outbreaks, procedural demand and clinician awareness.

Blood banking infrastructure:
India maintains a heterogeneous system of blood banks run by government, private hospitals and independent organisations. There are about 2600 blood banks in India. Roughly one-third of all blood banks are in the government sector, often attached to medical college and other large public hospitals. Public blood banks are geared towards supporting a vast low-income segment of the population, collecting and providing blood to patients at relatively low prices.

Another third of blood banks in India are managed by private / corporate hospitals in large cities, which typically collect blood from middle- and higher-income patients, and charge higher for blood as for other care and services. The final one-third of blood banks is comprised of independent private facilities, typically small commercial units or larger centres run by non-profit organisations such as Rotary and Red Cross.

Whole blood dominates blood collections in India
Under the Indian regulatory system, blood banks must obtain separate licences for blood storage, collection, component separation and component collection. According to licensing records of the Central Drugs Standard Control Organization, approximately 90% of blood banks are involved only in whole blood collection and distribution.

Whole blood collections reached 8.5 million units in 2008, well short of WHO standard requirements based on population. A small majority of whole blood collections is from voluntary donors, and their share is expected grow by about 2% every year. With payment to donors banned, the other key segment is directed or replacement donors – especially important at hospital blood banks.

Blood components: Aphaeresis collections remain rare, but demand is growing
About 250 blood banks are equipped to process previously collected whole blood into components such as red blood cells, platelets and plasma. About 100 blood banks have the capabilities to directly collect components via aphaeresis – mainly platelets. Aphaeresis capability is currently limited to blood banks associated with government medical colleges in the public sector, and those associated with corporate hospitals in the private sector. Adoption rates have varied by state particularly in the government sector; top territories to date are Maharashtra, Delhi, Chandigarh, Gujarat and Tamil Nadu. There is a countrywide push for aphaeresis adoption, with the National AIDS Control Organisation tasked with providing financial and infrastructural support to blood banks to enable collection of safer blood.

Platelet aphaeresis collections are conducted only on demand and almost exclusively from replacement donors, due to high cost of kits and short platelet life span. Donors are typically pre-screened for infectious disease and transfusion reaction markers. Double dose collections are rare, due to scarcity of eligible donors and apprehensions about impact on donor health.

Whole blood collections will grow at 10–15% during the forecast period; aphaeresis collections will follow at 10% leaving respective shares of total collections unchanged. Private hospital-based blood banks are likely to lead aphaeresis adoption over the next few years, since they find the new process more efficient (fewer donors are required to prepare one dose) and profitable (patients are charged higher for single donor platelets from aphaeresis, than for random donor platelets processed from whole blood). Charitable and government hospitals continue to rely on cheaper random donor platelets, which their typically poorer patients can afford.

Dengue outbreaks, growth in relevant procedures such as chemotherapy and transplants, and growing awareness among clinicians are key factors driving growth of aphaeresis in India. The top barrier remains cost; other important barriers are low demand from clinicians and poor interest from donors.

Blood safety situation: Awareness and government efforts are improving blood safety
Increasing reliance on voluntary donors has steadily improved blood safety in India over the past decade. Since the ban on paid or professional donors, HIV transmission through blood has fallen from 9% of all HIV cases in the late 1990s to 1.03% currently.

All blood collected in India is tested for (a) HIV I and HIV II antibodies, (b) Hepatitis B Surface antigen, (c) Hepatitis C virus antibody, (d) VDRL, and (e) malarial parasites. Mandated bacterial screening is most prevalent at blood banks, and is often the only regular quality control measure employed at smaller blood banks. The regulated 1% is widely considered a sufficient check, because the closed system used in component separation is perceived to eliminate risk of bacterial contamination. The second most popular measure is leuko-reduction, typically performed ad-hoc for recipients of multiple transfusions such as thalassemia patients.

A handful of large blood banks in the private sector perform Nucleic Acid Testing for infectious disease markets. NAT is prohibitively expensive and in its infancy, but looks set to grow in line with growing awareness of haemo-vigilance. Most NAT sites currently use mini-pool tests first to keep costs low, exploring further if a batch tests positive for any pathogen.

Kavitha Hariharan, Associate at Clearstate