The Director General of the National Agency for Food and Drugs, Administration and Control (NAFDAC), Prof. Mojisola Adeyeye has said that the absence of stringent punishment for manufacturers of substandard products was a morale booster for its manufacturers, suppliers, retailers and others in the supply chain.
Adeyeye disclosed this on Tuesday, October 11, 2022, while answering questions filed by journalists at a Press Briefing On The Substandard (Contaminated) Paediatric Cough Syrups Circulating In Gambia held in Abuja.
TheFact Daily recalls that NAFDAC, on Sunday, October 9, 2022, alerted Nigerians on four substandard (contaminated) paediatric cough syrups circulating in Gambia following a global alert issued by the the World Health Organisation (WHO) on July 5, 2022 warning that they (the cough syrups) could be linked to acute kidney injuries and the children’s deaths in July, August, and September in The Gambia.
According to the warning, the substandard syrups, Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup, were manufactured by an Indian company known as Maiden Pharmaceuticals.
The NAFDAC Boss said interviews conducted on bereaved parents in The Gambia by health authorities and law enforcement agencies revealed how their children were not able to pass urine after being given the syrups.
She explained that, as their condition worsened, efforts to save their lives were fruitless which resulted in the death of over 66 children. This, she said was “a worrisome development which once again beams a searchlight on the essence of effective regulation and control of medical products.
“As a member of the WHO Programme on International Drug Monitoring and following our active participation in the WHO member state mechanism on substandard and falsified medical products, NAFDAC is leaving no stone unturned in ensuring that these products do not cause harm to our people.
“As part of our regulatory controls, NAFDAC have issued an alert to the public on the Public Alert No. 039/2022 – Alert on Substandard (contaminated) paediatric cough syrups circulating in Gambia. This alert has been widely circulated on our website and all social media handles and sent to all health care providers on our database as well as professional bodies and association in the medicine supply chain”, Prof. Adeyeye said.
Speaking on the Counterfeit and Fake Drugs and Unwholesome Processed Food (Miscellaneous Provision) Act, the NAFDAC DG disclosed that a public hearing was held recently on the Bill for an Act to repeal it and a new one was being enacted to ensure strong deterrent measures and protect citizens from harmful products.
“This bill will increase the penalty to make sure that there is deterrence. It backs us up on our enforcement. When somebody is caught with tramadol, and that person is sentenced to five years or fined N250,000, who doesn’t know that the person will just use his ATM card?
“So the C-34 bill will be more strengthened so that there is deterrence. When we think of strong regulatory agencies in the world, it is because they have strong deterrent measures,” she said.
“In the US, if your company is worth $200 million, and you violate the rule, the US Food and Drug Administration will fine you $215 million. So there is the fear that if one do wrong, they will lose everything.
“So the average company or practitioner is on the edge, they are on their toes to make sure that the products they are making have quality. This is because of the strong system. So we are looking up to that in our C-34 bill,” she further informed.