JUDGMENT

Prathiba M. Singh, J. (Oral) - This hearing has been done through hybrid mode.

2. The present batch of petitions have been filed by the Petitioners who are children suffering from rare diseases. 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.

Status of the writ petitioners

3. On 19th January, 2024, AIIMS was directed to submit a chart regarding the status of treatment of each of the Petitioners before this Court. Further, on the said date, notice was issued in the petitions bearing no. W.P.(C) 436/2024 & W.P.(C) 479/2024, and AIIMS was directed to examine the case of these patients, and to place a status report in that regard.

4. Today, vide status report dated 23rd February, 2024, the status of all the petitioners is provided as follows:

• 14 petitioners have already received treatment upto 50 lakhs under the National Policy for Rare Diseases, 2021 (hereinafter, `NPRD'), and for whom orders have been placed with M/s. Sarepta Therapeutics for further medicines.
• 2 Petitioners were selected and included in the clinical trials which are currently underway.
• The said status report also mentions names of the DMD Petitioners who were found amenable to the treatment, and whose treatment is yet to commence. The details are as follows:

-19 Petitioners were found amenable to the Exon-51 Skipping Therapy

-16 Petitioners were found amenable to the Exon-53 Skipping Therapy

-15 Petitioners were found amenable to the Exon-45 Skipping Therapy

• 31 Petitioners were found to non-amenable to treatment.
• 6 non-DMD Petitioners, are non-amenable to treatment or have refused evaluation.
• 2 Petitioners are still under evaluation at AIIMS, New Delhi.
• 1 Petitioner has decided to not avail the treatment of Rs.50 lakhs under the NPRD.
• 4 Petitioners are afflicted with disorders other than DMD. These 4 Petitioners have already received treatment of Rs.50 lakhs under the NPRD, and are continuing to receive treatment under the orders of this Court.
• 1 Petitioner is afflicted with disorder other than DMD. This Petitioner has already received treatment of Rs.50 lakhs under the NPRD.

5. Thus, the following table encapsulates the position in relation to treatment of children as on date:

S.No.CategoryNumber of Petitioners1DMD Petitioners who have received treatment of Rs.50 lakhs and for whom further medicines are to be provided by M/s Sarepta142DMD Petitioners who have been enrolled in clinical trials23DMD Petitioners found amenable to treatment19+16+15=504DMD Petitioners evaluated as non-amenable to treatment315Non-DMD Petitioners who have received treatment of Rs.50 lakhs and are continuing to receive treatment under orders of this Hon'ble Court46Non-DMD Petitioners who have received treatment of Rs.50 lakhs7Non-DMD Petitioners evaluated as nonamenable to treatment48Petitioners still under evaluation29Patients refused treatment/evaluation3Total111

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Meeting between DART and AIIMS

6. Thereafter, on 26th February, 2024, this Court directed as follows:

"7. Today, at the outset, two important issues have been raised:

i) Ms. Trehen, ld. Amicus, informs the Court that she has learned that M/s Hanugen Therapeutics has approached AIIMS for clinical trials in respect of three Exon Skipping Therapies, namely, Exon 51, Exon 53, and Exon 45. These are the three therapies which are made available even through M/s. Sarepta Therapeutics. Dr. Madhulika Kabra and Dr. Sheffali from AIIMS have confirmed that M/s. Hanugen Therapeutics has reached out to them last week, and the exact nature of the trial and the number of persons who can be enrolled has not yet been made clear. Mr. Oberoi, ld. Counsel for AIIMS also confirms this position, and stated that DART has reached out to take the trials forward. Thus, let AIIMS file an affidavit within one week, after meeting with M/s Hanugen Therapeutics Pvt. Ltd. as to the nature of the clinical trial. The details of the clini

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