Yemisi Izuora
The National Agency for Food and Drug Administration and Control, NAFDAC, has given its approval for production of Chloroquine for emergency stock for possible clinical trial treatment for Coronavirus.
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.
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.