Drug regulation developing countries

Hill S, Johnson K. Emerging challenges and opportunities in drug registration and regulation in developing countries. London Health Systems Resource Centre 2004. 

Finally, it should be noted that many developing countries lack officials with the requisite pharmaco-economic expertise or access to information, sufficient to permit rational negotiation over medicines prices (WHO 2004). The WHO (1999) World Drug Situation Survey 1999 showed that of 135 countries surveyed, 40 per cent had no regulation of medicines prices at all. 

In the human population the level of exposure to a chemical can, in some cases, be known precisely, for example known doses of drugs are given to patients. For industrial chemicals, and especially chemicals in the environment, however, this is much more difficult and sometimes impossible to know. Well-regulated chemical industries in highly developed countries will monitor workers by taking blood or urine samples from them at intervals. The air in the plant or factory can be monitored and workers may wear personal sampling devices that measure how much of a volatile chemical they are exposed to. This is not practised in all industries nor in less well-developed countries. In such cases, where there is environmental exposure to chemicals, the level of exposure will often have to be estimated, a process that is often fraught with uncertainty. For exposure via water or food, this can be estimated based on information... 

Furthermore, problems which evolve in developing countries in the establishment of drug control have been a consequence of the adaptation of the provisions established successfully elsewhere and of a complexity that precludes the effective implementation in the country of adoption. It should be emphasised that regulations and procedures must reflect conditions in the country and can then be adopted according to the available resources. However, regulatory authorities still have to implement the responsibilities that have been duly given by enactments. There is no doubt that the administrative and technical responsibilities which develop could be seen as steps toward quality assurance. 

The developed countries control their pharmaceutical industries in other ways. Environmental regulations, for example, cover transport of finished drugs and intermediate and starting chemicals. Bulk chemicals transported from one site to another are subject to toxicity testing that utilizes... 

The regulation of drugs emerged first in developed countries. The first initiatives of regulation appeared in 1862 with the Bureau of Chemistry in the Department of Agriculture of the United States, lead by Harvey Wiley, trying to regulate food. 

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