Blood banks provide plasma to sustain limited supply of human albumin in city

Even as there is acute shortage for human albumin across the country, Mumbai-based blood banks are providing the vital blood component called plasma required to manufacture albumin on a sustainable basis.

Though Reliance Life Sciences is 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 now imports every year fractionated components valued at more than Rs.50 crore.

According to stockists, human albumin is currently scarcely available with prices ranging between Rs.3897 and Rs.4092 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 up to Rs.36. 66 after being brought under Drug Price Control Order (DPCO) -2013 issued by the National Pharmaceutical Pricing Authority (NPPA). Albumin is an essential life-saving drug which should be priced reasonably, according to NPPA.

Cerus' Intercept Blood System for plasma receives US FDA approval

The US Food and Drug Administration (FDA) has approved Cerus Corporation's Intercept Blood System for plasma. The Intercept plasma system is approved for ex vivo preparation of plasma in order to reduce the risk of transfusion-transmitted infection (TTI) when treating patients requiring therapeutic plasma transfusion.

The Intercept Blood System inactivates a broad spectrum of enveloped viruses, non-enveloped viruses, Gram-positive and Gram-negative bacteria, spirochetes and parasites.

While current screening tests for a limited number of pathogens have lowered the risks from transfusion-transmitted infections, these tests are reactive approaches, requiring identification of specific pathogens for which tests can then be developed and implemented. In contrast, pathogen reduction by inactivation is a proactive safety measure-- the process can inactivate susceptible viruses, bacteria, and parasites present in plasma components independently of whether they have been identified as specific blood supply risks. This is critical because there is typically a lag between the emergence of new pathogens, and the recognition that an additional safety intervention may be needed.

"We believe this approval to be a pivotal step toward giving US blood centres a proactive approach for protecting the plasma supply," said William ‘Obi' Greenman, Cerus’ president and chief executive officer. "Cerus’ 22 year commitment to improving transfusion safety has been essential to achieving the US approval for Intercept plasma, and our continued work with FDA on reaching an approval decision for the Intercept Blood System for platelets."