The National Agency for Food and Drug Administration and Control (NAFDAC) has ordered for the manufacturing of the anti-malarial drug, Chloroquine, for emergency stock for possible clinical treatment of COVID-19 patients.
Director-General of NAFDAC, Prof. Mojisola Adeyeye, said in a statement on Monday, March 30, 2020 that the agency had approached a local manufacturing pharmaceutical company, May and Baker, to produce the drug.
Adeyeye said that the company 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 to produce the drug as an antimalarial many years ago before the discontinuation.
“The managing director expressed possible difficulty in getting the API, because the drug has been discontinued.
“He called shortly after that, saying 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 NAFDAC 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 as well as 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.
“They should have previously reported the products for clinical trial treatments in reputable scientific journals, or technical literature as safe as well as effective.
“Other researchers in France and U.S. have used the drug for clinical trial treatment of COVID-19 and they also reported effectiveness of the drug.
“Chloroquine as an old antimalarial is repurposed for the clinical trial treatment of Coronavirus,” Adeyeye said.
The 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 strict compliance of the clinical trial protocol guidelines.
The use of Chloroquine as an antimalarial was discontinued in Nigeria several years ago because of the resistance that the parasite developed against the drug.