faking and counterfeiting of drugs: evaluation of pharmacy...

Int. J. Curr. Res. Med. Sci. (2017). 3(10): 70-91

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International Journal of Current Research inMedical Sciences

ISSN: 2454-5716P-ISJN: A4372-3064, E -ISJN: A4372-3061

www.ijcrims.com

Original Research Article Volume 3, Issue 10 -2017

Faking and Counterfeiting of Drugs: Evaluation of PharmacyRegulatory, Privatisation, Social Welfare Services and its

Alternatives of Sudan

Abdeen Mustafa OmerOccupational Health Administration, Ministry of Health,

Khartoum, Sudan

Abstract

The strategy of price liberalisation and privatisation had been implemented in Sudan over the last decade, and has hada positive result on government deficit. The investment law approved recently has good statements and rules on theabove strategy in particular to pharmacy regulations. Under the pressure of the new privatisation policy, thegovernment introduced radical changes in the pharmacy regulations. To improve the effectiveness of the publicpharmacy, resources should be switched towards areas of need, reducing inequalities and promoting better healthconditions. Medicines are financed either through cost sharing or full private. The role of the private services issignificant. A review of reform of financing medicines in Sudan is given in this study. Also, it highlights the currentdrug supply system in the public sector, which is currently responsibility of the Central Medical Supplies PublicCorporation (CMS). In Sudan, the researchers did not identify any rigorous evaluations or quantitative studies aboutthe impact of drug regulations on the quality of medicines and how to protect public health against counterfeit or lowquality medicines, although it is practically possible. However, the regulations must be continually evaluated toensure the public health is protected against by marketing high quality medicines rather than commercial interests,and the drug companies are held accountable for their conduct.

Keywords: Counterfeits medicines, drug importers, quality of medicines, regulatory authorities

Introduction

The World Health Organisation [1] has defineddrug regulation as a process, which encompassesvarious activities, aimed at promoting andprotecting public health by ensuring the safety,efficiency and quality of drugs, andappropriateness accuracy of information [1].Medicines regulation is a key instrumentemployed by many governments to modify thebehaviour of drug systems. The regulation of

pharmaceuticals relates to control ofmanufacturing standards, the quality, the efficacyand safety of drugs, labelling and informationrequirements, distribution procedures andconsumer prices [2]. To assure quality ofmedicines, in most countries registration isrequired prior to the introduction of a drugpreparation into the market. The manufacturing,registration and sale of drugs have been the

DOI: http://dx.doi.org/10.22192/ijcrms.2017.03.10.012


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subject of restricts regulations and administrativeprocedures worldwide for decades [3]. Nobodywould seriously argue drugs should be proven tobe 100% safe. No set of regulations could achievethat goal argue, because it is impossible and alldrugs carry some risk [4].

Stringent drug regulation was introduced acrossmany countries in the 1960s following thethalidomide disaster, and had since beenembraced by the industry as a commercialessential seal of safety and quality [5]. In spite ofthe measures, many countries, especiallydeveloping one face a broader range of problems.In several developing countries drug quality is asource of concern. There is a general feeling ofhigh incidence of drug preparations that are not ofacceptable quality [6]. For example, about 70% ofcounterfeit medicines were reported bydeveloping countries [7]. Reports from Asia,Africa, and South America indicate 10% to 50%of consider using prescribed drugs in certaincountries may be counterfeit [8]. For instance, inNigeria fake medicines may be more than 60 -70% of the drugs in circulation [9], and 109children died in 1990 after being administeredfake Paracetamol [10]. In Gambia the drugregistration and control system resulted in theelimination of ‘drug peddlers’ and certain‘obsolete and harmful’ drugs, as well as a largedecrease in the percentage of brand andcombination drugs [11]). The percentage of drugsfailing quality control testing was found to bezero in Colombia, but 92% in the private sector ofChad [12]. Hence, it is very difficulty to obtainaccurate data. The proportion of counterfeit drugsin the USA marketplace is believed to be small -less than 1 percent [12]. In [13] reported twocases of counterfeit medicines that found theirway into legitimate medicine supply chain in theUK in 2004.

Poor quality drug preparations may lead toadverse clinical results both in terms of lowefficacy and in the development of drug resistance[14]. Regulations are the basic devices employedby most governments to protect the public healthagainst substandard, counterfeit, low qualitymedicines, and to control prices. Thoroughknowledge of whether these regulations produce

the intended effects or generate unexpectedadverse consequences is critical. The WorldHealth Organisation (WHO) undertook a numberof initiatives to improve medicines quality in itsmember states and promote global mechanismsfor regulating the quality of pharmaceuticalproducts in the international markets. Yet, thereare not any WHO guidelines on how to evaluatethe impact of these regulations. There arenumerous reports concerning drug regulations[15], but the published work on the impact ofthese regulations on the quality of medicinesmoving in the international commerce has beenscarce. Findings from most published studies lackcomparable quantitative information that wouldallow for objective judging whether and by howmuch progress on the various outcomes have beenmade by the implementation of thepharmaceutical regulations. To ignore evaluationsand to implement drug regulation based on logicand theory is to expose society to untriedmeasures in the same way patients were exposedto untested medicines [15].

The present policy of the national health–caresystem in Sudan is based on ensuring the welfareof the Sudanese inhabitants through increasingnational production and upgrading theproductivity of individuals. A health developmentstrategy has been formulated in a way that realisesthe relevancy of health objectives to the maingoals of the national development plans. Thestrategy of Sudan at the national level aims atdeveloping the Primary Health Care (PHC)services in the rural areas as well as urban areas.In Sudan 2567 physicians provide the publichealth services (554 specialists, 107 medicalregistrars, 1544 medical officers, 156 dentists, and206 pharmacists). Methods of preventing andcontrolling health problems are the following:

Promotion of food supply and propernutrition;

An adequate supply of safe water andbasic sanitation;

Maternal and child health-care; Immunisation against major infectious

diseases; Preventing and control of locally endemic

diseases; and


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Provision of essential drugs. This will be achieved through a health

system consisting of three levels (state,provincial and localities), including thereferral system, secondary and tertiarylevels. Pharmacy management should becoordinated and integrated with othervarious aspects of health. The followingare recommended:

The community must be the focus ofbenefits accruing from restructures, thelegislature should protect communityinterest on the basis of equity anddistribution, handover the assets to thecommunity should be examined; andcommunities shall encourage the transferthe management of health schemes to aprofessional entity.

The private sector should be used tomobilise and strengthen the technical andfinancial resources from within andoutside the country to implement theservices, with particular emphasis onutilisation of local resources.

The government should provide thenecessary financial resources to guide theprocess of community management ofpharmacy supplies. The governmentshould be a facilitator through setting upstandards, specifications and rules to helpharmonise the private sector and establisha legal independent body by an act ofparliament to monitor and control theproviders. Government should assist thepoor communities who cannot affordservice cost, and alleviate social-economicnegative aspects of privatisation.

The sector actors should create awarenessto the community of the roles of theprivate sector and government in theprovision of health and pharmacy services.

