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.
The Director-General of NAFDAC, Prof. Mojisola Adeyeye, said in a statement on Monday that the agency had approached a local manufacturing pharmaceutical company; May and Baker to produce the drug.
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 the its effectiveness.
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“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 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.
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“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.
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 discontinued in Nigeria many years ago for use as antimalarial; because of the resistance that the parasite developed against the drug.