Government Retains Discretion on Rare Disease Drug Tax Exemptions and Import Protocols Under Existing Regulatory Framework

HC dismissed writ petition challenging tax exemptions and import procedures for rare disease drugs. Court held government retains discretion on tax exemptions and maintained regulatory protocols for drug importation. Petitioners were directed to make representations to relevant authorities while their specific relief requests were rejected.

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Issues:
1. Exemption of drugs for rare diseases from taxes
2. Import of drugs for SMA treatment without approaching Centre of Excellence

Analysis:
1. The petition sought a writ of mandamus to exempt drugs for rare diseases from IGST, CGST, SGT, and Custom Duty. The Court held that it is the Government's prerogative to decide on such exemptions, and no mandamus can be issued to enforce the exemption. Therefore, the petitioners were not granted relief in this regard.

2. The petition also requested a writ to allow the direct import of drugs for SMA treatment without involving the Centre of Excellence. The Court refused to grant this relief, stating that there could be valid reasons for the drugs to be cleared by the Centre of Excellence. Consequently, the petitioners were not entitled to the relief sought in this aspect as well.

3. In conclusion, the Court dismissed the writ petition, stating that the petitioners were not entitled to the reliefs they sought. However, the Court allowed the petitioners to make a representation to the Union of India/Ministry of Health regarding their concerns. Any pending interlocutory applications were also disposed of as a part of this judgment.

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