5 Things You Need to Know About Remdesivir Clinical Trial in Nepal for the Treatment of Covid-19
A drug being used to treat hospitalized and critically ill coronavirus patients is being tested in Nepal.
The drug has been recommended for patients by some doctors in Nepal for some time now and details have been made public that it is being bought and sold at a high price.
Government authorities have also said they are “aware of this” and “should not do so.”
According to him, the hospital and doctors designated for testing the drug will be able to use it only with the written prior approval of the patient.
What is Remedesivir?
For some patients in Nepal, the most expensive drug is Remedesivir, developed to treat the Ebola virus.
It is being tested in various countries.
The drug was initially approved by the US Food and Drug Administration (FDA) as an emergency medicine for the treatment of coronavirus infections.
Experts say that the drug, manufactured by the American company Gilead, is also being manufactured by companies around the world with its approval.
It was decided that Nepal would also participate in the World Health Organization’s ‘Solidarity Trial’.
However, officials at the Nepal Health Research Council said the government was testing the drug itself after the organization said it could not immediately make it available to Nepal due to a lack of it.
According to government officials, there are five things to know about the drug being tested in Nepal:
1. Permission for testing only
Authorities say remedicivir coronavirus can only be used in Nepal as a trial.
Authorities from the Ministry of Health, the Nepal Health Research Council and the Department of Drug Administration said many were promoting the drug as accessible to all.
According to him, the drug cannot be prescribed by a doctor or used by a patient.
Narayan Prasad Dhakal, Director General of the Department of Drug Administration, says that the drug cannot be “sold in a pharmacy”.
Member Secretary of the Nepal Health Research Council, Dr. Pradip Gyawali also said that the drug is currently only approved for testing in Nepal.
“The ubiquitous practice of any ‘clinical trial’ is that it cannot be sold in the market,” he said.
“It is not possible to get it even after being prescribed by a doctor. It can be done only after the completion of the fourth stage ‘clinical trial’.”
Remedesivir is a drug in the third phase of clinical trials.
Doctors claim that the drug is being used in many hospitals in Nepal, even though government officials claim it can only be used for testing.
Doctors at some of the hospitals at Covid-19 treatment center confirmed to the BBC that Remedesivir was being sold at exorbitant prices and was widely used, on condition of anonymity.
DDA Director Dhakal also said that such details have come.
He said, “As the number of cases has increased in our country, we have heard that it was brought by some people through smuggling. It cannot be bought anywhere. But people have got it.”
2. Not a certified medicine
The drug has not been confirmed to cure Covid-19.
But tests in various countries, including the United States, have shown that patients who have been given the drug will soon recover from Covid-19.
Tests in the United States also found that patients recovered faster.
3. Pre-approval of the patient is mandatory
According to the council, the drug is currently being tested in about 100 people in Nepal.
For this, a group of doctors from 15 hospitals has been formed in the public and private sectors.
These physicians are only allowed to use the drug with the written consent of the patient.
Every detail should be kept and if the patient does not use the medicine, it cannot be used.
“If the patient does not want to take it, it has to be stopped,” Gyawali said.
4. Patients cannot be charged
According to Gyawali, member secretary of the council, the fee for the medicine used during the test cannot be paid to the patient.
“Patients don’t pay after research,” he said.
“Either the company or the institution or the government should bear the cost. We are also managing the budget for that.”
He said the council had already received permission from the health ministry for the test but more decisions were needed on the budget.
However, he said that it would not be done in Nepal as it would not be possible to collect fees from patients during trials all over the world.
5. 11 doses to the serious patient
Authorities said that only those patients who showed symptoms of Covid-19 and were admitted to the intensive care unit would be tested for Remdesivir.
According to him, the patients admitted to the ICU with normal symptoms will be given two doses for the first time and then one dose each and six doses for five days.
Similarly, patients who need to be kept on a ventilator are initially given two doses and then one dose at a time and given 11 doses of remedicivir in 10 days.
At present, three companies have been allowed to import the drug to Nepal for testing, said Dhakal.
According to him, the other 12/15 will also bring but the department has not yet made a decision.
According to Dhakal, each company is now allowed to bring a total of 6,000 doses of medicine at the rate of 2,000 / 2,000 doses.
Currently, the lowest bidder among the drug importers has offered Rs 6,400 per dose.
Dhakal informed that some others have proposed to bring the medicine at the rate of Rs 4,500 per dose.
- Department of Drug Administration Important Notice Regarding Remdesivir Injection
- Beximco Pharmaceuticals has Launched the First Generic Remdesivir- BEMSIVIR
- Quality of Essential Medicines in Public Health Care Facilities of Nepal, 2019
- Essential Medicines (Drugs) Concept
- Department of Drug Administration- DDA Important Information Regarding Recall of Medicine
- Department of Drug Administration Notice Regarding Misinformation of Covid-19
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