• 25 Jan 2021
• Admin
• News Article

Gujarat FDCA Issues Licenses To 16 More Plasma Banks To Maintain Adequate CP Supply For Covid-19 Management

The Gujarat Food and Drug Control Administration (FDCA) has issued licenses to 16 more plasma banks to maintain adequate convalescent plasma (CP) supply for Covid-19 management.As of today, there are 28 functional plasma banks in the state of Gujarat. The state regulator has also been urging the Drugs Controller General of India (DCGI) to encourage use of CP therapy in Covid-19 patients.“CP therapy is safely administered on patients strictly on the supervision and prescription of the doctor. The condition of the patient is also considered while administering CP therapy. There is also demand for CP across the state but we are following the protocols and guidelines based on the fact that not every patient should be given CP. Besides this, there is no price control on CP which is why we are closely monitoring its supplies,” informed Gujarat FDCA Commissioner Dr H G Koshia.As per the ICMR advisory, indiscriminate use of CP therapy is not advisable. It is speculated that CP having low concentration of specific antibodies against SARS-CoV-2 may be less beneficial for treating Covid-19 patients as compared to plasma with high concentration of such antibodies.This advisory therefore embraces the principle that a potential donor for convalescent plasma should have sufficient concentration of antibody working against Covid-19 as narrated in the matrix below. It also highlights that presence of antibody against Covid-19 in a potential recipient makes transfusing convalescent plasma a futile intervention.Based on ICMR PLACID trial conducted in 39 hospitals across the country, it was, however, concluded that CP therapy did not lead to reduction in progression to severe Covid-19 or all-cause mortality in the group that received CP therapy as compared to the group that did not receive CPT.Based on the PLACID trial, the Central Government has also been considering removing CP therapy from the national clinical management protocol for Covid-19.However, clinicians have contested that clinical trial studies to prove the efficacy of CP therapy are still ongoing and need some more time to arrive at the right conclusion in the interest of patient safety.An evidence based advisory was also issued by the ICMR to the stakeholders to address inappropriate use of convalescent plasma in Covid-19 patients.As per the ICMR advisory, CP therapy or passive immunotherapy has been tried in the past for treatment of viral infections like H1N11, Ebola and SARS-CoV-13 etc. Benefits of CPT in improving the clinical outcomes, reducing severity of disease, duration of hospitalization and mortality in Covid-19 patients are dependent on the concentration of specific antibodies in convalescent plasma that could neutralize the effects of SARS-CoV-2.The appropriate age for CP donation is between 18 and 65 year three to seven days from onset of symptoms but not later than 10 days. There should be screening to rule out ABO incompatibility and blood borne pathogens such as HIV, HBV, HCV etc. There should be required concentration of IgG antibody against Covid-19 Titre of 1:640 (ELISA) or 13 AU (Absorbance Unit)/mL9 (CLIA) or Neutralising Antibody Titres of 1:80 (PRNT/MNT), as per the advisory.