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. 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. 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 clinical trial, if any, being conducted either in AIIMS or in any other institute in the country, number of patients likely to be enrolled etc., shall also be mentioned in the said affidavit after ascertaining the same from M/s Hanugen Therapeutics Pvt. Ltd . The details of the clinical trial, if any, being conducted either in AIIMS or in any other institute in the country, number of patients likely to be enrolled etc., shall also be mentioned in the said affidavit after ascertaining the same from M/s Hanugen Therapeutics Pvt. Ltd . ii) Mr. Kirpal, ld. Senior Counsel appearing for M/s. Sarepta Therapeutics submits that though an offer was made by M/s. Sarepta Therapeutics to the NRDC, there has been no negotiation in respect of the same, as there was no counter offer from the Union of India. Further, M/s. Sarepta Therapeutics is willing to still explore the possibility of supplying the therapies for DMD patients as well. 8. In terms of the reports received from the NRDC and the submissions made by ld. Counsels, one of the most important outstanding issues in these petitions relates to the treatment of DMD. Considering the large number of DMD patients and the physical and mental health of the families involved in these cases, it is deemed appropriate to direct that the NRDC shall, within the next two weeks, meet with M/s. Sarepta Therapeutics. Mr. Kirtiman Singh, ld. CGSC shall arrange for the said meeting to take place between the NRDC and the representatives from M/s. Sarepta Therapeutics. Any information gained from M/s. Sarepta Therapeutics during these meetings shall be kept confidential and shall be submitted only to the Court. The NRDC, after its meetings with M/s. Sarepta Therapeutics, shall submit a report detailing the discussions and any further relevant details as also their recommendations. This report should be submitted to the Court by the next date of hearing." 7. Pursuant to the order dated 26th February, 2024, AIIMS has filed a status report dated 13th March, 2024, where the details of the different clinical trials are provided. The relevant portion of the said affidavit reads as follows: "(i) Scientific Title of Study: A Double Blind, Placebo-Controlled, Multicentre Study with an Open-Label Extension to Evaluate the Efficacy and Safety of 2'0 Methyl Antisense Oligonucleotide in Patients with Duchenne Muscular Dystrophy A copy of registration of the Clinical Trial as registered with the Clinical Trial Registry-India bearing CTRI No. CTRI/2021/04/032498, Registered on 01.04.2021, is annexed herewith and marked as ANNEXURE R-1. (ii) SPONSOR/SOURCE OF MONETARY OR MATERIAL SUPPORT: Dystrophy Annihilation Research Trust (DART) - Vibrance Clinical Research, 295, 14th Cross, Dollars Colony, RMV II Sanjay Nagar, Bangalore, Karnataka, 560094, India. (iii) PERMISSION TO CONDUCT CLINICAL TRIAL UNDER NEW DRUGS AND CLINICAL TRIAL RULES, 2019 ("NDCT RULES, 2019"): Form CT-06, No. CT/ND/79/2020 dated 25.08.2020 is annexed herewith and marked as ANNEXURE R-2. (iv) LICENSE TO MANUFACTURE THE DRUG FOR PROTOCOL No ICH/MD/WB VERSION 3 (DATED 27.02.2020) AND DART CT DMD-01 VERSION 03 (DATED 15.06.2020): Form Ct-11 no. ND/CT-11/53/2020 dated 25.08.2020 is annexed herewith and marked as ANNEXURE R-3. (v) CLINICAL TRIAL AGREEMENT WITH PROTOCOL No AND DART CT DMD-01 VERSION 03 (DATED 15.06.2020): Clinical Trial Agreement entered into between DART, Bangalore and AIIMS, New Delhi in October, 2021 is annexed herewith and marked as ANNEXURE R-4. (vi) ETHICS COMMITTEE APPROVAL (IEC) DATED 16.11.2021: Changes approved from ethical angle. Internal Ethics Committee approval letter dated 16.11.2021 is annexed herewith and marked as ANNEXURE R-5. (vii) CDSCO/DCGI GRANT OF EXTENSION OF VALIDITY FOR CONDUCTING OF CLINICAL TRIAL AND FOR MANUFACTURE OF NEW DRUG/INVESTIGATIONAL DRUG: Vide two separate letters dated 30.08.2023, extension was granted to DART and M/s Hanugen Therapeutics Pvt. Ltd., respectively, for conducting the clinical trials and for manufacture of new/investigational drug for a period of one year with effect from 25.08.2023. Copies of the letters dated 30.08.2023 are annexed herewith and marked as ANNEXURE R-6 (Colly.)." 