Abstract:
Antibiotics are available as innovators and generics. An innovator or branded drug is a medicine
that is discovered, developed and marketed by a pharmaceutical company which also holds the
patent for that drug. Generics only become available after the patent on the innovator expires.
Generic drugs are required to have the same active ingredient, strength, dosage form, and route of
administration as the innovator product. Generics should be bioequivalent to the innovator and
when used, should have the same efficacy and safety profile. This is crucial for parenteral
antibiotics because according to the World Health Organization and U.S. Food and Drug
Administration criteria, parenteral generic products do not need to provide evidence for in-vivo
bioavailability or bioequivalence before they can be marketed. Published evidence shows that there
is a disparity in the efficacy of different generic antibiotic products. In-vitro microbiological
methods of efficacy testing have been recognized as a standardized and cost-effective approach to
clarify doubts regarding the efficacy of generic parenteral antibiotics. However, in-vitro methods
used alone, might not be a good measurement of antibiotic efficacy as several studies have shown
disparities between in-vitro and in-vivo efficacy of parenteral antibiotics.
