Delhi HC asks Centre to reconsider ₹50 lakh cap for rare disease treatment

The Delhi High Court has ordered the Centre to reconsider the upper limit of ₹50 lakhs fixed for the treatment of rare disease patients under the National Policy for Rare Disease saying the “cap is inadequate” for some rare diseases falling in the Group 3 category.

The rare diseases have been identified and categorized into three groups: Group 1: Disorders amenable to one-time curative treatment. Group 2: Diseases requiring long term/lifelong treatment with relatively lower cost of treatment. Group 3:- Diseases for which definitive treatment is available but very high cost and lifelong therapy.

Justice Prathiba M. Singh, who is hearing a bunch of petitions by rare disease patients and their parents to provide continuous and uninterrupted treatment “free of cost”, directed that donations for rare diseases be added in Schedule VII of the Companies Act to enable Corporate Social Responsibility (CSR) contribution by companies, including Public Sector Undertakings.

It also directed the Centre to establish the National Fund for Rare Diseases (NFRD) for which a sum of ₹974 crores shall be allocated for the financial years 2024-25 and 2025-26.

“Similarly, the same amount if not a higher amount, shall be allocated for the next two financial years of 2026-27 and 2027-28. The Court is conscious that the said fund may not be fully sufficient for the number of patients,” the court ordered on October 4.

The court said NDRF will be administered by the National Rare Diseases’ Cell consisting of one or more Nodal Officers in the health ministry, who shall release the funds for treatment of patients under the National Policy for Rare Diseases, as directed by the National Rare Diseases’ Committee (NRDC).

“The fund would not lapse or revert due to under-utilisation. Monthly reports of utilization of the fund and the number of patients receiving treatment shall be submitted to the NRDC,” it added.

“The upper limit of ₹50 lakhs under NRDP, 2021 for the treatment of rare diseases shall be flexible in case of rare diseases in Group 3 category such as DMD, SMA, Gaucher etc. as per the recommendation of NRDC,” the court ordered.

The court also ordered the Centre to within a period of three months, develop and operationalize a centralized National Rare Disease Information Portal that includes a patient registry, available treatments, nearest Centres of Excellence (CoEs) for treatment, and updates on fund utilization. This portal will be accessible to patients, doctors, and the general public.

The court also said there is no proper analysis of the number of patients suffering from rare diseases. “Therefore, there is a need to create a proper database and a central agency for patients with rare diseases, including their contact details, so they can be referred to the nearest Centre of Excellence for evaluation and treatment,” it said.

Its said details of the crowdfunding platform under health ministry for rare disease shall be publicized in print and electronic media as also on online platforms within a period of two weeks. The funds coming into the platform shall be automatically transferred to the NDRF, it said.