The Delhi High Court on Monday asked the Centre to provide details within two days on the allocation of funds and expenditure for rare diseases along with details of the proposed consortium for the management of rare diseases.
A single-judge bench comprising of Justice Prathiba M. Singh heard a batch of connected matters relating to the allocation of funds for people suffering from rare diseases.
On March 2, the Delhi High Court had constituted a nine-member Committee for the examination of feasibility of accelerated approvals and explore confidential proposal put up by M/s Sarepta Therapeutics for the purpose of making the therapy available for children suffering from rare disease Duchenne Muscular Dystrophy (DMD).
“It appears that clinical trials are already underway in India for drugs/therapies for the treatment of DMD,” the Court had noted in its order.
The court was hearing the batch of petitions filed by the parents of children suffering from DMD seeking direction to the Central Government to provide free treatment for the rare disease as the disease fall under the category of Rare Disease in the Draft Health Policy for Rare Diseases, 2020.
Over the issue of Crowdfunding the bench had observed,
“The clear stand of the Union of India appears to be that until the policy gets notified and the eplatform for crowdfunding is created, there can be no crowdfunding which can be explored.”
However, counsel appearing for the Ministry of Health submitted that he has written to four organisations to arrange for funding for treatment of the said patients.
The bench had appointed Dr. Renu Swarup, Secretary of Department of Biotechnology, Govt. of India as the Chairperson of the committee and other members from All India Institute of Medical Sciences, Sir Ganga Ram Hospital, Dystrophy Annihilation Research Trust, Institute of Child Health, CHILDS Trust Hospital and Ministry of Health and Family Welfare.
The bench had directed the committee to submit a report over the major aspects:
- How to immediately provide treatment and therapy options to the Petitioners and similarly situated patients suffering from DMD, Hunter’s syndromes and other rare diseases.
- Steps to be taken to indigenize the development of the therapies in India, and reasonable timelines required to be followed thereof
- Whether accelerated approval processes can be considered especially in view of the research currently being undertaken in India for DMD?
- Immediate concrete proposals for crowdfunding of the costs of treatment for children with rare diseases.
The bench had further directed the Central Government to file an affidavit specifying the budget for health in the last five years and whether any part of the budget has been unused and can be used for the purpose of treatment of the Petitioners or the indigenous development of therapies for the treatment of rare diseases.
The matter would now be heard on March 17.