International Medical Products Anti-CounterfeitingTaskforce

Nigeria : Demographics Area: 923,768 km² Structure: 36 states Capital: Abuja Other main cities: Lagos, Port Harcourt & Kano Population: 140million Adult literacy rate : 111/179- (71.0) Below poverty line: 34.1% Development index: 154 (0.499) GDP Per capita PPP USD : 139 /179-(1,852) –Sources: Human Development Report 2006 World Development Report 2006, Economist 2007 Encarta encyclopedia 2008 Nigeria is a country in west Africa bordered to the East by Cameroun, the West by Benin Republic, and the North by Niger Republic.

DEFINITION : WHAT IS COUNTERFEIT/FAKE MEDICINE? Herbal preparations fraudulently mixed with orthodox medicine Drugs without full name and address of the manufacturer Re-labeled drugs with the intention of extending the shelf lifeRe-labeled drugs with the intention of extending the shelf life Clones of fast moving drugsClones of fast moving drugs "А counterfeit medicine is one which is deliberately and fraudulently mislabeled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging. WHO/IFPMA(1992) In addition to the above, NAFDAC has also identified other forms of counterfeit/fake drugs as listed below:

1.COUNTERFEIT AND FAKE DRUGS AND UNWHOLESOME PROCESSED FOOD (MISCELLANEOUS PROVISION ACT CAP C34 LAWS OF THE FEDERATION OF NIGERIA FOOD, DRUGS AND RELATED PRODUCTS (REGISTRATION ETC.) ACT CAP F33 LAWS OF THE FEDERATION OF NIGERIA FOOD AND DRUGS ACT CAP F32 LAWS OF THE FEDERATION OF NIGERIA 2004 Our National Legislation

1.MIN. – 5YEARS; MAX – 15 YEARS, FINE MAX. N500,000. ($3,500) 2. 2 YEARS IMPRISONMENT, OR FINE OF 50,000 ($350), FOR INDIVIDUAL, 100,000 ($700), FOR CORPORATE BODIES 3. 50,000 ($350) FINE OR IMPRISONMENT FOR 2YEARS Penalties

DIRECTORATE OF ENFORCEMENT/ TASKFORCE ON COUNTERFEIT AND FAKE DRUGS AND UNWHOLESOME PROCESSED FOOD. National coordination

How were these cases detected? number of cases Patients complaintsLow Health professionals reportsMedium Enforcement/investigation workHigh Routine checksHigh Reported by affected manufacturer/importerHigh Other (Whistle Blowers)High Counterfeiters in Nigeria target drugs with high volume of use in public health Over 60% of drugs used in Nigeria are imported; most of the identified counterfeit/fake products in circulation are imported Pharmaceutical counterfeits in Nigeria 16.7% NAFDAC Reg. Nos. & sophisticated printings on packages are now faked

45 convictions have been secured in respect of counterfeit drug related cases, while 67 cases are pending in courts Number of prosecutions, convictions & pending cases

Forming global, continental, regional and local anti-counterfeiting collaborations with all stakeholders Entering into anti-counterfeiting information-sharing MOUs with other countries and other interested groups Stationing our well-trained staff at source of production to monitor GMP and give us advance information about manufacturing companies and their products that are intended for Nigerian markets Re-train our border inspection staff to meet up with the current challenges Use of cutting-edge technologies (Raman Spectrometry, Minilabs, SMS, etc Better collaboration with other border control agencies (The Nigerian Customs Service, NDLEA, SON, etc), Our proposals for action