The court emphasized the urgency of establishing a national policy for rare diseases, mandating timely action by the government for funding and treatment provisions.

JUDGMENT

Prathiba M. Singh, J. (Oral)--This hearing has been done through video conferencing.

2. Vide order dated 23rd March, 2021, detailed directions were issued in respect of the further steps to be taken for provision of treatments and indigenisation of treatments for rare diseases. The said directions are as under:

"21. In view of the above, the following directions are issued by this Court:

i) The `National Policy for Rare Diseases' shall be finalized and notified by the Government of India, on or before 31st March, 2021.

ii) As a part of the said policy, the `National Consortium for Research and Development on therapeutics for Rare Diseases' shall also be set up.

iii) A Rare Diseases Committee shall be set up at AIIMS consisting of Prof. (Dr.) Madhulika Kabra and Prof. (Dr.) P. Ramesh Menon, who shall examine the applications for treatment and funding, received from any patient suffering from Rare Diseases. The said Committee can, depending upon the condition of the patient, also co-opt any one member from any specialized field into the said Committee. The Committee would, upon examination, recommend the kind of treatment which would be made available to the patients. Upon the approval of the Committee, the expenses for the treatment involved shall be drawn from the Rare Diseases Fund after approval by the Director, AIIMS.

iv) The entire unspent budget allocated for Rare Diseases, for the years 2018-19, 2019-20 and 2020-21, as per the amounts extracted above, shall be immediately moved into a fund called the `Rare Diseases Fund', which shall be managed and utilized by AIIMS, which shall serve as a nodal agency for this fund. A separate bank account for the Rare Diseases Fund shall be opened by the Director, AIIMS for this purpose.

v) The digital platform that is created in the Policy, for the purposes of receiving crowdfunding and other kinds of funding, shall be linked to the Rare Diseases Fund. All individuals, organizations, companies etc., who wish to contribute to the said fund, shall make direct contributions. The Rare Diseases Fund shall be under the direct control and supervision of the Director, AIIMS. Periodic reports may be called for, by the Ministry of Health and Family Welfare, UOI, from AIIMS, in respect of the contributions that are received, as well as qua the utilization of the said fund.

vi) The other Institutes which shall be notified under the policy, as centres for excellence, for Rare Diseases shall also be entitled to receive applications from patients who need treatment, and shall forward the same to the Rare Diseases Committee based in AIIMS.

vii) In the case of direct applications being made to AIIMS, a decision shall be taken by the Rare Diseases Committee within a period of two weeks, in respect of the treatment and funding etc. In case, the application is routed through other institutes/centres of excellence which are notified in the Health Policy for Rare Diseases, a decision upon the treatment and funding shall be taken by the Committee within a period of four weeks. viii) In the context of Rare Diseases, the Government may consider increasing the budget for the year 2021-22 for the Rare Diseases Fund.

ix) The National Consortium for Research and Development on therapeutics for Rare Diseases shall be the nodal agency for supervising and monitoring the indigenization of treatments and therapies, manufacture of drugs, technology transfer, approvals, etc. for Rare Diseases. The said Consortium, as recommended in the report, shall consist of representatives from DBT, IC