NAFAC DG Approves Mass Production of Chloroquine.
The DG of NAFDAC, Prof Mojisola Adeyeye, on monday has directed the mass production of Chloroquine for emergency stock for possible treatment of the COVID-19 virus.
She noted that Lagos would begin clinical trial of the drug to evaluate its effectiveness, while calling on 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.
She said, “Chloroquine, an old anti-malarial, is being re-purposed for the clinical trial treatment of coronavirus 2019-nCoV. 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.
According to Adeyeye, despite initial difficulty expressed by the managing director of the company, the hurdle was later removed, leading to the production of the drug with more to be manufactured.
She added, “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 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. 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.
“NAFDAC advises 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. 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.”