Support agencies should assist withfinancial and technical support, trainingfacilities, coordination, development anddissemination of health projects, as well asevaluation of projects.

Aim and Objective

The main purpose of this study is to analyse anddetermine the opinion of a group of pharmacistswho are the owners or shareholders in theSudanese medicine importing companies and theirperception concerning the effects of thegovernment’s new Pharmacy, Poisons, Cosmeticsand Medical Devices Act has had on the qualityof medicines in Sudan. To achieve this purposethe following questions would be answered:

(1) Do the Sudan pharmacy legislationsprohibit marketing of low quality medicines?(2) What is the impact of the transfer ofveterinary medicines registration system to theMinistry of Animal Resources after theapproval of the Pharmacy and Poisons Act 2001?(3) Does pre-marketing analysis of medicineshelp to detect the counterfeit medicines?(4) Does importation of non-registered1

medicines by the government and non-governmental organisations exacerbate theproblem of low quality medicine if any?

In Sudan, the researchers did not identify anyrigorous evaluations or quantitative studies aboutthe impact of drug regulations on the quality ofmedicines and how to protect public healthagainst counterfeit or low quality medicines,although it is practically possible. However, theregulations must be continually evaluated toensure the public health is protected against fakemedicines by ensuring the exclusive marketing ofhigh quality medicines rather than commercialinterests, and the drug companies are heldaccountable for their conducts [16].

The availability of medicines in Sudan iscontrolled on the basis of safety, quality andefficacy. Thus, the government effects control inaccordance with the Pharmacy, Poisons,Cosmetics and Medical Devices Act 2001 and itsinstruments. The Federal or State Departments ofPharmacy (DOP) and directives issued orders.

1All medicines should be registered by the General Directorate ofPharmacy to get marketing approval. Each manufacturer or importermust present extensive information on the product (or products)submitted to allow Technical Standing Committee for drugregistration evaluates the quality, safety, efficacy and price ofmedicines.


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The primary objective of both Federal and States’Departments of Pharmacy is to safeguard publichealth by ensuring all medicines andpharmaceuticals on the Sudan market meetappropriate standards of safety, quality andefficacy. The safeguarding of public health isachieved largely through the system of medicines’registration and licensing of pharmacy premises.

The first Pharmacy and Poisons Act was enactedin 1939. This Act had been amended three timessince then. In 2001 amendments, cosmetics andmedical devices were also brought under itspurview. Thus, the name was changed toPharmacy, Poisons, Cosmetics and MedicalDevices Act (hereafter the Act). The Act regulatesthe compounding, sale, distribution, supply,dispensing of medicines and provides differentlevels of control for different categories, e.g.,medicines, poisons, cosmetics, chemicals formedical use and medical devices.

The Act makes provision for the publication ofregulations and guidelines by the FederalPharmacy and Poisons Board (FPPB), thepharmaceutical regulatory authority and itsexecutive arm - the Federal General Directorate ofPharmacy (FGDOP). The FGDOP regulatesmainly four aspects of medicines use: safety,quality, efficacy and price. Traditionally,governments in many countries, particularlydeveloped nations have attempted to ensure theefficiency, safety, rational prescribing, anddispensing of drugs through pre-marketingregistration, licensing and other regulatoryrequirements [17]. When applying to register themedicine manufacturers and importers arerequired to furnish the FGDOP with a dossier ofinformation including among others, theindication of the medicine, its efficacy, sideeffects, contraindication, warnings on usage byhigh risk groups, price, storage and disposal [17].The role of the FGDOP includes among others:

(1) Regulation and control of the importation,exportation, manufacture, advertisement,distribution, sale and the use of medicines,cosmetics, medical devices and chemicals;(2) Approval and registration of newmedicines - the Act requires FGDOP should

register every medicine before be sold ormarketed. Companies are required to submitapplications for the registration of medicines forthe evaluation and approval;(3) Undertake appropriate investigations intothe production premises and raw materials fordrugs and establish relevant quality assurancesystems including certification of the productionsites and regulated products;(4) Undertake inspection of drugs’ whole andretail sellers owned by both public or privatesectors;(5) Compile standard specifications andregulations and guidelines for the production,importation, exportation, sale and distribution ofdrugs, cosmetics, etc.(6) Control of quality of medicines: This willbe done by regular inspection and post-marketingsurveillance;(7) Licensing of pharmacy premises (i.e.,pharmaceutical plants, wholesalers and retailpharmacies);(8) Maintain national drug analysislaboratories for the pre- and post- marketinganalysis of medicines;(9) Coordination with states departments ofpharmacy to ensure the enforcement of the Actand its rules and directives.

Health and Pharmacy Systems

The health system in Sudan is characterised byheavy reliance on charging users at the point ofaccess (private expenditure on health is 79.1percent), with less use of prepayment system suchas health insurance. The way the health system isfunded, organised, managed and regulated affectshealth workers' supply, retention, and theperformance. Primary Health Care was adopted asa main strategy for health-care provision in Sudanand new strategies were introduced during the lastdecade, including:

Health area system. Polio eradication in 1988. Integrated management of children illness(IMCI) initiative. Rollback malaria strategy. Basic developmental need approach in1997.


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Safe motherhood, making pregnancy saferinitiative, eradication of harmful traditionalpractices and emergency obstetrics’ careprogrammes.

The strategy of price liberalisation andprivatisation had been implemented in Sudan overthe last decades, and has had a positive result onthe government deficit. The investment law [18]approved recently has good statements and ruleson the above strategy in particular to health andpharmacy areas. The privatisation and priceliberalisation in healthy fields has to re-structure(but not fully). Availability and adequatepharmacy supplies to the major sectors. The resultis that the present situation of pharmacy servicesis far better than ten years ago.

The government of Sudan has a great experiencein privatisation of the public institutions, i.e., theSudanese free zones and markets, Sudantelecommunications (Sudatel) and Sudan airlines.These experiences provide good lessons about theefficiency and effectiveness of the privatisationpolicy. Through privatisation, the government isnot evading its responsibility of providing health-care to the inhabitants, but merely shifting its rolefrom being a provider to a regulator and standardsetter. Drug financing was privatised early in1992. Currently, the Federal Ministry of Health(FMOH) has privatised certain non-medicalservices in hospitals such as catering services,security and cleanings.

The overall goal of the CMS ownershipprivatisation is to improve access to essentialmedicines and other medical supplies in order toimprove health status of the inhabitantsparticularly in far states (e.g., Western andSouthern States).

Establishment of alternative ownership for theCMS can be achieved by selling the majority ofshares to the private sector. This will achieve thefollowing objectives:

High access to essential medicines of goodquality and affordable prices to the states’population and governments.

Efficiency and effectiveness in drugdistribution system to avoid the serious pitfallsand incidences that was reported during the lastten years in the CMS. Equity by reaching all remote areascurrently deprived from the formal drugdistribution channels. Improvement of the quality and quantityof delivery of medicines to the public healthfacilities.

