FDA issues anti-counterfeiting guidance on PCIDs in medicines

The US Food and Drug Administration (FDA) has issued draft guidance on the use of inks, pigments, flavours and other physical-chemical identifiers (PCIDs) by pharmaceutical manufacturers to make medicines more difficult to duplicate and thereby thwart counterfeiters. PCIDs should also make it easier to identify whether the drug is genuine or not.

The document provides guidance on the use of PCIDs in solid oral dosage forms, which include pills and capsules, for anticounterfeiting purposes.

A PCID is a substance possessing a unique physical or chemical property used to identify and authenticate a drug product or dosage. In addition to inks, pigments, and flavours, specific chemicals may be used as molecular tags in a PCID. In some cases it will be easy for wholesalers or pharmacists to identify PCIDs to determine if they have authentic products. In others, special analytical instruments may be necessary to identify whether the PCID is present.

The FDA anticipates that many of the potential PCID ingredients are already used as food additives, colourants, or other types of inactive ingredients with established safety profiles.

To minimise adverse effects, the draft guidance recommends using the lowest level of PCID that ensures identification of the product. It also says the PCID should be a substance with no medicinal effect, and placed within the dosage form so that it does not interact with the drug's active ingredient.

"Drug counterfeiting is a serious public health concern," said Margaret Hamburg, FDA commissioner of food and drugs. "We look forward to working with industry to help ensure that consumers are not exposed to products containing unknown, ineffective, or harmful ingredients."

The FDA invites comments on Draft Guidance for Industry: Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting, which is in the Newly Added Guidance Documents section after clicking on this FDA link.