Abstract

A NEW ERA OF RESEARCH: ORPHAN DRUGS

Jaydip M. Sapariya, Dr. Dilip G. Maheshwari *

ABSTRACT

As Pharmaceutical companies generally invest many millions of dollars to develop single new drug, the interest of companies were diverted towards the development of drugs that are used for the large patient population (Non-Orphan drugs). But due to enforcement of the own legislation regarding the incentives, tax credits and research grants, the companies now attracted towards the development and marketing of the Orphan drugs. For easy and quick approval process for the Orphan designated drugs, the individual countries (US, Europe and Japan) have adopted the Fast-track approval process (As there is decrease in the time up to 0.8 years or 273 days in US) for quick marketing authorization. So this area of Orphan drugs is newer enough for research purpose. In this article it defines the Orphan drugs, challenges faced by the company and advantages of Orphan drugs development and the regulations claimed by US, Europe and Japan.

Keywords: Orphan drugs, Orphan disease, Neglected disease.