THE NATIONAL VETERINARY DRUG POLICY

THE NATIONAL VETERINARY DRUG POLICY Ministry Of Agriculture, Animal Industry and Fisheries P.o. Box 102, Entebbe- UGA DA November 2002

TABLE OF CONTENTS: Page Foreword 1 Acronyms 3 Introduction 4 Situation analysis 6 Policy Statement 7 Implementation of the policy 15

FOREWORD The Ministry of Agriculture, Animal Industry and Fisheries is mandated to support, promote and guide the production of livestock and crops for self-sufficiency and export. This mandate is under the provisions of the macroeconomic policies of liberalisation, privatisation and the Plan for Modernisation of Agriculture (PMA). The core function of the Ministry of Agriculture, Animal Industry and Fisheries is to formulate policies and 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 of which invariably involves in part, the use of veterinary drugs. A policy to ensure that this area of the provision of veterinary services is adequately addressed is therefore vital. The veterinary drug policy covers the following areas: Veterinary drug supply; Veterinary drug legislation and inspection; Licensing of veterinary drug outlets; Disposal of expired or otherwise unwanted veterinary drugs and veterinary 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. 1

My Ministry will be responsible for the implementation of the policy on veterinary drugs in conjunction with other relevant agencies. The veterinary drug policy will operate along side the policy of the delivery of veterinary services and the two will constitute the National Animal Health Policy. Successful implementation of this veterinary drug policy shall call for the involvement of all the key stakeholders who should carefully focus on the most practical ways for effective collaboration to ensure that the policy objectives are sufficiently addressed. It should be borne in mind that a policy is dynamic and must be responsive to the changing circumstances. 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 ~~.~ W.Kisamba Mugerwa (Dr.) MP MINISTER OF AGRICULTURE, ANIMAL INDUSTRY AND FISHERIES 2 3

1.0 INTRODUCTION 1.1 Background Government established a National Drug Policy and Authority Statute (NDPAS) (1993) to ensure the availability, at all times of essential, efficacious and cost-effective drugs to the entire human and animal population of Uganda. The Ministry of Health is the custodian of the Drug Policy and Authority Statute. During its formulation, the veterinary sector was not adequately consulted although the NDPAS was to govern both human and veterinary drugs. Consequently, over the last seven years, veterinary drugs have been managed under a policy and legislation that had been designed on human drug management that does not suit the veterinary sector. The mandate of MAAIF is to support, promote and guide the production of crops, livestock and fisheries so as to ensure improved quality and quantity of agricultural produce and products for domestic consumption, food security and export. Inline with this mandate, MAAIF is responsible for the disease control, which entails the use of drugs among other things. Sectoral policy formulation is a core responsibility of MAAIF. It is therefore pertinent that a policy on Veterinary Drugs is developed and implemented by the parent ministry. This renders justification to the formulation of the veterinary drug policy within the Ministry of Agriculture, Animal Industry and Fisheries. An overall policy for the Delivery of Veterinary Services has been put in place, which specifies the roles of the public and private sectors and outlines strategies for their delivery as well as making recommendations for delivery standards. The National Veterinary Drug Policy will operate hand in hand with the policy on the Delivery of Veterinary Services. Botb policies will constitute the National Animal Health Policy framework that will support and promote the developmental issues of the sub-sector as articulated in the Plan for the Modernisation of Agriculture. 1.2 Current Animal Population and Distribution The livestock population in Uganda consists of about 5.6 million cattle, 3.8 million goats, 1.3 million sheep, 1.5 million pigs and 23 million poultry. The population of dogs/cats is estimated at 1.5 million. Over 90% of the cattle are indigenous Sanga, Zebu and Nganda which are kept by smallholder farmers and grazed communally. There are about 278,000 dairy and 200,000 improved beef cattle About 50% of the cattle population is found in southern and western Uganda where the average number of cattle per household is 2.11 compared to eastern and northern Uganda at 0.67 and the national average at 1.37. There is potential for the sub-sector to increase the production and productivity of the national animal resource if achievable animal health strategies are put in place in a sustainable way. 4 5

2.0 SITUATION ANALYSIS The National Drug Authority and Statute (1993) has insufficient guidelines in respect ofthe management and administrative issues concerning veterinary drugs. The Ministry of Agriculture, Animal Industry and Fisheries shall house the National Veterinary Drug Policy and shall ensure that appropriate strategies and a legal structure are in place to achieve the desired objectives. Representation of the veterinary sector at both the NDA and management levels is inadequate. Whereas the medical sector has statutory committees that specifically address issues related to human drugs, only an adhoc committee with statutory powers represents the veterinary sector. A policy articulating drug issues pertinent to the practice of veterinary medicine is therefore appropriate and this fits into the current mandate of the line ministry. In the proposed National Veterinary Drug Policy, the following areas are focused on: i. Veterinary drug quantification, manufacturing,.. li. 111. IV. v. VL.. ViI. Vlll. IX. procurement, storage, distribution and usage Veterinary drug registration and inspection Licensing veterinary drug outlets Disposal of expired or otherwise unwanted veterinary drugs Monitoring of drug residues in foods of animal origin Research in veterinary drugs and ethnoveterinary medicines Quality assurance Veterinary drug information management system Correct and safe use of veterinary drugs r r t 3.0 POLICY STATEMENT The National Veterinary Drug Policy statement and strategic framework has been formulated within the context of the 1995 Constitution, the Local Government Act of 1997 and in line with the broad National Policies of Liberalisation and Privatisation. The statement also takes into consideration the objectives of the multisectoral strategic plan for the Modernisation of Agriculture. 3.1 The Vision Access to quality veterinary drugs by au stakeholders for sustainable animal health and production. 3.2 The Mission To promote and ensure the availability and use of quality veterinary drugs in a professional manner. 3.3 Policy Objective The overall objective of the veterinary drug policy is to provide an enabling environment for the manufacture, procurement and proper usage of good quality veterinary drugs by all stakeholders in the country. 6 7

