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 NAFDAC approves Chloroquine mass production after clinical trials in China

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For possible clinical trial treatment of COVID-19 patients, the National Agency for Food and Drug Administration and Control (NAFDAC) has approved mass production of emergency stockpile of Chloroquine.

NAFDAC Director-General, Prof. Mojisola Adeyeye, disclosed this in a statement in Abuja on Monday.

 

Chloroquine was reported to have demonstrated marked efficacy and acceptable safety in treating COVID-19 associated pneumonia in multi-centre clinical trials conducted in China.

The study, which involved 10 hospitals in Wuhan, Jingzhou, Guangzhou, Beijing, Shanghai, Chongqing and Ningbo, was reported to be superior to controlling pneumonia associated with COVID-19 and shortening the cause of the disease.

Nigeria discontinued the use of Chloroquine as an anti-malaria drug many years ago because of the resistance the parasite developed against the drug.

Adeyeye, however, said sourcing the raw material — Active Pharmaceutical Ingredient (API) chloroquine phosphate — could be difficult because its was discontinued in the country years ago.
“About four weeks ago, I approached a local drug manufacturing company in Nigeria (May and Baker), a member of Pharmaceutical Manufacturing Group of Manufacturing Association of Nigeria (PMGMAN), 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 antimalarial many years ago before the discontinuation. But my fear is possible difficulty in getting the API due to the fact that the drug has been discontinued long ago.

“But a few days after, they called that they were able to get the API, and I asked them 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.

She warned Nigerians against using it without a medical doctor or clinician’s prescription 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,” she warned.
The DG said the agency would ensure that the clinical trial protocol guidelines are followed.
“NAFDAC wishes the clinical research teams great success in stopping the raging pandemic.”
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