THE NATIONAL VETERINARYDRUG POLICY

Ministry Of Agriculture, Animal Industry and FisheriesP.o. Box 102,Entebbe- UGA DA November 2002

TABLE OF CONTENTS: Page

Foreword 1Acronyms 3Introduction 4

Situation analysis 6

Policy Statement 7

Implementation of the policy 15

FOREWORD

The Ministry of Agriculture, Animal Industry and Fisheries is mandatedto support, promote and guide the production of livestock and crops forself-sufficiency and export. This mandate is under the provisions of themacroeconomic policies of liberalisation, privatisation and the Plan forModernisation of Agriculture (PMA). The core function of the Ministryof Agriculture, Animal Industry and Fisheries is to formulate policiesand strategies to fulfil the above mandate.

The livestock sector is a very significant contributor to food security.However, animal production is constrained by diseases, the control ofwhich invariably involves in part, the use of veterinary drugs.

A policy to ensure that this area of the provision of veterinary services isadequately addressed is therefore vital. The veterinary drug policy coversthe following areas:

• Veterinary drug supply;• Veterinary drug legislation and inspection;• Licensing of veterinary drug outlets;• Disposal of expired or otherwise unwanted veterinary drugs andveterinary waste materials;

• Monitoring of drug residues in foods of animal origin;• Quality assurance of veterinary drugs;• Veterinary drugs information management system;• Research in veterinary drugs and etbnoveterinary medicines; and• Correct and safe use of veterinary drugs.

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My Ministry will be responsible for the implementation of the policy onveterinary drugs in conjunction with other relevant agencies. Theveterinary drug policy will operate along side the policy of the deliveryof veterinary services and the two will constitute the National AnimalHealth Policy.

Successful implementation of this veterinary drug policy shall call forthe involvement of all the key stakeholders who should carefully focuson the most practical ways for effective collaboration to ensure that thepolicy objectives are sufficiently addressed. It should be borne in mindthat a policy is dynamic and must be responsive to the changingcircumstances.

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W.Kisamba Mugerwa (Dr.) MPMINISTER OF AGRICULTURE, ANIMAL INDUSTRY AND FISHERIES

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ACRONYMS

MAAIF - Ministry of Agriculture, Animal Industry & Fisheries

NDPAS - National Drug Policy and Authority Statute

NDA - National Drug Authority

UYB - Uganda Veterinary Board

MOH - Ministry of Health

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1.0 INTRODUCTION

1.1 BackgroundGovernment established a National Drug Policy and AuthorityStatute (NDPAS) (1993) to ensure the availability, at all times ofessential, efficacious and cost-effective drugs to the entire humanand animal population of Uganda. The Ministry of Health is thecustodian of the Drug Policy and Authority Statute.During its formulation, the veterinary sector was not adequatelyconsulted although the NDPAS was to govern both human andveterinary drugs. Consequently, over the last seven years,veterinary drugs have been managed under a policy and legislationthat had been designed on human drug management that does notsuit the veterinary sector.

The mandate of MAAIF is to support, promote and guide theproduction of crops, livestock and fisheries so as to ensureimproved quality and quantity of agricultural produce andproductsfor domestic consumption, food security and export. Inline withthis mandate, MAAIF is responsible for the disease control, whichentails the use of drugs among other things. Sectoral policyformulation is a core responsibility of MAAIF. It is thereforepertinent that a policy on Veterinary Drugs is developed andimplemented by the parent ministry. This renders justification tothe formulation of the veterinary drug policy within the Ministryof Agriculture, Animal Industry and Fisheries.

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An overall policy for the Delivery of Veterinary Services has beenput in place, which specifies the roles of the public and privatesectors and outlines strategies for their delivery as well as makingrecommendations for delivery standards. The National VeterinaryDrug Policy will operate hand in hand with the policy on theDelivery of Veterinary Services.Botb policies will constitute the National Animal Health Policyframework that will support and promote the developmental issuesof the sub-sector as articulated in the Plan for the Modernisationof Agriculture.

1.2 Current Animal Population and Distribution

The livestock population in Uganda consists of about 5.6 millioncattle, 3.8 million goats, 1.3 million sheep, 1.5 million pigs and23 million poultry. The population of dogs/cats is estimated at1.5 million. Over 90% of the cattle are indigenous Sanga, Zebuand Nganda which are kept by smallholder farmers and grazedcommunally. There are about 278,000 dairy and 200,000improved beef cattle

About 50% of the cattle population is found in southern andwestern Uganda where the average number of cattle per householdis 2.11 compared to eastern and northern Uganda at 0.67 and thenational average at 1.37. There is potential for the sub-sector toincrease the production and productivity of the national animalresource if achievable animal health strategies are put in place ina sustainable way.

