NAFDAC Approves Chloroquine Production for Clinical Trial

pharmacy

The Director General, National Agency for Food and Drug Administration and Control (NAFDAC) Prof. Moji Adeyeye, has approved the production of chloroquine for clinical trial in Nigeria, following the publication of two clinical trials in China and USA recently.

Adeyeye made the disclosure in a press conference at the NAFDAC office, Oshodi, Lagos, on Friday.

Explaining reasons for the temporary production approval of the antimalarial, which was banned 14 years ago due to the resistance of plasmodium falciparum to chloroquine, she said clinical trials done in China and Minnesota have shown that chloroquine is safe and superior in the control of COVID-19 and associated pneumonia, but it must be used on prescription by a medical doctor.

She said: “Chloroquine has been found earlier to have broad spectrum anti-viral property, aside from the anti-inflammatory and antimalarial properties that we all know it for.

“Mechanism of action by which chloroquine act is by increasing the endosomal PH, i.e when you have a cell and inside that cell, there are different organelles, and the virus thrives when there is acidic PH. So chloroquine prevents the virus from replicating itself.

“Chloroquine also suppresses low inflammatory cytokine, i.e if somebody has an injury and there’s inflammation, chloroquine will subdue it, but all these are in vitro evidence that was why the agency reverted to a report published in China on the clinical evidence of chloroquine in the treatment of coronavirus”.

She further explained that the clinical trials involved 100 patients, 10 hospitals and six cities.

“It was done quickly to test clinical safety and efficacy with treatment of associated pneumonia with COVID-19.It was reported in the article that chloroquine is safe and superior in the control of associated pneumonia to the virus.

“It was found that it reduces the viral load and shortens the time to get better from severe to mild cases. The strength prescribed in the study was 500mg twice a day for 10 days”, she stated.

Following the publication of the China’s clinical trial on chloroquine for the treatment of coronavirus, the NAFDAC boss narrated how she urgently called on the May & Baker managing director, Pharm. Nnamdi Okafor, as a pharmaceutical company known for its brand of chloroquine then, to see the possibility of manufacturing a batch for trial use in Nigeria.

Being a banned drug, she noted that Okafor expressed some initial difficulty in getting the Active Pharmaceutical Ingredient (API), which he was able to resolve later, and a batch of the drug was produced two weeks ago in the country.

“Being a banned product, I knew that it will be difficult to get raw material for chloroquine. So I called a manufacturing company May & Baker, Managing Director, a member of PMGMAN, whose flagship product in those days was chloroquine and they were known for it.

“I asked the MD to see how the tablet can be manufactured, though he expressed possible difficulty initially in getting the API, but he called me later that he was able to get the API. So I asked him to manufacture a batch for us in Nigeria, and the batch was ready in two weeks ago and the company plans to make more batches if needed”, she explained.

Approval for other pharma companies and adverse effects of chloroquine

She however highlighted the side effects of the drug to include: gastrointestinal upsets, blurred vision, headache and itching. Prolonged use can also cause eye impairment known as retinopathy. It has to be used with caution and prescription by a medical doctor.

“NAFDAC will give emergency production approval of chloroquine or hydroxychloroquine products to other pharmaceutical companies, which have documented scientific evidence of efficacy in prophylaxis treatment in any population.

“That is what NAFDAC is supposed to be doing and that is what we are doing”, she asserted.

Adeyeye also urged researchers for more scientific evidence on the use of chloroquine for treatment of the viral disease, saying safety and efficacy is paramount and based on the former use of the drug, this has been established.

May & Baker’s reaction to the emergency approval

Speaking with the May & Baker Managing Director, Pharm. Nnamdi Okafor, in a telephone interview, he said the approval for clinical trial was a pragmatic approach to address the situation, as it has been used in China, though research is still ongoing on the usage for coronavirus.

“We commend the government for the initiative, as it is a pragmatic way to address the situation, though research is still in progress”.

Asked on how many batches the pharmaceutical company can produce to tackle the outbreak in Nigeria based on recommendation, he said that can’t be determined for now, as the number of cases in the country has not been thoroughly established, due to lack of disclosure from members of the public, already showing symptoms of the disease.

“We have been receiving calls in the last 48 hours from Nigerians who are having symptoms or whose relations who just returned from abroad are showing signs of the disease, on how to get the drug, but these people are not willing to disclose their status to relevant authorities.

“So we will produce as much as we can, when we start receiving orders from government and private hospitals in the country”, he assured.