It Is Disturbing, In Spite of The Existence of Appropriate Legislation, Illegal Distribution of Medicines

The World Health Organization [1] has defined drug regulation as a process, which encompasses various activities, aimed at promoting and protecting public health by ensuring the safety, efficiency and quality of drugs, and appropriateness accuracy of information [1]. Medicines regulation is a key instrument employed by many governments to modify the behaviour of drug systems. The regulation of pharmaceuticals relates to control of manufacturing standards, the quality, the efficacy and safety of drugs, labelling and information requirements, distribution procedures and consumer prices [2]. To assure quality of medicines, in most countries registration is required prior to the introduction of a drug preparation into the market. The manufacturing, registration and sale of drugs have been the subject of restricts regulations and administrative procedures worldwide for decades [3]. Nobody would seriously argue drugs should be proven to be 100% safe. No set of regulations could achieve that goal argue, because it is impossible, and all drugs carry some risk [4]. Stringent drug regulation was introduced across many countries in the 1960s following the thalidomide disaster and had since been embraced by the industry as a commercial essential seal of safety and quality [5]. In spite of the measures, many countries, especially developing one face a broader range of problems. In several developing countries drug quality is a source of concern. There is a general feeling of high incidence of drug preparations that are not of acceptable quality [6]. For example, about 70% of counterfeit medicines were reported by developing countries [7]. Reports from Asia, Abstract

Africa, and South America indicate 10% to 50% of consider using prescribed drugs in certain countries may be counterfeit [8]. For instance, in Nigeria fake medicines may be more than 60 -70% of the drugs in circulation [9], and 109 children died in 1990 after being administered fake Paracetamol [10]. In Gambia the drug registration and control system resulted in the elimination of 'drug peddlers' and certain 'obsolete and harmful' drugs, as well as a large decrease in the percentage of brand and combination drugs [11]).
The percentage of drugs failing quality control testing was found to be zero in Colombia, but 92% in the private sector of Chad [12].
Hence, it is very difficult to obtain accurate data. The proportion of counterfeit drugs in the USA marketplace is believed to be smallless than 1 percent [12]. In [13] reported two cases of counterfeit medicines that found their way into legitimate medicine supply chain in the UK in 2004.
Poor quality drug preparations may lead to adverse clinical results both in terms of low efficacy and in the development of drug resistance [14]. Regulations are the basic devices employed by most governments to protect the public health against substandard, counterfeit, low quality medicines, and to control prices. Thorough knowledge of whether these regulations produce the intended effects or generate unexpected adverse consequences is critical. The

World Health Organization (WHO) undertook a number of initiatives
to improve medicines quality in its member states and promote global mechanisms for regulating the quality of pharmaceutical products in the international markets. Yet, there are not any WHO guidelines on how to evaluate the impact of these regulations. There are numerous reports concerning drug regulations [15], but the published work on the impact of these regulations on the quality of medicines moving in the international commerce has been scarce.
Findings from most published studies lack comparable quantitative information that would allow for objective judging whether and by how much progress on the various outcomes have been made by the implementation of the pharmaceutical regulations. To ignore evaluations and to implement drug regulation based on logic and theory is to expose society to untried measures in the same way patients were exposed to untested medicines [15].
The present policy of the national health-care system in Sudan is

Aims and Objectives
The main purpose of this study is to analyse and determine In Sudan, the researchers did not identify any rigorous evaluations or quantitative studies about the impact of drug regulations on the quality of medicines and how to protect public health against counterfeit or low-quality medicines, although it is practically possible. However, the regulations must be continually evaluated to ensure the public health is protected against fake medicines by ensuring the exclusive marketing of high-quality medicines rather than commercial interests, and the drug companies are held accountable for their conducts [17].

Medicines Legislation Framework in Sudan
The availability of medicines in Sudan is controlled on the basis of safety, quality and efficacy. Thus, the government effects control in accordance with the Pharmacy, Poisons, Cosmetics and

Medical Devices Act 2001 and its instruments. The Federal or State
Departments of Pharmacy (DOP) and directives issued orders.

