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New Regulations Needed: To Test & Implement Plasma Therapy for COVID-19

Plasma Therapy may decrease fatality from COVID-19 but testing and implementing it will require a change in the regulatory regime, says Avi Singh.





Some early stage reports suggest that harvesting blood plasma - a component of blood, separate from blood cells, containing proteins - from patients who have recovered from COVID-19, and giving it to those who are critically ill may be a treatment option.  If this holds, it will decrease fatality from COVID-19 and positively affect the contours of this public health crisis. The Karnataka and Delhi governments have asked for clinical trials for plasma therapy for coronavirus. The Indian Council of Medical Research (ICMR) has too.  But the power rests with the Drug Controller General of India and other central agencies. Also, implementing these trials and the therapy (if proved successful) will require a change in the regulatory regime for plasma collection. Here is the why and how:  - In 1996, the Supreme Court of India banned ‘professional’ blood donors and established a National Council for Blood Transfusion (NBTC), centralized regulatory powers and directed other key changes in the regulatory system.  - This move was needed. It was a reaction to the frequent selling of blood by people and the unregulated nature of the industry. It has led to comprehensive regulations (especially safety regulations) on the licensing of blood banks. But it effectively added to the shortage of an already scarce blood supply in the country and didn’t consider its potential impact on plasma protein therapy.  - Today Plasma is only allowed to be collected in blood banks but for the bulk of blood banks the focus remains blood collection. Even if plasma is to be extracted, it is extracted from the blood donated. This is a problem because for the purpose of plasma therapy, only plasma of donors with a particular profile should be taken directly, and not as a byproduct of blood donation. This is why India has to import most of its human plasma products such as albumin, immunoglobulins and other proteins- and why they’re often scarce. - However, the Drugs and Cosmetics Rules do not lay out sufficient regulations for the profiling of plasma donors and ensuring them reasonable compensation. Also, there are severe regulations on the amount of plasma one can donate and on the frequency with which this can be done.  - There is also poor infrastructure to extract, screen and transport the plasma. On the whole, India has a weak fractionation (a separation process in which a mixture is divided into smaller quantities with varying compositions) capability.  - For plasma therapy to be tested and used (if and where it is proved effective), plasma regulations must be amended so that profiled, specific donors are allowed to donate more than the limited amount for fair (and regulated) compensation.  - Finally, to address the infrastructural deficiencies, private hospitals and companies will have to be allowed to set up plasma collection centres. 

Read the full article here:https://www.thequint.com/voices/opinion/coronavirus-potential-treatment-plasma-therapy-drug-controller-clinical-trials


Avi Singh is an advocate who specialises in transnational law and serves as the Additional Standing Counsel for the government of NCT of Delhi. #regulations #plasma #plasmatherapy #COVID-19 #regulatoryregime #AviSingh #bloodcells #proteins #treatment #publichealthcrisis #Karnataka #Delhi #clinicaltrials #ICMR #IndianCouncilofMedicalResearch #DrugControllerGeneralofIndia #DCGI #centralagencies #plasmacollection #SupremeCourt #blooddonors #NationalCouncilforBloodTransfusion #NBTC #safetyregulations #bloodbanks #plasmaproteintherapy #bloodcollection #donors #blooddonation #albumin #immunoglobins #India #DrugsandCosmeticRules #profiling #infrastructure #regulations #fractionation #plasmaregulations #compensation #privatehospitals #companies #plasmacollectioncentres 


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