Category: Health and Fitness: Pharmacy

According FDA (U.S. Food and Drug administration, to gain FDA approval, a generic medication must: comprise identical active ingredients as the innovator drug (inactive ingredients may differ), be bioequivalent in concentration, dose form and route of administration; comply with the same batch requirements for identity, strength, purity and quality; be made under the same strict standards of FDA's Good Manufacturing Practice regulations compulsory for brand name drugs and medicines. To put it differently, their pharmacological effects are identical to those of their branded counterparts.Although generic medicines are chemically identical to their branded counterparts, they are ordinarily sold at considerable discounts from the brand name cost. It is estimated that generics save consumers $8 to $10 billion per year at retail pharmacies. Even more billions are saved when hospitals use generic medicines.The principal reason for the relatively low price of generics is that competition goes up among manufacturers when medicines no longer are protected by patents. Manufacturers incur fewer costs in creating a generic drug, and are, hence, able to sustain profitability at a lower cost to customers. The costs of these generic drugs are so low that many developing countries can easily afford them. For instance, Thailand is going to purchase millions of doses of the generic version of Plavix, a blood-thinning medicine to forestall heart attacks, at a cost of 3 US cents per dose from India, the leading producer of generic medicines.Producers of generic medications do not incur the price of medication discovery, and instead are able to reverse engineer known medicine compositions to allow them to produce bioequivalent versions. Companies do not need to prove the safety and potency of the medications through clinical trials, because these trials have already been conducted by the branded firm.Sometimes, generic versions of a medicine have different colors, flavors, or combinations of inactive ingredients in comparison with original medicines. According to the U.S. Trademark laws, generic medicines are not allowed to look exactly like brand name medicines. Yet, active ingredients in both preparations must be identical, insuring that both have the same medicinal effects.