financial assistance for a chronic disease such as gaucher, which involves lifelong expenditure. There are even no incentives in place for Indian manufacturers to develop local alternatives to orphan drugs. 43. This Court is of the opinion that neither any promising orphan drug will be developed nor the prohibitive cost of 'orphan drugs' will see a reduction unless changes are made in the applicable laws to reduce the costs of developing such drugs and to provide financial incentives to develop such drugs like in the abovementioned countries. COURT CANNOT DIRECT EITHER PARLIAMENT TO PASS A LEGISLATION OR THE EXECUTIVE TO FRAME A POLICY. 44. Keeping in view the concept of separation of powers as incorporated in the Constitution, this Court cannot direct Parliament to enact a Central legislation on Right to Public Health or with regard to rare diseases or orphan drugs, even though the same may be eminently desirable. 45. Similarly, as formulation of a policy is within the exclusive domain of the Executive, this Court refrains from issuing directions. A Division Bench of this Court in J.K. Sawhney Vs. Punjab National Bank, 2010 VII AD (DELHI) 756 has held , "Moreover, it is imperative to emphasise that the formulation of a policy is within the exclusive domain of executive and the Courts should shy away from issuing directions for formulation of a policy which has financial, economic and other implications, which at the best should be left to the wisdom of the executive." ISSUE HAS TO BE DECIDED IN THE CONTEXT OF INDIAN CONSTITUTION 46. Consequently, the issue raised in the present proceedings is to be decided in the context whether the Indian Government owes a constitutional W.P.(C) 7279/2013 Page 21 of 41

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