The above objectives are expected to:

Increase geographical and economicaccess to essential medicines in all states (i.e., inboth rural and urban areas) to reach at least 80%of the population (currently less than 50% ofpopulation have access to essential medicines). The tax collection from the new businessbecomes more efficient and will increase afterprivatisation. The tax revenues could be used tofinance other health-care activities. If the government reserves some shares(not more than 50%) in the new business, then itsshares’ profit could be used to finance freemedicines project in hospitals outpatients’ clinic,and other exempted medicines, e.g., renal dialysisand haemophilic patients’ treatment.

Privatisation of Public PharmaceuticalSupplies

The term privatisation has generally been definedas any process that aims to shift functions andresponsibilities (totally or partially) from thegovernment to the private. More broadlymeaning, it refers to the restriction ofgovernment's role and putting forward somemethods or policies in order to strengthen the freemarket economy [19]. Privatisation can be anideology (for those who oppose government andseek to reduce its size, role, and costs, or for thosewho wish to encourage diversity, decentralisation,and choice) or a tool of government (for thosewho see the private sector as more efficient,flexible, and innovative than the public sector)[19]. In [19] contends that “the invisible hand ofthe market is more efficient and responsive to theconsumer needs and the public administrativebudgets consume large portion of tax monies that


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could otherwise be used for service delivery”. Theemphasis is on improving the efficiency of allpublic enterprises, whether retained or divested.Privatisation may take many forms including:

Elimination of a public function and itsassignment to the private sector for financialsupport as well as delivery (police, and firedepartments, schools, etc.). Opponentscharacterise this as “load-shedding”. Deregulation: the elimination ofgovernment responsibility for setting standardsand rules concerning goods or services. Assets sales: the selling of a public asset(city buildings, and sports stadiums) to privatefirms. Vouchers: are the government provided orfinanced cards or slips of paper that permit privateindividuals to purchase goods or services from aprivate provider (food stamps) or circumscribedlist of providers. Franchising: the establishment of modelsby the public sector that is funded by governmentagencies, but implemented by approved privateproviders. Contracting: the government financing ofservices, choice of service provider, andspecification of various aspects of the serviceslaid out in contracts with the private-sectororganisation that produces or delivers theservices. User fees: public facilities such ashospitals that maximise their income or financesome goods from private sources, either throughdrug sales or other services. This kind ofprivatisation has been applied in Sudan since theearly 1990s, as the health financing mechanism(especially for medicines).

In Sudan, the government has decided to distanceitself from direct involvement in business, andthus divest most of its interests whether in loss orprofit making public enterprises. The publicreform programme was set firmly in the contextof the broader reforms [19], which wereintroduced in 1992. It had become clear theprevious policies had delivered led to poor results.This reform based on the transfer of activitiesvested with the government institutions to theprivate sector. It signalled the government

intention to reduce its presence in the economy, toreduce the level and scope of public spending andto allow market forces to govern economicactivities. Privatisation also forms part of thegovernment strategy of strengthening the role ofthe private in the development to achieve thevision of the 25 years strategy in which theprivate sector will be the engine for economicgrowth. The privatisation started in 1992 byliberalisation of local currency, foreign exchangetransactions, internal and external trade, pricesand health services (e.g., user fee as a mechanismof drug financing and other services). This reformhad led to greater reliance on individual initiativeand corporate accountability rather than ongovernment as a decision-maker in businessmatters.

The privatisation policy goal is to improve theperformance of the public sector companies, sothat they can contribute to the growth and thedevelopment of the economy by broadeningownership, participation in management, andstimulating domestic and foreign privateinvestment.

The following are the primary objectives, whichhave been defined in the government’s policystatement on public sector reform [19]:

Improve the operational efficiency ofenterprises that are currently in the public sectorby exposing business and services to the greatestcompetition for the benefit of the consumer andthe national economy. Reduce the burden of public enterprises onthe government’s budget by spreading the shares’ownership as widely as possible among thepopulation. Expand the role of the private sector in theeconomy (permitting the government toconcentrate on the public resources) on its role asprovider of basic public services, includinghealth, education, social infrastructure, and tocompact the side effects of the privatisation. Encourage wider participation of thepeople in the ownership and management ofbusiness.


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In pursuing the primary objectives theprivatisation policy aims to transform theperformance of most significant enterprises in thepublic sector and ensure liquidation of all viableand non-viable public enterprises as soon aspossible through commercialisation, restructuringand divesture.

Public sector reform efforts are thus aimed atreducing government dominance and promoting alarger role for the private sector, while improvinggovernment’s use of resources. Movementtowards those goals in some countries issupported by components of a structuraladjustment loan, which helped initiate theprogramme and establish the legislative andinstitutional base.

Opponents argue that the original objectives ofstate ownership were to ensure the corporatesector of the economy was in national handsrather than being controlled by either foreigninvestors or the minorities that enjoyed businessdominance upon independence. A furtherobjective was to use investment in state firms toaccelerate development in a situation, in whichprivate sector was reluctant to take risks.

Medicines Legislation Framework in Sudan

The availability of medicines in Sudan iscontrolled on the basis of safety, quality andefficacy. Thus, the government effects control inaccordance with the Pharmacy, Poisons,Cosmetics and Medical Devices Act 2001 and itsinstruments. The Federal or State Departments ofPharmacy (DOP) and directives issue orders. Theprimary objective of both Federal and States’Departments of Pharmacy is to safeguard publichealth by ensuring all medicines andpharmaceuticals on the Sudan market meetappropriate standards of safety, quality andefficacy. The safeguarding of public health isachieved largely through the system of medicines’registration and licensing of pharmacy premises.

The first Pharmacy and Poisons Act was enactedin 1939, and has been amended three times since.In the 2001 amendments, cosmetics and medicaldevices were also brought under its purview.

Thus, the name was changed to Pharmacy,Poisons, Cosmetics and Medical Devices Act(hereafter the Act). The Act regulates thecompounding, sale, distribution, supply,dispensing of medicines and provides differentlevels of control for different categories, e.g.,medicines, poisons, cosmetics, chemicals formedical use and medical devices.

The Act makes provision for the publication ofregulations and guidelines by the FederalPharmacy and Poisons Board (FPPB), thepharmaceutical regulatory authority and itsexecutive arm - the Federal General Directorate ofPharmacy (FGDOP). The FGDOP regulatesmainly four aspects of medicines use: safety,quality, efficacy and price. Traditionally,governments in many countries, particularlydeveloped nations have attempted to ensure theefficiency, safety, rational prescribing, anddispensing of drugs through pre-marketingregistration, licensing and other regulatoryrequirements. When applying to register themedicine manufacturers and importers arerequired to furnish the FGDOP with a dossier ofinformation including: the indication of themedicine, its efficacy, side effects,contraindication, warnings on usage by high riskgroups, price, storage and disposal.

Sudan Medicines’ Quality Measures

The following summarises the quality measuresof all medicines.

