ABSTRACTIt was not until a few decades ago that orphan drugs, still enjoyed†the status of pharmaceutical touch-me-not entities. However, the past two decadeshave witnessed a radical shift in the approach of global pharmaceutical industry toward orphan drugs. This has stemmed from an apparent innovationcrisis 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 associatedwith orphan drug development endeavor. This combined with the high degree of incentivization attached with orphan drug development makes it avery lucrative avenue for further investment by the pharmaceutical industry. Sadly, the Indian scenario with respect to orphan drugs is a throwbackto the dark ages.†The progress seen across the developed nations, for instance, the United States of America has not permeated into the Indianmarket. India, with its huge population base, stands to provide a hugely lucrative market for orphan drug development. However, this point seemsto have escaped the notice of the Indian authorities and the pharmaceutical sector in India. Thus, with the various patient advocacy groups and nongovernmentorganizationschampioning the cause of orphan diseased patientsin India, the time is ripe forthe concerned authoritiesand the pharmasectorin India totakecognizance of this gapinglacuna in the health-careservices and undertakemeasurestoaddressthis situation.Keywords: Pharmaceutical touch-me-not, Orphan, Indian scenario.Â
