Orphan drugs are medicinal products intended for diagnosis, prevention or treatment of life-threatening or very serious diseases or disorders that are rare. In USA, the Orphan Drug Act was passed in 1983 to give drug companies incentives to develop treatments for rare diseases. India does not have laws on orphan drugs though CDSCO defined orphan drugs as those intended to treat a condition which affects fewer than 200,000 people.
source https://www.pharmatutor.org/articles/orphan-drugs-in-india-and-challenges
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