The primary legislation related to organ donation and transplantation in India, Transplantation of Human Organs Act, was passed in 1994 and is aimed at regulation of removal, storage and transplantation of human organs for therapeutic purposes and for prevention of commercial dealings in human organs.

In India, health is a State subject. Therefore this Central Act is applicable in the proposing States & the Union Territories. The amendment to the Act was passed by the parliament in 2011, and the rules were notified in 2014. The same is adopted by the proposing states and union territories by default and may be adopted by other states by passing a resolution.