Codeine: NAFDAC goes after firms distributing banned syrup in Nigeria

The National Agency for Food and Drug Administration and Control (NAFDAC) said it has commenced investigation on involvement of four pharmaceutical firms responsible for the distribution of codeine cough syrup in the country.

Director General of NAFDAC, Prof Mojisola Adeyeye, told newsmen on Thursday that the Agency was determined to get to the bottom of the matter.

The agency said appropriate sanctions would be applied for regulatory violations.

The pharmaceutical firms located in Lagos, Ilorin and Kano were linked to illicit supply and distribution of codeine, as contained in the documentary of an undercover investigation unveiled recently by BBC Africa.

The product was recently banned by the Nigerian government.

Adeyeye said: “As we speak, our inspection and enforcement teams are in the premises of the four pharmaceutical companies that were shown in the video. Our officials are there putting things on hold, and everything is being documented. When completed, we will prepare our report and then we will take appropriate action.

“The teams have got cartons of one of the products from one company in Ilorin and it has been put on hold. When we go for inspection and enforcement, the Standard Operating Procedure is utilised, so, if products that are fake or substandard are discovered, such products will be seized and destroyed.”

She described the magnitude of codeine syrup abuse in the country as unfortunate, however, said companies found culpable would not be spared. She said: “These companies that were caught, from our records, have limited amount of codeine, but from what the documentary showed there is indication that the production is more than the quantity that was approved. So the question can be asked, was there smuggling involved?

“Our findings will determine what happens next, but ordinarily we will take and destroy products, and if we go through their books and we find they have committed violations, sanctions will apply, and for having loose distribution chain, we will not give you permit for renewal.

“We have to start from somewhere and it is unfortunate that it is tragedies like this that are forcing us to start from somewhere. NAFDAC has not done optimally what it is supposed to do, we are supposed to be inspecting these companies at least once a year, but we are so limited in our capacity. We do not have vehicles to inspect fully.

“I met with my directors, what we decided as a regulatory agency is that what we are going to do is put a temporary ban or embargo on issuance of permits for codeine, because we have had a lot of problem with distribution of the products.

“Yes it is a ban, but a ban that needs time and concerted efforts. The ban will be in place until we all get our act together because we cannot just continue the way things are now. It is to enable us to have enough time to address the issues that needs to be addressed.”

On the absence of NAFDAC at the Ports, she said: “NAFDAC going back to the Ports has not been resolved. The letter has been written to get us back to the Ports from the Presidency, but what I heard lately is that the letter is now with the Ministry of Trade and Industries for vetting. We have not received it and until we receive that letter, we will keep having problems like this.”

“If NAFDAC is not at the Ports, it would not just be codeine, or Tramadol, or fake Augumentin but worse. Once we are in the ports, we would not have as much problems as we are currently having. “NAFDAC is not perfect, but let them be given full support and responsibility of carrying out their mandate,” she said.