Product specific guidance for generics – a scientifically invalid concept/practice

The purpose of generic products, such as tablet and capsule, evaluation is to establish that the two or more products containing the same drug provides the same/similar plasma profiles of the drug -independent of their formulation and manufacturing attributes. Thus, evaluation or testing must be product-independent. If requirement and standards are based on product specific attributes, then these would not be applicable for other products, including generics, as they could have different attributes (formulation/manufacturing). Product specific testing and standards are similar in concept as to labeling the weight of an item (drug, excipient etc.) with a weighing-scale associated with it – which obviously would be unacceptable.

The concept of product-independent product evaluation would not only be scientifically valid but would also facilitate simpler and expeditious product evaluation and approval.

Therefore, the concept of product dependent assessment of products requires reconsideration. I hope this suggestion will be given a favorable consideration.

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