Drug Quality Under Scrutiny: Are Sudanese Regulations Enough?
"An in-depth look at the perceptions of pharmacists regarding the effectiveness of Sudan's pharmaceutical regulations in ensuring the quality and safety of medicines."
Ensuring the safety, efficacy, and quality of medicines is a cornerstone of public health. Medicines regulation, as defined by the World Health Organization (WHO), is a multifaceted process designed to protect the public by ensuring that all drugs meet the required standards. This includes controlling manufacturing processes, verifying drug quality, assessing efficacy and safety, and ensuring accurate labeling and information.
Across the globe, governments employ various strategies to regulate pharmaceuticals, most commonly requiring registration before a drug can enter the market. Despite these measures, the challenge of substandard and counterfeit drugs persists, especially in developing countries. This article delves into the specifics of pharmaceutical regulation in Sudan, exploring its impact on medicine quality from the perspective of those working directly with drug importation.
This article aims to analyze how pharmacists who own or have shares in Sudanese medicine importing businesses perceive the impact of the government’s Pharmacy, Poisons, Cosmetics and Medical Devices Act on the quality of medicines available in Sudan. It seeks to answer critical questions about the effectiveness of current legislation.
Are Current Regulations Enough to Guarantee Drug Quality?
A survey was conducted among 30 pharmacists who are owners or shareholders in medicine importing companies in Sudan. The pharmacists were asked about the effectiveness of existing drug regulations. A significant majority, 89% considered the medicines on the Sudanese market to be of generally good quality. This indicates a positive perception among professionals directly involved in the import and distribution of medicines.
- Splitting of Authority: 91% of respondents believed that dividing drug registration responsibilities between the Ministry of Health (MOH) and the Ministry of Animal Resources (MOAR) weakens overall medicine control. This division potentially creates gaps and inconsistencies in regulatory oversight.
- Non-Registered Medicine Distributors: A significant 93% agreed that the increasing number of non-registered medicine distributors facilitates the marketing of low-quality medicines. This underscores the need for stricter control over the distribution channels to prevent substandard drugs from entering the market.
- Pre-Marketing Surveillance: Nearly three-quarters (71%) felt that pre-marketing surveillance is insufficient to ensure the quality of medicines. This suggests a need for more robust and comprehensive testing and evaluation processes before drugs are released to the public.
Strengthening Sudan's Pharmaceutical Future
The study underscores the need for continuous evaluation and improvement of pharmaceutical regulations in Sudan. While the current system has strengths, identified weaknesses must be addressed to safeguard public health effectively.
Based on the research findings and the pharmacists’ perspectives, the following recommendations can help enhance the pharmaceutical regulatory framework:
<ul> <li><b>Re-evaluate Regulatory Structure:</b> The government should consider consolidating drug regulatory authority under a single entity to avoid inconsistencies and improve coordination.</li> <li><b>Enhance Surveillance and Enforcement:</b> Strengthening pre- and post-marketing surveillance, coupled with stricter control over medicine distribution channels, is essential to prevent the proliferation of low-quality drugs.</li> <li><b>Invest in Resources:</b> Adequate funding and resources should be allocated to drug analysis laboratories and state departments of pharmacy to ensure effective monitoring and enforcement of regulations.</li> <li><b>Address Public Sector Practices:</b> The practice of public sector organizations distributing unregistered medicines should be ceased to maintain the integrity of the regulatory system and prevent unfair competition.</li> </ul>