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Through this paper an attempt has been made to put forward the challenges faced by rare disease drug development and
the current scenario of orphan drugs legislations in India. An orphan drug is a pharmaceutical agent that is used to treat a
rare medical condition (viz., Huntington?s disease, myoclonus disease, Tourette syndrome etc.). Developed countries like US, EU,
Japan; Australia has laid down legal framework for combating rare diseases. A path breaking legislation was formulated by the U.S
government way back in 1983, known as ?Orphan Drugs Act (ODA)'. The key purpose of ODA was to incentivize R&D initiatives
for such drugs to treat millions of population suffering from ?Orphan Diseases?. Though the percentage of patients suffering from
?Rare Diseases? in India is reportedly higher than the world average, unfortunately even today such cases get little help from
our government. By considering the importance of ODA, Indian government should also encourage its domestic pharmaceutical
industry to get engaged in research to discover drugs for rare diseases by putting an ?Orphan Drugs Act? in place and extending
financial support, and regulatory concessions like smaller and shorter clinical trials, without further delay. Thus India could well
demonstrate that the concept of Orphan Drugs for Orphan Diseases is really not Orphan in India.
I am saikiran reddy pursuing 1st M.Pharm in pharmaceutical regulatory affairs from JSS College of Pharmacy, JSS University, Mysore. I actively took
part in various seminars and presented papers in national level symposiums.
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