New Delhi: 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 May 19 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.
“Mr. 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 August 5.
“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 presently available at the various Centers of Excellence.
In December last year, the court had directed AIIMS to forthwith start the treatment of eligible children suffering from rare diseases and asked the Centre to provide funds, saying it is painful to see kids in this situation and they cannot be made to suffer.
It had said the direction to AIIMS and other Centres for Excellence (COE) to commence the medical treatment of these children will include procurement of medicines whose expense will be borne by the central government and funds will be given to COE.
Earlier, the court had passed a slew of directions in connection with the treatment of persons with rare diseases, including a direction to notify the National Health Policy for Rare Diseases by March 31, 2021, and setting up a National Consortium for Research, Development, and Therapeutics, a rare diseases committee at AIIMS and a fund for such ailments.
The matter would be heard next on September 9.