I can't quite get past Mr. Kumar statement, "Counterfeiting is an issue of trademark violation and has no bearing on public health." That is certainly true if it not consumed by the public. Could this comment somehow be out of context? For instance, generic drugs can have the same formulation as off-patent drugs, but still violate trademark law if the packaging violates those laws. I hope this is what he meant. The new definition must include substandard products, or at the least expired products. Otherwise, the definition does not meet public expectations of a safe and effective product. It should also include an exception: donations. For instance, bandages can expire, but the expired product may be better than having to wash and reuse them as we have seen in 3rd world countries today.