8. The status report further states that a meeting was conducted between AIIMS, New Delhi, and DART/Vibrance Clinical Research on 19th February 2024. The said meeting focused on initiating a DMD study/clinical trials at AIIMS, New Delhi. According to the status report, the discussion revealed that the study had been delayed for over two years due to funding issues. DART declared that it would now finance the study with its own funds and is prepared to begin the clinical trial at AIIMS. Additionally, plans are in place to expand to additional trial sites after the initiation at AIIMS, Delhi. It was confirmed that all necessary approvals from DCGI for conducting the study and manufacturing the investigational drug have been received. Furthermore, a Clinical Trial Agreement signed in 2021 with AIIMS may need to be updated. 9. During the meeting, AIIMS also raised concerns about the need for a coordinator and physiotherapist for the intensive study. It was confirmed that all necessary approvals from DCGI for conducting the study and manufacturing the investigational drug have been received. Furthermore, a Clinical Trial Agreement signed in 2021 with AIIMS may need to be updated. 9. During the meeting, AIIMS also raised concerns about the need for a coordinator and physiotherapist for the intensive study. DART agreed to provide these through a third party and requested AIIMS' assistance in identifying a suitable physiotherapist. DART has committed to funding these positions. Finally, it was agreed that DART would submit the necessary documentation to AIIMS for further review and to address any additional administrative needs. As per the status report, as captured in a letter dated 7th March, 2024, the said study plans to include a total of 54 randomized DMD patients across these sites in India, with each site aiming to recruit 12-15 patients. 10. Today, ld. counsel for the Petitioner wishes to withdraw the W.P.(C) 13177/2023 . Accordingly, W.P.(C) 13177/2023 is dismissed as withdrawn. 11. It has been stated that negotiations are currently underway between the M/s. Sarepta Therapeutics and National Rare Diseases' Committee (hereinafter, `NRDC') as per the submission made by ld. Counsel appearing for the Union of India. 12. Insofar as the medicines for the 14 patients are concerned, the customs duty exemption certificate is stated to have been submitted and the medicines are likely to be released shortly. The Customs authorities are directed to release the medicines expeditiously in terms of the order dated 26th February 2024, so that the patients do not wait for the medicines. The directions given in the said order are set out below: "12. Further, the Ministry of Finance, Department of Revenue vide gazette notification bearing no. G.S.R. 235 (E) dated 29th March, 20232, issued under the Customs Act, 1962 notified as follows: (6) after S. No. 607A and the entries relating thereto, the following S.No. and entries shall be inserted, namely:- (1) (2) (3) (4) (5) (6) "607B. 9804 Drugs, Medicines or Food for Special Medical Purposes (FSMP) used for treatment of rare diseases specified in List 38. Nil - 115"; 13. In terms of the said gazette notification, List 38 includes inter alia the following Rare Diseases: Gaucher Disease Type I and III Hunter syndrome (MPS II) Pompe Disease Duchenne Muscular Dystrophy Spinal Muscular Atrophy 14. 9804 Drugs, Medicines or Food for Special Medical Purposes (FSMP) used for treatment of rare diseases specified in List 38. Nil - 115"; 13. In terms of the said gazette notification, List 38 includes inter alia the following Rare Diseases: Gaucher Disease Type I and III Hunter syndrome (MPS II) Pompe Disease Duchenne Muscular Dystrophy Spinal Muscular Atrophy 14. Thus, in addition to the above Press Release issued by the Ministry of Finance, and the gazette notification, it is hereby clarified that custom duties and charges shall not be levied on medicines, drugs and therapies for rare diseases. 15. Whenever medicines are brought in respect of rare diseases, the custom authorities shall ensure that the same are cleared expeditiously and no unnecessary impediments are caused in ensuring that the same reach the concerned hospital. Let the present order be communicated to Central Board of Indirect Taxes and Customs (`CBIC') for compliance by the Registry, as also through ld. CGSC Mr. Kirtiman Singh." 13. In the meantime, let the next meeting be scheduled between the NRDC and M/s. Sarepta Therapeutics as per the convenience of the committee members and let the same be communicated to the representatives of M/s. Sarepta Therapeutics. 14. A copy of this order be communicated to the Central Board of Indirect Taxes and Customs (`CBIC') by the ld. CGSC. 15. Since there is no time left, list these matters for final hearing on 10th May, 2024. 16. These are part-heard matters.