Why rare-disease drugs could become India’s next pharma frontier

Each rare disease affects very few people . However, there are around 8,000 rare diseases, and they cumulatively affect hundreds of millions of people. In India, 1,004 rare genetic disorders have been reported so far.

It used to be that because the number of patients for a rare-disease drug was very small, so the pharmaceutical industry’s interest in developing such drugs was limited. Therefore they were called orphan drugs.

In order to overcome this hesitancy, many governments have incentivised companies to develop orphan drugs. Examples include the Orphan Drug Act, which the U.S. passed in 1983 to provide tax incentives, seven years of market exclusivity for the first approved product for a given condition, grants, regulatory fee waivers, etc. That is, it reduced the costs of developing the drugs and enabled companies to make a good profit.