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2023 DIGILAW 3908 (DEL)

Master Arnesh Shaw v. Union of India

2023-07-10

PRATHIBA M.SINGH

body2023
JUDGMENT Prathiba M. Singh J. (Oral) 1. This hearing has been done through hybrid mode. 2. Dr. Arun Shastry on behalf of Hanugen Therapeutics/DART, submits that the arrangement with Indian Council of Medical Research (ICMR) did not materialize. In view of the same, he submits that they have decided to proceed on their own by obtaining third party investment in accordance with the contract with Biotechnology Industry Research Assistance Council (BIRAC). 3. Accordingly, Hanugen Therapeutics/DART are allowed to proceed for clinical trials. They shall update the Court periodically on the progress of the trials. National Rare Diseases' Committee (hereinafter "Committee"). 4. The minutes of meeting dated 13th June, 2023 of the Committee have been handed over to the Court. One of the issues that appears to have been raised in the said meeting is in respect of Drugs Controller General of India (DCGI) clearance for market authorisation by M/s Sarepta Therapeutics. 5. Clearly, M/s Sarepta Therapeutics does not have any marketing approvals at this point, however, it needs to be borne in mind that AIIMS and other centres of excellence have already been importing the medication from M/s Sarepta Therpeutics through its distributors and have been administering doses to the patients across the country. Thus, the Committee may proceed further in the matter for negotiating with M/s Sarepta. Urgent consideration be given to the amount of medications needed for patients who have already been administered the doses and who need further doses. 6. It is submitted that the next date of the Committee meeting is on 17th July, 2023. The Committee shall endeavour to expedite process of medicines procurement at national level so as to ensure that there are no further delays for administering the same to the patients. Let the minutes of the meeting dated 17th July, 2023 also be placed on record. 7. Mr. Swamendu Singha, Ministry of Health and Family Welfare, who is present in Court on almost all dates of the present proceedings shall be present in the meeting of the Committee in order to update the Committee of the various directions being issued by the Court in these proceedings. W.P.(C) 2943/2020 8. Insofar as the Petitioner - Alishba Khan who is suffering from Gaucher disease is concerned ld. Counsel for the Petitioner submits that she was last given treatment in January 2023. 9. The Court in the last order has directed as under: "12. Ld. W.P.(C) 2943/2020 8. Insofar as the Petitioner - Alishba Khan who is suffering from Gaucher disease is concerned ld. Counsel for the Petitioner submits that she was last given treatment in January 2023. 9. The Court in the last order has directed as under: "12. Ld. Counsel for the Petitioner in W.P.(C) 2943/2020, i.e., Ms. Alishba Khan submits that she suffers from Gaucher disease, and treatment to the extent of Rs.50 lacs has already been provided to her. 13. The Committee shall also consider her case for continuation of further treatment and for the said purpose may also contact, Sanofi India if it deems necessary. " 10. The Committee shall consider her case for continuation of further treatment and contact M/s Sanofi India Ltd. for the said purpose. 11. Since, the sum of rupees ten crores released by the Union of India is stated to have been received by AIIMS, let AIIMS procure the next level of treatment for Ms. Alishba Khan. W.P.(C) 11610/2017 12. Let this petition be listed for hearing on 17th July, 2023. 13. Let a copy of the paper book be served of the W.P.(C) 11610/2017 to ld. Amicus Curia and ld. CGSC. W.P.(C)s 7756/2023, 8200/2023, 8947/2023, 8948/2023, 8973/2023, 8978/2023, 8986/2023 & 8996/2023 14. These are the petitions filed by children who are suffering from DMD/ SMA seeking directions to the Respondents to provide continuous and uninterrupted treatment to the Petitioners. 15. Issue notice. 16. Let the said Petitioners be examined under the supervision of Dr. Kabra and a report be placed on record as to the feasibility of providing them treatment. 17. List all matters except W.P.(C) 11610/2017 for hearing on 3rd August, 2023 at 3:30 p.m.