ORPHAN DRUGS: THE CURRENT GLOBAL AND INDIAN SCENARIO

Abstract

ABSTRACT
It was not until a few decades ago that orphan drugs, still enjoyed†the status of pharmaceutical touch-me-not entities. However, the past two decades
have witnessed a radical shift in the approach of global pharmaceutical industry toward orphan drugs. This has stemmed from an apparent innovation
crisis in the domain of common diseases, progressively increasing stringency in the regulations, and the decline of the blockbuster business model.
Further, the success stories of a few orphan drugs, for instance, eculizumab has gone a long way in breaking the myth of non-profitability associated
with orphan drug development endeavor. This combined with the high degree of incentivization attached with orphan drug development makes it a
very lucrative avenue for further investment by the pharmaceutical industry. Sadly, the Indian scenario with respect to orphan drugs is a throwback
to the dark ages.†The progress seen across the developed nations, for instance, the United States of America has not permeated into the Indian
market. India, with its huge population base, stands to provide a hugely lucrative market for orphan drug development. However, this point seems
to have escaped the notice of the Indian authorities and the pharmaceutical sector in India. Thus, with the various patient advocacy groups and nongovernment
organizations
championing the cause of orphan diseased patients
in India, the time is ripe for
the concerned authorities
and the pharma
sector
in India to
take
cognizance of this gaping
lacuna in the health-care
services and undertake
measures
to
address
this situation.
Keywords: Pharmaceutical touch-me-not, Orphan, Indian scenario.