HC asks Centre if financial aid for rare diseases covers clinical trials of experimental DMD drug

The Delhi High Court has asked the Centre to state if its financial aid for the treatment of rare diseases would cover the expenses of the second and third phases of clinical trials of an experimental drug for Duchenne Muscular Dystrophy (DMD) and the treatment of children enrolled in those trials.

The court noted that a Central government office memorandum of 19th May envisaged the extension of financial support up to Rs 50 lakhs for treatment of patients suffering from any of the rare diseases under the National Policy for Rare Diseases of 2021, including DMD, and the decision “could be considered” as covering the expenses in course of administration of the trial drug.

DMD, one of the various forms of muscular dystrophy, is a rare genetic disease that affects boys almost exclusively and causes progressive weakness.

The court, which was hearing a batch of petitions concerning the treatment of children suffering from rare diseases, recorded that requisite statutory permission has been granted for clinical trials of the experimental drug and the same would entail an outlay of at least Rs 20 lakhs in the manufacture of doses for each of the 54 children who have been enrolled.

“Chetan Sharma, learned ASG, is thus requested to obtain instructions with respect to the issues flagged above and more particularly with regard to the Office Memorandum of 19 May 2022 being applied to meet the expenses likely to be incurred in the second and third phase of clinical trials of the experimental drug and the treatment of children enrolled in those trials,” said Justice Yashwant Varma in the order dated 5th August.

“The court is of the considered view that the financial support which is envisaged in the Office Memorandum of 19 May 2022 and its terms which speak of financial aid ‘for treatment’ could be considered as covering the expenses likely to be incurred in the course of administration of the trial drug by the competent authority in the Union Government,” it added.

It stated the consideration of the authorities would be guided by factors such as the stark difference in the price of the trial drug and the other experimental remedies currently available as well as the possibility of the indigenously developed drug being adopted for the treatment of many more DMD-afflicted children.

The trials may perhaps lead to the rollout of a readily accessible drug for DMD in the country itself, it added.

The court said that several factors merited consideration of the competent authority on whether the expenses which are likely to be incurred in the course of administering the drug to the 54 enrolled patients would stand covered under its order.

Such a consideration, the court clarified, would be in addition to the authorities concerned duly attending to cases of children who are not enrolled in the clinical trials and are to undergo treatment in terms of alternatives currently available at the various Centres of Excellence.

The matter would be heard next on 9th September.

Edits by EP News Bureau