National Drug Policy - World Health Organization

1 National drug PolicyPUBLISHED BYFederal Ministry of HealthIN COLLABORATION WITHW orld Health OrganisationFIRST REVISION 2003 National drug Policy 2005 National drug Policy 2005 FOREWORDI am indeed very delighted to write the foreword to this second edition of theNational drug Policy . The maiden edition of the Policy was launched in many of the expectations of that edition were unrealized due mainly tolack of political will by past governments and the absence of a well-structuredmonitoring system. This revised edition has taken care of those identified was developed with adequate consultation with relevant stakeholders in thePharmaceutical sector in order to ensure a coherent and multisectoral platformfor achieving the main goals of the National drug launching of this edition is against the backdrop of the overall Health SectorReform (HSR) Programme of my Ministry.

2 One of the major outputs of the on-going HSR is the adoption of a revised National Health Policy by the FederalGovernment. While the chronological synchronization of the revised National DrugPolicy with the updated National Health Policy may appear coincidental, it isnonetheless providential and matter how vibrant a Health Policy , without availability of good quality andaffordable medicines, that Policy will be sterile. Fortunately, the Government ofPresident Obansanjo has been paying special attention to the pharmaceutical sub-sector. The Presidential Forum on the Pharmaceutical Sector held in November2003 underscored this special focus. Since that event, the Government has takena number of pragmatic steps towards boosting the local capacity for themanufacture of essential medicines.

3 This is to ensure that the local pharmaceuticalindustry becomes a major actor in providing good quality essential medicines forour Health care recently released 2005 Fiscal Policy is the most favourable ever, as far as thepharmaceutical sector is concerned. It provides very attractive incentives both tothe existing players and prospective investors in the production of life-savingessential medicines. It is my earnest hope that the launching of the second editionof the National drug Policy will further increase the vibrancy of the pharmaceuticalsector for the overall improvement of people s concluding this foreword, I would like to express my sincere appreciation tothe National drug Policy Review Committee headed by Dr. Philip Emafo, arenowned pharmacist and a World Health Organisation consultant.

4 The diligenceof the committee is warmly and heartily acknowledged. Without the financialand technical support of the Nigerian Country office of the World HealthOrganisation, the review exercise would not have succeeded. I feel greatly indebtedto them. Government shall do its utmost to ensure that this revised edition isfaithfully and successfully Eyitayo LamboHonourable Minister of Health ,Abuja, April 200512 National drug Policy 2005 National drug Policy 2005 ACKNOWLEDGEMENTSThe contributions of the following are gratefully acknowledged:Benue State Ministry of HealthConsumer Protection Council of NigeriaCross River State Ministry of HealthDepartment of Health Planning, Research & Statistics of the Federal Ministry ofHealthFederal Ministry of Science and TechnologyKebbi State Ministry of HealthLagos State Ministry of HealthNational Association of Chambers of Commerce, Industry Mines and Agriculture(NACCIMA )Nasarawa State Ministry of HealthNational Agency for Food and drug Administration and Control (NAFDAC) National drug Formulary and EDL Review CommitteeNigerian Medical AssociationPharmaceutical Society of NigeriaPharmacists Council of NigeriaPlanned Parenthood Federation of Nigeria (PPFN)

5 Sokoto State Ministry of HealthUniversity of UyoVeterinary Council of NigeriaACRONYMSCIDAC anadian International Development AgencyDFIDD epartment for International DevelopmentDICDrug Information CentreDRADrug Regulatory AuthorityDRFDrug Revolving FundDTCD rugs and Therapeutic CommitteeECOWASE conomic Community of West African StatesEDLE ssential Drugs ListEVDLE ssential Veterinary Drugs ListFMOHF ederal Ministry of HealthGMPGood Manufacturing PracticesINNI nternational Non-Proprietary NamesLGAL ocal Government AreaMDCNM edical and Dental Council of NigeriaNAFDACN ational Agency for Food and drug Administration and ControlNCNN ursing Council of NigeriaNDFN ational drug FormularyNDLEAN ational drug Law Enforcement AgencyNDPN ational drug PolicyNEMAN ational Emergency Management Agency34 National drug Policy 2005 National drug Policy 2005 NIMRN ational Institute for Medical ResearchNIPRDN ational Institute for Pharmaceutical Research andDevelopmentNPIN ational Programme on ImmunisationNUCN ational Universities CommissionOTCOver the CounterPCNP harmacists Council of NigeriaPMG-MANP harmaceutical Manufacturing Group of the ManufacturingAssociation of NigeriaPPMVLP atent and Proprietary Medicine Vendors LicenceQCQuality ControlRMRDCRaw Materials Research and Development CouncilSMOHS tate Ministry of HealthSTGS tandard Treatment GuidelinesSVTGS tandard Veterinary Treatment GuidelinesTBTuberculosisTRIPST rade Related Aspects of Intellectual Property RightsUNICEFU nited Nations Children

6 S FundUNIDOU nited Nations Industrial Development OrganisationUNODCCPU nited Nations Office for drug Control and Crime PreventionUSAIDU nited States Agency for International DevelopmentVCNV eterinary Council of NigeriaVDFV eterinary drug FormularyVRIV eterinary Research InstituteWHOW orld Health Organisation56 National drug Policy 2005 National drug Policy 2005 TABLE OF CONTENTSFOREWORD1 ACKNOWLEDGEMENTS2 ACRONYMS3 TABLE OF OF THE National drug OBJECTIVES OF THE National drug TARGETS OF THE National drug FOR IMPLEMENTING THENATIONAL drug OF DRUGS OF DRUGS REVOLVING FUND SCHEME Policy STORAGE DISTRIBUTION drug USE and Training: Prescribing.