Registration of Medicines

The FGDOP is responsible for the appraisal, andregistration of all medicines and otherpharmaceuticals for both human and veterinaryuse on the Sudan market. It is also responsible forthe verification of the competence ofmanufacturing companies, the manufacturingplants, the ability to produce substances orproducts of high quality before registering thesecompanies and allowing them to apply forregistration of their products in Sudan. Whennecessary, visits conducted to those companiesand their manufacturing units, to verify their


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compliance with good manufacturing practicerecommended by the WHO. The applicant forregistration of pharmaceutical product mustsubmit all prescribed data and the certificatesrequired under the WHO certification scheme fora pharmaceutical product moving intointernational commerce, and any otherinformation that is necessary for assuring thequality, efficiency and stability of the productthrough its shelf life [19].

Licensing of pharmacy premises

The licensing is a registration exercise to providethe DOP at state level (Federal level in case oflocal manufacturing plants) with the informationnecessary for the full implementation of the Act.Licenses are granted for a period of one year, andmay be renewed at the end of December everyyear (applications to the relevant DOP beforeexpiry of the current license). To improve theeffectiveness of the public pharmacy, resourcesshould be switched towards areas of need,reducing inequalities and promoting better healthconditions. Medicines are financed either throughcost sharing or full private. The role of the privateservices is significant. The present policy of thenational health–care system in Sudan is based onensuring the welfare of the Sudanese inhabitantsthrough increasing national production andupgrading the productivity of individuals. Thestrategy of price liberalisation and privatisationhad been implemented in Sudan over the lastdecade, and has had a positive result ongovernment deficit.There are three major licenses as follows:

a) License A (Wholesaler License)

The pharmaceutical importing companies havesubjected to two broad categories of regulation.Those are the registration and administrativeprocess, and the regulation of qualitymanufacturing standards, efficacy andinformation disclosure.

License A authorises the holder to sell aregistered medicine to a person who buys themedicine for the purpose of sale or supply tosomeone else under the direct supervision of a

registered pharmacist or licensed medical doctor.Licensing of the wholesalers involvesidentification of the wholesaler and suitability ofthe premise. There are 175 wholesalers in Sudan.The majority (162 wholesalers) are local agentsfor the goods manufactured from abroad. The restare 13 “local manufacturer” wholesalers atKhartoum State (KS) and distribute the medicinesto the whole country. Wholesalers are inspectedby the state DOP before license is granted andthereafter at least once per year.

b) License B (Retail Pharmacy License)

Authorises the holder to sell a registered medicineto a patient on prescription or over-the counterbasis under direct supervision of the registeredpharmacist. The pharmacies are inspected beforea license is issued and thereafter at least twice peryear.

c) License D (Manufacturer’s License)

Manufacturing includes many processes carriedout in the course of making a medicinal product.A manufacturer’s license covers all aspects- bulkdrug, product manufacture, filling, labelling andpackaging- under supervision of a registeredpharmacist. There are 13 generic manufacturingsites at Khartoum State (KS). The Federal DOPinspects each one. Good manufacturing practice(GMP) is the basis of the inspection. Effectivecontrol of quality requires a manufacturer possess,and the appropriate facilities with respect topremises, equipment, staff, expertise and effectivewell-equipped quality control laboratory.Normally, before a license is granted, aninspection of premises is made and Federal DOPtakes this into account. The local manufacturersproduce 65 pharmaceutical dosage forms ofessential drugs and cover 60% of the CentralMedical Supplies Public Organisation (CMSPO)purchases.

In Sudan there are two types of retail pharmacy:


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Commercial Private Pharmacies

These are private establishments retailingregistered drugs and medical supplies at a mark-up of 18%. The source of the drugs andpharmaceuticals is private wholesalers. In 2002,though unlawful, the CMSPO started to sell itsnon-registered medicines to the privatepharmacies. By the end of 2004, there were 779private pharmacies in Sudan.

People’s Pharmacies

These are quasi-public establishments retailingdrugs and medical supplies below the marketprices to improve access and availability ofpharmaceuticals. They were founded in the early1980s as a pilot study for a drug cost recoverysystem. Those differ from the private commercialpharmacies. Firstly, in having access to theCMSPO drugs, i.e., generic and large packproducts, in addition the brand products from theprivate wholesalers. Secondly, the peoples’pharmacies are only owned by publicorganisations (e.g., hospitals, peoples’committees, trade unions and Non GovernmentalOrganisations (NGOs)). Mark-up on cost fordrugs from the CMSPO (35%), and from privatedrug wholesalers (profit margin is 10%).However, they have become commercialised nowand operate in a similar way to privatepharmacies. The total number of such pharmacieswas approximately 200 in Sudan.

Public Sector Medicines Supply System

In Sub-Saharan Africa countries discussions aboutmedicine distribution system reform haveconcentrated on ways to improve sustainabilityand quality of access to essential medicines.These discussions also include debate on theimpact of privatisation of public drug supplyorganisations on effectiveness, efficiency, qualityand cost of medicines in the public healthfacilities, as well as on the respective role of thepublic and private sectors.

Until the mid 1980s, some governments in Africa(i.e., Mali and Guinea) assumed responsibility for

providing drugs to their citizens. The privatedistribution of all drugs including aspirin wasillegal. In many countries, including Sudan therewere two parallel government distributionsystems. The public health network of hospitalsand health centres gratuitously distributed drugs.In the public sector pharmacies, the drugs weresold to the public at subsidised prices.

During the 1990s, Sudan initiated a number ofinitiatives to establish drug-financing mechanismsas part of the health reform process anddecentralised decision-making at a state level. In1992 when a law was passed, medicines were nolonger free of charge (i.e., privatised) in the publichealth system. The aim of the government is toincrease equitable access to essential medicines,especially at the states’ level. As a result theCentral Medical Stores, which was responsible formedicines supply system of the public healthfacilities, became an autonomous drug supplyagency, and was renamed as the Central MedicalSupplies Public Corporation (CMS) and operatedon cash-and-carry basis. It was capitalised and anexecutive board was installed. Since states andfederal hospitals have to buy their own medicines,and other medical supplies. They organised theirown transport means and distribution to theirprimary health-care facilities and hospitals. Inaddition, all hospitals became financiallyautonomous entities and have had to organisetheir own medicines procurement system.

The public drug supply system has not beenworking well throughout Sub-Saharan Africa andthis includes Sudan. There are serious shortagesor no medicines at all, particularly in rural areas.A study in Cameroon found the rural healthcentres received only 65% of the stock designatedfor them, and 30% of the medicines that arrived atthe centres did not reach the clients. The loss rateafter arrival in hospitals was estimated at 40%. InSudan, Graff and Evarard (2003) who visited thecountry on a WHO mission reported, “Althoughthe cash-and-carry system took off well, but lackof sufficient foreign exchange hampered the CMSprocurement activities and resulted in low stocklevels of all medicines and even stock out of life-saving products. Hospitals had to purchase themedicines from elsewhere and often had to buy


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from private sector. Overall hospitals’ budgetswere tied to allocate drug budget and salesincome was not sufficient to cover the purchase ofneeded medicines supplies. This resulted themedicines were not available most of the times.The in- or outpatients with their prescriptionswere directed to the private pharmacies. In 2003,Khartoum Teaching Hospital-the biggest hospitalin Sudan (not further than 5 km away from theCMS) had a medicine stock of only LS 83,000(US$ 31). This would not fill one prescription foran anaemic patient as a result of renal failure.This is a common practice that patients or theirrelatives are given prescriptions to buy anypharmaceutical supplies that are needed includingdrugs and other disposables from private sectorpharmacies.

