The National Agency for Food and Drug Administration and Control, NAFDAC, has ordered the manufacturing of Chloroquine for emergency stock for possible clinical treatment of COVID-19 patients.
The Director-General of NAFDAC, Prof. Mojisola Adeyeye, said in a statement on Monday that a local manufacturing pharmaceutical company, May and Baker had been approached to produce the drug.
Mrs Adeyeye said that the company, which flagship product was Chloroquine in the past, had produced a batch of the drug for emergency stock for the treatment of COVID-19.
She said Lagos State would start a clinical trial on the drug to evaluate its effectiveness.
“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.
“The company, whose flagship product in the past was Chloroquine, has produced 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,” she said.
The director-general said that the agency had earlier at a press briefing on March 20, gave expedited provisional approvals for the manufacture of any commodity for preventing the disease and drug or medical device that could be used for the clinical trial testing and treatment of the virus.
She said 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 and U.S have used the drug for clinical trial treatment of COVID-19 and they reported effectiveness of the drug.
“Chloroquine as an old antimalarial is being repurposed for the clinical trial treatment of Coronavirus,” Mrs Adeyeye said.
NAFDAC chief 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.
She said that the agency, through its regulatory activities, would ensure that the clinical trial protocol guidelines were followed.
Chloroquine was discontinued in Nigeria many years ago for use as antimalarial because of the resistance that the parasite developed against the drug.