Maharashtra FDA, CDSCO jointly issues licenses to 39 blood banks to produce plasma for convalescent plasma therapy for COVID-19 patients

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With convalescent plasma (CP) therapy proving efficacious for COVID-19 patients, the Maharashtra Food and Drug Administration (FDA) and Central Drugs Standard Control Organization (CDSCO) have jointly issued licenses to 39 blood banks to produce plasma in the state to facilitate CP therapy for COVID-19 patients.

State FDA and CDSCO issuance of license is also a big boost to the Maharashtra government’s recently launched Project Platina which aims to treat 5,000 COVID-19 patients through CP therapy by August, 2020. “As of today 400 units have been produced and close to 250 units being used up to treat COVID-19 patients in the state,” according to an official associated with the development.

CP therapy involves convalescent plasma to be transfused into critical patients to boost their immune response to COVID-19 Union health ministry has allowed its off-label use on compassionate grounds for moderately ill patients since June 13, 2020. Plasma donations take from 45 minutes to an hour after basic tests are run on the donor. After this, a certificate is given to the donor acknowledging his service. Any COVID-19 patient who recovered from the disease 14 days prior is eligible to donate plasma. The donor should weigh at least 50 kilograms and be in the 18-60 age group.

Touted to be the world’s largest plasma therapy trial for treatment of COVID-19 patients with severe symptoms, Maharashtra government launched Project Platina aimed at enhancing chances of survival of serious COVID-19 patients by providing free plasma therapy at 21 government-run centres in Maharashtra, including four in Mumbai.

“It will be world’s largest trial cum treatment project, where in we intend to benefit and save around 500 lives of critically ill COVID-19 patients of Maharashtra. The donors are available in large numbers,” the state government had said in a press statement. “This trial will help formulate definite treatment guidelines for the entire country in managing serious COVID-19 patients and thus be a milestone in turning a page in the pandemic,” the state government said.

Considering the growing demand for convalescent plasma for COVID-19 patients, Central Drugs Standard Control Organization has fast-tracked approvals for plasma banks to boost clinical trials and therapy for COVID-19.

Plasma banks have been set up in Delhi, Kolkata, Punjab, Rajasthan and Mumbai. CP therapy has gained a lot of prominence in the country amidst growing demand for medicines like remdesivir and tocilizumab among other expensive drugs. Clinicians strongly recommend CP therapy as a feasible one as plasma can be stored for a year at a temperature of minus 30 degree centigrade.

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