Time to unlock the Value Chain of In vitro Diagnostics (IVD) Manufacturing in Nigeria by Prof. Tosan Erhabor
Time to unlock the Value Chain of In vitro Diagnostics (IVD) Manufacturing in Nigeria by Prof. Tosan Erhabor
The Registrar of Medical Laboratory Science Council of Nigeria MLSCN, Prof. Tosan Erhabor has called for unlocking the Value Chain of In vitro Diagnostics (IVD) Manufacturing in Nigeria.
He noted that this can be achieved by strengthening in-country IVD Regulatory Capacity through ISO certification for Medical Laboratory Science Council of Nigeria
(MLSCN).
The Registrar made the call during the capacity building workshop for MLSCN National IVD Laboratory Staff supported by World Health Organization (W.H.O) and facilitated by Standard Organization of Nigeria (SON) and GMDN, United Kingdom at the MLSCN IVD training center Yaba Lagos from 28th October to 1st of November 2024.
In his speech, Prof. Tosan Erhabor summarized the important roles of IVD Laboratory as “MLSCN via her ISO 17025:2017 accredited Public Health In-vitro Diagnostic Control Laboratory, Yaba, Lagos centre, an internationally accredited center rendering world class services in validation, verification and evaluation processes of all in-vitro diagnostic products imported into the country or produced in Nigeria, serving as the reference standard for all importers, manufacturers and marketers of IVD products within the West Africa sub region.”
He called for the inclusion of MLSCN in Nigerian Trade Portal, Export / Import Guideline in line with extant laws of Nigeria (Act 11, 2003, Sub-section 4d and 4e) and that there should be a stop to the harrassment of clients with MLSCN Import permit and seizure of IVD products. He called on the general public to demand for MLSCN LISTING ON ALL IVD PRODUCTS IN NIGERIA.
The Registrar reiterated that to support the IVD regulation and expansion of quality assured IVD manufacturing in the West African sub-region, MLSCN conducted this capacity building workshop to strengthen the national IVD Manufacturing Assessors especially with the knowledge on IVD products global harmonized nomenclature, ISO 14971:2019- RISK MANAGEMENT and ISO 13485:2016 FOR QUALITY MANAGEMENT SYSTEM FOR IN VITRO DIAGNOSTICS MANUFACTURERS. This is in sync with the vision of the current administration of the Federal Ministry of Health to meet to utilize locally manufactured in vitro diagnostic products in the testing programmes of diseases of public health impact like HIV/AIDS, malaria and tuberculosis, etc. MLSCN regulatory capacity is positioned to assess, certify and support local IVD manufacturers via assessment and follow-up mentorship to attain ISO 13485 and ISO 14971 quality management system and risk assessment requirements in Nigeria respectively. This is expedient to expedite access to critical procurement pathways for diagnostic products in Nigeria, he concluded.
The Laboratory Manager to MLSCN PUBLIC HEALTH IN-VITRO DIAGNOSTICS CONTROL LABORATORY and Head of IVD Department, Mr. Offutalu Paulinus Nnamdi, in his speech enumerated some of the outcomes of the training to include: Reviewed assessment checklists and protocols for assessment and certification of the six registerd IVD Manufacturing facilities awaiting audit and certification and the 50 IVD importers in Nigeria. He noted that of the over 250 IVD Listed IVD products in Nigeria, 98% are imported. Thus, there was an urgent need to build the IVD manufacturing capacity for Nigeria. This will no doubt reduce over dependence on imported IVD products and provide access to affordable IVD products in Nigeria.
The facilitators from SON and GMDN, UK emphasised the need for RISK MANAGEMENT below residual risk levels and harmonized standard nomenclature for IVD products.
Dr. Laxmikant Chavan, WHO AMR/Laboratory Team Lead and Mr. Jubril Kareem harped on the need for strategic partnerships and inter-agency collaboration for the promotion of quality IVDs in Nigeria.
The training had in attendance the facilitators from the Standard Organization of Nigeria (S.O.N), Mr Victor Odiaua and Mrs Oludunke Oluwafunmilayo, Dr Francisca Nwaokorie, an associate Professor from University of Lagos, Adekoya Abimbola Julius, Chairman GMLD Lagos, Mr Oparanozie Jude, Chief Medical Laboratory Scientist and the Quality Assurance Manager of the IVD Laboratory and other members of staff of the IVD Laboratory.