Master Drashtant Jhala Through His Next Friend And Natural Father Sh. Jaydeep Singh Jhala vs. Union Of India & Anr.

$~2(SB) to 106(SB) * IN THE HIGH COURT OF DELHI AT NEW DELHI

W.P.(C) 5315/2020 & connected matters Page 1 of 39 Signature Not Verified Digitally Signed By:DHIRENDER KUMAR Signing Date:28.09.2024 18:00:11

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Through: Mr. Rahul Malhotra & Mr. Kaustubh Punj, Advocates. W.P.(C) 5315/2020 & connected matters Page 5 of 39 Signature Not Verified Digitally Signed By:DHIRENDER KUMAR Signing Date:28.09.2024 18:00:11

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W.P.(C) 5315/2020 & connected matters Page 8 of 39 Signature Not Verified Digitally Signed By:DHIRENDER KUMAR Signing Date:28.09.2024 18:00:11 + W.P.(C) 3859/2021 & CM APPL.11647/2021 SIDDHARTH SWARNKAR, 9 YEARS OLD, THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. DINESH KUMAR SWARNKAR ..... Petitioner

W.P.(C) 5315/2020 & connected matters Page 9 of 39 Signature Not Verified Digitally Signed By:DHIRENDER KUMAR Signing Date:28.09.2024 18:00:11 + W.P.(C) 4259/2021 & CM APPL. 12948/2021 ISHAAN, 10 YEARS OLD, THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. RAJVIR SINGH ..... Petitioner

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Through: Mr. Ashok Agarwal, Mr. Kumar Utkarsh & Mr. Manoj Kumar, Advs. versus UNION OF INDIA & ORS. ..... Respondents Through: Mr. Sanjeev Uniyal, Mr. Dhawal Uniyal & Mr. Rahul Kumar, Advs for R-1. (M:9560806614) Mr. Rishikesh Kumar ASC with Mr Aditya Raj, Mr. Muhammad Zaid, Mr. Sheenu Priya, Mr. Sudhir Kumar Shukla & Mr Sumit Choudhary, Advs. Mr. Kirtiman Singh, CGSC, Mr. Waize W.P.(C) 5315/2020 & connected matters Page 12 of 39 Signature Not Verified Digitally Signed By:DHIRENDER KUMAR Signing Date:28.09.2024 18:00:11

W.P.(C) 5315/2020 & connected matters Page 13 of 39 Signature Not Verified Digitally Signed By:DHIRENDER KUMAR Signing Date:28.09.2024 18:00:11

W.P.(C) 5315/2020 & connected matters Page 14 of 39 Signature Not Verified Digitally Signed By:DHIRENDER KUMAR Signing Date:28.09.2024 18:00:11 (43) WITH + W.P.(C) 4535/2023 & CM APPL.17331/2023 MASTER CHINMAY BARUPAL THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. ASHOK KUMAR BARUPAL ..... Petitioner

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W.P.(C) 5315/2020 & connected matters Page 16 of 39 Signature Not Verified Digitally Signed By:DHIRENDER KUMAR Signing Date:28.09.2024 18:00:11

W.P.(C) 5315/2020 & connected matters Page 17 of 39 Signature Not Verified Digitally Signed By:DHIRENDER KUMAR Signing Date:28.09.2024 18:00:11 + W.P.(C) 7549/2023 and CM APPL. 29273/2023 MASTER CHUNNU YADAV THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. SANJEEV KUMAR ..... Petitioner

W.P.(C) 5315/2020 & connected matters Page 18 of 39 Signature Not Verified Digitally Signed By:DHIRENDER KUMAR Signing Date:28.09.2024 18:00:11 ADITYA KUMAR YADAV THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. PREM SHANKAR ..... Petitioner Through: Mr. Ashok Agarwal, Mr. Kumar Utkarsh & Mr. Manoj Kumar, Advs. Mr. Rahul Malhotra, Advocate. versus UNION OF INDIA & ANR. ..... Respondents Through: Mr. Ripudaman Bhardwaj, CGSC with Mr. Kushagra Kumar, and Mr. Abhinav Bhardwaj, Advs. for UOI. (56) WITH + W.P.(C) 10063/2023 and CM APPL. 38727/2023 SUMIT KUMAR SINGH THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. AMARJIT SINGH ..... Petitioner

