The Delhi High Court recently issued directives to improve the availability of “orphan drugs,” which are used to treat rare diseases.
Orphan drugs are pharmaceutical agents developed specifically to treat rare diseases or conditions, often referred to as “orphan diseases.” These diseases affect a small percentage of the population, making it less commercially viable for drug companies to invest in research and development for treatments, as the market for such drugs is small. To incentivize the development of orphan drugs, many governments provide benefits such as tax credits, market exclusivity, grants, and reduced regulatory fees.
Rare diseases, as defined by the WHO, are conditions that affect fewer than 1 in 1,000 people. In India, 55 medical conditions, including Gaucher’s disease and certain muscular dystrophies, are classified as rare diseases.
However, less than 5% of these diseases have available therapies, leading to significant challenges for patients seeking treatment.
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