Direct off-label plasma use sans approval hints at racket

Nagpur: Recovered Covid-19 patients and citizens volunteering to help critical patients may not be aware that they are unknowingly becoming part of alleged convalescent plasma racket.
The off-label plasma use, authorized by Drug Controller General of India (DGCI) and Indian Council of Medical Research (ICMR) across India, has been permitted under strict supervision of a three-layered process involving the state’s Project Platina task force, dean’s committee and preliminary assessment officer, who is a doctor.
The convalescent plasma of moderate recovered patients is assumed to carry antibodies which help in fighting the novel coronavirus. Seniors doctors at government medical colleges are worried about the growing trend of convalescent plasma being sought openly on social media citing it as matter of life and death. Many gullible donors are instantly responding to the seemingly emergency alerts bypassing the scrutiny.
Of late, a lot of messages are being posted on social media giving requirements about the needy patient, blood group and contact number.
When TOI posed queries to a couple of people sending such requests, they hung up saying they would call back later. TOI asked how and where the plasma is being collected and if DGCI, ICMR or Food and Drug Authority (FDA) had given permission to them.
This paper also spoke to a couple of recovered patients soon after they donated their plasma at certain blood banks in the city on Saturday.
Sources said some enterprising recovered patients are putting their plasma on sale as can be seen in many WhatsApp posts doing rounds with name and numbers. Amid this, calls have been made for regulation of plasma collection and donation which seemed to have gone unchecked.
Project Platina task force officials referred TOI queries to FDA, which is the nodal agency for allowing plasma use as a drug under emergency authorization. FDA joint commissioner Mahesh Gadekar didn’t answer to TOI’s calls and messages.
FDA officials confirmed that only GMCH and IGGMCH were permitted to collect convalescent plasma for Covid-19 treatment in the city.
Stakeholders admitted there is lack of proper awareness regarding donation and how to make requests in emergencies which has led to the matter spilling on to social media.
Sources said the convalescent plasma is being allegedly traded upwards of Rs10,000 per bag while it is collected for free from donors.
A man, whose mother is admitted in a private hospital on Kamptee road, said he paid Rs7,700 on Saturday and Rs10,000 per bag around 10 days bag. The man was directly asked to bring the plasma. “The hospital asked me to bring it on my own. I circulated online appeals and approached a blood bank. The bank charged me and also asked to provide a donor,” he said, adding that he had to run pillar to post to arrange the life-saving resource.
Another man said he read an appeal on WhatsApp for a doctor admitted in a private hospital in Ramdaspeth. The donor agreed he failed to ensure if his plasma would go to intended beneficiary.
3-layered scrutiny
* The treating physician/hospital needs to send an e-mail to the state Project Platina task force for off-label plasma use and justify the need
* The email is immediately forwarded to the concerned doctor who assesses the application
* If found fit, it is forwarded to the dean’s committee for final approval
* The committee needs to have a quorum of two members from task force to approve the use
* This takes not more than 3 to 4 hours.
Guide for volunteers
* The donor needs to directly walk in at GMCH or IGGMCH, as per officials
* Here, blood sample is collected and sent for testing the antibody titer
* Antibodies are present in recovered patient who need to fulfil another set of criteria to become eligible for convalescent plasma donation
* If found eligible, the donor is called again for plasma extraction