The Algerian Court of Auditors has released a damning report on the country's medication control practices, revealing that most imported and locally produced medicines are not systematically checked. The report, published in the Official Journal, highlights significant shortcomings in the control process carried out by the National Laboratory for Pharmaceutical Product Control (LNCPP). According to the report, investigations by the Court of Auditors found that LNCPP services release multiple batches of medications, as well as chemical reagents and products, without subjecting them to the required quality control phases.
The report emphasizes that there is no systematic physico-chemical control for pharmaceutical product registration due to a lack of reagents and equipment. As a result, the LNCPP relies on manufacturers to provide the necessary reagents and equipment, creating a conflict of interest and potentially compromising the objectivity of the results. The Court of Auditors also found that many products, particularly those acquired through temporary use authorizations (ATU), escape prior controls. ATUs are derogations for importing medications registered in their country of origin, with sufficient proof of efficacy and safety, for use by a specifically designated patient.
The report explains that ATUs are typically granted for medications used to treat rare or life-threatening diseases that cannot be replaced by other registered medications. These authorizations are issued by the Ministry of Health's pharmacy department and validated by a central commission. However, the report notes that these products, not being registered in Algeria, evade prior controls and are commercialized by the Central Pharmacy of Hospitals (PCH) without undergoing LNCPP quality control.
The Court of Auditors report cites data from 2014 to 2017, revealing that 337 products were imported and commercialized by the PCH without LNCPP analysis or control. Of these, 43% concerned metabolism, nutrition, and diabetes, while 19% were painkillers. Furthermore, the report states that 90% of medication batches received by the PCH are not controlled, with most products being released based on the manufacturer's certificate of analysis rather than an LNCPP certificate of conformity.
The report also examines the control of medical devices, which must undergo quality control before commercialization and homologation by the Ministry of Health. However, the report finds that several commercialized products are not subject to prior homologation or systematic LNCPP control. In response, the LNCPP director general attributed the practice of receiving products without control to avoiding shortages.
The Court of Auditors report highlights additional concerns, including the lack of quality control for medical devices produced locally, which account for over 90% of batches received by the PCH. Specifically, the report notes that 6,272 pacemakers were not controlled by the LNCPP between 2014 and 2016. Moreover, the report reveals that chemical reagents and products, like pharmaceuticals, are subject to quality control but are not systematically checked.
The report concludes by citing the LNCPP's limitations in controlling certain products, such as vaccines. In response to an expertise request from the Pasteur Institute of Algeria, the LNCPP stated that it lacked the necessary equipment and software to perform quality control on vaccines. The report's findings underscore significant weaknesses in Algeria's medication control system, raising concerns about public health and safety.
Key points
- Most imported and locally produced medications in Algeria are not systematically checked by the LNCPP.
- The lack of control affects various types of medications, including those acquired through temporary use authorizations (ATU) and medical devices.
- The Court of Auditors report highlights a conflict of interest in the LNCPP's reliance on manufacturers for necessary reagents and equipment.