The primary objective of both Federal and States' Departments of
Pharmacy is to safeguard public health by ensuring all medicines and pharmaceuticals on the Sudan market meet appropriate standards of safety, quality and efficacy. The safeguarding of public health is achieved largely through the system of medicines' registration and licensing of pharmacy premises. The strategy of price liberalization and privatization had been implemented in Sudan over the last decades and has had a positive result on the government deficit. The investment law [19] approved recently has good statements and rules on the above strategy in particular to health and pharmacy areas. The privatization and price liberalization in healthy fields has to re-structure (but not fully). Availability and adequate pharmacy supply to the major sectors. The result is that the present situation of pharmacy services is far better than ten years ago. The government of Sudan has a great experience in privatization of the public institutions, i.e., the Sudanese free zones and markets, Sudan telecommunications (Sudatel) and Sudan airlines. These experiences provide good lessons about the efficiency and effectiveness of the privatization policy. Through privatization, the government is not evading its responsibility of providing health-care to the inhabitants, but merely shifting its role from being a provider to a regulator and standard setter. Drug financing was privatized early in 1992.
Currently, the Federal Ministry of Health (FMOH) has privatized certain non-medical services in hospitals such as catering services, security and cleanings.
The overall goal of the CMS ownership privatization is to improve access to essential medicines and other medical supplies in order to improve health status of the inhabitants particularly in far states (e.g., Western and Southern States). Establishment of alternative ownership for the CMS can be achieved by selling the majority of shares to the private sector. This will achieve the following objectives: a. High access to essential medicines of good quality and affordable prices to the states' population and governments.
b. Efficiency and effectiveness in drug distribution system to avoid the serious pitfalls and incidences that was reported during the last ten years in the CMS.

c.
Equity by reaching all remote areas currently deprived from the formal drug distribution channels.
d. Improvement of the quality and quantity of delivery of medicines to the public health facilities.
The above objectives are expected to: a) Increase geographical and economic access to essential medicines in all states (i.e., in both rural and urban areas) to reach at least 80% of the population (currently less than 50% of population have access to essential medicines).
b) The tax collection from the new business becomes more efficient and will increase after privatization. The tax revenues could be used to finance other health-care activities.

c)
If the government reserves some shares (not more than 50%) in the new business, then its shares' profit could be used to finance free medicines project in hospitals outpatients' clinic, and other exempted medicines, e.g., renal dialysis and hemophilic patients' treatment.

Privatization of Public Pharmaceutical Supplies:
The term Privatization has generally been defined as any process that aims to shift functions and responsibilities (totally or partially) from the government to the private. More broadly meaning, it refers to the restriction of government's role and putting forward some methods or policies in order to strengthen the free market economy [20]. Privatization can be an ideology (for those who oppose government and seek to reduce its size, role, and costs, or for those who wish to encourage diversity, decentralisation, and choice) or a tool of government (for those who see the private sector as more efficient, flexible, and innovative than the public sector) [20]. In [20]contends that "the invisible hand of the market is more efficient and responsive to the consumer needs and the public administrative budgets consume large portion of tax monies that could otherwise be used for service delivery". The emphasis is on improving the efficiency of all public enterprises, whether retained or divested.

Privatization May Take Many Forms Including:
Contracting: The government financing of services, choice of service provider, and specification of various aspects of the services laid out in contracts with the private-sector Organization that produces or delivers the services.
User fees: Public facilities such as hospitals that maximise their income or finance some goods from private sources, either through drug sales or other services. This kind of Privatization has been applied in Sudan since the early 1990s, as the health financing mechanism (especially for medicines).
In Sudan, the government has decided to distance itself from direct involvement in business, and thus divest most of its interests

Medicines Legislation Framework in Sudan:
The availability of medicines in Sudan is controlled on the basis of safety, quality and efficacy.

Sudan Medicines' Quality Measures
The following summarises the quality measures of all medicines.

