ArticlePLOS global public health2023
Assessment of the availability of repurposed orphan drugs in India.
Article in PLOS global public health, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
3 citing papers in PubMed.
- The Economics of Drug Development: A Comparison between Orphan and Non-orphan Drugs.Current drug discovery technologies · 2026Article
- The role of public health in rare diseases: hemophilia as an example.Frontiers in public health · 2025Review
- Navigating health policies and programs in India: exploring opportunities to improve rare disease management and orphan drug research.Orphanet journal of rare diseases · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
India has a massive burden of rare diseases (RDs), with an estimated 96 million people living with RDs but limited options for treatment. Repurposing drugs used for other common conditions are essential alternative for RDs due to their cost-effectiveness and reduced timeline. India's patent regime prevents the evergreening of drugs, and a large generic manufacturing industry provides ample opportunity to explore the potential of repurposed drugs for treating RDs, known as repurposed orphan drugs (ROD). However, there is no portal or other source for information on orphan drugs in India. This study assesses the availability of RODs in India through quantitative analysis. In the absence of a separate orphan drug designation in India, we consider USFDA-approved orphan-designated products as the reference. We searched USFDA-approved RODs in recognized sources in India, such as CDSCO, AYUSH gazette, FSSAI, and Indian Pharmacopeia, which provides a list of drugs approved for marketing in India. We classified the drugs into separate groups based on their record from different sources and explored the regulatory implications of the differential representations. We found that almost 76% of the USFDA-approved RODs are listed in one of the Indian regulatory bodies' records either in the same form (61%) or in a different fixed-dose combination. For 67 drugs no information was found, these drugs have to be imported for use. Only 17 of the 43 RDs mentioned in the National Policy for Rare Diseases, matched the indications listed for approval of one of the 279 RODs identified in the study. This underscores the scarcity of RD treatment and the pressing need for accessibility in India. This information on RODs will help relevant stakeholders to efficiently manage RDs in India. The study also highlights existing gaps in Indian regulatory databases that limits access to accurate information about the availability of drugs.
Identifiers
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.