Onyebuchi Ezigbo in Abuja
As part measures to combat the sale of substandard and falsified medicines in the country, the National Agency for Food and Drug Administration and Control (NAFDAC) has said that it would not hesitate to clamp down on wholesale and retail outlets where fake drugs are dispensed for public use.
The agency said that it had started engaging stakeholders in the pharmaceutical products supply chain in its resolve to put an end to the menace and effectively safeguard the health of Nigerians.
A statement by NAFDAC’s Resident Media Consultant, Sayo Akintola, said that the Director General, Prof Mojisola Adeyeye, gave the warning last Thursday at a stakeholder’s meeting organised by NAFDAC in Lagos.
Adeyeye emphasised the need to explore how to combat the sale and distribution of substandard and falsified medical products within the supply chain, insisting that the agency would not hesitate to clamp down on wholesale and retail outlets where fake drugs are dispensed for public use.
According to her, the engagement with Pharma supply chain stakeholders in Nigeria serves as a means of thinking together and putting in place a position that will represent or guide collective efforts and strategy to prevent, detect, and respond to substandard and falsified medicinal products.
She also stated that the goal is to ensure that medical products in circulation are of the quality standard required and safe for public use.
The NAFDAC boss noted that the high prevalence of substandard and falsified medicines in Africa is a major threat to public health, attributing this to the fact that regulation in the region is limited.
Adeyeye further noted with dismay that the poor regulatory practice allowed for poorly regulated manufacturers to supply their products in Africa where technologies to detect and trace them are limited.
She added that the menace of substandard and falsified medical products threatens access to safe, efficacious, and affordable medicines, undermining health systems and the achievement of universal health coverage globally.
She said that the burden on the agency is to lead the fight against such medical products in Nigeria and support efforts that will see a reduction in the prevalence of such medical products both locally manufactured and imported.
The DG explained that NAFDAC is not the only regulatory agency in terms of substandard falsified medicines, adding that the Pharmaceutical Council of Nigeria (PCN) probably has more to do in the fight against fake drugs.
Adeyeye explained that currently, NAFDAC is doing its best to fight this issue of said substandard and falsified products, stating that the fight against the products is based on three broad thematic areas: Prevent, Detect, and Respond (PDR).
She said that NAFDAC operatives are not just going on the streets to look for substandard falsified medicines, but also going after products that have been approved in Southeast Asia en route Nigeria.
She reiterated that 70 per cent of medicines used in Nigeria come from outside which necessitated the establishment of a pre-shipment testing scheme that has stopped over 124 products that were approved from coming into the Nigerian market.
According to her, some of the medicines do not have content, some will not disintegrate, and some will not dissolve. In contrast, some of them have wrong labelling and all sorts of non-compliance, adding that the agency is dealing with that now with the World Health Organisation (WHO).
Adeyeye further disclosed that most of the products stopped from coming into the Nigeria market have fake certificates of pharmaceutical product.
‘’it is us Nigerians that connive with them to bring in cheap products at the detriment of lives in Nigeria,’’ she alleged.
Furthermore, she disclosed that over 124 shipments have been stopped, adding that these are products that had been approved, that could have been in circulation in Nigeria for five years.
‘So, if 10 containers per year for one particular product or two containers per year should find their way into Nigeria, you can figure out what the consequences might be,” she said.
The NAFDAC boss, however, announced the berthing of a new regulatory directive with emphasis on the source of raw materials used in the production process.
She explained that for those that are registering new products, they must procure raw materials from approved sources like WHO pre-qualified sources or other stringent regulatory authorities.
’If you don’t source from a pre-qualified source, we will not register the product,’’ she said.
Adeyeye however, dispelled the report over alleged proliferation of fake drugs in the country, saying the proliferation news that has been going on is false.
‘’There is no proliferation of substandard medicines. We do national survey, sampling of products using scientific methods from different parts of the country.’’, she said, adding that the survey was done in 2021 and 2022 for anti-malaria with a 10 per cent prevalence level.
‘’We couldn’t do it in 2020 due to the COVID-19 Pandemic. She explained further, ‘’If you live very close to the border where people come in and out the prevalence may be higher there. That’s statistics. The average is about 10 per cent,’’
“The fact that we have a shortage of medicines does not mean there is a proliferation of substandard falsified medicines. The survey for 2023 is not ready yet. We will publish 2021 and 2022.”
Adeyeye said that the state of the economy shouldn’t be an excuse for people to buy poison under the guise of cheap products.
‘’I enjoin you to sustain your support to NAFDAC to ensure that only safe, efficacious, and quality medicines are used in Nigeria. NAFDAC, as the regulatory agency is seeking the support of all stakeholders in the pharma industry and supply chain system to improve our chances of winning the war on SF medical products,” she said.