7 Dispensing Information Services and Therapeutics Committees Medication DRUGS drug PRODUCTION LEGISLATION INSPECTION OF DRUGS IMPORTATION AND EXPORTATION OF DRUGS REGISTRATION OF DRUGS PATENTS1 QUALITY ASSURANCE REGULATIONS FOR PRESCRIBING AND DISPENSING DRUGS PHARMACOVIGILANCE drug INFORMATION AND PROMOTION drug FINANCING AND AFFORDABILITY RESEARCH AND DEVELOPMENT Research and Development Research HERBAL AND OTHER TRADITIONAL REMEDIES HUMAN RESOURCES DEVELOPMENT CONTROL OF VETERINARY DRUGS INTERNATIONAL COOPERATION MONITORING AND EVALUATION 2578 National drug Policy 2005 National drug Policy maiden National drug Policy (NDP) for Nigeria was adopted and launchedin 1990 against the background of inadequacies in drug availability, supply anddistribution resulting from various factors, such as: An ineffective system of drug administration and control; Inadequate funding of drug supply and drug control activities; High dependence on foreign sources for finished drug products,pharmaceutical raw materials, reagents and equipment; Inadequate facilities for storage, transportation and distribution of drugs; Poor selection and procurement practices; The involvement of unqualified persons in procurement, distribution andsale of drugs.

8 Poor performance of drug suppliers to public Health care institutions; an Lack of political will to provide safe, efficacious and good quality drugs tomeet the Health needs of Policy was formulated with laudable goals and objectives intended to addressthe unsatisfactory situation at that time. Its adoption was seen as a positivedevelopment by observers. After over a decade of its adoption and implementation,some modest progress has been recorded. These include the publication of anEssential Drugs List (EDL), and a National drug Formulary (NDF), theestablishment of a statutory agency with responsibility for drug administrationand control, and the introduction of drug registration procedures. However, muchmore still remains to be done in many areas, such as the realisation of self-sufficiency in local production of essential drugs, the establishment of an effectivedrug procurement system, evolving a well-ordered drug distribution system, theharmonisation and updating of drug legislation, the effective control of drugadvertisement and promotion, the entrenchment of and commitment to rationaluse of drugs at all levels of Health care, and drug research and development revision of the Policy presents an excellent opportunity for formulating newstrategies, for consolidating achievements in areas where progress has beenrecorded, and addressing those areas that call for more positive action.

9 It is hopedthat with judicious implementation of the revised Policy , as laid out in theaccompanying implementation plan, the Nigerian people will have sustainableaccess to safe, efficacious and good quality includes any substance or mixture of substances manufactured, sold oradvertised for use in the diagnosis, treatment, mitigation or prevention of anydisease disorder, abnormal physical state, or the symptoms thereof, in man or inanimals; restoring, correcting or modifying organic functions in man or in animals;disinfection, or the control of vermin, insects or pests; or contraception; OF THE National drug POLICYThe goals of the Policy shall be to make available at all times to the Nigerianpopulace adequate supplies of drugs that are effective, affordable, safe and ofgood quality; to ensure the rational use of such drugs; and to stimulate increasedlocal production of essential OF THE National drug POICYThe objectives of the Policy ensure efficient and effective drug management in the public and privatesectors; ensure access to safe, effective, affordable and good quality drugs atall levels of Health care on the basis of Health needs; promote the rational use of drugs by prescribers, dispensers andconsumers; increase local drug manufacture/production and promote export.

10 Ensure that all drugs in the National drug distribution system are safe,efficacious, effective and of good quality; strengthen administrative, legislative, and regulatory controls of theimportation, manufacture, procurement, storage, distribution, supply, saleand use of drugs; promote research on herbal remedies and integrate those found to besafe and efficacious into the Health care system; promote pharmaceutical research and development of raw materialsfor the production, compounding and formulation of pharmaceuticalproducts, as well as operational research for the effective implementationof the National drug Policy ; enlist government commitment at all levels for the achievement of thegoals and objectives of the National drug TARGETS OF THE National drug POLICYThe implementation of the NDP shall be directed towards accomplishing thefollowing of a National drug Policy Monitoring and Evaluation Divisionin the Food and Drugs Services Department of the Federal Ministry ofHealth by the year 2005