WHO issues new edition of the International Pharmacopoeia (IntPh)

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 (WHO) has released a new edition of the International Pharmacopoeia (IntPh), which provides specifications for the content, purity and quality of active ingredients and pharmaceutical products according to internationally approved standards.

The IntPh is aimed especially at those countries where national regulatory authorities may not have enough funds or staff to function optimally, and will be particularly useful in identifying counterfeit and sub-standard medicines, notably antimalerials, says the WHO.

Concerned especially with increasing access to effective treatment, the IntPh gives priority to medicines for illnesses affecting developing country populations disproportionately, such as HIV/AIDS, tuberculosis, malaria and diseases neglected by conventional pharmaceutical markets. For example, it includes all Artemisin-based antimalarials known to date. These are seen as the most effective medicines to treat drug-resistant malaria, affecting about 40% of the 500m people contracting malaria each year.

The monographs contained in the IntPh can be used in any country or setting, and are therefore designed to cater to both high-tech methods of testing and alternative methods which are less technically demanding. In addition to monographs, the 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.