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Through: Mr. Ashok Agarwal, Mr. Kumar Utkarsh & Mr. Manoj Kumar, Advs. W.P.(C) 5315/2020 & connected matters Page 21 of 39 Signature Not Verified Digitally Signed By:DHIRENDER KUMAR Signing Date:28.09.2024 18:00:11

W.P.(C) 5315/2020 & connected matters Page 22 of 39 Signature Not Verified Digitally Signed By:DHIRENDER KUMAR Signing Date:28.09.2024 18:00:11

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Through: Mr. Ashok Agarwal, Mr. Kumar W.P.(C) 5315/2020 & connected matters Page 25 of 39 Signature Not Verified Digitally Signed By:DHIRENDER KUMAR Signing Date:28.09.2024 18:00:11

W.P.(C) 5315/2020 & connected matters Page 26 of 39 Signature Not Verified Digitally Signed By:DHIRENDER KUMAR Signing Date:28.09.2024 18:00:11

Through: Mr. Ashok Agarwal, Mr. Kumar Utkarsh & Mr. Manoj Kumar, Advs. versus UNION OF INDIA & ANR. ..... Respondents Through: Mr. Shashank Garg, CGSC with Mr. Vanshul Pali, Adv. (M: 9711552649) (88) WITH + W.P.(C) 13453/2023 & CM APPL. 53123/2023 TIRTH RAVI KHAIRNAR THROUGH HIS NEXT FRIEND AND W.P.(C) 5315/2020 & connected matters Page 27 of 39 Signature Not Verified Digitally Signed By:DHIRENDER KUMAR Signing Date:28.09.2024 18:00:11 NATURALFATHER SH. KHAINAR RAVI BHAI..... Petitioners

W.P.(C) 5315/2020 & connected matters Page 28 of 39 Signature Not Verified Digitally Signed By:DHIRENDER KUMAR Signing Date:28.09.2024 18:00:11 (92) WITH + W.P.(C) 14141/2023 & CM APPL. 55947/2023 TAKSH KAUSHIK THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH VED PRAKASH ..... Petitioner Through: Mr. Ashok Agarwal, Mr. Kumar Utkarsh & Mr. Manoj Kumar, Advs. versus UNION OF INDIA & ANR. ..... Respondents Through: Mr. Neeraj, SPC along with Mr. Vedansh Anand and Mr. Mahesh Kumar Rathore, Advs. UOI. (93) WITH + W.P.(C) 15263/2023 & CM APPL. 61134/2023 MOHAMMAD AYAAN SHEIKH THROUGH HIS NEXT FRIEND AND NATURAL MOTHER MRS. AYESHA SHEIKH..... Petitioner

W.P.(C) 5315/2020 & connected matters Page 29 of 39 Signature Not Verified Digitally Signed By:DHIRENDER KUMAR Signing Date:28.09.2024 18:00:11 Mr. Kushagra Kumar Adv. for UOI. (96) WITH + W.P.(C) 15315/2023 & CM APPL. 61386/2023 NIKUNJ GUPTA THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. ASHWANI GUPTA ..... Petitioner Through: Mr. Ashok Agarwal, Mr. Kumar Utkarsh & Mr. Manoj Kumar, Advs. versus UNION OF INDIA & ANR. ..... Respondents Through: Mr. Ripudaman Bhardwaj CGSC with Mr. Kushagra Kumar Adv. for UOI. (97) WITH + W.P.(C) 15334/2023 & CM APPL. 61502/2023 DEVANSH AGARWAL THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. CHANDRAPRAKASH AGARWAL ..... Petitioner Through: Mr. Ashok Agarwal, Mr. Kumar Utkarsh & Mr. Manoj Kumar, Advs. versus UNION OF INDIA & ANR. ..... Respondents Through: Mr. Ripudaman Bhardwaj & Mr. Anurag Ahluwalia, CGSCs with Mr. Kushagra Kumar Adv. for UOI. (98) WITH + W.P.(C) 15336/2023 & CM APPL. 61505/2023 RAHUL ..... Petitioner Through: Mr. Ashok Agarwal, Mr. Kumar Utkarsh & Mr. Manoj Kumar, Advs. versus UNION OF INDIA & ANR. ..... Respondents Through: Mr Anurag Ahluwalia, CGSC with Mr Tarveen Singh Nanda & Ms. Hridyanshi Sharma, Adv. for R-1 Mr. Ripudaman Bhardwaj CGSC, Mr. Kushagra Kumar, Adv. Ms. Purva Chugh & Ms. Pooja Arora, Advs. (99) WITH + W.P.(C) 15618/2023 & CM APPL. 62576/2023 KULDEEP SINGH NARUKA & ANR. ..... Petitioners Through: Mr. Ashok Agarwal, Mr. Kumar W.P.(C) 5315/2020 & connected matters Page 30 of 39 Signature Not Verified Digitally Signed By:DHIRENDER KUMAR Signing Date:28.09.2024 18:00:11

