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Once National Policy on rare diseases is notified, individual cases can be dealt accordingly: HC told

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The Delhi High Court on Wednesday was informed by the Centre that once it notified the National Policy on Rare Diseases, the individual cases can be dealt with accordingly and the patients can be referred to the notified centers in the different institutes.

The submissions came while the Court was hearing the batch of petitions filed by the parents of children suffering from Duchenne Muscular Dystrophy (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.

A Single-Judge bench of Justice Prathiba M. Singh has asked Dr. Renu Swarup Secretary of Department of Biotechnology, Govt. of India with regards to the implementation of national policy of rare diseases.

The Delhi High Court had earlier constituted a committee with Dr. Renu Swarup as its Chairperson and directed the committee to file a detailed report on major aspects of the said subject.

The report, inter alia mentioned that once the government notifies the national policy on rare diseases under facilities therein, individual cases can be dealt with, accordingly. These patients can be referred to the notified centers in the different institutes. The Department of Biotechnology (DBT) said that there are nine notified centers of excellence which will deal with treatment of rare diseases.

The report also mentioned that “the Duchenne Muscular Dystrophy (DMD) trial approved by the Drugs Controller General of India is ready to roll off.”

Justice Singh inquired; “Who is the institute or organisation conducting the trial?”

Dr. Swarup replied “…There are three trials that we have indicated (in annexure 3 of the report) and the names of the institutes have also been mentioned there.”

Justice Singh questioned “Is this a private trial or any public funding is involved?”

Dr. Swarup answered “No public funding is involved except the last one where the funding is approved and sanctioned but no funds have been released so far.”

Justice Singh asked “Are there any patents or products for treating this kind of condition?”

Dr. Swarup said “there are companies both in India and globally working on patents for treatment of rare diseases and that landscaping regarding the same shall be done to assess the situation and an IP landscape report needs to be created.”

Justice Singh asked “What is the proposal for the National Consortium for Research and Development and what role will it play in the implementation of the policy?”

Dr. Swarup said “The implementation of policy will be done by the Ministry of Health and Family Welfare as the Department of Biotechnology doesn’t have the mandate to take on such a task.”

Justice Singh said that she would like to hear the matter further before making an order as the consent of the patient’s family would be necessary.

The matter was listed for 22 March for further hearing.

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 e-platform 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.

Read Also: Supreme Court stays Kerala HC order barring aided school teachers from contesting elections

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