Even as there are limited facilities available in India to manufacture human plasma at a scale sufficient enough to produce human albumin for the ailing patients, the NPPA is scheduled to meet National Aids Control Organisation (NACO) on February 25, 2015 on supply gap issues related to shortage of human plasma in the country.
Several states in the country continue to reel under severe shortage of life-saving drug human albumin due to shortage of human plasma. NPPA chairman Injeti Srinivas has, however, clarified that the albumin shortage in the country is not related to price control as reported by market sources but due to the unavailability of human plasma required for its production on a large scale.
As it is given to understand from various quarters of the industry, that import of plasma is as well being restricted due to safety concerns. It is also a known fact that Reliance Life Sciences is awaiting an approval to import plasma for its facility to work at an optimum capacity. The NPPA NACO meet is going to explore the solutions on these burning issues among others with the end objective of making it available to the patients at the right time in an affordable manner.
Against the backdrop of restricted supply of the life saving drug human albumin in several parts of the country, NPPA had held elaborate discussions with the manufacturers and found that price is not the constraint. In fact, Reliance Life Sciences have stated in writing that the ceiling price for human albumin is not at all a constraint. Reliance has also expanded its capacity to one million vials per annum, but it is unable to produce at that level due to limited availability of human albumin.
Reliance Life Sciences is the major producer of human albumin accounting for nearly 6 lakh vials per annum. Baxter supplies around 3 lakh vials, which are entirely imported from their principals. The rest account for around one lakh vials. "The supply level has not significantly dipped in the past few months, but shortages may be due to supply-gap as compared to demand', the NPPA chairman said.
Human albumin is currently scarcely available with prices ranging between Rs.3,897 and Rs.4,092 respectively for 100 ml. Intas, Bharat Serums and Baxter are major manufacturers and suppliers of albumin in Indian 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 NPPA.