30th March, 2020
The National Agency for Food and Drug Administration and Control (NAFDAC) has ordered the manufacture of Chloroquine for an emergency stock and clinical trial for the treatment of coronavirus(COVID-19).
The Director-General of NAFDAC, Prof. Mojisola Adeyeye, made this known in a statement on Monday.
According to her, “In a very recent publication, chloroquine was reported in a press briefing by the State Council of China, indicating that chloroquine phosphate had demonstrated marked efficacy and acceptable safety in treating COVID-19 associated pneumonia in multi-center clinical trials conducted in China.
“The study involved 10 hospitals in Wuhan, Jingzhou, Guangzhou, Beijing, Shanghai, Chongqing and Ningbo, and 100 patients. The investigators reported that chloroquine phosphate is superior to the control in inhibiting pneumonia associated with COVID-19, and shortening the course of the disease.
“Chloroquine was discontinued in Nigeria many years ago for use as antimalarial because of the resistance that the parasite developed against the drug. Therefore, sourcing the raw material – active pharmaceutical ingredient (API) – chloroquine phosphate could be difficult.
“About four weeks ago, I approached a local manufacturing company (May and Baker), a member of Pharmaceutical Manufacturing Group of Manufacturing Association of Nigeria (PMGMAN), whose flagship product in the past was chloroquine to make a batch of the drug for emergency stock. The company had NAFDAC approval for the production of the drug as antimalarial many years ago before the discontinuation.
“The Managing Director expressed possible difficulty in getting the API due to the fact that the drug has been discontinued. He called shortly after that he was able to get the API and was asked 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”.
“As stated in my press briefing on March 20, 2020, 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.
“Other researchers in France, the US have used the drug for clinical trial treatment of COVID-19 and they reported 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”.
NAFDAC, therefore, advises the public to desist from the use of chloroquine without the guidance of a medical doctor or clinician for cases of clinical trial treatment of COVID-19.
The agency noted that it has side effects such as gastrointestinal upset, blurred vision, headache, and pruritis (itching).
The itching can be relieved by using antihistamine.
Prolonged use can also cause retinopathy or vision impairment.