Many ministries of health, services’ providers andresearchers have identified many characteristicsthat lead to poor performance in Africa publicdrug supply systems. These characteristicsinclude:

(1) Absence of competition:

Competition is the best way to ensure the goodsand services desired by the consumer are providedat the lowest economic cost. Given the customers(i.e., public health facilities) freedom of choiceenables market forces to provide sustainedpressures on companies to increase efficiency.Privatised companies generally operate in acompetitive market environment.

(2) Insufficient funding:

For example in Sudan with exception ofKhartoum, Gezira and Gedaref states, all otherstates do not have enough funds to establish anefficient drug supply system. In spite of beingprofit-making organisation, the CMS failed toavail such funds during the past 14 years.

(3) Inefficient use of available resources:

Since CMS was established in early 1990sworking as a profit-making organisation. Due tothe absence of privatisation the CMS engaged inan instalment of repackaging joint venture

pharmaceutical factory in 1999 and recentlyannounced its commitment to build apharmaceutical city with not less than US$ 20million, despite the lack of life-saving medicinesin the public health facilities. Such amount couldbe sufficient to establish a reliable supply systemfor all states of Sudan. The lack of prioritisation isa typical symptom and sign of most publicorganisations.

(4) Poor management:

There are a number of constraints inherent inoperating government drug supply service.

These constraints comprise:

(a) Civil servants are hired, rather thanpersons with business experience and skills.Managers confront different challenges in publicsetting. They are not easily hired or fired. Thelack of accountability results from the lack ofshareholders, who would be free to removeincompetent administrators.(b) Even if the services can recruit outside ofcivil service, the wages are often too low to attractexperienced managers. In addition, the managersdo not share in dividends or other monetaryactivities as do private managers and incentivesfor doing well are often attenuated in abureaucracy.(c) There are cultural and structuralconditions that promote corruptions includingenormous pressure of wages earners to support anextended family and a strong incentive to morethan their fixed government wage, traditional giftgiving practice and a proprietary view of publicoffices.

Privatisation of the CMS’s Ownership

The public sector drug supply institutions havenot succeeded (CMS is not exceptional) so far inorganising a reliable and regular essential drugsupply for the public health facilities (Huss,1996). One of the most criticisms of the publicdrug supply system generally in Africa andparticularly in Sudan is how badly they areinternally managed. There are those who agreethe greater amount of real pharmaceutical


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resources could be made available to the publichealth- care system and the access to essentialmedicines could be significantly increased, ifmanagerial efficiency of the system improved(Akin, 1987). Given the limitation of the publicsector - due to constraints inherent in operating agovernment drug supply organisation even afterautonomous experience - and the stabilised role ofthe private sector organisations such as privatepharmaceutical sectors organisations (rapidincrease in importing companies, manufacturersand pharmacies). Telecommunications, e.g.,Sudatel is one of the obvious solutions of choicefor the government pharmaceutical policy wouldbe to privatise the ownership of the CMS to theextent possible.

Advantages of Private Agencies

There are many arguments in favour ofprivatisation of public institutions. Advocates ofthis method claim privatisation have the followingadvantages:

Privatisation is efficient and effectivebecause it fosters and initiates competition. Thecompetition among firms drives the cost down.Empirical studies clearly prove the cost of theservices provided by the government is muchhigher than when the services are provided byprivate contractors. For example CMS’s declaredmark-up on cost (35%) amounted to 2.3 times theprivate mark-up (15%). In addition, private sectorpays taxes, customs and other governmental fees(CMS exempted). Privatisation also provides bettermanagement than the public management.Because decision making under privatisation isdirectly related to the costs and benefits. In otherwords, the privatisation fosters good managementbecause the cost of the service is usuallyobscured. Privatisation would help to limit the sizeof government at least in terms of the number ofemployees. On the other hand, it is a fact thatoverstaffing is common in publicly ownedenterprises. Privatisation can help to reducedependence on a government monopoly, which

causes inefficiencies and ineffectiveness inservices. Private sector is more flexible in terms ofresponding to the needs of citizens. Greaterflexibility in the use of personnel and equipmentwould be achieved for short-term projects, part-time work, etc. Bureaucratic formalities are verycommon when government delivers the service.Less tolerance and strict hierarchy in bureaucracyare the reasons of the inflexibility in publiclyprovided services.

Medicines Supply System

The Act, for the first time in Sudan has given theresponsibility of veterinary medicines to separatecommittees. The Ministry of Animal Resourcestook the law “in hand”, and started the registrationof veterinary medicines and the licensing of theveterinary medicines premises. The conflict in theshared authorities between the Ministry of Healthand the chairman of the FPPB lead to the freezingof the Board since October 2002. The FGDOPcontinues in the process of medicines registration,inspection of the pharmaceutical premises and thelicensing as before establishment of the FPPB.

The Act also obliges the states’ governments totake all steps necessary to ensure compliance withmarketing of registered medicines in licensedpremises. But, the weaknesses of the regulatoryinfrastructure and lack of political commitment atstate levels, the leakage of low quality,unregistered medicines to those states are highlysuspected. This left the door widely opened forinformal marketing of medicines particularly infar states. The states regulatory authorities shouldtake the advantage of the legal authority grantedby the Sudan constitution and the Pharmacy,Poisons, Cosmetics and the Medical Devices Act2001 to enforce the regulations and increase thefrequency of the inspection visits to drugcompanies and retail pharmacies.

Experience has shown the poor regulation ofmedicines can lead to the prevalence ofsubstandard, counterfeit, harmful and ineffectivemedicines on the national markets and theinternational commerce. The Sudanesepharmaceutical legal framework was described as


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one of the strictest pharmaceutical system in theregion. One of the great loopholes in this systemwas found to be the increased number of non-registered medicines-governmental sources suchas the Central Medical Supplies PublicOrganisation (CMSPO) and not-for-profit non-governmental Organisations (NGOs).Respondents were hopeful the double standard ofrules enforcement would be lifted after the newnational unity government take over, arguing thecurrent situation in which public organisations(such as the CMSPO) sell non-registeredmedicines to the private pharmacies couldenhance trading of counterfeit medicines andcreate unfair competition environment.

One of the respondent reported, “It is disturbing,in spite of the existence of appropriate legislation,illegal distribution of medicines by the CMSPO.The CMSPO continues to flourish, giving theimpression the government is insensitive toharmful effect on the people of medicinesdistribution unlawfully, and some are of doubtfulquality”. During the past three years the CMSPOstarted to sell unregistered medicines to theprivate pharmacies. The CMSPO practice (headded) will undermine the inspection andmedicines control activities and ultimatelyjeopardise the health of the people takingmedication.

Not surprisingly all respondents strongly agreedthe increased number of sources of non-registeredmedicines will lead to entrance of low qualitymedicines. This result is inline with the WHOrecommendation, which encourages theregulatory authorities and state members`government to register all medicines before themarketing. The medicines imported by publicsector organisations are not excluded.

