Introduction
Rare diseases pose some of the gravest challenges in healthcare.
Though uncommon individually, they collectively affect millions of
people worldwide. Often these diseases require specialized,
lifelong treatments that come with exorbitant price tags. In India,
patients suffering from conditions such as spinal muscular atrophy
(SMA), haemophilia, thalassemia, and others face tremendous hurdles
obtaining affordable medicines. This has placed compulsory
licensing, a legal provision allowing production of generic
versions of patented drugs without the consent of patent holders,
firmly in the spotlight as a tool necessary to safeguard public
health.
Understanding Compulsory Licensing and Its Legal
Framework in India