Italian regulator has counterfeits in its sights

The Italian Medicines Agency (AIFA) has started a project to develop analytical methods that can be used to identify counterfeit medicines, as well as testing generic and biosimilar medicines for bioequivalence.

The overall aim is to develop alternative methods to evaluate "specific chemicals and chemical-physical parameters in order to obtain information about the quality of ... drugs," according to AIFA, which says the pharmaceutical industry group Farmindustria, as well as individual drugmakers, will also contribute expertise to the project.

The programme will look at both finished dosage forms and active pharmaceutical ingredients (APIs) and will make use of the latest available lab technologies, in a bid to make analyses more accurate and cost effective, according to Prof. Guido Rasi, AIFA's director general.

The anti-counterfeiting element comes under a project on the control of active substances, the first of three topics covered by the new programme.

The project will try to develop quantitative and qualitative methods for determining the strength and determination of purity of the active substance and any other components in the pharmaceutical form.

It will also look into analytical chemistry techniques to obtain information about the presence of impurities, degradation products, the chemical structure, spatial conformation and the isomeric composition of a sample, according to AIFA.

At a press conference to unveil the programme at the Italian embassy in Washington, Prof. Rasi said a key part of the programme is the "identification and validation of standardised methodologies to be applied ... in combating counterfeiting."

The other two projects cover animal studies to determine and predict bioavailability of medicines, and a bioinformatics model for predicting bioequivalence in humans.

AIFA has a number of initiatives ongoing to tackle the issue of medicines counterfeiting, and last summer launched a public awareness campaign though posters and leaflets disseminated through 75,000 Italian pharmacies.

Alongside the IMPACT Italia group which brings together anti-counterfeiting experts from AIFA, the Ministry of Health, Italian police and the Istituto Superiore di Sanità, AIFA also runs training programmes for police and customs officers and regulatory authority staff.

AIFA and IMPACT Italia also carry out sampling studies of medicines procured over the Internet. Italian law prohibits online pharmacies but cannot prevent the Italian public from buying drugs from websites operating overseas.