In the wake of reports of surplus plasma being wasted in some blood banks, the Union health ministry has now permitted blood banks having component separation facility to exchange their surplus plasma with indigenous fractionators in the country based on a uniform exchange value of Rs. 1,600 per litre of plasma.
Demand for plasma currently stands at over 70,000 vials per month in the country, according to official sources. The manufacturers, however, are able to produce only half of the current demand.
“The health ministry's approval is a welcome change to help blood banks provide surplus plasma to indigenous fractionators in the country under the conditions that the fractionators must undertake to fulfill needs of Indian market first. None of the products recovered from the Indian plasma should be exported before fulfilling domestic demand,” according to a senior health ministry official.
According to a senior official, prices of plasma has increased globally because of its consumption and therefore it also has a bearing on the cost of life saving human albumin. The current shortage of human albumin in the country can also be attributed to the limited number of plasma fractionation centres in the country. It has now become non-profitable for the companies to manufacture it globally and therefore imports have also been impacted and have literally stopped.
The technology to produce albumin is capital intensive. A fractionation unit costs worth Rs. 500 to Rs. 600 crore to process 6 lakh litres or even more of plasma to produce the vital human albumin.
The modalities for use of exchange value would be finalized by the respective State Blood Transfusion Councils (SBTCs) and would be primarily directed towards ensuring availability of plasma derived products to patients requiring them.
As per the conditions of the approval, there is a provision for buy back of plasma derived products of equivalent value for clinical use by needy patients accessing care at the institution where the blood bank exchanging the plasma is located.
Blood component separation units would directly enter into an agreement with the fractionators, as per the mutually agreed terms and conditions approved by respective SBTC before sending plasma for fractionation.
Feedback would be provided by fractionators to NBTC or respective SBTC in order to provide evidence of the quality of the plasma being fractionated so as to enable corrective and preventive action.
NBTC would review the fractionators periodically so as to prevent any misuse of this strategy. All blood banks must ensure taking of the informed consent of the blood donor for allowing the use of his blood for fractionation and derivation of essential plasma derived medicines there-from.