Generic Drug Development and Current Scenario

Abstract

Drugs or medicines are those which are used for treatment, diagnosis, mitigation and prevention of diseases. But it’s very expensive. Not or all but for lower- and middle-class people taking treatment is very difficult because of the cost of the medicines. Many deaths are caused because the patient cannot afford the cost of the medicines. The entry of generic medicines in market brought a revolutionary change in healthcare system and the market share is continuously increasing. In the present scenario generic drugs have an important role in pharmaceutical market. Generic drugs are bioequivalent to brand drugs and are much cheaper as compared to brand drugs because of no R&D cost and minimum marketing expenses.This review presents considerations which can be employed during the development of a semisolid topical generic product. This includes a discussion on the implementation of quality by design concepts during development to ensure the generic drug product has similar desired quality attributes to the reference-listed drug (RLD) and ensure batch to batch consistency through commercial production.