NAFDAC Seeks Tougher Sanctions against Peddlers of Substandard Medicines

Onyebuchi Ezigbo in Abuja

The National Agency for Food and Drug Administration and Control, (NAFDAC), has said enforcement of more stringent penalties would drastically reduce sales and distribution of substandard and falsified (SF) medicines in the country.

The agency put the value of global commerce in sub-standards and counterfeit drugs in 2016 at $4.4 billion, accounting for 0.84 per cent of all pharmaceutical product imports globally but excluded a sizeable amount of locally produced and consumed SF medicines.  

In Nigeria, the highest penalty, on conviction, in dealing with SF medicine was that the suspect would be liable on conviction to a fine not exceeding N500,000 or imprisonment for a term of not less than five years or more than 15 years or to both such fine and imprisonment.
NAFDAC said the menace of substandard and falsified medicines were presently constituting a global threat that presented huge public health challenges to national medicines regulatory authorities in both developed and developing countries.

It also said the illicit practice had brought catastrophic consequences on the local pharmaceutical industry,
NAFDAC Director General, Prof. Mojisola Adeyeye, noted that the ridiculously light penalties against offenders have made the illicit trade attractive
In a statement signed by NAFDAC’s Resident Media Consultant, Sayo Akintola, the NAFDAC DG warned that the menace of substandard and falsified medicines portends grave financial losses, possible divestment, and close of shop for the pharmaceutical industry and threatens the attainment of the United Nations Sustainable Development Goals of access to safe, effective, quality, and affordable essential medicines.

The NAFDAC DG expressed the concerns while speaking at the 21st NECCI Public Relations Roundtable in Lagos last Thursday.
In her keynote speech, Adeyeye said with the exponential growth in e-commerce, and global trade facilitation, illicit trade in fake goods had continued to be a significant and growing threat to economies globally, adding that the socio-economic impact of this menace for any nation was enormous.

“In addition to harming the economy generally, it also has the potential to weaken the rule of law and erode public confidence in the government,” she said, noting with dismay that when it comes to medicines, the proliferation of SF medicines has even greater and significant dangerous public health ramifications.
Adeyeye, put the value of global commerce in sub-standards and counterfeit drugs in 2016 at $4.4 billion, accounting for 0.84 per cent of all pharmaceutical product imports globally but excludes a sizeable amount of locally produced and consumed SF medicines.  

“In the meta-analysis of 96 studies that examined 50 or more samples, totalling 67, 839 drug samples, it was estimated that the incidence of SF medicines in low- and middle-income countries stood at 13.6 per cent.
“The largest incidence was observed in Africa with 18.7 per cent and 13.7 per cent in Asia,” it added.
According to the WHO Global Surveillance and Monitoring System, the continent of Africa accounted for 42 per cent of the 1,500 incidents of SF and counterfeit medical products recorded between 2013 and 2017.

Adeyeye warned that medications of all types and classifications were subject to falsification and counterfeiting, adding that generics, branded, OTCs, and Prescription Only Medicines (POMs) are impacted.

The NAFDAC boss disclosed that the agency had deployed cutting-edge technologies like the TRUSCAN (handheld device built on Raman spectroscopy) for on-the-spot detection of SF medicines in circulation and at the ports of entry into the country.

She further explained that the Agency had put in place the Clean Report of Inspection and Analysis (CRIA), a Pre-shipment inspection arrangement set up as part of measures by NAFDAC to curb the increasing rate of importation of fake, substandard, and unwholesome finished pharmaceuticals and other regulated products, raw materials, and chemicals from India and China.