The work, goals, challenges, achievements, and recommendations of orphan medicinal product organizations in India: an interview-based study.

ABSTRACT: BACKGROUND:Orphan medicinal products (OMPs) are intended for the diagnosis, prevention, management or treatment of rare diseases (RDs). Each RD affects only a small fraction of the population, and therefore, historically, industry hesitated to undertake relevant research and development (R&D). In response, the governments of many countries came up with orphan drug policies and RD policies which were hugely successful in incentivizing companies to do so. In India, in the absence of any such policy until recently, there are very few organizations involved in RD R&D. OBJECTIVES:We wished to understand (i) the OMP Organizations' (OMPOs') areas of work and the nature of their work, (ii) their goals, (iii) the challenges they faced and how they were overcoming them, (iv) their achievements, and

SUBMITTER: Choudhury MC 

PROVIDER: S-EPMC6829914 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature