Argentinian regulators are unsure how best to implement new gluten-free rules for drugs that could mean all excipients need to be tested.
In 2009, in response to sustained pressure from the coeliac disease lobby, the Argentinian Government passed laws (available here in Spanish ) requiring that manufacturers of gluten-free food reduce the amount of the wheat-derived protein in their products from the 10mg/kg level that was previously permitted.
In May this year the country's Ministry of Health (ANMAT) decided to apply the rule to drugs and introduced the requirement that product labels include information about gluten content. It also asked marketing authorisation holders that wanted to mark their medications as 'gluten-free' to submit their products for analysis.
All ‘gluten-free’ oral-dosage form products must comply with the new regulation by May next year. Producers that cannot guarantee their drugs are free of gluten by that date will need to detail its presence on the label and justify its presence to the regulator.
While the new laws have been welcomed by Argentina’s coeliac disease lobbying group, Ley Celiaca , they have raised concerns at INAME, the ANMAT agency that regulates drugs, which is yet to decide how it will implement the regulations.
The major concern is that law D2574 may mean that all batches of drugs and excipients need to be tested to show they are gluten-free, which could potentially increase costs for both the manufacturer and the regulator.
Some of INAME’s concerns were discussed by industry group IPEC-Americas, which visited Argentina for the first time last month to present its excipient workshop to the drug regulator.
IPEC Americas’ Dave Schoneker explained that at present routine testing of drug excipients for gluten is not required anywhere in the world and predicted that it would be unlikely that multi-national companies would institute this type of analysis.
Whether this message was reassured INAME is hard to say, but it does underline that the US excipients industry group is not the only organisation to have concerns about the global regulatory vogue for gluten reduction.
The presentation in Argentina followed a few weeks after IPEC Americas asked the US Food and Drug Administration (FDA) to work with industry before making any decision on the suggestion, published in the Federal Register , that manufacturers consider removing gluten derived ingredients.