Shardul Nautiyal, Mumbai
Thursday, September 24, 2020, 08:00 Hrs [IST]
Plasmapheresis for convalescent plasma (CP) therapy is the need of the hour for treating mild to moderate COVID-19 cases supplemented with drug prescribed by infectious disease specialists. It is a short term measure, but an effective one till an efficacious drug or vaccine is available in the market, according to experts.
This is very urgently required as there are only close to 60 plasma banks in the country and hospitals have been struggling to get donors for CP therapy. Blood banks in India are finding it extremely difficult to offer CP on a regular basis to hospitals for COVID-19 patients due to shortage of plasmapheresis machines.
Plasmapheresis is a process in which the liquid part of the blood, or plasma, is separated from the blood cells. Typically, the plasma is replaced with another solution such as saline or albumin, or the plasma is treated and then returned to the body.
“A COVID-19 patient requires 400 ml of plasma and plasmapheresis gives 500 ml of plasma in one sitting as a maximum collection granted by FDA from a human blood while component separation centrifuge method from whole blood gives 200 ml in one sitting or session. As per Indian Council of Medical Research (ICMR) guidelines issued on June 13, 2020, plasma collection should be done by centrifugal separation using an apheresis machine or equipment at the healthcare facility,” said transfusion medicine expert Rajnish Giri.
The issue of unavailability of titration kits has also been raised by clinical experts, blood banks and blood transfusion medicine doctors in the past based on the premise that plasma IgG titer stipulated as per ICMR guidelines of above 1:640 cannot be validated in Indian healthcare settings due to lack of testing kits for the same.
“More than 70,000 patients have been treated with convalescent plasma in the country. It is easily available and cheap, unlike specific drugs or vaccines that will take time to develop, test and produce. The only cost involved in CP therapy is in extraction and storage,” explained pharma consultant Dr Sanjay Agrawal.
Clinical experts have revealed that one can get effective plasma depending upon antibodies available in plasma of recovered COVID-19 patients in the early stages. “Apheresis is not only used for plasma collection for COVID-19 patients but also provides platelets for cancer patients, dengue patients among others.
Transfusion medicine as a specialty has evolved at a faster pace over the last few years and has changed the scenario of blood banking and transfusion cell therapy. It is an untapped market for doctors and hospitals towards optimum utilization of modalities and techniques such as red cell exchange, bone marrow transplant, stem cell, granulocyte collection, immuno-adsorption procedure etc. Today, transfusion medicine doctors are well equipped with the technology and can play a key role for implementation of CP therapy,” Giri further explained.
Dedicated cell in state food and drug administrations (FDA’s) and Central Drugs Standard Control Organisation (CDSCO) for blood banks must be created for implementation of newer medical advancements like CP therapy aligned with the norms of State Blood Transfusion Council (SBTC), National Blood Transfusion Council (NBTC) and corporate hospital blood bank associations, he further added.
“Plasmapheresis is as safe as a blood transfusion. The US Food and Drug Administration (FDA) has approved use of CP for COVID-19 only for
severe or life threatening cases. It makes sense because convalescent plasma is a limited resource and it would be improper to use it extensively in asymptomatic and pre-symptomatic patients for prophylaxis,” concluded Anshu Yadav.
When it comes to West Zone of India, it has less plasmapheresis licenses due to stringent FDA approvals especially with reference to Mumbai which is lacking Infrastructure facility like plasmapheresis machine, trained technicians and lack of compliance to FDA, SBTC, NBTC norms. Not much has been effectively done on this front as compared to North India and South India in terms of treating COVID patients. The turnaround time for getting a license is 15 to 60 days for many standalone blood banks which apply for license for plasmapheresis in the country.