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Maharashtra FDA directs blood banks to supply plasma to tide over albumin shortage
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Shardul Nautiyal, Mumbai
October 29 , 2016
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The Maharashtra Food and Drugs Administration (FDA) has sent a directive
to the blood banks in the state to help manufacturers procure
unutilised plasma from the blood banks to address the shortage of the
life-saving drug human albumin in the country. There are 309 blood banks
across the state of Maharashtra.
Meanwhile, Drug Controller
General of India (DCGI) has also granted approval to the manufacturers
to import plasma to tide over the shortage.
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.
Says Maharashtra FDA Commissioner Dr
Harshadeep Kamble, “Based on our deliberations with the manufacturers
and blood banks, the state FDA has sent a directive to blood banks to
supply surplus plasma on a commercial basis so that both the parties can
mutually take the process forward.”
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 Ahmedabad based Intas Pharmaceuticals.
Demand
for plasma currently 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.
Out of the 450
facilities in the country, Maharashtra is equipped with 250 component
separation facilities to be able to supply plasma 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.
This has led production of plasma to increase to the tune of 2 lakh
litres annually.
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.
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.
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