…On Prevention, Detection, And Response To Substandard And Falsified Medicine

The NAFDAC has Vowed to close down the sale and distribution outlets Facilitating the Spread of Fake Drugs, as It stresses it’s determination to combat the incidence of Substandard and Falsified (SF) medicines in the country,

The National Agency for Food and Drug Administration and Control NAFDAC has subsequently engaged stakeholders in the pharmaceutical products supply chain in its resolve to put an end to the menace and effectively safeguard the health of Nigerians.

The Director General, Prof Mojisola Adeyeye, at a stakeholders meeting organized by NAFDAC on Thursday, emphasized 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, adding 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 SF in Africa is a major threat to public health, attributing this to the fact that regulation in the region is limited with about 10% of African National Regulatory Agencies NRAs having achieved ML3. 

Prof Adeyeye noted with dismay that this allows for poorly regulated manufacturers to supply their products in Africa where technologies to detect SF and track/trace 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.

With the mandate to regulate and control the manufacture, importation, exportation, distribution, advertisement, sale, and use of drugs, cosmetics, chemicals, detergents, medical devices, and packaged water generally referred to as Regulated Products, she noted that this puts a burden on the Agency to lead the fight against SF medical products in Nigeria and support efforts that will see a reduction in the prevalence of SF 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 Pharmacy Council of Nigeria (PCN) probably has more to do in the fight against fake drugs. 

She, however, relished a cordial relationship that exists between the two sister agencies, insisting that we must do this fight together. 

Prof Adeyeye explained that currently, NAFDAC is doing its best to fight this issue of Substandard and Falsified products, stating that the fight against Substandard/Falsified medical 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 to Nigeria. 

She reiterated that 70 percent 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 SF 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). 

Prof Adeyeye further disclosed that most of the products stopped from coming into the Nigerian market have fake certificates of pharmaceutical products. Noting that it takes two to tango, Prof. Adeyeye opined that its not just India bringing substandard falsified medicines to us, it is us; Nigerians that connive with them to bring in cheap products at the detriment of lives in Nigeria. 

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 ten 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.

The NAFDAC boss, however, announced the berth of a new regulatory directive with emphasis on the source of raw materials used in the production process. For those that are registering new products, she said they must procure raw materials from approved sources like WHO Prequalified sources, FDA, or other stringent Regulatory Authorities. 

If you don’t source from a prequalified source, we will not register the product, she said. 

She, however, dispelled the news going around, over the 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 a 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 ant-malaria with a 10 percent 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. Thats statistics. 

The average is about 10%, she said, insisting that proliferation is not synonymous with shortage because the two words are now used together. 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.

She noted that the Pharmaceutical Supply chain plays a vital role in ensuring that safe, quality, and efficacious medicines reach the end users, adding that there is therefore a need to foster complementary partnerships that will seek to identify lapses in the supply chain system to improve the chances of winning the war on substandard and falsified medical products in Nigeria. 

We have formal and informal markets. Do not buy medicines from the informal market. We do a lot of raids in Oke- Arin, Idumota markets Lagos, Onitsha head bridge where you can buy a product maybe 50 per cent or 80 per cent cheaper because of low quality, she added, 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.

The Supply chain stakeholders made very useful contributions for input into the National Strategic document to guide our collective efforts towards combating the menace of the SF in the country.

The stakeholders present at the supply chain engagements include the World Health Organization (WHO), United States Pharmacopeia (USP), Pharmaceutical Manufacturers Group of Manufacturers Association of Nigeria ( PMG-MAN), Association of Community Pharmacist of Nigeria (ACPN), Pharmaceutical Wholesalers Association of Nigeria (PWDAN), Nigerian Representatives of Overseas Pharmaceutical Manufacturers (NIROPHARM), Association of Pharmaceutical Importers of Nigeria (APIN), Association of Hospital and Administrative Pharmacist of Nigeria (AHAPN), Nigeria Army Medical corps, Nigeria Medical Association (NMA), National of Veterinary Medical Association(NVMA). Others are different companies represented under PMG-MAN, APIN, PWDAN, and Niropharm.