In order to address the shortage of the life-saving drug human albumin in the country, the Maharashtra Food and Drugs Administration (FDA) is now planning to help the manufacturers procure unutilised plasma from the blood banks in the state to cater to the demand which stands at over 70,000 vials per month in the country, according to official sources. The manufacturers, however, are able to produce only half of the current demand.
There are 309 blood banks across the state of Maharashtra and the state FDA is currently in consultation with the blood banks on the issue. Blood bank officials say that Maharashtra is equipped with 250 component separation facilities out of the 450 facilities in the country to supply plasma to help boost the production of human albumin to cater to the demand.
There has been a six-fold increase in blood donation camps across the state leading to an increase in whole blood collection from 3.6 lakh units in 1997 to 14.76 lakh units last year. This has led production of plasma to increase to the tune of 2 lakh litres annually.
According to a senior FDA official, prices of plasma has increased globally because of its consumption and therefore it also has a bearing on the cost of albumin. It has now become non-profitable for the companies to manufacture it globally and therefore imports have also been impacted and have literally stopped.
The technology to produce albumin is capital intensive. A fractionation unit costs worth Rs. 500 to Rs. 600 crore to process 6 lakh litres or even more of plasma to produce the vital human albumin. The production of albumin therefore depends on the unit’s capacity to produce albumin. The shortage of human albumin in the country can be attributed to the limited number of plasma fractionation centres in the country, major ones being Navi Mumbai based Reliance Life Sciences and Intas Pharmaceuticals.
It has been learnt that blood banks primarily stock whole blood based on voluntary blood donation drives. Therefore expert opine that there is a need to strengthen the blood banks in BMC run hospitals in Mumbai to aggressively take up component separation to generate packed cells, platelets and plasma on a consistent basis. Simultaneously, there is a need to develop peripheral hospitals in the city on the lines of blood storage centres, the expert says.
Blood availability through voluntary donation is increasing but no serious effort is made to maximise the use of every unit of blood procured by blood banks. Blood need to be separated into packed cells or RBCs, platelets and plasma for its maximum utilisation."The problem can be addressed in its entirety if the concept of component separation is implemented on ground," experts suggest.
Human albumin serum is a protein in human plasma of the blood which is produced in liver. It maintains levels of calcium in the body and transports nutrients or drugs effectively in the blood stream. The body can suffer a shortage of albumin if a patient is affected by liver disease, kidney failure, burns, malnourishment, etc.