Harboursandport.com: Lagos - The National Agency for Food and Drug Administration and
Control, NAFDAC, has approved the manufacturing of Chloroquine for emergency
stock for possible clinical trial treatment for Coronavirus.
Announcing this in a press statement, the Director-General of
NAFDAC, Prof Christiana Adeyeye disclosed that the Agency has already
approached a local manufacturing company (May and Baker), whose flagship
product in the past was chloroquine to make a batch of the drug for emergency
stock.
Adeyeye said the company had NAFDAC approval for the production of
the drug as antimalarial many years ago before the discontinuation.
She recalled that chloroquine was discontinued in Nigeria many
years ago for use as antimalarial because of the resistance that the parasite
developed against the drug, adding that, sourcing the raw material – active
pharmaceutical ingredient (API) – chloroquine phosphate could be difficult.
According to her, “Chloroquine, an old antimalarial is currently
being repurposed for the clinical trial treatment of COVID-19. The drug was
first tested in vitro (in the lab) using standard assays to measure the effects
on the cytotoxicity, virus yield and infection rates of 2019-nCoV.
The drug was
reported to function as antiviral at both the entry and post-entry stages of
2019-nCoV infection. Chloroquine has also recently been reported as a potential
broad-spectrum antiviral drug.”
Giving an update on the discussion with the company, she said
although the Managing Director expressed possible difficulty in getting the API
due to the fact that the drug has been discontinued, he was able to get the
API.
She said the company has been directed to manufacture a batch
for emergency stock just in case more people become exposed and infected with
the virus.
“The batch has been manufactured and the company plans to make
more batches if needed. “NAFDAC is giving expedited provisional approvals for
the manufacture of any commodities for preventing contracting the disease
(sanitizers) and drug or medical device that could be used for the
clinical trial testing and treatment of COVID-19 pandemic.
“The Agency had reduced the 120 working days for approval to 10
days due to the crisis. The products should have been previously reported for
clinical trial treatments in reputable scientific journals or technical literature
as safe and effective.”
The Director-General added that other researchers in France,
United State, US have used the drug for the clinical trial treatment of
COVID-19 and they reported the effectiveness of the drug.
“Lagos State will be starting a clinical trial on chloroquine to
evaluate the effectiveness. Chloroquine works by increasing endosomal pH
from the acidic environment required for virus/cell fusion, resulting in the
inhibition of infection of SARS-CoV. It also interferes with the
glycosylation of cellular receptor, angiotensin-converting enzyme 2. This may
inhibit the virus-receptor binding and terminate the infection. The antiviral
and anti-inflammatory effects of chloroquine contribute to the efficacy in
treating COVID-19 patients,” She stated.
Continuing, the agency advised the public to desist from its use
without the guidance of a medical doctor or clinician for cases of clinical
trial treatment of COVID-19 because of its side effects such as gastrointestinal
upset, blurred vision, headache and pruritis (itching).
She stated that the Agency, through her regulatory activities
will ensure that the clinical trial protocol guidelines are followed while
wishing the clinical research team great success in stopping the raging
pandemic. The mandate of NAFDAC is to safeguard the health of the country.
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