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Regulatory Overview on Rare Diseases and Orphan Drugs in India
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| Author:
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JYOTHI M S, BALAMURALIDHARA V, NAGARAJU.S
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| Abstract:
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Orphan drugs are the drugs and natural products used in treatment, diagnosis, or prevention of rare disease. To date, Indian scenario has reported~450 rare diseases in India. Statistically, the rare disease and disorder population in India was estimated to be 72,611,605. Considering the severity and effect of rare diseases on patients and their families and Delhi High Court's orders, the policy , i.e. “National policy on treatment of rare diseases” has been prepared to facilitate access to rare disease care. The National Pharmaceutical Pricing Authority (NPPA), in coordination with the 'Ministry of Health and Family Welfare’, takes measures to identify a rare disease.And central government support scheme for patients with specified rare diseases under the “Rashtriya Arogya Nidhi” (RAN) umbrella scheme offers financial assistance to poor patients living below the threshold poverty line and suffering from specified rare diseases for treatment facilities in government hospitals / institutes with super specialty. Interpreting the study results to learn about orphan drug from an Indian perspective and what are the policies in India to support rare disease patients and the need for orphan drug regulations.
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| Keyword:
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Orphan drug, IDMA, NPPA, RAN, “National policy on treatment of rare diseases”, MoHFW (Ministry of Health and Family Welfare)
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| EOI:
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-
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| DOI:
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https://doi.org/10.31838/ijpr/2020.SP1.258
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| Download:
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