(2001; 96 pages) [French] [Spanish]
8.1 Need for drug regulation and quality assurance
The drug regulatory authority (DRA) is the agency that develops and implements most of the legislation and regulations on pharmaceuticals. Its main task is to ensure the quality, safety and efficacy of drugs, and the accuracy of product information. This is done by making certain that the manufacture, procurement, import, export, distribution, supply and sale of drugs, product promotion and advertising, and clinical trials are carried out according to specified standards. Several of these functions also contribute to efforts to promote rational drug use (see Chapter 9).
Drugs of poor quality can have serious health and economic consequences. There are many ways in which the quality of a drug may be unacceptable or poor. Drugs may not contain the right active ingredients in the quantities stated on the label; they may contain no active ingredient at all, or contain substances that could be harmful. The quality may have deteriorated because of poor storage conditions, contamination or repackaging; or the drug may simply have passed its expiry date.
Apart from the medical consequences of ineffective treatments or toxic effects, money is wasted because of the extra costs to the health care system. Considerable wastage may also occur if drugs are not packaged and stored properly, so that new stocks must be procured. There is also a more general psychological effect. If people do not have confidence in the quality of the drugs they receive, they may lose confidence in the drug policy and the health services as a whole.
In recent years, national and international authorities have recognized the presence of substandard and counterfeit drugs as a growing challenge to those involved in quality assurance. Some of this development is linked to trends towards liberalization and globalization of trade. It is a real challenge for a regulatory control system to prevent the procurement, marketing and use of such drugs. WHO has developed guidelines on measures to combat counterfeit drugs.44