3.4 Guiding Principles The following constitute the guiding principles for the veterinary drug policy: o Equitable distribution of quality veterinary drugs shall be o assured for animal owners using both the public and private veterinary service providers. Proper use of veterinary drugs shall be regularly monitored to reduce risks associated with public health and development of resistance to drugs and chemicals. o Assurance that production, usage and disposal of veterinary drugs is in accordance with the guidelines of the National Environmental Management Action Plan. 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 Areas To achieve this objective, the policy shall address the following areas: 3.5.1 Animal Drugs Supply (Quantification, manufacture, procurement, storage, distribution and usage) To support and promote a reliable cost-effective veterinary drugs supply system in order to ensure that the required essential animal drugs are available and accessible. Explanation A reliable supply of cost-effective veterinary drugs is essential in the maintenance of a healthy animal population. 3.5.2 Objective To ensure availability of safe, efficacious and affordable veterinary drugs. 3.5.3 Strategies MAAlF shall guide the private sector to ensure that it efficiently and effectively makes available safe and efficacious veterinary drugs in accordance with the national requirements. MAAIF shall identify non-fast moving but essential veterinary drugs and encourage the private sector to trade in them. The NDA shall establish an appropriate registration and inspection system for veterinary drugs. MAAlF in conjunction with the Uganda Veterinary Board shall put in place a National Veterinary Formulary and the Essential Veterinary Drug List. MAAJF shall regularly assess the national veterinary drugs requirements. MAAIF in conjunction with other relevant authorities shall monitor drug residues in foods of animal origin. 8 9

3.6 Quality Assurance 3.7 Safe disposal of expired or otherwise unwanted veterinary drugs and materials cr 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. To safeguard humans, animals and the environment against any hazards due to unused and unwanted drugs and other veterinary medical wastes. Explanation Regular monitoring and assessment of the quality of veterinary drugs and vaccines are necessary to ensure the purity, potency, efficacy and safety of the drugs in use. Explanation Unsafe and unwanted drugs that do not meet the required standards pose environmental hazards if their disposal is not properly done. These drugs shall therefore be disposed off in accordance with approved methods. 3.6.1 Objective To ensure that veterinary drugs in use are of good quality. 3.6.2 Strategies MAAlF and NDA shall strengthen the existing facilities for the analysis of veterinary drugs to ensure their quality at all levels of production and distribution networks. Government shall establish a system of regulating and controlling the commercial production, manufacture and distribution and use of ethnoveterinary medicines. The private sector shall be required to avail samples of their drugs for regular testing; and sampled consignments found not 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. 3.7.1 3.8 Strategies MAAIF in conjunction with relevant authorities shall set up a monitoring system for verification and removal of expired or otherwise unwanted veterinary drugs and clinical waste materials. The NDA shall ensure safe disposal of expired or otherwise unwanted veterinary drugs and materials in accordance with the established environmental protection requirements. Research in Veterinary drugs and Ethnoveterinary medicines o- 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. 10 11

Explanation 0- Research in veterinary drugs and ethnoveterinary medicines i.simportant in strengthening the improvement of animal health and industry. 3.8.1 Objective cr To promote research in the production and utilisation of veterinary 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 to promote 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 integration of ethnoveterinary medicine in animal health care programmes. 3.9 Veterinary Drug Information Management System To keep all stakeholders abreast with the current and correct information about veterinary drugs.. Explanation Drug information management is essential for the effective distribution and utilisation of veterinary drugs by all stakeholders. 3.9.1 Objective To promote access to and utilisation of information on veterinary drugs 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 To ensure that veterinary service providers and animal owners are adequately knowledgeable in the correct and safe use of veterinary drugs. Explanation The training of personnel in the correct and safe use of drugs enhances proper use and handling of veterinary drugs.. 3.10.1 Objective To 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 12 13

safe use of veterinary drugs. UVB shall require veterinary service providers to undertake periodic refresher training programmes. All duly qualified veterinary service providers shall be registered by the UVB. MAAIF in conjunction with local governments shall design sensitisation programmes for animal owners. 3.11 Licensing of persons handling veterinary drugs To regulate the persons veterinary drugs. allowed to handle and administer Explanation Correct handling and safe use of classified veterinary drugs require professionally competent persons 4.0 IMPLEMENTATION OF THE POLICY The Ministry of Agriculture, Animal Industry and Fisheries shau implement the National Veterinary Drug Policy. Aspects of regulatory nature shall be implemented by the NDA which wilj be appropriately restructured to efficiently address the needs and peculiarities of the veterinary sector. 4.1 Strategies MAAIF shall collaborate with other institutions in the implementation of this policy MAAlF shall ensure that the veterinary sector is adequately and effectively represented on all organs and fora that address veterinary drugs. MAAlF puts in place the necessary infrastructure and machinery to implement the policy. 3.11.1 Objective To 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. 14 15