NEW DELHI: The Delhi High Court on Friday mandated the Centre to establish a “national rare diseases fund” to ensure the effective treatment of patients suffering from rare diseases.
In its order, the court also mandated monthly meetings to monitor the fund’s disbursement, with the first meeting to be held within 30 days, to identify and address any delays in the process.
A bench, led by Justice Prathiba M. Singh, extended the term of the National Rare Disease Committee (NRDC) by five years. This committee, originally formed by the Court in 2023, will continue to oversee the implementation of rare disease policies and treatment efforts across the country.
The court also instructed that Rs 974 crore be allocated for the financial years 2024-25 and 2025-26, based on the NRDC’s recommendations and pending approval from the Health Ministry.
The judgement was issued while resolving a batch of 105 petitions related to the treatment of children suffering from rare diseases.
These petitions sought free-of-cos treatment for these children, as the necessary therapies are often prohibitively expensive. The court has been addressing these petitions since 2020, offering ongoing guidance to ensure access to essential medical treatments.
As part of the judgement, Justice Singh issued a series of guidelines for the Union Government. In her ruling, Justice Singh also emphasised that the right to health, guaranteed under Article 21 of the Constitution, applies equally to patients with rare diseases.
Key directives
The creation of a centralized Rare Disease Information Portal within three months.
Establishing a Fast Track approval process for rare disease drugs within 60 days, with applications to be processed within 90 days
The Drug Controller General of India (DCGI) and the Central Drugs Standard Control Organization (CDSCO) are to monitor clinical trials, both globally and locally, to enroll more patients and explore exemptions for trialse
Approval for fund transfers by relevant ministries is to be completed within 30 days
Waivers on GST, customs duties, and tax exemptions for rare disease treatments are to be issued within 30 daysstriving hard