The FGDOP should define the norms, standardsand specifications necessary for ensuring thesafety, efficacy and quality of medicinal products.The availability, accuracy and clarity of druginformation can affect the drug use decisions. TheFGDOP does not have a well-developed systemfor pre-approval of medicines labels, promotional,and advertising materials. The terms andconditions under, which licenses to import,

manufacture and distribute will be suspended,revoked or cancelled. This should be stringentlyapplied to public, private and not-for-profit NGOsdrug supplies organisations.

The predominant view, shared between themedicines’ importers is the current pharmacylegislation to some extent satisfactory andmanaged to prohibit the marketing of low qualitymedicines. The recent post-marketing studycarried by the National Drug Quality ControlLaboratories, suggested the power of the currentregulation is overestimated. The finding of thiscommunication indicates the applicationprocedures of the current measures to ensure thequality of medicines should be revisited. Thetechnical complexity of regulations, political,commercial and social implications, makesnecessary a degree of mutual trust betweenconcerned stakeholders (i.e., suppliers, doctors,pharmacists, consumer representatives andgovernment agencies).

Rational For The Research

The drug distribution network in Sudan during thepast few years was in a state of confusion. Itconsists of open market, drug vendors (known ashome drug store), community (private)pharmacies, peoples' pharmacies, private andpublic hospitals, doctors’ private clinics, NGOsclinics, private medicines importers (wholesalers),public wholesalers (i.e., Central Medical Suppliesand Khartoum State Revolving Drug Fund) andlocal pharmaceutical manufacturers. It is acommon phenomenon in far states (e.g., Westernand Southern states) to see street sellers or mobilesellers (hawkers) sell cigarettes, perfumes, orangeand astonishingly medicines that range fromParacetamol and Aspirin tablets to antibiotics andanti-malarial drugs including injections. Themedicines are usually left under the sun, and suchconditions could facilitate the deterioration of theactive ingredients.

The states’ departments of pharmacy statutorilylicensed community and Peoples’ pharmacies. Asuperintending pharmacist, who is permanentlyregistered with the Sudan Medical Council andlicensed, oversees the pharmacy any time it is


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opened for business [19]. With such pharmaciesthere should not be any serious of the sale of fakedrugs. Unfortunately, however there are manypharmacies working without qualifiedpharmacists.

This study is significant because the people rightto health includes the right access to a reliablestandard of health care and assurance themedicines received are not only genuine but alsosafe, effective, of good quality and affordable[20]. The Sudan government has designed variousways to protect the public against low qualitymedicines. It is expected to equip the departmentsof pharmacy especially in remote areas, poorstates with material and trained staff to effectivelyperform duties.

A recent unpublished post-marketing surveillancerevealed that 35% of the CMSPO samples and16% of the private companies (registeredproducts) samples obtained from differentpharmacy shops failed to pass the quality test[20]. However, very few studies if any have beenundertaken to evaluate the impact of theregulations put in place by the government longtime ago.

This study should reveal strength and weaknessesof the legal pharmaceutical framework in Sudanfrom drug importers perspective. The findings ofthis investigation would be instructive toregulatory authorities in the developing countries.It also highlights how systematically the drugcompanies perceived the role of pharmacyregulations in assuring high quality of medicinesand what suggestions (if any) they had to make inorder to improve the regulatory framework.

Methodology

The study proposal was discussed to identify andimprove the quality of medicines in Sudan. Thesurvey was deliberately drug importers biased, aslow quality medicines from informal sources willaffect their business [21]. The authors thendesigned a self-administered questionnaire of 14close-ended questions and one open question. Thequestionnaire was designed to address main sixissues:

The quality of medicines. The consequences of splitting of theregulatory authority functions between theFederal Ministry of Health (FMOH) and theMinistry of Animal Resources (MOAR). Views on the role of the recentlyestablished Federal Pharmacy and Poisons Board,and Pre- and Post- Marketing Surveillance. Decentralisation, and Increased number of suppliers of non-registered medicines.

The final version of the questionnaire had beentested (three pharmacists working with drugcompanies in Sudan were asked to fill thequestionnaire and feed the authors back whetherthere was unclear question or not). Thequestionnaire was tested to make sure all relevantissues were covered, pre-coded and adjustedbefore its distribution (Appendix 1).

The questionnaire was distributed to all fortyparticipants at a seminar held in July 2004. Totalnumbers of drug importers companies were 175 in2004. The seminar was organised by the FGDOPon the new proposal to limit (agree a ceiling foreach item) the number of commercial brandproduct registered from each generic drug (thecurrent situation is open). The owners andshareholders of drug companies were theparticipants. This was seen by the authors as agreat opportunity to collect data of the drugimporters’ perspective on the quality ofmedicines. Hence, the study participants were sobusy and it was very difficult to devote a time tobe interviewed by the authors. In addition, thepostal services in Sudan are poor (too slow andunreliable).

Before the beginning of the seminar, theparticipants were requested by the secretariat tocomplete the questionnaire and hand it back to thesecretariat before departure. The participants wereinformed it is anonymous questionnaire. Thereasons given to the participants for filling out thequestionnaire was to enable an academic researchto assess the impact of the new Act on the qualityof medicines. Finally, at the end of the seminar,the secretariat managed to get 30 questionnaires,representing 75% out of 40 distributed.


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The information necessary to conduct thisevaluation was collected from 30 pharmacistsworking with medicines’ importing companies.Data gathered by the questionnaire wereelectronically analysed using Statistical Packagefor Social Sciences (SPSS) version 12.0 forwindows.

Results and Discussion

The drug distribution network in Sudan consistsof open market, drug vendors (known as homedrug store), community (private) pharmacies,people's pharmacies, private and public hospitals,doctors’ private clinics, NGOs clinics, privatemedicines importers (wholesalers), publicwholesalers (i.e., Central Medical Supplies andKhartoum State Revolving Drug Fund) and localpharmaceutical manufacturers. The states’departments of pharmacy statutorily licensedcommunity and Peoples’ pharmacies. Asuperintending pharmacist, who is permanentlyregistered with the Sudan Medical Council andlicensed, oversees the pharmacy any time it isopened for business [22]. With such pharmacies

there should not be any serious of the sale of fakedrugs. Unfortunately however, there are manypharmacies working without qualifiedpharmacists [23].

During the last decade, the pharmacy workforceshave witnessed a significant increase in thenumber of pharmacies, drug importing companiesand pharmaceutical manufacturers as shown inTable 1. In the public sector, adoption of costsharing policy as a mechanism of financing foressential medicines at full price cost requires farmore expertise than simply distributing freemedicines. This policy increases the demand forpharmacists in hospitals. The new concept ofpharmaceutical care and recognition pharmacistsas health care team members will boost thedemand for the skilled pharmacist registered(PHRs). The Federal Ministry of Health (MOH)faces two major issues with the PHRs: first, thecurrent shortage of pharmacists in the publicsector; secondly, the future role of pharmacistswithin the health cares system.

