Controlling medicine and drugs in Sudan: Challenges should be faced
The number of registered medicines in Sudan is 5,288 human drug , including 1,192 national medicines .
Khartoum:Haffiya Elyas
Sudan is witnessing severe drugs, medicines, and medical supplies shortages, which present a major impediment to the provision of emergency healthcare services. Drug insecurity in Sudan is as a result of several accumulated factors, primarily due to worsening economic condition, inappropriate pricing policy, privatization of the pharmaceutical sector, poor manufacturing and weak weak weregulatory system.
According yo science direct , these could threaten patient health through replacement of highly efficacious medicines with less effective alternatives and by impacting the scheduling of urgent medical operations and procedures. Drug and medicine shortages are of catastrophic impact especially amid the current epidemic of COVID-19 where these are salient needs. Efforts should be quickly directed to ensure immediate access to pharmaceutical products and other essential health commodities. Effective policies on drug importation, production, pricing, and distribution should be established to avoid the consequences of an impending crisis.
The use of drugs is especially widespread among youth nowadays. They are often addicted themselves. Several young men and women students selling drugs at secondary schools and universities say that they are mainly driven by poverty.
The National Council for Drugs and Poisons announced the application of the computerization system for dispensing narcotic drugs and psychotropic substances from companies to pharmacies to avoid leakage outside the health system, and revealed its trend to computerize prescriptions, calling on pharmacies to check the prescription before dispensing it.
The Secretary of the General Secretariat of Registration, Dr. Manhal Sayed Ahmed, revealed that Sudan has approved the introduction of 11 coronavirus vaccines from various sources.
She added that the number of registered medicines in the country is 5288 human drug classes, including 1192 national medicines, and the registration of 1919 foreign veterinary medicines, in addition to the registration of 34 national, 1614 nutritional supplements and 33510 medical requirements, as well as the presence of 25 pharmaceutical factories in the country and 8 factories for medical gases.
Regulatory Framework
The pharmaceutical regulatory authority in Sudan is called the National Medicines and Poisons Board (NMPB) and its executive arm – the National General Directorate of Pharmacy (NGDOP). The NGDOP regulates mainly four aspects of medicines use: safety, quality, efficacy and price. When applying to register any medicine, manufacturers and importers are required to furnish the FGDOP with a dossier of information including: the indication of the medicine, its efficacy, side effects, contraindication, warnings on usage by high risk groups, price, storage and disposal.
Medicine Registration
The NGDOP 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.
Licensing
Licenses are granted for a period of one year and may be renewed at the end of December every year (applications to the relevant DOP before expiry of the current license). To improve the effectiveness of the public pharmacy, resources should be switched towards areas of need, reducing inequalities and promoting better health conditions. Medicines are financed either through cost sharing or full private. The role of the private services is significant.
The present policy of the national health–care system in Sudan is based on ensuring the welfare of the Sudanese inhabitants through increasing national production and upgrading the productivity of individuals. 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 licenses being issued include, retail pharmacy license, manufacturer’s license for both public and private firms.
Inspection
In Sudan, legal provisions exist allowing for appointment of government pharmaceutical inspectors to inspect premises where pharmaceutical activities are performed. By law, inspections have to be performed and are a pre-requisite for licensing facilities. The inspection requirements are the same for public and private facilities. However, the regulatory authority has its own inspectors.
Import Control
Medicines are granted the legal authority for importation. Importation is only allowed through certain ports of entry. Legislations exist that allow for inspection of imported pharmaceutical products at the authorized port of entry upon arrival. Imported medicines are then sampled out and tested before being distributed into the market.
ŹMarket Control and Quality Control
A laboratory exists in Sudan for Quality Control testing. Samples are collected by government inspectors for post-marketing surveillance testing from locally manufactured or imported medicines. Medicines that fail to meet the required quality standards are not allowed for distribution or entry into the country, if imported. The results of the quality control testing are not publicly available. Only recalled medicines are published on the MRA website.
Medicines Advertising and Promotion
In Sudan, legal provisions exist to control the promotion and/or advertising of all medicines. The National Medicines and Poisons Board (NMPB) is responsible for regulating promotion and/or advertising of medicines. Legal provisions prohibit direct advertising of all medicines to the public. Legal provisions require a pre-approval for medicines advertisements and promotional materials. Guidelines and regulations exist for advertising and promotion of non-prescription medicines. There is no national code of conduct concerning advertising and promotion of medicines by marketing authorization holders.
Clinical Trials
In Sudan, legal provisions exist requiring authorization for conducting Clinical Trials by the MRA. Laws require the agreement by an ethics committee or institutional review board of the Clinical Trials to be performed. Registration of the clinical trials into international/national/regional registry is not required by law.
Pharmacovigilance
There are no legal provisions in the Medicines and Poisons Act that provide for pharmacovigilance activities as part of the MRA mandate. Legal provisions do not exist requiring the Marketing Authorization holder to continuously monitor the safety of their products and report to the MRA. The national medicines and poisons board emphasize the importance of pharmacovigilance activity.