Registration of Medicines
The FGDOP is responsible for the appraisal, and registration of all medicines and other pharmaceuticals for both human and veterinary use on the Sudan market. It is also responsible for the verification of the competence of manufacturing companies, the manufacturing plants, the ability to produce substances or products of high quality before registering these companies and allowing them to apply for registration of their products in Sudan. When necessary, visits conducted to those companies and their manufacturing units, to verify their compliance with good manufacturing practice recommended by the WHO. The applicant for registration of pharmaceutical product must submit all prescribed data and the certificates required under the WHO certification scheme for a pharmaceutical product moving into international commerce, and any other information that is necessary for assuring the quality, efficiency and stability of the product through its shelf life [20].

Licensing of Pharmacy Premises
The licensing is a registration exercise to provide the DOP at

People's Pharmacies
These are quasi-public establishments retailing drugs and medical supplies below the market prices to improve access and availability of pharmaceuticals. They were founded in the early 1980s as a pilot study for a drug cost recovery system.

Public Sector Medicines Supply System: In Sub-Saharan
Africa countries discussions about medicine distribution system reform have concentrated on ways to improve sustainability and quality of access to essential medicines. These discussions In 1992 when a law was passed, medicines were no longer free of charge (i.e., privatised) in the public health system. The aim of the government is to increase equitable access to essential medicines, especially at the states' level. As a result, the Central Medical Stores, which was responsible for medicines supply system of the public health facilities, became an autonomous drug supply agency, and was renamed as the Central Medical Supplies Public Corporation (CMS) and operated on cash-and-carry basis. It was capitalised and an executive board was installed. Since states and federal hospitals have to buy their own medicines, and other medical supplies.
They organised their own transport means and distribution to their primary health-care facilities and hospitals. In addition, all hospitals became financially autonomous entities and have had to organise their own medicines procurement system. The public drug supply system has not been working well throughout Sub-Saharan Africa and this includes Sudan. There are serious shortages or no medicines at all, particularly in rural areas. A study in Cameroon found the rural health centres received only 65% of the stock designated for them, and 30% of the medicines that arrived at the centres did not reach the clients. The loss rate after arrival in hospitals was estimated at 40%. In Sudan, Graff and Evarard (2003) who visited the country on a WHO mission reported, "Although the cash-and-carry system took off well, but lack of sufficient foreign exchange hampered the CMS procurement activities and resulted in low stock levels of all medicines and even stock out of life-saving products. Hospitals had to purchase the medicines from elsewhere and often had to buy from private sector. Overall hospitals' budgets were tied to allocate drug budget and sales income was not sufficient to cover the purchase of needed medicines supplies.
This resulted the medicines were not available most of the times.    [20]. With such pharmacies there should not be any serious of the sale of fake drugs. Unfortunately, however there are many pharmacies working without qualified pharmacists. This study is significant because the people right to health includes the right access to a reliable standard of health care and assurance the medicines received are not only genuine but also safe, effective, of good quality and affordable [21].

Methodology
The study proposal was discussed to identify and improve the quality of medicines in Sudan. The survey was deliberately drug importers biased, as low-quality medicines from informal sources will affect their business [22]. The authors then designed a self-

Result and Discussion
The Some states (e.g., Southern states has only 2 pharmacists) were not included in Table 2. This anomaly seems to imply the number of pharmacists in the public sector (has not only been insufficient in absolute terms, but also has been inefficient in its distribution).
This number will be depleted and the situation may be getting worse. One reason is migration to the private sector. The results are described in Figure 1.  In the absence of past baselines data, decisive conclusions should not be drawn from this article regarding the impact of the pharmaceutical regulations on ensuring good quality medicines.
Nevertheless, the survey did serve to confirm the general impression about medicines of good quality on the Sudanese market.

Medicines Supply System
The Act, for the first time in Sudan has given the responsibility

Discussions
In Sudan, with more than ten million people don't have adequate access to health care; twenty million inhabitants are without access to pharmacy, and a very low proportion of people being treated in hospitals. The investment, which is needed to fund the extension and improvement of these services, is substantial.
Most governments in developing countries are ready to admit that which would allow the utility to allocate more resources to improve and extend services. Redressing productivity, subsidy and crosssubsidy issues before the private sector is invited to participate, has proven to be less contentious.
Despite the constraints, over the last decade the rate of implementation of rural and peri-urban pharmacy supplies and healthy programmes has increased considerably, and many people are now being served more adequately. The following are Sudan experience in pharmacy supply and healthy projects:

At Community level:
i. Participatory approaches in planning, implementation and monitoring.
ii. Establishment and training of reliable financial and maintenance management.
iii. Sensitive timing of health and hygiene education.

