Back
2024 Supreme(Del) 688
IN THE HIGH COURT OF DELHI AT NEW DELHI
Prathiba M. Singh, J.
Master Arnesh Shaw - Appellant
Versus
Union of India & Anr. - Respondents
W.P.(C) 5315 of 2020 & CM APPL. 19189 of 2020, 4237 of 2023
Decided On : 22-03-2024
Mr. Rahul Malhotra, Advocate, for the Petitioner.
Ms. Shyel Trehan, Mr. Rohan Poddar & Ms. Shivalika Rudrabatla, Advocates, for the Petitioner.
Mr. Asif Ahmed, Advocate, for the Petitioner.
Mr Saurabh Kirpal, Senior Adv and Mr Anish Chawla Advocate, for the Sarepta.
Mr. Kirtiman Singh CGSC, Mr. Waize Ali Noor, Ms. Vidhi Jain & Ms. Anvi Garg Advocate, Advocates, for the UOI.
Mr. Ripudaman Bhardwaj CGSC and Mr. Kushagra Kumar, Ms. Manaswini Kondepudi, Advocate, for the UOI.
Mr. Tanveer Oberoi& Mr. Jaswinder Singh, Advocates, for the (AIIMS).
Mr. Dharmender Verma and Mr. Vishal Singh, Advocates for BIRAC. Dr. Sheffali Gulati, (AIIMS).
Mr Dharmender Verma Advocate, Mr. Vishal Singh Advocate, Mr. Shantanu Garg, Advocate, for the BIRAC.
Mr. Sudarshan Rajan, Mr. Hitain Bajaj and Mr. Mahesh Kumar, Advocates, for the Respondent-3.
Ms. Shyel Trehan, Mr. Rohan Poddar, Ms. Shivalika Rudrabatla, Advocates, for the Respondent.
Mr. Dinesh Kumar and Mr. Prakash Raj Thakur, Advocates for the DGCI.
IMPORTANT POINT
The court prioritized the expedited release of medicines for rare diseases and facilitated discussions and meetings between relevant parties to ensure the availability of treatment for petitioners.
Headnote:
Rare Diseases - Treatment of Children - National Policy for Rare Diseases, 2021 - CTRI No. CTRI/2021/04/032498, NDCT RULES, 2019, Form CT-06, Form Ct-11, Clinical Trial Agreement - Gazette notification G.S.R. 235 (E) dated 29th March, 20232 - List 38 - Gaucher Disease Type I and III, Hunter syndrome (MPS II), Pompe Disease, Duchenne Muscular Dystrophy, Spinal Muscular Atrophy
Fact of the Case:
The court reviewed the status of treatment for children suffering from rare diseases, including the number of petitioners receiving treatment, clinical trials, and evaluations. The court also directed meetings between various parties to discuss clinical trials and the release of medicines for patients.
Finding of the Court:
The court found that negotiations were underway for the release of medicines and directed customs authorities to expedite the release of medicines for rare diseases. The court also directed meetings between the National Rare Diseases' Committee and pharmaceutical companies for further discussions.
Issues: Status of treatment for children with rare diseases, clinical trials, negotiations for the release of medicines, customs duty exemption for medicines for rare diseases
Ratio Decidendi: The court emphasized the importance of expediting the release of medicines for rare diseases and directed meetings between relevant parties to facilitate clinical trials and treatment for petitioners.
Final Decision: The court dismissed one petition and scheduled the matters for final hearing on 10th May, 2024.
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:
-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
5. Thus, the following table encapsulates the position in relation to treatment of children as on date:
| S.No. | Category | Number of Petitioners |
| 1 | DMD Petitioners who have received treatment of Rs.50 lakhs and for whom further medicines are to be provided by M/s Sarepta | 14 |
| 2 | DMD Petitioners who have been enrolled in clinical trials | 2 |
| 3 | DMD Petitioners found amenable to treatment | 19+16+15=50 |
| 4 | DMD Petitioners evaluated as non-amenable to treatment | 31 |
| 5 | Non-DMD Petitioners who have received treatment of Rs.50 lakhs and are continuing to receive treatment under orders of this Hon'ble Court | 4 |
| 6 | Non-DMD Petitioners who have received treatment of Rs.50 lakhs | 1 |
| 7 | Non-DMD Petitioners evaluated as nonamenable to treatment | 4 |
| 8 | Petitioners still under evaluation | 2 |
| 9 | Patients refused treatment/evaluation | 3 |
| Total | 111 |
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
