Drug quality developing countries

Only ART drug combinations containing at least 3 drugs from at least 2 ARV classes lead to durable suppression of HIV and translate into an improved immunologic state and quality of life. Individuals from RLS have been fortunate to benefit from earlier studies in developed countries and therefore early start of ART (CD4 count > 500/pl) or monotherapy/ dual therapy have been avoided in these settings. Several combination regimens with demonstrated effectiveness in achieving durable suppression of HIV replication are available. 

Humankind has reaped extraordinary benefits from the pharmacological revolution of the twentieth century. Conditions such as poliomyelitis, diphtheria and whooping cough have been largely eliminated in developed countries by immunization. Many lethal communicable diseases can be readily cured with antimicrobial agents. And drugs have improved the quality of life for many people with chronic diseases to an extent that would have been unthinkable in the nineteenth century (p. 360). 

At that time there was the need to align with the worldwide movement regarding the issue of quality for pharmaceutical products. The World Health Assembly (WHA) discussed the issue of quality of drugs on many occcisions as the distribution of substandard products continued to increase significantly in developing countries. 

In spite of these efforts and because many developing countries are dependent on imported drugs, the need for controls or a formal licensing system was unavoidable. It is recalled that the WHO certification scheme on the Quality of... 

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. 

In our consideration of future trends, certain issues are raised, especially as they concern the quality, stability and safety of drugs, mainly because of the increasing numbers of reports of substandard and counterfeit drugs being found on the market in many developing countries. Furthermore, we need to remember that... 

Only 10 firms account for 75% of agrochemicals sales, while the 15 largest drug companies have a market share of only 33% (Stinson, 1995). About 85% of fine chemicals are manufactured by companies of the triad the United States (28%), Western Europe (39%), and Japan (17%). Italy, with 4.0 million litres reactor capacity and 71 manufacturers, topped the European fine chemicals industry (Layman, 1993). Recently India, China, and Eastern-Central European countries have gained a significant proportion of the market, as a result of the lower direct labour costs and the more relaxed environmental and safety standards. It is fair to state that the high quality of chemists in these countries has also contributed to this development. In 1993, the cost of producing fine chemicals in India was 12% below that in Europe (Layman, 1993). 

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