Repositioning laboratories for accurate diagnosis

The CBN  circular dated April 24th 2014 and  signed by the acting director of trade and exchange department, J.O. Ajewole, to all authorized dealers and the general public informed them that henceforth all importers of the in-vitro diagnosis products into Nigeria must register with MLSCN.This development did not sit well with some practitioners in the  […]

The CBN  circular dated April 24th 2014 and  signed by the acting director of trade and exchange department, J.O. Ajewole, to all authorized dealers and the general public informed them that henceforth all importers of the in-vitro diagnosis products into Nigeria must register with MLSCN.
This development did not sit well with some practitioners in the  health sector.
The incoming president of Nigerian Medical Assocaition Dr Lawrence Kayode Obembe said the move would only slow progress already made in medicine and add to the numerous blockages that are already bedeviling the health sector.
According to him, the country had established NAFDAC and SON to maintain standards and ensure quality, adding that involving another regulatory body would only create more bottle necks that would not augur well for the sector.
He said other developed countries try to ease whatever processes if someone is importing medical equipment by removing obstacles like custom duties, duty free and making logistics free and easy and Nigeria should not be an exception.
The NMA president explained that “already, importation of medical products is being regulated by the National Agency for Food and Drug Administration Control (NAFDAC) and the Standards Organisation of Nigeria (SON).”
He observed that regulatory agencies  “are already established so that standards will be maintained, if we go on to proliferate, it is very destructive and very devastating.”
However, the Chief Registrar of MLSCN, Prof. Anthony Emeribe,  has a different opinion. He said the circular should not be seen as a threat to progress in the health sector but rather as a ladder to aid effective development which he emphasized is in the interest of every Nigerian.
He pointed out that only anti-quality service unions would antagonise the new CBN circular.
According to Emeribe, rather than express fears about the circular, it should rather be seen as an instrument that will “enhance medical services by ensuring that medical laboratory equipment are of good quality.”
He explained that about 50 per cent of medical laboratory equipment in the country are fake, a situation he said led President Goodluck Jonathan to inaugurate the quality assurance laboratory in Lagos.
Emeribe explained that the council is determined to reduce the number of sub-standard fake, expired or poorly stored and distributed test kits, equipment, reagents, chemicals and other laboratory equipment in the Nigerian market to ensure accurate and reproductive results for effective medical diagnosis, treatment, surveillance and forecasting.
He added that instead of seeing the directive given by the apex bank as a hindrance to the health sector the involvement of the council should rather be applauded as a collaborative gesture to boost the efforts of other regulatory bodies to ensure that the Nigerian populace gets the best.
This notion is shared by the Director General of the National Agency for Food and Drug Administration Control (NAFDAC) Dr Paul Ohrii when during a courtesy visit by the boss of the Standard Organisation of Nigerian had said the more the merrier.
Ohrii had explained that though some may see the duties of both regulatory agencies as collapsing into each other, it would allow them to collaborate better and make the terrain extremely difficult for those who sought to cut corners.
He said, “If I miss something, am sure the SON will arrest them, this will make my job easier and quickly sanitize the system.
Proliferation of sub-standard materials in the market has not helped the sector in any way. The MLSCN boss said, “Indiscriminate importation of laboratory test kits in Nigeria is the major cause of misdiagnosis, treatment failure and preventive deaths in the country.
“The council has been unrelenting in its efforts to drive the culture of quality and efficient health laboratory care to the public with the view to stemming medical tourism for quality health care abroad with attendant capital flight, as empirical data have confirmed that 60 to 70 percent of indices required for effective medical diagnosis, treatment are based on accurate and reproducible health laboratory results.”
He reasoned that if that was the case was it not then important that no stone be left unturned to ensure that the diagnosis is gotten right.?
Emeribe lamented that over 50% of public health in-vitro diagnostics including test kits, equipment, reagents, chemicals in the Nigeria open market are sub-standard, fake, expired or poorly stored or distributed. This he said is the bane of quality test results, as against less than 17% for fake or sub-standard drugs and foods products.
He was quick to add that no regulatory body worth its salt will stand aloof while such a chaotic state of affairs remains.
The Minister of Health Professor Christian Onyebuchi Chukwu said the recently turn of events would only improve productivity in the health sector.
Chukwu buying into the idea, enjoined manufacturers, producers and importer alike of diagnostics laboratory reagents and chemicals to submit their products to the MLSCN’s Public Health In-Vitro Diagnostic Control laboratory in Lagos for necessary testing, analysis and certification.
He said, “Doing so is not only an ethical requirement but indeed compliance with extant laws, the Public Health In-Vitro Diagnostics Control Laboratory in Lagos marks the beginning of a new era in the production, importation, storage and sale of diagnostic laboratory reagents and chemicals in Nigeria was necessitated by the general principle underlying the Transformation Agenda of the federal government and is aimed at achieving the MDGs on health which is largely dependent on strengthening the health system, the laboratory being a critical component of the health sector”.
Emeribe said, “If all of us regulators, practitioners, importers, marketers and even patients join hands in taking on the noble, virtuous and altruistic task of ensuring that only the right, verified and certified IVDs are brought into the country and used in our medical laboratories, quality would soon become the hallmark of the health laboratory care in our country. This we believe is the dream of all Nigerians”.