Generic medicines: issues and relevance for global health.

ABSTRACT

Generic medicine is a pharmaceutical product which is bioequivalent to the innovator product in terms of dosage form, strength, route of administration, quality, safety, performance characteristics, and intended use. Generic medicines are a cornerstone for providing affordable medicines to patients. The major generic markets in the world include United States of America followed by European Union, Canada, Japan, and Australia. The major suppliers of generic medicines China and India are showing tremendous growth in the generic medicine sector. There are many legal and regulatory issues along with quality concerns associated with the use of the generic products. Lately, bilateral international agreements called free trade agreements, delaying tactics by originator companies like strategic patenting and litigations on generic manufacturers, have been a major setback for the generic medicine industry. These issues need to be addressed to optimize the use of generic medicines. The sustainability of generic medicine sector is crucial for improving access to essential medicines for the worldwide.