Developing countries safety studies

Kheni, N. A., Dainty, A. R. J., Gibb, A. (2008). Health and safety management in developing countries A study of construction SMEs in Ghana. Construction Management and Economics, 26, 1159-1169. 

Generally, in most developing countries, dmg regulation is very weak, and the safety, efficacy and quality of imported or locally manufactured dmgs cannot, therefore, be assured. Studies carried out in some countries show that about 20% of tested dmg products fail to meet quality standards. Reports have also shown that the prevalence of substandard and counterfeit dmgs is higher in countries where dmg regulation is ineffective. 

In recent years in some developed countries, the requisite of presenting economic evaluation (that is, pharmacoeconomic) studies of new dmgs has been introduced alongside the existing one of clinical trials. These studies have to provide proof of their efficiency (or cost-effectiveness) as a condition for the public financing of the new product. These studies improve information and market transparency and may help to make competition keener, but like the earlier requirements regarding effectiveness and safety, they constitute an additional cost factor and as such raise further barriers to entry. 

The extent of safety studies necessary to obtain food additive approval can be demonstrated by the studies carried out on acesulfame K (trade name Sunett ), one of the sweeteners developed in course of the last 25 years,7 which has been endorsed for food use by the Joint Expert Committee on Food Additives (JECFA) of the WHO and FAO and the Scientific Committee for Foods (SCF) of the EU and has meanwhile been approved in more than 100 countries. This program shows the wide range of studies necessary. 

As a tool to make mutual acceptance of risk assessments possible, OECD has developed the concept of Good Laboratory Practice (GLP). The OECD Principles of GLP are an integral part of the 1981 OECD council decision on the Mutual Assessment of Data (MAD) in the Assessment of Chemicals (revised 1997, Section 2.2.2). MAD also harmonizes procedures of GLP compliance monitoring, ensuring that preclinical safety studies are carried out according to the principles of GLP and that countries can have conftdence in the quahty and rigor of safety tests. 

Outside the United States, the Organization for Economic Cooperation and Development (OECD) publishes GLPs that have been adopted by its members and the European Union. These GLPs apply to the testing of chemicals to obtain information about their properties and/or their safety with respect to human health and the environment. The Japanese Ministry of Health and Welfare (MHW) has also published GLPs that apply to non-clinical laboratory safety studies that support applications to manufacture or import drugs or applications to re-examine new drugs in accordance with the country s Pharmaceutical Affairs Law. ... 

Medicinal plants can offer alternative remedies with tremendous opportunities compared to synthetic modem pharmaceuticals. They not oidy provide access and affordable medicine to poor people they can also generate income, employment and foreign exchange for developing countries. Many traditional healing herbs and plant parts have been shown to have medicinal value, especially in the rural areas and these can be used to prevent, alleviate or cure several human diseases. The safety of raw medicinal plant materials clearly provides a compelling rational for both additional scientific study and national health care pohcies that can address the judicious use of traditional medicines to improve the quality and quantity of these materials and to ensure their efficacy. 

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