The National Agency for Food and Drugs Administration and Control (NAFDAC) is notifying the public of an observed parallel importation of some Novartis Prescription-Only-Medicines (POM) brands.
The Ports Inspection Directorate of the Agency observed increased incidents of seizure of unregistered Novartis brands of some Prescription-Only-Medicines (POM) at the Murtala Mohammed International Airport, Ikeja, Lagos between August and September 2023. The original brands of these unregistered medicines have already been registered with NAFDAC by Novartis Nig. Ltd.
The Marketing Authorization Holder (MAH) Norvatis Nig Ltd when contacted, claimed they had observed the presence of the unregistered brands of GalvusMet Tablets at a Pharmacy in Yenagoa, Bayelsa State.
The differences between the registered brand and the unregistered brand of GalvusMet Tablets are tabulated below:
| Registered Brand of GalvusMet | Unregistered Brand of GalvusMet* | |
| NAFDAC Registration Number | GalvusMet 50/500mg Film-coated Tablet: A4-6077 GalvusMet 50/850mg Film-coated Tablet: A4-6078 Galvus Met 50/1 000mg FilmCoated Tablet A4-607 | No NAFDAC Registration number |
| Labelling Text | English and French | Turkish |
| Storage Condition | Do not store above 3O”C’ | Do not store above 25″C’ |
| Shelf life | 18 months based on stability studies carried out under Climatic Zone lV b | 24 months based on stability studies carried out under Climatic Zone ll |
| Address of Manufacturing Site | Novartis Pharma Productions, GmbH, Wehr, Germany for Novartis Pharma AG, Basle, Switzerland. | Novartis Saglik, Gida ve Tarim Urunleri San.Ve Tic. A.S Yenisehir Mahallesi, Ihlara Vadisi Sokak, No:2, Kurtkoy Pendic, lstanbul, Turkey |
Intelligence gathered reported that the products were purchased by several persons from different pharmacies in Turkey and pooled together for eventual export into Nigeria.
Other products intercepted by the Port Inspection Directorate at the Murtala Mohammed International Airport, Ikeja, Lagos are packages of Parlodel Tablets, Exforge HCT Tablets, Glucophage tablets, Tegretol CR tablets, and the various packaging materials for the products that were intended for distribution and use in Turkey.
The illegal importation or marketing of medicines or counterfeit medicines poses a risk to the health of people, since by not complying with the legal importation, the safety, quality, and efficacy of the products are not guaranteed.
NAFDAC has heightened surveillance in the Ports and States to prevent or stop the importation, distribution, and sale of unregistered products.
Importers, distributors, retailers, healthcare providers, and patients are implored to always exercise caution and vigilance within the supply chain to avoid the importation, distribution, sale, and administration or use of falsified or substandard medicinal products. All medical products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.
If you have any of these products, please DO NOT use them. Suppose you, or someone you know, have used the products or suffered any adverse reaction/event after use. In that case, you are advised to seek immediate medical advice from a qualified healthcare professional.
Healthcare professionals and consumers are advised to report any suspicion of adverse drug reactions, or substandard and falsified medicines to the nearest NAFDAC office, NAFDAC on 0800-162-3322 or via email: sf.alert@nafdac.gov.ng
Similarly, healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of the medicinal product to the nearest NAFDAC office, or through the use of the E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng or via the Med- safety application available for download on android and IOS stores or via e-mail on pharmacovigilance@nafdac.gov.ng
NAFDAC……..Customer-focused, Agency-minded!!!
Signed Management
