Counterfeit can mean different things in different countries. While according to WHO standards, the term can be applied to medicines that do not have the right ingredients or have ingredients in wrong quantities or contain false claims of where they are from, developed nations have often thwarted competition by branding high-quality generics as counterfeits.
More important, the term has been liberally used in trademark agreements to define drugs that are in contravention of intellectual property rights granted to a pharma company in a particular jurisdiction. But, with WHO now separating the issue of IPR from actual counterfeiting of drugs, there is some relief in store for many drug exporters.
The organisation’s newly-constituted committee to define substandard/spurious/falsely-labelled/falsified/counterfeit drugs decided to classify all counterfeits as falsified drugs.and thus delineate counterfeit from anything relating to IPR.
The move doesn’t make it easy for Indian generics—that constitute 20% of the global generics market—but it makes flagging a drug solely on the basis of IPR concerns as counterfeit, a practice that has been followed for at least the last one decade, that much more difficult. EU authorities had first detained shipments of generic drugs, including basic antibiotics and anti-retrovirals, from India to several developing countries in 2008 by labelling them counterfeit.
All Indian generics may not be safe—as is evident from the many concerns of drug quality flagged both internationally and within India—but India, and other generic exporters, would be benefit more if WHO were to redefine norms related to high-quality generic drugs, important for developing and under-developed nations looking to provide access to cheaper medicines.