39. In the United States, Orphan Drug Act, 1983 defines the term 'rare disease or condition' to mean any disease or condition which occurs so infrequently that there is no reasonable expectation that the cost of developing and making available a drug for such disease or condition will be recovered from sales of such a drug. The Orphan Drug Act, 1983 not only extends tax credit as well as patent term of such drugs but the government also gives grants and enters into contracts with entities to assist in defraying the costs of expenses incurred in connection with the development of drugs. 40. The European Union Regulation 1999 provides incentive of market exclusivity to the sponsors of orphan drugs. Further, through the EUROPLAN, the European Union has mandated that each member country develop a National Strategy Plan for rare diseases comprising a seven step intervention, viz. policy making, definition and codification of rare diseases, research on rare disease, creation of centres of expertise for rare diseases, gathering expertise at EU level, empowering patient organizations and sustainability of the strategies. 41. Several other countries such as Japan, Australia and Israel have developed policies/strategies to combat the problems of rare diseases and orphan drugs. NO POLICY/STRATEGY IN PLACE IN INDIA WITH REGARD TO ORPHAN DRUGS 42. Unfortunately, the Government of India does not have any policy measure in place to address rare diseases, particularly those of a chronic nature. All the Central and State schemes at the highest provide for a onetime grant for life-saving procedures and do not contemplate continuous W.P.(C) 7279/2013 Page 20 of 41