President Goodluck Jonathan has declared zero tolerance for substandard laboratory practices, equipment, diagnostic reagents and chemicals in the country even as he commissioned the first ever In-Vitro Diagnostics, IVDs, Control Laboratory in Nigeria and West Africa.
To this end, a new comprehensive policy has been mapped out to ensure that henceforth, only IVDs – equipment, kits, reagents and consumables that meet international standards would be manufactured, imported, distributed or used in the country.
The President who made the declaration in Lagos said health laboratories play a pivotal role in diagnostics and monitoring of diseases and doing otherwise would have a hugely negative impact on the health of Nigerians.
Diagnosis and monitoring of diseases rely on the availability of the highest possible quality of personnel, equipment, reagents and chemicals to produce consistently reliable results for the correct diagnosis and proper monitoring of many disease conditions, the President observed.
“In establishing this laboratory, the Medical Laboratory Science Council of Nigeria, MLSCN, has substantially carried out my directive to all our standards and regulatory agencies when they met with me early in the life of this administration to give full effect to our declared zero tolerance to the existence of substandard, fake or adulterated products in the country, be they food, drugs, laboratory reagents and chemicals or even household consumer items.”
The new facility would obviously strengthen the regulatory function of the MLSCN with respect to the verification, validation, listing and registration of in-vitro laboratory diagnostics among others.
Further, Jonathan, who was represented by Minister of Health, Professor Onyebuchi Chukwu, directed manufacturers, producers and importers of diagnostic laboratory reagents and chemicals to submit their products to the laboratory for testing, analysis and certification. “Doing so is not only an ethical requirement but indeed compliance with extant laws.”
In a response, the Registrar, MLSCN, Professor Anthony Emeribe, said the establishment of the laboratory was informed by the need to drive the culture of quality and efficient health laboratory care to the public as well as stem medical tourism for quality healthcare abroad with attendant capital flight.
He said from empirical data, 60-70 percent of indices required for effective medical diagnosis, treatment, monitoring, surveillance and forecasting are based on accurate and reproducible health laboratory results.
He said over 50 percent of public health IVDs in the open market is substandard, fake, expired or poorly stored and distributed as compared to less than 17 percent for fake or sub-standard drugs and food products.
“Under such prevailing conditions, it becomes difficult to obtain accurate, reliable and reproducible results and reports from medical laboratories, which are on the receiving end of the supply chain. No reputable regulatory agency can stand aloof, while such a chaotic state of affairs remains,” he asserted.
