Quality Assurance and Safety issue of Pharmaceutical Products marketed in Developing countries

Abstract

The circulation of substandard medicines remains a serious problem in the resource limited countries like Sub-Saharan Africa, where most of the drugs available are imported. Medicines sold in these markets are frequently found to have ingredients at concentrations that are too high or too low. They tend to contain impurities and poor quality ingredients. They are also often labeled inadequately. There are a number of reasons for these shortfalls. Most Sub-Saharan countries lack adequate regulations for ensuring the safety and efficacy of their medicines. Porous borders between the countries in the region facilitate the illicit importation of drugs and drugs piracy. We surveyed a selection of drugs available in six of the 15 countries that make up the Economic Community of West African States (ECOWAS) to gauge the extent of, and the main reasons for, the circulation of substandard drugs in Sub-Saharan Africa. Free trade and globalization policies have led to an anarchical invasion of poor quality medicines into the markets of developing countries. Medicines in the ECOWAS region can be purchased from pharmacies and other outlets. Drugs for sale can be found exposed in bowls or trays along the streets and in market stalls or carried on the head by itinerant hawkers (<em>Hawkers: Medicine sellers who wander along streets and from house to house</em>), all these practices are carried out under inappropriate climate conditions. Between January and March 2010, we purchased, without prescriptions, 68 treatment packs and blisters of antibacterial agents and an antimalarial from various types of drug outlets, i.e. pharmacies, market stalls, drug stores and itinerant hawkers on the street and at bus stations. Documentation collected during our survey of the national medicine agencies from the six ECOWAS countries illustrated that, while on paper there are rules governing the pharmaceutical sector, the implementation of said rules in practice is weak due to a lack of political will. Our survey revealed that, it is more likely that the drugs we assessed were substandards as a result of bad manufacturing practices rather than as a result of fraudulent manufacturing. This study is aimed to evaluate the regulatory flaws and some quality parameters of the most commonly used essential drugs. The results will be useful to the ongoing drug registration harmonization process and especially to the West African Health Organization (WAHO) in developing appropriate intervention strategies to ensure that only effective drugs are allowed on the ECOWAS market and to promote the public confidence in the quality of the medicinal drugs.