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2.0 SITUATION ANALYSIS

The National Drug Authority and Statute (1993) has insufficientguidelines in respect ofthe management and administrative issuesconcerning veterinary drugs.

Representation of the veterinary sector at both the NDA andmanagement levels is inadequate. Whereas the medical sectorhas statutory committees that specifically address issues relatedto human drugs, only an adhoc committee with statutory powersrepresents the veterinary sector. A policy articulating drug issuespertinent to the practice of veterinary medicine is thereforeappropriate and this fits into the current mandate of the lineministry.

In the proposed National Veterinary Drug Policy, the followingareas are focused on:i. Veterinary drug quantification, manufacturing,

procurement, storage, distribution and usageVeterinary drug registration and inspectionLicensing veterinary drug outletsDisposal of expired or otherwise unwanted veterinarydrugsMonitoring of drug residues in foods of animal originResearch in veterinary drugs and ethnoveterinarymedicinesQuality assurance

Vlll. Veterinary drug information management systemCorrect and safe use of veterinary drugs

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The Ministry of Agriculture, Animal Industry and Fisheries shallhouse the National Veterinary Drug Policy and shall ensure thatappropriate strategies and a legal structure are in place to achievethe desired objectives.

3.0 POLICY STATEMENT

The National Veterinary Drug Policy statement and strategicframework has been formulated within the context of the 1995Constitution, the Local Government Act of 1997 and in line withthe broad National Policies of Liberalisation and Privatisation.The statement also takes into consideration the objectives of themultisectoral strategic plan for the Modernisation of Agriculture.

3.1 The VisionAccess to quality veterinary drugs by aUstakeholders forsustainable animal health and production.

3.2 The MissionTopromote and ensure the availability and use of quality veterinarydrugs in a professional manner.

3.3 Policy ObjectiveThe overall objective of the veterinary drug policy is to providean enabling environment for the manufacture, procurement andproper usage of good quality veterinary drugs by all stakeholdersin the country.

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3.4 Guiding PrinciplesThe following constitute the guiding principles for the veterinary

drug policy:

o Equitable distribution of quality veterinary drugs shall beassured for animal owners using both the public and private

veterinary service providers.

PurposeTo support and promote a reliable cost-effective veterinary drugssupply system in order to ensure that the required essential animaldrugs are available and accessible.

ExplanationA reliable supply of cost-effective veterinary drugsis essential in the maintenance of a healthy animalpopulation.o Proper use of veterinary drugs shall be regularly monitored

to reduce risks associated with public health anddevelopment of resistance to drugs and chemicals. 3.5.2 Objective

To ensure availability of safe, efficacious and affordable veterinarydrugs.o Assurance that production, usage and disposal of veterinary

drugs is in accordance with the guidelines of the National

Environmental Management Action Plan.3.5.3 Strategies

• MAAlF shall guide the private sector to ensure that itefficiently and effectively makes available safe and efficaciousveterinary drugs in accordance with the national requirements.

• MAAIF shall identify non-fast moving but essential veterinarydrugs and encourage the private sector to trade in them.

• The NDA shall establish an appropriate registration andinspection system for veterinary drugs.

• MAAlF in conjunction with the Uganda Veterinary Boardshall put in place a National Veterinary Formulary and theEssential Veterinary Drug List.

• MAAJF shall regularly assess the national veterinary drugsrequirements.

• MAAIF in conjunction with other relevant authorities shallmonitor drug residues in foods of animal origin.

o Assurance that the veterinary drug policy objectives comply

with international standards.

o Assurance of importation and exportation of quality, safe

and efficacious veterinary drugs.

3.5 Policy AreasTo achieve this objective, the policy shall address the following

areas:

3.5.1 Animal Drugs Supply (Quantification, manufacture, procurement,storage, distribution and usage)

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3.6.1

3.7Quality Assurance

Purposecr To ensure that veterinary drugs in use are of the appropriate

quality.o- To protect the animal population from harmful effects which

may be caused by the use of poor quality drugs.

ExplanationRegular monitoring and assessment of the quality of veterinarydrugs and vaccines are necessary to ensure the purity, potency,

efficacy and safety of the drugs in use.

ObjectiveTo ensure that veterinary drugs in use are of good quality.

