A generic drug is a drug defined as “a drug product that is comparable to a brand/reference listed drug product in dosage form, strength, quality and performance characteristics and intended use. It has also been defined as a term referring to any drug marketed under its chemical name without advertising. A generic drug is a bioequivalent form of a branded drug and is considerably cheaper. Although they may not be associated with a particular company,
generic drugs are subject to the regulations of the governments of countries where they are dispensed. Generic drugs are labeled with the name of the manufacturer and the adopted name (nonproprietary name) of the drug.
A generic drug contains the same active ingredients as the original formulation. According to the U.S. Food and Drug Administration (FDA), generic drugs are identical or within an acceptable bioequivalent range to the brand-name counterpart with respect to pharmacokinetic and pharmacodynamic properties. When generic products become available, the market competition often leads to substantially lower prices for both the original brand name product and the generic forms. The time it takes a generic drug to appear on the market varies. In most countries of the world, patents give 20 years of protection. For a common person, the decision to choose a branded or generic medicine is a difficult one. Being similar in efficacy, activity, potency, safety, purity, quality, strength, administration route, pharmacopoeial standards to the branded one, the drug is neither frequently prescribed nor available at the nearest chemist shop. Reducing labeling, clinical research studies cost, the patent expiry period of branded drugs makes the generic medicines cheaper. In spite of poverty, an imbalance in the inflation and constant salaries has led to the increasing availability and use of generic medicines to replace more expensive, branded drugs.
From the current review, it will be demonstrated that why doctors do not prescribe generic drugs and what are the hurdles in the way of making generic medicines available to the common people. The present paper highlights the need of publicity and essential steps that government should take to modify the drug price policy, regulate uniformity in generic supply chain, organize general communicational programs and promotional schemes for awareness of people that should pass from the manufacturer, wholesaler, retailer, doctor, pharmacist and the customer. Availability of lower priced and equipotent generic medicines in market are highly essential to make the medicines affordable to the common and poor patients.
Dr. Harish Kumar,
M.Pharm, PhD, Scientist