NAFDAC approves emergency production of chloroquine


The National Agency for Food and Drug Administration and Control (NAFDAC) has directed the manufacturing of chloroquine for emergency stock for possible clinical trial treatment of coronavirus.

The agency’s director general, Prof Mojisola Adeyeye, said in a statement that the drug was reported to have functioned as anti-viral at both the entry and post-entry stages of the coronavirus infection.

She also said chloroquine was reported as potential broad spectrum anti-viral drug.

The director general said Lagos would begin clinical trial of the drug to evaluate its effectiveness.

She called on the public to desist from using the drug without the guidance of a medical doctor or clinician for cases of clinical trial treatment of COVID-19.

“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.

“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 potential broad spectrum antiviral drug. 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 a multi-center clinical trial 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 the pneumonia associated with COVID-19, and shortening the course of the disease,” she said.

Adeyeye further stated that chloroquine was discontinued in Nigeria many years back for use as anti-malarial because of the resistance that the parasite developed against it.

“Therefore, sourcing the raw material – active pharmaceutical ingredient- 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, 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 anti-malarial many years ago before the discontinuation,” she added.

She said despite the 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.

“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,” said Adeyeye.


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