DCGI Current Affairs - 2020

CSIR: Clinical Trial of “Sepsivac” drug on critically ill COVID-19 patients

On April 22, 2020, the Council of Scientific and Industrial Research announced that it is to go for clinical trials on critically ill COVID-19 patients.

Background

The Drugs Controller General of India recently approved the trial of “Sepsivac”. The drug is available commercially. With the DCGI approving the drug, CSIR is to start clinical trials of the drug.

Currently, India is working on the strategy of repurposing of drugs.

Sepsisvac

The drug is used to treat Gram Negative Sepsis patients. The symptoms and ailments of both critically ill COVID-19 patients and Gram Negative Sepsis patients are almost similar.

The immune response of these patients is altered with a massive change in Cytokine profile. The major cause of death of COVID-19 patients is cytokine storm. During the cytokine storm, the immune system of the body starts attacking both infected and uninfected cells.

Cytokines

Cytokines are produced in human body in response to infections. There are different types of cytokines. They are interferons, lymphokines, interleukins and tumor necrosis.

DCGI approves COVID-19 drug to reduce mortality rate

On April 20, 2020, the Drugs Controller General of India (DCGI) approved trial of a drug to reduce mortality rate of COVID-19 patients.

Highlights

The COVID-19 drug that was developed by the Cadila Pharmaceuticals along with Council of Scientific and Industrial Research (CSIR) is to enter into trial. The clinical trial has been approved by DCGI. The drug had been used to treat critically ill patients suffering from Gram Negative Bacterial Sepsis.

Gram Negative Bacteria

Gram Negative Bacteria with Sepsis is a systematic disease that are caused by micro-organisms. It is common in children with weak immune system. Gram Negative Bacteria are those bacteria that have strong membranes around their cells than the gram positive bacteria. This makes them much more difficult to treat.

Sepsis

Sepsis is a life-threatening condition. Normally, human body released chemicals into the blood stream to fight an infection. When the chemicals in the bloodstream go out of balance, sepsis occurs;

Why used for COVID-19?

The patients suffering from COVID-19 and Gram Negative Bacterial Sepsis have similarities and hence the drug is being used to treat patients suffering from COVID-19. The drug used to treat Gram Negative Bacterial Sepsis has been proved to be safe and has not reported any systemic side effects so far.