To address the shortage of human albumin in the country on a priority basis, National Pharmaceutical Pricing Authority (NPPA) is contemplating to invoke paragraph 3 of DPCO (Drug Price Control Order) -2013 which empowers it to issue directions to the manufacturers for regulating distribution of drugs, in case of emergency or in case of non - commercial use in public interest with a view to achieve its adequate availability.
Meanwhile, the drug pricing regulator has also approached the Union health ministry to look into the issues associated with the availability, supply and shortage of plasma, which is scarcely available and required on a large scale for producing human albumin at an optimum level.
In an interview with Pharmabiz, NPPA stated, "Ministry of Health and Family Welfare (MoEF) has been requested to look into the issues related to shortage and supply of plasma. NPPA is also contemplating to invoke para 3 of DPCO - 2013 with reference to exports of human albumin by certain manufacturers." NPPA has further emphasized that albumin shortage in the country is not related to price control but due to the non-availability of human plasma required for its production on a large scale.
NPPA had capped the price of one ml albumin injection of 20 per cent at Rs.36.66 after bringing it under Drug Price Control Order (DPCO) -2013 to make it affordable to the public.
According to stockists, human albumin is currently scarcely available with prices ranging between Rs.3,897 and Rs.4,092 for 100 ml respectively. Pharmaceutical companies like Bharat Serums and Baxter were among the major manufacturers, importers and suppliers of albumin in Indian markets. After slashing of prices by the NPPA, they have stopped supply to domestic markets.
As per para 3 of DPCO -2013, NPPA may give directions to manufacturers of active pharmaceutical ingredients or bulk drugs or formulations (i) with a view to achieve adequate availability and to regulate the distribution of drugs, in case of emergency or in circumstances of urgency or in case of non - commercial use in public interest, direct any manufacturer of any active pharmaceutical ingredient or bulk drug or formulation to increase the production and to sell such active pharmaceutical ingredient or bulk drug to such other manufacturer(s) of formulations and to direct formulators to sell the formulations to institutions, hospitals or any agency as the case may be.
Ahmedabad-based Intas Pharmaceuticals and Mumbai-based Reliance Life Sciences are the only two manufacturers producing albumin through their own facilities currently, according to sources. Reliance Life Sciences is, however, also 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.
NPPA chairman Injeti Srinivas informed,“The present supply level is around one million vials per annum. Reliance Life Sciences is the major producer 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."
He further said that the NPPA had held elaborate discussions with the manufacturers and found that price is not the constraint. In fact, Reliance has expanded its capacity to one million vials per annum, but it is unable to produce at that level due to limited availability of plasma. Further, there are restrictions on import of human plasma due to safety concerns. Reliance Life Sciences has also stated in writing that the ceiling price for human albumin is not at all a constraint.
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.