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Generics market: an inspection structure on raw materials is needed

«In Europe, the 75% of the active ingredients of generics in quantitative terms comes from Asian countries, above all in China and India, where self-certification is in force and nobody goes to see the manufacturing practices except the US FDA (Food and Drug Administration)» . This was stated by the president of Aschimfarma, the national association of manufacturers of active and intermediate ingredients for the pharmaceutical industries, Gian Mario Baccalini at the forum promoted by the same member of Federchimica. «The rules must be the same for everyone» added Baccalini «but Italy has an effective system in itself while Europe does not. And we suffer the consequences of that, and the system ends up spiraling out of control. It is serious that Italian companies must have Aifa inspections which are serious, while competitors in Europe are not. And the European Union is making legislation that is absolutely not sufficient, because it is impossible to identify substances from uncontrolled production sites: there is no traceability of the active ingredient". The producers are now asking for «a system of inspection controls for all plants, domestic and foreign, which manufacture active ingredients and drugs sold in Italy. Even at their expense," they underline. This is a mechanism that is being successfully developed in the United States, Gdufa, a paid service for the generic drug market, which the FDA is already successfully developing. «The advantages deriving from the introduction of this new inspection structure are undeniable» concludes the president of Aschimfarma «to guarantee safety for citizens in the use of generic drugs and for industry with certain and faster times for inspections and the registration of dossier. Therefore we ask for the launch of an operational table between the authorities and companies to follow the US-model payment system". Assogenerici also expresses itself on the subject by dampening the tones of the alarm: «The problem of control exists» affirms Giorgio Foresti the president «when there is no control on the part of the companies. But in generic, low-margin products, counterfeiting doesn't exist. The raw material in a generic affects in terms of production costs less than 1%. The world of generics therefore does not have the counterfeiting problem that products with high added value such as those with patents do have".

Pharmacist33 – 14 October 2011


(ASCA) - Rome, Oct. 13 - "A system of inspection controls for all plants (domestic and foreign) that manufacture active ingredients and drugs sold throughout the country.

 This is the request of Aschimfarma, the national association of manufacturers of active and intermediate ingredients for the pharmaceutical industry, which is part of Federchimica, to deal with the rampant phenomenon of drug counterfeiting.

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Fedaiisf Federazione delle Associazioni Italiane degli Informatori Scientifici del Farmaco e del Parafarmaco