Table 1. Pharmacists labour market [23]

Institutions 1989 2003 Increase in (%)Faculties of Pharmacy 1 7 600%Registered Pharmacists 1505 2992 99%Public Sector Pharmacists 162 300 85%Hospital Pharmacies 205 304 48%Community Pharmacies 551 779 41%Drug Importing Companies 77 175 127%Drug Manufacturers 5 14 180%

Table 2. Pharmacists’ distribution at state levels [24]

StateNumber ofpharmacists

Department of Pharmacy (DOP)Khartoum State* 8

DOP-North Darfur 7DOP-Sennar 2DOP-North Kordofan 5DOP-South Kordofan 7DOP-White Nile 2DOP-Kassala 7DOP-River Nile 3DOP-Northern State 3DOP-Al Gezira* 6Total** 50

* The Pharmacists who work with Revolving Drug Funds are not included. ** Information about other.


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States is not available (10 Southern states, 2Darfur states, 2 Eastern states, 1 Blue Nile state,and 1 West Kordofan state).

Around 3000 pharmacists are registered in Sudan.Only 300 (10%) works with the public sector. 25,25, 20 pharmacists were employed in Khartoum,Khartoum North and Omdurman hospitalsrespectively. Some states (e.g., Southern stateshas only 2 pharmacists) were not included inTable 2. This anomaly seems to imply the numberof pharmacists in the public sector (has not onlybeen insufficient in absolute terms, but also hasbeen inefficient in its distribution). This numberwill be depleted and the situation may be gettingworse. One reason is migration to the privatesector. The results are described in Figure 1.

In the absence of past baselines data, decisiveconclusions should not be drawn from this articleregarding the impact of the pharmaceuticalregulations on ensuring good quality medicines.Nevertheless, the survey did serve to confirm thegeneral impression about medicines of goodquality on the Sudanese market.

89% of respondents considered the medicines onthe Sudanese market are generally of goodquality. Although 55% of the study populationeither strongly agree (21%) or agree (34%) withthe statement the drug legislations in Sudanprohibit marketing of low quality medicines. 35%believe the transfer of authority to recentlyestablished the Federal Pharmacy and PoisonsBoard (FPPB) will undermine on medicinesquality assurance system. 38% of the participantsthought the replacement of the FGDOP by theFPPB will improve the medicines quality controlsystem.

Only one-fourth of respondents were not veryconfident in current systems and safeguard toensure the quality of medicines. 69% of

respondents were somewhat confident in theFGDOP regulates and monitors quality ofmedicines. The majority 79% of respondentsagree with the statement ‘‘decentralisation oflicensing and inspection of pharmaceuticalpremises will improve the pharmaceuticalcontrol’’.

After the approval of the Pharmacy and PoisonsAct 2001, the Ministry of Animal Resources(dominated by veterinarians) took theresponsibility of registration of veterinarymedicines and the licensing of the whole andretail sellers of veterinary medicines. Asexpected, 91% of respondents thought, thesplitting of drug registration between the MOHand the MOAR weakens the medicines control,compared with only 9% who thought thearrangement would improve the quality ofmedicines. One of the respondents added: “Thesplitting of the drug authority between MOH,which according to the Sudan constitution is fullyresponsible for the public health and MOAR willcreate contradiction in lines of commands andpublic health would be compromised”. 84% ofrespondents agreed with the statement “This newarrangement could cause conflict between tworegulatory authorities”

93% of participants either strongly agree (73%) oragree (20%) the increased number of non-registered medicines distributors will facilitate themarketing of low quality medicines (Figure 1).When asked about updated requirements ofmedicines registration, only 25% of respondentsthought the updated requirements are notsufficient to prevent marketing of low qualitymedicines. Nearly three-quarters (71%) agreedthe pre-marketing surveillance is not enough toensure the quality of medicines. The lawregulating medicines was judged by therespondents as generally adequate (68%).


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73.40%

20%

3.30%

3.30%

Strongly agree

A gree

D isagree

Strongly disagree

Figure 1. The increased numbers of non-registered medicines importers will facilitate the marketing of lowquality medicines.

Medicines Supply System

The Act, for the first time in Sudan has given theresponsibility of veterinary medicines to separatecommittees. The Ministry of Animal Resourcestook the law “in hand”, and started the registrationof veterinary medicines and the licensing of theveterinary medicines premises. The conflict in theshared authorities between the Ministry of Healthand the chairman of the FPPB lead to the freezingof the Board since October 2002. The FGDOPcontinues in the process of medicines registration,inspection of the pharmaceutical premises and thelicensing as before establishment of the FPPB.

The Act also obliges the states’ governments totake all steps necessary to ensure compliance withmarketing of registered medicines in licensedpremises. But, the weaknesses of the regulatoryinfrastructure and lack of political commitment atstate levels, the leakage of low quality,unregistered medicines to those states are highlysuspected. This left the door widely opened forinformal marketing of medicines particularly infar states. The states regulatory authorities shouldtake the advantage of the legal authority grantedby the Sudan constitution and the Pharmacy,Poisons, Cosmetics and the Medical Devices Act2001 to enforce the regulations and increase thefrequency of the inspection visits to drugcompanies and retail pharmacies.

Experience has shown the poor regulation ofmedicines can lead to the prevalence ofsubstandard, counterfeit, harmful and ineffective

medicines on the national markets and theinternational commerce. The Sudanesepharmaceutical legal framework was described asone of the strictest pharmaceutical system in theregion. One of the great loopholes in this systemwas found to be the increased number of non-registered medicines-governmental sources suchas the Central Medical Supplies PublicOrganisation (CMSPO) and not-for-profit non-governmental Organisations (NGOs).Respondents were hopeful the double standard ofrules enforcement would be lifted after the newnational unity government take over, arguing thecurrent situation in which public organisations(such as the CMSPO) sell non-registeredmedicines to the private pharmacies couldenhance trading of counterfeit medicines andcreate unfair competition environment.

One of the respondent reported, “It is disturbing,in spite of the existence of appropriate legislation,illegal distribution of medicines by the CMSPO.The CMSPO continues to flourish, giving theimpression the government is insensitive toharmful effect on the people of medicinesdistribution unlawfully, and some are of doubtfulquality”. During the past three years the CMSPOstarted to sell unregistered medicines to theprivate pharmacies. The CMSPO practice (headded) will undermine the inspection andmedicines control activities and ultimatelyjeopardise the health of the people takingmedication.


86

Not surprisingly all respondents strongly agreedthe increased number of sources of non-registeredmedicines will lead to entrance of low qualitymedicines. This result is inline with the WHOrecommendation, which encourages theregulatory authorities and state members`government to register all medicines before themarketing. The medicines imported by publicsector organisations are not excluded [25].

The FGDOP should define the norms, standardsand specifications necessary for ensuring thesafety, efficacy and quality of medicinal products.The availability, accuracy and clarity of druginformation can affect the drug use decisions. TheFGDOP does not have a well-developed systemfor pre-approval of medicines labels, promotional,and advertising materials. The terms andconditions under, which licenses to import,manufacture and distribute will be suspended,revoked or cancelled. This should be stringentlyapplied to public, private and not-for-profit NGOsdrug supplies organisations.

