(ANSA) - ROME, OCTOBER 13 - For the active ingredients of medicines there is "widespread recourse to purchases from production sites, especially in China and India which are neither controlled nor certified by third parties". This was stated by the National Association of Active and Intermediate Ingredients Manufacturers for the Pharmaceutical Industries, Aschimfarma, which is part of Federchimica. The manufacturers are 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 - to deal with the rampant phenomenon of drug counterfeiting". This is a mechanism that is being successfully developed in the United States, and Gdufa, a paid service for the generic drug market that the FDA is already successfully developing. Italy, historically one of the major producers of active ingredients worldwide with a turnover of 3.2 billion in 2010, was virtuous in this field. But an EU directive dated 1 July, which the member countries must transpose within eighteen months, no longer ensures that the active ingredients used in Europe comply with 'good manufacturing standards': in fact, there are no mandatory inspections in non-EU sites. "The advantages deriving from the introduction of this new inspection structure are undeniable - finally affirms the president of Aschimfarma, Gian Mario Baccalini - to guarantee safety for citizens in the use of generic drugs and for industry with certain and faster times for inspections and dossier registration. So we ask the launch of an operational table between the authorities and companies to follow the US-model payment system”.
Gian Mario Baccalini