Through: Mr. Ashok Agarwal, Mr. Kumar Utkarsh & Mr. Manoj Kumar, Advs. versus UNION OF INDIA & ANR. ..... Respondents Through: Mr. Ripudaman Bhardwaj CGSC with Mr. Kushagra Kumar Adv. for UOI. Ms. Pratima N Lakra CGSC with Ms Kashish G Baweja, Advocate. (101) WITH + W.P.(C) 14150/2023 & CM APPL. 55962/2023 TANVEER SHARMA THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. DEEPAK SHARMA ..... Petitioners Through: Mr. Ashok Agarwal, Mr. Kumar Utkarsh & Mr. Manoj Kumar, Advs. versus UNION OF INDIA & ANR. ..... Respondents Through: Mr Vedansh Anand, Adv. for UOI. Mr. Ripudaman Bhardwaj CGSC with Mr. Kushagra Kumar Adv. for UOI. Mr. Neeraj, SPC along with Mr. Vedansh Anand (GP) and Mr. Soumyadip Chakraborty, Advs. UOI. (102) WITH + W.P.(C) 16267/2023 & CM APPL. 65509/2023 PRINCE PAREEK THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. PANKAJ PAREEK ..... Petitioners Through: Mr. Ashok Agarwal, Mr. Kumar Utkarsh & Mr. Manoj Kumar, Advs. versus UNION OF INDIA & ANR. ..... Respondents Through: Mr. Kirtiman Singh, CGSC, Mr. Waize W.P.(C) 5315/2020 & connected matters Page 31 of 39 Signature Not Verified Digitally Signed By:DHIRENDER KUMAR Signing Date:28.09.2024 18:00:11

W.P.(C) 5315/2020 & connected matters Page 32 of 39 Signature Not Verified Digitally Signed By:DHIRENDER KUMAR Signing Date:28.09.2024 18:00:11