The predominant view, shared between themedicines’ importers is the current pharmacylegislation to some extent satisfactory andmanaged to prohibit the marketing of low qualitymedicines. The recent post-marketing studycarried by the National Drug Quality ControlLaboratories, suggested the power of the currentregulation is overestimated [26]. The finding ofthis approach indicates the application proceduresof the current measures to ensure the quality ofmedicines should be revisited. The technicalcomplexity of regulations, political, commercialand social implications, makes necessary a degreeof mutual trust between concerned stakeholders(i.e., suppliers, doctors, pharmacists, consumerrepresentatives and government agencies).

Conclusion and Recommendations

The study reveals the need for further research tofind out how efficient the regulatory authorities atboth federal and state levels are. The research alsoneeded to discover whether or not counterfeitmedicines are sold on the Sudanese market.From the data obtained in this article somegeneral inferences could be made:

1. The brad outlines remain intact, butpreventing drug smuggling across nationalboarders (Sudan shares frontiers with 9countries) is hard to police.

2. The enforcement of the Act and itsregulation governing the manufacture,importation, sale, distribution and exportationof medicines are not adequate enough tocontrol the illegal importation and sale ofmedicines in Sudan.

3. The splitting of the drug regulatoryauthority between two ministries and themarketing of unregistered medicines by publicdrug suppliers (namely the CMSPO, andRDFs), and NGOs undermine the quality ofmedicines and ultimately jeopardise the healthof the people taking medication.

In the light of the findings the followingrecommendations could be useful at variouslevels:

1. There is an urgent need for government toimplement the provisions of existing Act.

2. The government should adequately equip andfund the National drug Analysis laboratoriesto start active post-marketing surveillance.

3. A more spirited effort need to be made by theFGDOP and the States’ Departments ofPharmacy to ensure all the medicines on thepharmacies’ shelves are registered and comefrom legal sources.

4. The states’ departments of pharmacies are notin existence should be re-established andinvigorated. They should be adequatelyfunded to be able to acquire the necessaryfacilities for their operations.

5. The CMSPO should stop importation,manufacture and distribution of unregisteredmedicines. It should also cease selling thetenders’ product to the private pharmacies.The latter practice undermines the inspectionoutcomes, because it makes inspectors tasktoo difficult (i.e., can not identify the sourceof medicine whether it is CMSPO or not).


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Ethical clearance and data protection consent

Before starting the data collection, ethicalclearance was obtained from the Federal Ministryof Health (MOH)-Research Ethics Committee.The first author signed the data protection consentand the respondents were informed it was ananonymous questionnaire and all the datacollected are for the FGDOP assessment purpose.Nevertheless, the participants were also informedthe data processing would not be used to supportany decision-making and would not cause anydamage, and distress them or to their business.

Research Limitations

The selection of one group of stakeholders andignorance of the rest (such as the CMSPO, retailpharmacies, drug manufacturers, NGOs,consumers organisations, policy-makers,

regulators, police, customs, doctors, other healthcare professionals, and health professional unions,etc.) were not included. This means great cautionmust be exercised in any extrapolation to acountry level statistical analysis, and percentagegiven must be regarded as rough estimates.

Reliability and Validity of the Research Instrument

The sample chosen is indicative rather than fullyrepresentative and has been sized to be feasible inthe time and resources available for the authors.However, the sample is thought to be sufficient toallow valid statistical analysis. Establishing thereliability and validity of measures are importantfor assessing their quality [7]. The mentionedtime, and resources constraints did not allow theauthors to test the reliability and validity of theresearch instrument.

Appendix 1. Research Questionnaire

Please mark the best answer with an X

Example:

Strongly agree XAgreeNeither (agree or disagree)DisagreeStrongly disagree

1. Thinking about pharmaceutical products available in Sudan today, would you consider medicinesto be?

High quality 1Generally of goodquality

2

Low quality 3Very low quality 4I do not know 5

2. Do you agree or disagree the drug legislations prohibit marketing of low quality medicines inSudan?

Strongly agree 1Agree 2Neither (agree or disagree) 3Disagree 4Strongly disagree 5


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3. How much confidence do you have in the systems and safeguards currently in place to ensure thequality of drugs available in Sudan today?

Very confident 1Somewhat confident 2Not very confident 3Not at all confident 4

4. How much confidence do you have in the way the Federal government regulates and monitorsquality of medicines?

Very confident 1Somewhat confident 2Not very confident 3Not at all confident 4

5. After approval of the Pharmacy and Poisons Act 2001, the Ministry of Animal Resources took theresponsibility of registration and control of veterinary medicines and the licensing of their premises.This action will: (Tick more than one)

Yes =1

No =2

Improve the quality control of medicinesWeaken the role of the Ministry of Health inpublic health protectionCause conflict between medicine controlauthorities

6. According to the Pharmacy and Poisons Act 2001, the authority of controlling quality of medicinesand poisons was given to Federal Pharmacy and Poisons Board instead of the General Directorate ofPharmacy. This amendment:

Will improve the medicines quality assurancesystem

1

Will have no effect at all 2Will to some extent, undermine the medicine qualitycontrol system

3

Will entirely undermine the medicine qualitycontrol system

4

7. The provisions of the Pharmacy and Poisons Act 2001 gave the authority of licensing of pharmaciespremises and their inspection to state health authorities. This action will enhance the medicinescontrol:



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8. Increased number of unregistered medicines importers will facilitate the marketing of low qualityand counterfeit medicines:


9. Do you think that over the past four years, low quality (counterfeit) medicines in Sudan have?

Has not changed 1Become less of a problem 2Become more of a problem 3

10. How serious a problem do you believe low quality medicines (counterfeit) are in Sudan today? Isthis a problem that is?

Not at all serious 1Not very serious 2Somewhat serious 3Very serious 4

11. Are the recently updated medicines registration requirements sufficient to prohibit the marketingof low quality medicines?

Yes, sufficient 1No, not sufficient 2I do not know 3

12. Do you think the pre-marketing analysis of medicines is sufficient to assure their quality?

Yes, sufficient 1No, not sufficient 2I do not know 3

13. To ensure the overall quality of medicines used by consumers in Sudan today, do you believe thatsuch pre-marketing analysis of medicines is?

Critically important 1Important, but not critically 2Not very important 3


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14. Are you satisfied or dissatisfied with the current Sudan legal pharmaceutical framework inassuring medicines quality?

Very satisfied 1Satisfied 2Neither satisfied nor dissatisfied 3Dissatisfied 4Very dissatisfied 5Not sure 6

15. If you have any other comments about Sudan pharmaceutical legal framework, please do not hesitate toreport them (Arabic comments are also be accepted)

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How to cite this article:Abdeen Mustafa Omer. (2017). Faking and Counterfeiting of Drugs: Evaluation of PharmacyRegulatory, Privatisation, Social Welfare Services and its Alternatives of Sudan Int. J. Curr. Res. Med.Sci. 3(10): 70-91.DOI: http://dx.doi.org/10.22192/ijcrms.2017.03.10.012

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