At State and National level:
i. Integrated multi-sectoral approach development.
ii. Training approach and material development for state and extension staff.
iii. Continuing support from integrated multi-sectoral extension team.
iv. Establishment of technical support system.  Pensions and other benefits 7.7 Table 4: 'Why are you intending to leave the public sector?' (N= 16).

Reasons Percent
High wages and incentives in the private sector 87.5 Private sector offers vehicles 56.3 The private give full treatment when feeling ill 50.0 Job satisfaction in the private 6.3 In answering the question 'Why did you leave the public sector?' (51.4%) of respondents had left the public sector because policymakers did not care of pharmacy ( Table 5). The main reasons for choosing the private sectors mentioned by respondents are the salaries (61.8%); the job satisfaction (52.9%) and the vehicle (26.5%) are shown in Table 6 and Figure 2. Substantial percentage (78.4%) of the respondents answer "yes" to the question: thinking about your own job; could you leave the private and join the public sector at some time in the future? Table 7 shows the reasons, which encourage pharmacists who were in the private sector (at the time of the study) and are willing to join the public sector. The most important reasons discourage the pharmacists who were in the private sector during the study period from joining the public sector are presented in Table 8.    Public Sector Pharmacy Workforces: The public health sector reform seems to have undermined pharmacy human resources in health sector as often as making a positive contribution.  states has only 2 pharmacists) were not included in Table 10. This anomaly seems to imply the number of pharmacists in the public sector (hasn't only been insufficient in absolute terms, but also has been inefficient in its distribution). This number will be depleted and the situation may be getting worse. One reason is migration to the private sector.

Conclusion and Recommendation
The study reveals the need for further research to find out how efficient the regulatory authorities at both federal and state levels are. The research also needed to discover whether or not counterfeit medicines are sold on the Sudanese market. From the data obtained in this article some general inferences could be made: a.
The brad outlines remain intact, but preventing drug smuggling across national boarders (Sudan shares frontiers with 9 countries) is hard to police. b.
The enforcement of the Act and its regulation governing the manufacture, importation, sale, distribution and exportation of medicines are not adequate enough to control the illegal importation and sale of medicines in Sudan.
c. The splitting of the drug regulatory authority between two ministries and the marketing of unregistered medicines by public drug suppliers (namely the CMSPO, and RDFs), and NGOs undermine the quality of medicines and ultimately jeopardise the health of the people taking medication.
In the light of the findings the following recommendations could be useful at various levels: a.
There is an urgent need for government to implement the provisions of existing Act.  change for change field sites may not be used effectively (continue to evaluate and disseminate the lessons that emerge from these sites).

Ethical Clearance and Data Protection Consent
Before starting the data collection, ethical clearance was obtained from the Federal Ministry of Health (MOH)-Research Ethics Committee. The first author signed the data protection consent and the respondents were informed it was an anonymous questionnaire and all the data collected are for the FGDOP assessment purpose. Nevertheless, the participants were also informed the data processing would not be used to support any decision-making and would not cause any damage and distress them or to their business.

Research Limitations
The selection of one group of stakeholders and ignorance of the rest (such as the CMSPO, retail pharmacies, drug manufacturers, caution must be exercised in any extrapolation to a country level statistical analysis, and percentage given must be regarded as rough estimates.

Reliability and Validity of the Research Instrument
The sample chosen is indicative rather than fully representative and has been sized to be feasible in the time and resources available for the authors. However, the sample is thought to be sufficient to allow valid statistical analysis. Establishing the reliability and validity of measures are important for assessing their quality [7].
The mentioned time, and resources constraints did not allow the authors to test the reliability and validity of the research instrument.