Reply to the editorial - "Only generics (drugs/names): Is India ready?".

Sir,

In the case of branded gliclazide MR (Diamicron® MR), now available as Diamicron® XR 60 the principal novelty of the formulation is its controlled gastric dissolution characteristics because of a specially developed hydrophilic polymer matrix tablet.[1] When taken in the morning, the quantum of gliclazide released is related to subsequent breakfast, lunch, and dinner. Optimum gliclazide is thus released in relation to food intake over 24 h without surges in plasma concentration.[2] This, it is claimed, enables more effective and smoother 24 h glycemic control with less risk of hypoglycemia. The clinical veracity of these outcomes was tested and confirmed in the ADVANCE study.[3] Clearly then, the benefit of the original branded gliclazide modified release, is related, as much to its hydrophilic polymer matrix tablet, as it is to the active ingredient it contains.

However, nuances such as this are ignored when a generic modified release formulation is claimed to be “as good.” For instance, at present, the basic requirement for Food and Drug Administration (FDA) approval in the USA is that the generic tablet should deliver a blood concentration within 10% above or below that achieved with the original brand. According to the FDA, generic copies do not need to contain the same inactive binding materials such as the hydrophilic polymer matrix in branded gliclazide modified release.[4] While this may not make a difference between generic and branded immediate release formulations, it could mislead physicians into assuming parity in clinical outcomes for extended release formulations as well.

The purpose of treating chronic disease such as type 2 diabetes, often for life, is to reduce mortality and cardiovascular risk. Perhaps physicians will better serve their patients by prescribing only those formulations, whether branded or generic, that has actually been shown to reduce such risk in at least one outcome clinical trial. Selecting a less expensive generic which has not been proven to fulfill this central purpose is a waste of even the little that is spent.

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Conflicts of interest

There are no conflicts of interest.