NAFDAC orders production of chloroquine for COVID -19 clinical trials
The National Agency for Food and Drug Administration and Control (NAFDAC) has directed the manufacturing of chloroquine for emergency stock for possible clinical treatment of the coronavirus otherwise known as COVID-19.
Director-General of the agency, Prof. Mojisola Adeyeye, in a statement made available to journalists on Monday, said that the old anti-malarial drug is now being repurposed for the clinical trial treatment of COVID-19.
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Adeyeye said the decision follows the use of chloroquine in other countries to treat the coronavirus.
She said that “other researchers in France and US have used the drug for the 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.’’
She also explained how chloroquine was demonstrated in China to be effective in treating COVID-19, adding that “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-centre clinical trials conducted in China.
“The study involved 10 hospitals in Wuhan, Jingzhou, Guangzhou, Beijing, Shanghai, Chongqing, Ningbo and 100 patients. The investigators reported that chloroquine phosphate is superior to the control in inhibiting the pneumonia associated with COVID-19, and shortening the course of the disease.”
Adeyeye explained further that chloroquine was discontinued in Nigeria many years ago for use as anti-malarial because of the resistance that the parasite developed against the drug, but now she has approached a manufacturing company to make a batch of the drug for emergency stock.
“About four weeks ago, I approached a local manufacturing company (May and Baker), a member of the Pharmaceutical Manufacturing Group of Manufacturing Association of Nigeria (PMGMAN), whose flag ship 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 anti-malarial 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.”
NAFDAC however, advised the public to desist from the use of chloroquine without the guidance of a medical doctor or clinician for treatment of COVID-19.
NAFDAC boss noted that the drug has side effects such as gastrointestinal upset, blurred vision, headache and itching.
She added that through her regulatory activities of NAFDAC, it would ensure that the clinical trial protocol guidelines are followed and wished the clinical research team great success in stopping the raging pandemic.
