Mumbai: Ten blood banks receive plasma licence, but access still an issue

MUMBAI: Despite a nod for ‘off-label’ use of the convalescent plasma therapy, city clinicians said that access to the blood component is shrouded in bureaucratic tangles. Primarily, most blood banks in the city don’t have the licence to extract plasma and can get one only after applying to the state Food and Drug Administration (FDA).
Secondly, and perhaps more importantly, most physicians themselves are unclear about how to administer and where to source it from.This has even led to skirmishes between families and treating doctors in hospitals. In one such incident, the treating doctor asked the family to get written permission from the Drug Controller General of India (DCGI) that he was allowed to administer plasma to the patient. “The local DCGI officer never responded to the family’s letter,” a source said.
Plasma therapy, which is being trialled world over, including in India and Maharashtra, couldn’t be administered outside of trial till June 13 when the Union health ministry included it among investigational therapies and allowed its off-label use on compassionate grounds for moderately ill patients. But, soon doctors realised there weren’t many blood banks that had the licence to carry out the process of apheresis (involves removal of whole blood from a patient or donor, separation of plasma from whole blood and re-transfusion of remaining components to the patient/donor).
Clearing the air, FDA officials said that they have issued a circular on Monday allowing selective use of plasma therapy on moderately ill patients. The circular also states that hospitals must maintain proper records that can be shared with DCGI or ICMR, if the need arises.
FDA chief Arun Unhale said they have expedited granting of licences to blood banks. “So far, we have given the nod to 10 banks in the city and review of two more applications is in process. Many more have been given permissions in the state. Looking at the urgency, we are giving permission in two days,” he said. While banks have to submit applications to FDA, a joint scrutiny is done by FDA and the local DCGI’s office.
A senior blood transfusion expert said many donors are ready to donate, but currently only Nair Hospital accepts donations under the trial. “If more banks are allowed, more donors will come forward,” he said.