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New Tool to Boost Access to Quality Medicines and Detect Counterfeits

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International Pharmacopoeia to Include all Available New Antimalarials

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) releases a new edition of the International Pharmacopoeia (IntPh) on March 23.

The IntPh 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 (bodies charged with assuring the quality and safety of medicines) may not have enough funds or staff to function effectively.

The IntPH will be useful particularly in identifying counterfeit and sub-standard medicines. These are growing concerns worldwide and especially affect developing countries.

For instance, a recent survey found that 40 percent of Artemisin-based anti-malarials were counterfeit as they contained no active ingredients. Although countries do not always reveal data about the sub-standard quality of their medicines, those that do demonstrate that, on average, 10 percent to 20 percent of medicines in developing country markets are sub-standard.

Poor quality medicines may cause death, serious harm to health or, at best, have no therapeutic effect. Counterfeit and poor quality antimalarial medicines for example also contribute to the dramatic growth in resistance to antimalarials, which has serious health and economic impacts.

“The consequences of sub-standard or counterfeit medicines are extremely serious and detrimental to all efforts to control disease and save lives,” said Gro Harlem Brundtland, director-general of WHO. “This is a critical aspect of the struggle for access to medicines and a fundamental feature of WHO’s work on this issue.”

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.

In its fifth volume, the IntPh includes all Artemisin-based antimalarials known to date. These are now seen as the most effective medicines to treat drug-resistant malaria, affecting about 40 percent of the 500 million people contracting malaria yearly.

The monographs contained in the IntPh 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, 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.

Publication of the IntPh is part of a comprehensive WHO programme to help regulatory authorities, health services, and manufacturers to 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 including for HIV/AIDS, malaria, and tuberculosis

Source: World Health Organization (WHO)