Master Arnesh Shaw vs Union Of India & Anr.

Prathiba M. Singh J. (Oral)

This hearing has been done through hybrid mode.

The present batch of petitions has been filed by the Petitioners who are children suffering from rare diseases. The case of the Petitioners is that medicines and therapies for the said diseases are exorbitantly expensive and if the same are not made available, the health and physical well-being of these children would be severely jeopardised. These matters have been heard by the Court from time to time and various directions have been issued for enabling treatment and making medicines available to the Petitioners.

Vide order dated 2^nd November, 2023, this Court recorded the stand of the Union of India, wherein the Court was informed of a positive development regarding the treatment of children with Duchenne muscular dystrophy (hereinafter, ‘DMD’). It was stated that M/s Sarepta Therapeutics had agreed to provide free therapy for 14 children who had already begun treatment, covering a three-month period. It was also understood that M/s Sarepta Therapeutics had committed to continue treating these patients for the next three months, and supply the medication free of cost. Accordingly, Dr. Madhulika Kabra, AIIMS was asked to expedite the procurement of medicines for these 14 patients to resume their treatment and place the order for therapies within one week. Additionally, the National Rare Diseases’ Committee (hereinafter, ‘NRDC’) was instructed to present its final proposal before the next hearing based on their ongoing discussions with companies. The relevant extract of the said order is set out below:

As per status report dated 6^th December 2023 filed by AIIMS, vide email dated 5^th December 2023, M/s Sarepta Therapeutics communicated to Dr. Madhulika Kabra, AIIMS that M/s Sarepta Therapeutics would be willing to provide 3 months’ free treatment to the 14 DMD patients, if a path forward could be agreed upon for all the patients that were identified.

Today, Mr. Charles Gerrits from M/s Sarepta Therapeutics appeared online through the video-conferencing link. It is clarified that if M/s Sarepta Therapeutics wishes to be heard in these matters, it shall have to engage a counsel and be represented before this Court.

On behalf of the National Rare Diseases Committee (NRDC), a note containing quotations from various manufacturers has been submitted to the Court in a sealed cover. The said note specifies the best prices offered to the Union of India. The medical conditions for which these quotations have been provided are as under:

Insofar as DMD is concerned, M/s Sarepta Therapeutics appears to have provided a quotation to the NRDC under the condition that the same would not be shared, even with the Court. Thus, insofar as DMD is concerned, no figures are available before the Court for consideration today.

The note also sets out the impact that the treatments would have on these medical conditions. Further, it is stated that the final report of the NRDC has been prepared, and the same is awaiting the approval of competent authorities.

Mr. Swarnendu Singha, Under Secretary- Rare Disease Cell, Ministry of Health and Family Welfare (MoHFW) submits that further time is needed to place the said report before the Court.

Let the final report of the NRDC be placed before the Court by the next date of hearing. The MoHFW and all authorities concerned are directed to ensure expedited processing of the approval of the final report of the NRDC. Mr. Swarnendu Singha to send a copy of this order to the concerned branch/person/authority, to ensure compliance.

Vide order dated 2^nd November, 2023, this Court directed as follows:

In terms of the above directions, insofar the patients suffering from rare diseases are concerned, except DMD, those patients for whom treatment have already been commenced, the treatment shall be continued by AIIMS.

For the said purpose, required funds shall be released by the MoHFW to AIIMS, to ensure that there is no stoppage of treatment. Let a copy of this order also be communicated by AIIMS as also the Registry of this Court to the Mr. Sudhansh Pant, Secretary, MoHFW at the Email: [email protected].

In the event that funds are not released by the MoHFW, for whatever reasons, for the treatment of all those patients whose treatment has already been commenced, Mr. Sudhansh Pant, Secretary, MoHFW shall remain present in Court on the next date of hearing.

Vide order dated 6^th March, 2023, this Court noted that the DART trial had already been approved by the Drugs Controller General of India (hereinafter, ‘DCGI’), and therefore, directed the NRDC to hold a meeting on clinical trials for developing indigenous therapies for rare diseases including DMD and Gaucher with DART/ Hanugen Therapeutics Pvt. Ltd.

Today, given M/s Sarepta Therapeutics’ stance, insofar as status of Clinical trials for DMD, ld. Amicus is advised to contact Hanugen Therapeutics Pvt. Ltd. and DART to inquire about the progress of trials of the indigenous therapies for DMD.

Hanugen Therapeutics Pvt. Ltd and/or DART are free to appear before the Court on the next date for the provide the status of the said trials.

Insofar as the DGCI is concerned, there is no representation despite specific orders of the Court on 2nd November, 2023. Repeatedly, the DCGI has been asked to place on record the details of all the trials taking place in India for DMD, in respect of approvals for trials sought by different manufacturers. However, till date, no such affidavit is forthcoming by the DCGI.

Upon specific directions issued by the Court, during the hearing, Dr. Rajeev Raghuvanshi, DCGI joined online and submitted that the data in respect of all the pending trials for the rare diseases is available with the DCGI, and that the same would be placed on record within a week.

The Court notes the communication from M/s Sarepta Therapeutics dated 10^th May, 2023, addressed to one of the Petitioners, stating that at least two clinical trials for the treatment of DMD are being conducted in India without a placebo control group.

Let the DCGI include details of all the Clinical trials for the treatment of DMD by Sarepta Therapeutics or any other entity in its report. Further, specific information shall be given in the said report, specifying if the said trials are ‘open to recruitment’ and, if so, the number of participants from India that can be enrolled in the said Clinical trial. The DCGI shall submit as to the manner in which the recruitment for the trials can be maximised.

Let the DCGI place on record a status report concerning all Clinical Trials concerning DMD as a last opportunity within two weeks.

Insofar as the Rare Diseases Fund (hereinafter, ‘RDF’) is concerned, this Court has repeatedly observed that more than Rs.200 crores of unspent amount from the budget for rare diseases continues to remain with the MoHFW and the same has not been released. The said issues shall be dealt with in the final report of the NRDC.

Master Ayushman Chaturvedi is a DMD patient. His condition is stated to have improved while he received treatment, and he was able to walk. However, recently due to non-availability of treatment for DMD, his condition deteriorated and he is now bed ridden.

It is directed that a team from AIIMS who is present in the Court headed by Dr. Kabra shall examine the said patient and take whatever steps can be taken to improve his condition.

List on 5th January, 2024.

These are fresh petitions filed by children who are suffering from rare diseases seeking directions to the Respondents to provide continuous and uninterrupted treatment to the them.

Issue notice. Let AIIMS examine the case of these patients and place its report by the next date of hearing.

List on 5^th January, 2024.