The role and experience of Sudan in assisting to develop and implement national drug policies

April 15, 2020

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Global Research Journal of Pharmaceutical and Drug Discovery
Volume 1, Issue 1, June 2020, Pages: 12-20
Received: Mar. 17, 2020; Accepted: Apr. 17, 2020; Published: Apr. 27, 2020

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Author: Abdeen Omer, Ministry of Health and Social Welfare, Khartoum, Sudan.

Abstract:

The strategy of price liberalization and privatization had been implemented in Sudan over the last decade and has had a positive result on government deficit. The investment law approved recently has good statements and rules on the above strategy in particular to pharmacy regulations. Under the pressure of the new privatization policy, the government introduced radical changes in the pharmacy regulations. The 2001 Pharmacy and Poisons Act and its provisions established the Federal Pharmacy and Poison Board (FPPB). All the authorities of the implementation of the Pharmacy and Poisons Act were given to this board. This article provides an overview of the impact of the pharmaceutical regulations on the quality of medicines on the Sudanese market from the perspective of the pharmacists working with drug importing companies. The information necessary to conduct the evaluation was collected from 30 pharmacists who are the owners or shareholders in medicines’ importing companies. The participants were selected randomly. 89% of respondents considered the medicines on the Sudanese market are generally of good quality. The design of the research itself may be considered inadequate with regard to the selection process. However, the authors believe it provides enough evidence, and the current pharmaceutical regulations have some loopholes. The Pharmacy, Poisons, Cosmetics, and Medical Devices Act-2001 and its regulation should be enforced. The overall set-up, including the Act itself, needs to be revised. The emerging crisis in pharmacy human resources requires significant additional effort to gather knowledge and dependable data that can inform reasonable, effective, and coordinated responses from government, industry, and professional associations. Furthermore, research should be carried out to understand the scope, magnitude directions of the migratory flows, within and outside the country, as well as the characteristics and skills of the emigrated pharmacists.

Keywords: Counterfeits Medicines, Drug Importers, Quality of Medicines, Regulatory Authorities.

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To citation of this article: Abdeen Omer, The role and experience of Sudan in assisting to develop and implement national drug policies, Global Research Journal of Pharmaceutical and Drug Discovery

References:

[1] Ministry of Health (MOH). (2001). Act 2001: Pharmacy, Poisons, Cosmetics and Medical Devices. Ministry of Health (MOH): Sudan.

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Introduction: The World Health Organisation 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. 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, labeling and information requirements, distribution procedures, and consumer prices. To assure the 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. Nobody would seriously argue drugs should be proven to be 100% safe. No set of regulations could achieve that goal because it is an impossibility, and all drugs carry some risk.

Stringent drug regulation was introduced across many countries in the 1960s following the thalidomide disaster and had since been embraced by the industry as an essential commercial seal of safety and quality. In spite of the measures, many countries, especially developing ones, face a broader range of problems. In several developing countries, drug quality is a source of concern. There is a general feeling there is a high incidence of drug preparations, which are not of acceptable quality. For example, about 70% of counterfeit medicines were reported by developing countries. Reports from Asia, Africa, and South America indicate 10% to 50 % of considering using prescribed drugs in certain countries may be counterfeit. For instance, in Nigeria, fake medicines may be more than 60 -70% of the drugs in circulation, and 109 children died in 1990 after being administered fake Paracetamol. In the 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. The percentage of drugs failed quality control testing was found to be zero in Colombia, but 92% in the private sector of Chad. Hence, it is very difficult to obtain accurate data. The proportion of drugs in the USA marketplace are counterfeit is believed to be small – less than 1 percent. In reported two cases of counterfeit medicines found their way into the 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. Regulations are the basic devices employed by most governments to protect the public health against substandard, counterfeit, low-quality medicines, and to control prices. Thus, thorough knowledge of whether these regulations produce the intended effects or generate unexpected adverse consequences is therefore critical. The World Health Organisation (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. But, there are not any WHO guidelines on how to evaluate the impact of these regulations. There are numerous reports concerning drug regulations, but the published work on the impact of these regulations on the quality of medicines moving in 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.

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

Notes/Comments:

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:

The broad outlines remain intact, but preventing drug smuggling across national borders (Sudan shares frontiers with 9 countries) is hard to police.
The enforcement of the Act and its regulation governing the manufacture, importation, sale, distribution, and exportation of medicines are not adequate to control the illegal importation and sale of medicines in Sudan.
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 jeopardize the health of the people taking medication.

Conclusion and Recommendation:

From the data obtained in this article, some general inferences could be made:

The broad outlines remain intact, but preventing drug smuggling across national borders (Sudan shares frontiers with 9 countries) is hard to police.
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.
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 jeopardize the health of the people taking medication.

In light of the findings, the following recommendations could be useful at various levels:

There is an urgent need for the government to implement the provisions of the existing Act.
The government should adequately equip and fund the National drug Analysis laboratories to start active post-marketing surveillance.
A more spirited effort need to be made by FGDOP and the States’ Departments of Pharmacy to ensure all the medicines on the pharmacies’ shelves are registered and come from legal sources.
The states’ departments of pharmacies are not in existence should be re-established and invigorated. They should be adequately funded to be able to acquire the necessary facilities for their operations.
The CMSPO should stop importation, manufacture, and distribution of unregistered medicines. It should also cease selling the tenders’ product to the private pharmacies. The latter practice undermines the inspection outcomes because it makes inspectors task too difficult (i.e., cannot identify the source of medicine, whether it is CMSPO or not).