INTRODUCTION:
A generic drug is a pharmaceutical drug which is equivalent to a brand-name product in dosage, route of administration, strength, quality, Kinetics, and its intended use. It may also refer to any drug which is marketed under its chemical name without advertising. For getting the approval to market the generic drug an abbreviated new drug application termed as ANDA is to be submitted by the drug companies. The Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Act, allowed ANDAs to be possible by making a compromise in the drug industries. Hence, the generic drug gained access to the market for the prescribed drugs and discoverer companies gained restoration of patent of their products. Any new drug is developed under patent protection. This patent protects the investments involved in the development of the drug by allowing the company to have the right to sell the drug while the patent is in the effect. The manufacturer can apply to the FDA for the selling of generic version after the expiration of the patent period. Further, the ANDA process doesn’t require the sponsor to repeat test animals, ingredients or dosage forms which are already approved for the safety and its effectiveness. [6] [8]
The use of generic drugs is indicated from many countries in order to reduce medication price. However, some points, such as bioequivalence and the role of excipients, may be clarified regarding