To improve the quality and efficacy of medicines, facilitate control of counterfeit and substandard drugs and address problems of drug resistance, the World Health organization has released a new edition of The International Pharmacopoeia (see page 39).
The International Pharmacopoeia provides specifications for the content, purity and quality of active ingredients and pharmaceutical products according to internationally approved standards. While a practical tool for all settings, it is aimed especially at those countries where national regulatory authorities may not have enough funds or staff to function effectively.
The International Pharmacopoeia will be particularly useful in identifying counterfeit and substandard medicines. These are growing concerns worldwide and especially affect developing countries. A recent survey found that 40% of artemisinin-based antimalarials were counterfeit they contained no active ingredients. Although countries do not always reveal data about the substandard quality of medicines, those that do demonstrate that on average 10-20% of medicines in developing country markets are substandard.
Concerned especially with increasing access to effective treatment, The International Pharmacopoeia gives priority to medicines for illnesses affecting developing country populations disproportionately, such as HIV, tuberculosis, malaria and diseases neglected by conventional pharmaceutical markets. In its Fifth Volume, The International Pharmacopoeia includes all artemisinin-based antimalarials known to date. These are now seen ss the most effective medicines to treat drug-resistant malaria, affecting about 40% of the 500 million people contracting malaria yearly.
The monographs contained in the The International Pharmacopoeia can be used in any country or setting. For this purpose, they are designed to cater for both high-technology methods of testing or, when these are not available, for alternative methods which are less technically demanding.
In addition to monographs, WHO publishes basic tests for confirmation of the identity of active ingredients. These are especially useful when a fully equipped laboratory and analytical expertise are not available and when rapid control is needed. Publication of The International Pharmacopoeia is part of a comprehensive WHO programme to help regulatory authorities, health services and manufacturers assure the quality of medicines and to eliminate substandard products. Other elements of the programme include active support to regulatory authorities on combating counterfeit medicines, training in good manufacturing practices, and quality assessment of manufacturers of medicines.
Reference: WHO Press Release, 7 April 2003, http://www.who.int/medicentre/releases/2003 19