Though the Central Government has allowed the use of convalescent plasma therapy on moderately ill COVID-19 patients as of June 13, there appears to be some confusion among hospitals and doctors with regard to administering this form of treatment.
The concern here arises from the fact that blood banks across Mumbai do not have the required license to extract and store plasma. These permissions can only be acquired through the state’s Food and Drug Administration or FDA.
The FDA, meanwhile, has issued a clarification stating that they have posted a circular on Monday permitting the use of plasma therapy selectively on moderately ill COVID-19 patients. Additionally, hospitals conducting this treatment are required to maintain all relevant records so that it can be sent over to the Indian Council of Medical Research (ICMR) or the DCGI if and when required.
With regard to granting licenses to blood banks, FDA head Arun Unhale said that the governing body has already provided licenses and required permissions to 10 blood banks in Mumbai, while two more applications are said to be currently under process.
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He added that given the urgency of the matter, blood banks are receiving permissions within 2 days. Applications are required to be submitted to the FDA which will then be reviewed jointly by the FDA and the Drug Controller General of India (DCGI).
The process of extracting plasma and conducting the treatment, known as apheresis, involves separating the plasma from a blood sample and re-transfusing it to the patient.
A blood transfusion expert has said that institutions like Nair Hospital are only allowing plasma donations on a trial basis, which effectively means that those willing to donate plasma can’t do so at the moment.
The Maharashtra State Government recently introduced ‘Project Platina’ which is aimed at expediting plasma therapy on patients to have a detailed data set for future reference.
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