In the wake of the fact that there has been an acute shortage of human albumin across the country for more than six months, Drug Controller General of India (DCGI) has now written to the Department of Pharmaceuticals (DoP) to address the shortage in the interest of patient safety.
DCGI has assured that any matter related to getting clearances and NOCs would also be prioritised and expedited so that the shortage can be addressed on a war footing. Says Dr G N Singh, DCGI, "We have approached the Department of Pharmaceuticals (DoP) to proactively deal with the scarcity of human albumin that has impacted the entire country in a big way."
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.
Reliance Life Sciences have been awaiting central government's approval on imports of plasma required for its production on a large scale. Official sources inform that Reliance is currently supplying human albumin under its brand Albu Rel to limited hospitals based on the demand.
Plasma separated from whole blood is fractionated to produce many useful life-saving components such as Factor VIII, fibrinogen, albumin, and gamma globulin. India imports fractionated components valued at more than Rs.50 crore annually.
While hospitals, distributors and retail pharmacies have run out of supplies, shortages have also been reported in pharmacies and hospitals in cities like Mumbai, Pune, Delhi, Kolkata, Chennai and state like Gujarat.
Shortage of albumin can be attributed to the fact that the drug has been brought under DPCO-2013. "In such a scenario, some manufacturers might also resort to exporting the drug at higher prices for the sake of earning good profit," says a Mumbai-based health expert.
According to stockists, human albumin is currently scarcely available with prices ranging between Rs.3,897 and Rs.4,092 respectively. Pharmaceutical companies like Reliance, Intas, Bharat Serums and Baxter were major manufacturers and suppliers of albumin in Indian markets. After slashing of prices by the NPPA, they have stopped supply to domestic markets.
The price of one ml albumin injection of 20 per cent has been capped at Rs.36.66 after it was brought under DPCO -2013 issued by the NPPA. Albumin is an essential life-saving product which should be priced reasonably, according to NPPA. Stockists, however, argue that government should ensure that any drug policy should not only be aimed at affordability but also viability so that its availability is ensured.
It has also been reported that human albumin low sodium of 20 per cent strength in 100 ml used to cost around Rs.4,904 but was sold at a higher price of Rs.5,980 due to the shortage following NPPA price cut. The emergency drug which is generally being used as a life saving drug in cases of severe blood loss or in trauma cases was earlier being imported by few companies in India.