• ROSHANI GOEL Sanrachna, SGT University, Gurugram, Haryana, India.


Pharmaceutical industry is crucial for mankind and contributes in some way in socio economic development of the society through jobs, community welfare, and supply chains. Indian pharmaceutical companies are one of the largest markets in the world, estimated 10% of global production and 2% of world market. The industry is has shown significant growth in infrastructure development, producing wide range of pharmaceutical products with new technical advancements. The country is famous for producing and providing pharmaceutical products at much cheaper prices than the US and EU. However, the country lacks in investment in research on rare disease or orphan drugs. This paper tries to highlight the ways in which the market in orphan drugs can grow in India with the help of international partners.

Objective: The objective of the study was to look at existing orphan drug policies and how we can aim at making it more equitable in India.

Methods: Research is completely based on secondary data from online journals and government data. The study is analytical in its approach and is descriptive in nature.

Results: Pharmaceutical companies invest less in Orphan drugs as they do not mark an assured profit with present investment.

Conclusions: To maintain the interest of Indian pharmaceutical companies it is suggested that, Indian companies should work in collaboration with countries which lead in orphan drug markets.

Keywords: Orphan Drug, rare disease, pharmaceutical sales, government policies


1. Government of India. National Policy for Treatment of Rare Diseases. New Delhi: Ministry of Health and Family Welfare; 2017. p. 1-36.
2. Saviano M, Sergio B, Caputo F, Mattia L, Zanda S. From rare to neglected diseases: A sustainable and inclusive healthcare perspective for reframing the orphan drugs issue, sustainability. J Acc Res 2019;1:1-21.
3. Anon. The Portal for Rare Diseases and Orphan Drugs; 2020. Available from: https://www.orpha.net/consor/cgibin/Education_AboutOrphanDrugs.php?lng=EN&stapage=ST_EDUCATION_EDUCATION_ABOUTORPHANDRUGS_TWC.
4. Sharma A, Jacob A, Tandon M, Kumar D. Orphan drug: Development trends and strategies. J Pharm Bioallied Sci 2010;2:290-9.
5. Hughes DA, Hughes JP. Profitability and market value of orphan drug companies: A retrospective, propensity-matched case-control study. PLoS One 2016;11:0164681.
6. Pomeranz K. Orphan Drug Report 2019, Evaluate Pharma; 2019. Available from: https://www.info.evaluate.com/rs/607-YGS-364/images/EvaluatePharma%20Orphan%20Drug%20Report%202019.pdf?mkt_tok=eyJpIjoiWWpVMk1UVmtNRFpqT0dFeiIsInQiOiIrcmZ3QjNwamZWWV
7. Institute of Medicine, US. Committee on Accelerating Rare Diseases Research and Orphan Product Development; Rare Diseases and Orphan Products: Accelerating Research and Development; 2010. Available from: https://www.ncbi.nlm.nih.gov/books/NBK56184.
8. Akhtar G. Indian pharmaceutical industry: An overview. J Acc Res 2013;11:51-66.
9. Safiyya D, Wong-Rieger D, Harold M, Terry S. Review of 11 national policies for rare diseases in the context of key patient needs. Orphanet J Rare Dis 2017;12:63.
21 Views | 8 Downloads
How to Cite
GOEL, R. (2021). ORPHAN DRUG POLICY. Innovare Journal of Life Sciences, 9(1), 1-2. https://doi.org/10.22159/ijls.2021.v9i1.40593
Case Study(s)