India's Pharma Ambitions Turn to Rare-Disease Drugs
India could build a competitive rare-disease pharmaceutical sector through regulatory reform, incentives and public procurement.
India has established a global reputation for making medicines affordable. The next challenge, according to a fresh line of thinking in the pharmaceutical sector, is to extend that achievement to rare-disease drugs and demonstrate how they can be made accessible.
The argument rests on three pillars: a streamlined regulatory pathway, appropriate financial incentives, and government procurement. Together, these measures could allow India to build a rare-disease pharmaceutical sector that is globally competitive.
Rare-disease treatments are typically expensive and serve small patient populations, which makes them a difficult commercial proposition in most markets. India's track record in lowering drug costs is seen as a foundation on which a different model for these therapies could be built.
A clear and predictable approval process would reduce the time and cost of bringing such drugs to market. Financial incentives would aim to offset the limited returns that small patient numbers imply. Government procurement would create assured demand and help widen access.
If these elements come together, the country could move from being a maker of affordable medicines to a source of accessible rare-disease treatments for the world.