Abstract

COMPARISION OF GENERIC DRUG APPROVAL PROCESS IN REGULATED AND SEMI REGULATED MARKETS

Yarram Lakshmi Priya* and M. V. Nagabhushanam

ABSTRACT

Generic drugs are interchangeable with original proprietary drugs, as they have the same active pharmaceutical ingredients, dosage forms, strength, quality, indications, effects, directions, and dosage. The cost of generic drugs is lower than original drugs, because the developmental cost is lower. The application can be filed to the regulatory authorities, to get generic drug approval. Bioavailability and Bioequivalence study data is critical in the generic drug approval process as clinical trials can be omitted. This study was conducted with an objective to compare the regulatory framework of generic drug application and their approval process in various countries like United States, Europe, Japan, Canada, Brazil, India, China, Singapore and Saudi Arabia. This study mainly emphasizes on the application form, approval timelines and sequence of steps in the generic drug approval.

Keywords: Generic drugs, Regulatory authority, Approval process, Bioequivalence, Bioavailability, Abbreviated application.