A generic medicine is the therapeutic equivalent of an originator pharmaceutical product whose patents protecting that product have expired. A generic medicine contains the same active substance as and is essentially similar in action to the originator product. Equivalent generic medicines may contain different non-active ingredients (such as colorings, starches, saccharose etc), which have no therapeutic effect. In certain cases generics and originators may also differ in salts and esters, but these must not affect therapeutic equivalence between the two products. As with all other medicines, the quality, safety and efficacy of a generic medicine is assured the relevant regulatory agencies, such FDA in the United States. Amongst other things, FDA requires that the generic medicine be “bioequivalent”, that is, “essentially similar”, to the originator product. The generic drug is scrutinized thoroughly by FDA before it is granted a marketing approval to ensure that it complies with exactly the same controls over quality, safety and efficacy as all other medicinal products. Generic Drugs are manufactured and processed at site pre-approved by FDA. Such approved sites are subject to regular FDA inspection to ensure that these comply with the “Good Manufacturing Practice”. And lastly, just like originator products, once a generic drug is sold on the market, it must be monitored by the manufacturer in case any adverse reactions are reported. |