India to offer incentives for orphan disease drugs

Eager to boost the development of orphan drugs to treat rare diseases in India, the government is looking to offer incentives to drug companies in terms of faster approvals and extended periods of exclusivity.

India lacks a comprehensive registry for rare diseases, but among non-oncological orphan diseases, there are higher cases of Duchenne muscular dystrophy, spinal muscular atrophy, primary immunodeficiency disorders, limb girdle muscular dystrophy, inborn metabolic errors, cystic fibrosis, Hirschsprung's disease and hemangiomas across the country.

"A fast-track approval would ensure reduced costs and make such diseases more treatable," said an official. The grant of 7-10 years of exclusive marketing rights, including protection from imports, if a drug gets an orphan drug status is also on the cards, he added.