By Biola Lawal
Abuja (Flowerbudnews): NAFDAC Director General, Prof. Mojisola Adeyeye has assured Nigerians that close to 90% of medicines on sale in Nigeria are safe and of good quality.
Flowerbudnews reports that Prof Adeyeye gave the clarification in a statement titled: REJOINDER: Fifty percent of imported pharmaceutical products in Nigeria are fake;
issued to specifically debunk some erroneous media reports quoting her as saying that 50% of drugs imported into Nigeria were fake.
”This is to assure the public that NAFDAC will continue to deploy various methods to ensure that only quality, safe and efficacious medicines are available for distribution, sale and use within Nigeria,’ the NAFDAC DG stated.
She explained that NAFDAC set up Pre-shipment Inspection Scheme, also called the Clean Report of Inspection and Analysis (CRIA) Scheme, to support and strengthen the Agency’s efforts to prevent export of substandard, fake, and falsified pharmaceutical products into Nigeria from high-risk countries.
‘Prof Adeyeye clarified that NÀFDAC statement on 50% fake drugs blocked at source from entering, or from being shipped to Nigeria was misplaced and erroneously reported by a mass media as 50% fake drugs in Nigeria.
She explained that through the efficacy of the CRIA, about 50% of pharmaceutical products manufactured for shipment to Nigeria were proved falsified, rejected and blocked at source from being shipped to Nigeria.
Full Statement Reads:
REJOINDER: Fifty percent of imported pharmaceutical products in Nigeria are fake!
The attention of the National Agency for Food and Drugs Administration and Control (NAFDAC) has been drawn to various news publications on an interview with the Director General (NAFDAC) on efforts by the Agency at curbing the influx of substandard, fake, and falsified pharmaceutical products.
This is to inform the public that the Director General’s statement during the interview was seriously misunderstood. NAFDAC set up a Pre-shipment Inspection Scheme also called the Clean Report of Inspection and Analysis (CRIA) Scheme to support NAFDAC’s efforts at prevention of export of substandard, fake, and falsified pharmaceutical products into Nigeria from high-risk countries.
The CRIA scheme has led to the stoppage of the export of over 140 products to Nigeria after laboratory evaluation of those products revealed that they were substandard and did not meet quality and safety standards.
One of the required documents submitted for processing of the CRIA Reports is the Certificate of Pharmaceutical Products (CPP). The CPP is a reliance document issued by a National Regulatory Authority to a receiving country which guarantees that a medical product for export meets quality, safety, and efficacy requirements and that the production process conforms to Good Manufacturing Practice (GMP) as internationally accepted.
The Director General explained that NAFDAC found out that 50% of the CPPs submitted by Manufacturers for the failed products were found to be fake and did not follow regulatory requirements for issuance.
This does not mean that 50% of imported products in circulation are fake as all the products found to have failed laboratory evaluation were not shipped into Nigeria. It is also important to clarify that the level of substandard, fake, and falsified pharmaceutical products in Nigeria stands at between 10-12% and NAFDAC is making every possible effort to reduce this to around 5%.
NAFDAC as a stable maturity level 3 regulatory Agency has gained international recognition for her efforts at curbing the influx of substandard, fake, and falsified pharmaceutical products through the CRIA scheme and the interception of several consignments of such products. This has led to other countries within Sub-Saharan Africa understudying NAFDAC and embracing the Pre-Shipment Inspection and Analysis Scheme for medical products exported to their countries.
This is to assure the public that NAFDAC will continue to deploy various methods to ensure that only quality, safe and efficacious medicines are available for distribution, sale and use within Nigeria. (Flowerbudnews)