Master Arnesh Shaw vs Union Of India & Anr.

Prathiba M. Singh, J. (Oral)

This hearing has been done through hybrid mode.

At the outset, the ld. Amicus Ms. Shyel Trehan handed over an email communication and informed the Court that Dystrophy Annihilation Research Trust, Bangalore (hereinafter, ‘DART’) and M/s. Hanugen Therapeutics Private Limited (hereinafter, ‘Hanugen’) are about to commence the clinical trials for Duchenne Muscular Dystrophy (hereinafter, ‘DMD’) at AIIMS from next week. Preparations for the same are stated to have been finalised, and the final meeting was also held on 25^th July, 2024.

Dr. Arun Shastry from DART has also joined the Court proceedings virtually and has informed the Court that patients who are between 5 to 10 years of age, are ambulatory, and to whom EXON 45, EXON 51, and EXON 53 are to be prescribed, would be entitled to enrol in the DART trials. The details of the inclusion and exclusion criteria in the clinical DART are stated to have been finalised by AIIMS.

In view of this, since the list of all the writ Petitioners before the Court, and their present medical condition is already available with AIIMS, such Petitioners who would benefit from this trial and who satisfy the inclusion and exclusion criteria—up to about 15 patients as agreed between AIIMS and DART—may be enrolled in this trial. Let a complete status report be placed on record by the next date of hearing in respect of the clinical trials conducted by DART and AIIMS, and any other details thereof.

Vide order dated 22^nd July, 2024, this Court directed as follows:

It is submitted on behalf of ld. Amicus Mr. T. Singh Dev, ld. Counsel submits that the MRI reports are yet to be submitted to AIIMS, and is likely to be submitted tomorrow i.e., 2nd August, 2024.

Accordingly, let Dr. Kabra and her team at AIIMS proceed ahead with the decided plan in terms of the previous order as extracted above.

Ms. Vidhi Jain, ld. Counsel from the office of Mr. Kirtiman Singh, ld. CGSC, commenced her submissions and took the Court through an affidavit filed by the Ministry of Health dated 19^th July 2024, which shows that the total number of patients who have been given treatment in the last two years is 105 and 430, respectively, in 2022-2023 and 2023-2024.

The amounts that have been transferred to the various Centres of Excellence have also been filed by means of a chart, which shows that the amounts transferred are much less than the budgeted estimate approved by the Ministry of Health and Family Welfare towards the implementation of the National Rare Diseases’ Policy and towards the disbursal for the 50 lakhs amount under the said Policy.

Considering that there are large number of patients before the Court seeking treatment and the budgets are still available for their treatment, it is deemed appropriate to direct as under:-

Further, Ms. Jain, ld. Counsel, also submits that there are two trials currently approved by the DCGI in India for DMD therapies. The details of the two trials have been handed over to Mr. Chawla, who is appearing for M/s Sarepta Therapeutics. Mr. Chawla, ld. Counsel, under instructions, submits that the recruitments for the said trials are closed. However, it appears from the document handed over by the DCGI that the total number of subjects recruited by M/s Sarepta Therapeutics is less than the approved number of Indian subjects to be enrolled.

Let an affidavit in this regard be filed by M/s Sarepta Therapeutic by the next date of hearing. In the affidavit, M/s. Sarepta shall also state as to whether the pricing of its medicines for DMD varies in different countries and if so a chart shall be filed giving the retail price at which the products are available both before and after discounts in at least 10 advanced countries and 10 developing countries including India’s neighbouring countries. Let the said affidavit be filed by 10^th August 2024.

List on 21st August, 2024.

These are part-heard matters.