3.7.1

3.6.2 Strategies• MAAlF and NDA shall strengthen the existing facilities forthe analysis of veterinary drugs to ensure their quality at all

levels of production and distribution networks.• Government shall establish a system of regulating andcontrolling the commercial production, manufacture anddistribution and use of ethnoveterinary medicines.

• The private sector shall be required to avail samples of theirdrugs for regular testing; and sampled consignments foundnot to conform to the required standards shall be surrendered

for destruction.• MAAlF in conjunction with other relevant authorities shall

monitor drug residues in foods of animal origin.

3.8

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Safe disposal of expired or otherwise unwanted veterinary drugsand materials

PurposeTo safeguard humans, animals and the environment against anyhazards due to unused and unwanted drugs and other veterinarymedical wastes.

ExplanationUnsafe and unwanted drugs that do not meet the required standardspose environmental hazards if their disposal is not properly done.These drugs shall therefore be disposed off in accordance withapproved methods.

Strategies• MAAIF in conjunction with relevant authorities shall set upa monitoring system for verification and removal of expiredor otherwise unwanted veterinary drugs and clinical wastematerials.

• The NDA shall ensure safe disposal of expired or otherwiseunwanted veterinary drugs and materials in accordance withthe established environmental protection requirements.

Research in Veterinary drugs and Ethnoveterinary medicines

Purposeo- To support and promote research programmes on veterinary

drugs and ethnoveterinary medicines.«r To maximise the benefits and minirnise the hazards

associated with the use of ethnoveterinary medicines.

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Explanation0- Research in veterinary drugs and ethnoveterinary medicinesi.simportant in strengthening the improvement of animal health

and industry.

3.8.1 Objectivecr To promote research in the production and utilisation ofveterinary drugs and ethnoveterinary medicines.

o- To identify, investigate and characterise useful ethnoveterinary

medicines.

3.8.2 Strategies• MAAIF shall advocate for the establishment of a fund topromote and support research in veterinary drugs and

ethnoveterinary medicines.• MAAIF shall encourage the private sector to participate in

veterinary drug research programmes.• MAAIF shall support and encourage research in the integrationof ethnoveterinary medicine in animal health care

programmes.

3.9 Veterinary Drug Information Management SystemPurposeTo keep all stakeholders abreast with the current and correct

information about veterinary drugs.

. ExplanationDrug information management is essential for the effectivedistribution and utilisation of veterinary drugs by all stakeholders.

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3.9.1 ObjectiveTo promote access to and utilisation of information on veterinarydrugs and ethnoveterinary medicines.

3.9.2 Strategies• MAAlF, UVB and NDA shall establish an information

management system on veterinary drugs.• The private sector shall provide information on the use and

effects of animal health products.• UVB shall promote the periodic publication of information

on the use of veterinary drugs.

3.10 Correct and Safe U.5eof veterinary drugs

PurposeTo ensure that veterinary service providers and animal ownersare adequately knowledgeable in the correct and safe use ofveterinary drugs.

ExplanationThe training of personnel in the correct and safe use of drugsenhances proper use and handling of veterinary drugs. .

3.10.1 ObjectiveTo promote correct and safe use of veterinary drugs.

3.10.2 Strategies• UVB in conjunction with MAAIF and gazetted training

institutions shall set guidlines for training in the correct and

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•safe use of veterinary drugs.UVB shall require veterinary service providers to undertakeperiodic refresher training programmes.All duly qualified veterinary service providers shall beregistered by the UVB.MAAIF in conjunction with local governments shall designsensitisation programmes for animal owners.

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3.11 Licensing of persons handling veterinary drugs

PurposeTo regulate the persons allowed to handle and administerveterinary drugs.

ExplanationCorrect handling and safe use of classified veterinary drugs requireprofessionally competent persons

3.11.1 ObjectiveTo promote professional usage of veterinary drugs

3.11.2 Strategies• UVB shall issue practice licenses to registered veterinary

service providers in accordance with the law.• UVB in conjunction with NDA shall set guidelines for drugs

to be handled by non-registered service providers.

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4.0 IMPLEMENTATION OF THE POLICY

The Ministry of Agriculture, Animal Industry and Fisheries shaUimplement the National Veterinary Drug Policy. Aspects ofregulatory nature shall be implemented by the NDA which wilJbe appropriately restructured to efficiently address the needs andpeculiarities of the veterinary sector.

4.1 Strategies• MAAIF shall collaborate with other institutions in theimplementation of this policy

• MAAlF shall ensure that the veterinary sector is adequatelyand effectively represented on all organs and fora that addressveterinary drugs.

• MAAlF puts in place the necessary infrastructure andmachinery to implement the policy.

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