India Can Reduce Its Life-Saving Plasma Deficiency

India Can Reduce Its Life-Saving Plasma Deficiency

KOCHI, 20 OCT 2019:


Blood transfusion services (blood banks) have the dual responsibility of providing both a sufficient blood supply and ensuring the quality and safety of blood for patients. Blood, being a perishable entity, has to be constantly replenished. This requires recruitment of new individuals as blood donors and their retention to constantly renew the blood stock. In most cases, blood is donated freely, but when the same blood is issued to the patient, an exorbitant amount is charged. Blood centres are selling freely donated blood and making money.


The charges levied are for processing of the collected blood into components like red cells fresh frozen plasma, platelets and cryoprecipitate, mandatory screening for the five most important transfusion transmissible diseases, storage of blood components at optimum conditions to maintain viability, and compatibility testing between the donated unit and recipient before issuing the same. The maximum amount that can be charged for issuing blood is stipulated in the guidelines issued by the National Blood Transfusion Council from time to time.


Blood banks in India are given license to function by the Drugs Controller General of India. The entire functioning of the blood bank, including the personnel working, standard operating procedures to be followed, reagents and equipment to be used, its calibration, documents or records to be maintained are defined in the Drugs and Cosmetics Act 1940 and the license is issued only after a thorough audit of the bank. Guidelines for selection of blood donors, processing charges of blood and blood components, bulk transfer or issue of blood between banks is guided by the National AIDS Control Organisation. In short, no blood bank can take a decision on its whims and fancies.


Till recently, 100 per cent of plasma-derived medicinal products (PDMPs) were imported to India at exorbitant rates and hence inaccessible to the majority of patients. The National Plasma Policy was formulated in 2014, after a series of public interest litigations. The policy aims for making available adequate supply of high quality of PDMPs for clinical and therapeutic use at affordable rates in India. Plasma fractionation centres came up in Mumbai and Chennai under public sector, but the projects failed to take off due to flaws in operational and management systems.


The major hindrance was the availability of safe plasma as raw material consistently. The increasing volumes of surplus plasma (fresh frozen plasma has a shelf life of one year) in the blood banks which has been tested and found safe can be best utilised for this. The National Plasma Policy enables mobilising of this excess plasma stocks from blood banks to plasma fractionation centres for productions of PDMPs, thus enabling easy accessibility and affordability. Stringent regulatory and legislative measures to ensure compliance and robust quality management systems are in place for plasma collection, transportation, processing, production and distribution of PDMPs along with rigorous penalties for unauthorized or irregular practices in plasma processing and delivery of PDMPs under the National Plasma Policy.


The goal is to achieve 80 per cent component preparation in the blood banks (current is only 40 per cent) within the next three years. The surplus plasma in the blood banks can be optimally utilised by plasma fractionation for the manufacture of life-saving PDMPs. The New Indian Express