An acute shortage of human albumin, a life saving blood product under price control, is being experienced for some months now endangering the lives of several lakhs of patients in the country. Shortages have been reported particularly in pharmacies and hospitals in cities like Mumbai, Pune, Delhi, Kolkata, Chennai, and Ahmedabad. Pharmaceutical companies namely Reliance, Intas, Bharat Serums and Baxter are the major manufacturers and suppliers of albumin in India. Human albumin is a protein in human plasma of the blood which is produced in liver. Plasma separated from the whole blood is fractionated to produce many life-saving components such as Factor VIII, fibrinogen, albumin, and gamma globulin. Albumin maintains levels of calcium in the body and transports nutrients or drugs effectively into the blood stream. The human body can suffer a shortage of albumin if the patient is affected by liver disease, kidney failure, burns and malnourishment. Perhaps the main reason for the current shortage of albumin in the country is its inclusion of under the price control by the National Pharmaceutical Pricing Authority. The price fixation of the product by NPPA last year, considering its essentiality, has triggered its shortage in the country. Inclusion of albumin under DPCO is being opposed by the pharma companies on grounds of viability and the supplies of the product to hospitals and pharmacies started shrinking since then. To what extend that kind of a stand by the pharma companies is justifiable is a question to be decided with a humanitarian perspective.
One fundamental issue with regard to availability of albumin is its limited production in the country. Supplies of the product cannot match the growing demand even before the product was brought under price control. Regulatory authorities and policy makers should have addressed this matter long ago considering the demand growth of albumin in view of the dramatic change in the disease profile of the country. It is a product sourced from the human blood and with exploding population of the country there should not be any shortage of blood at any time. Here, the real problem is the fact that nearly 80 per cent of the blood collected is transfused as whole blood to the patients. The practice of fractionation of blood into separate components such as fresh frozen plasma, cryoprecipitates, platelet concentrates, etc. is not widely prevalent. If a unit of blood is fractionated that can meet the requirements of more than one patient. Treating many ailments, transfusion of only specific components is required not the whole blood. The components also have a better shelf life than the whole blood. In the wake of acute shortage of albumin across the country, Drugs Controller General of India has already written to the Department of Pharmaceuticals to address the matter expeditiously. The larger issue here is the limited fractionation capacity for blood components in the country. There is an urgent need to augment the capacity for blood fractionation by major hospitals throughout the country. That can only be the ideal and long term solution to this growing problem and not imports.