Prathiba M. Singh, J. (ORAL) 1. 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. Oral submissions in these matters concluded on 31st August, 2024. th CM APPL.56264/2024 (for recall of order dated 13 September, 2024) th 3. This is an application seeking recall of the impugned order dated 13 September, 2024, by which the Union of India was directed to release a sum of Rs.10 crores to AIIMS, Delhi to continue the treatment of 18 patients suffering from DMD, Gaucher’s disease and MPS. These children have already been administered medicines under the National Policy for Rare Diseases (hereinafter, ‘NPRD, 2021’) . The relevant portion of the said order th dated 13 September, 2024, reads as follows: “ Directions qua doses for the 14 patients. 13. On 9th September, 2024, the ld. Amicus apprised the Court that the doses for 14 patients had not been procured, though AIIMS had communicated regarding the release of funds for the said purpose to the Ministry of Health and Family Welfare (‘MoHFW’). In respect of the same, this Court directed as follows on 9th September, 2024: “6. Ld. Amicus has pointed out that the next doses for the 14 patients have not been procured, though, AIIMS, has written to the Ministry of W.P.(C) 5315/2020 & connected matters Page 33 of 39 Signature Not Verified Digitally Signed By:DHIRENDER KUMAR Signing Date:28.09.2024 18:00:11 Health and Family Welfare (‘MoHFW’). 7. On behalf of AIIMS, ld. Counsel Mr. Tanveer Oberoi submitted that a letter dated 28th August, 2024 was received from MoHFW, stating that the funding would only be provided in terms of the National Rare Diseases’ Policy, and the amount required for an additional three months of treatment is substantial. Regarding four other patients, it is the stand of AIIMS that the MoHFW has not released further funds. 8. Let Mr. Swarnendu Singha (Under Secretary, MoHFW) explain this to the Court by way of an affidavit, and he shall remain present in Court on the next date of hearing.” 14. Today, Mr. Swarnendu Singha, Under Secretary, Ministry of Health and Family Welfare (hereinafter ‘MoHFW’), is present in Court. According to Mr. Singha, the budget allocated for payments in terms of the National Rare Diseases’ Policy has been exhausted. 15. In the opinion of this Court, since treatment of the 14 patients has already commenced, it is directed that the MoHFW shall grant approval to AIIMS to place orders on M/s. Sarepta for the supply of the necessary medicines and release the corresponding funds, based on the price last quoted by M/s. Sarepta to the National Rare Diseases’ Committee (‘NRDC’). The said approval th shall be granted by 19 September, 2024, failing which action for contempt would be liable to be taken. 16. Upon receiving the approval, AIIMS shall place the order on the designated distributor, whose details shall be communicated by Mr. Anish Chawla, ld. Counsel appearing for M/s. Sarepta to Mr. Tanveer Oberoi, ld. Counsel appearing for AIIMS. 17. The concerned distributor of M/s. Sarepta, who would be taking responsibility for supplying the medicines, shall remain present in Court on the next date of hearing. W.P.(C) 5315/2020 & connected matters Page 34 of 39 Signature Not Verified Digitally Signed By:DHIRENDER KUMAR Signing Date:28.09.2024 18:00:11 Directions qua doses patients suffering from Gaucher’s and MPS. 18. It is submitted that further doses for four patients i.e., two patients suffering from Gaucher’s disease and two patients suffering from MPS have not been provided. 19. This Court is of the opinion that the medicines for these four patients ought not to be discontinued. The same is being directed after considering the following facts: • that, as per affidavit dated 19th July, 2024, filed by the Union of India, the budget for expenditure under the National Rare Diseases’ Policy, 2021 since FY 2022- 2023, has, in fact, been reduced from previous years, and, • that these four patients have already been administered the medicines. 20. Let the MoHFW release a sum of Rs.10 crores to AIIMS by the next date of hearing, so that even the non-DMD patients may be provided the requisite treatment(s) till the final judgment of this Court in these batch matters. It is made clear that the said approval/release of funds shall be subject to the final outcome in these batch matters. 21. Let a comprehensive status report in respect of all the directions contained in the present order be filed by the next date of hearing, by the respective parties, in respect of whom the directions have been issued. ” 4. In this application, the stand of the Union of India is that the budgeted amount for AIIMS has already been exhausted, and there are other Centres of Excellence (hereinafter, ‘CoEs’) , who have requested for release of funds. 5. In the context of rare diseases, this Court has recognised, from time to time, that AIIMS, Delhi is one of the nodal Centres of Excellence, actively W.P.(C) 5315/2020 & connected matters Page 35 of 39 Signature Not Verified Digitally Signed By:DHIRENDER KUMAR Signing Date:28.09.2024 18:00:11 administering treatment for patients suffering from rare diseases. Eighteen patients have already commenced treatment, and discontinuation of treatment would have a negative repercussion on their health. Moreover, the negotiated price with M/s. Sarepta, has been significantly reduced, as per the last quotation given to the National Rare Diseases’ Committee (hereinafter, ‘NRDC’) . 6. Under such circumstances, withholding the treatment of these 18 patients would be completely unjust and contrary to law, as the same would have a debilitating effect on their general living condition and health. Since the treatment of these children has already begun, the amount as directed shall be released within next three working days, failing which Ms. Latha Ganapathy, Joint Secretary, Ministry of Health and Family Welfare, shall remain present in Court on the next date of hearing. 7. It is alleged by Mr. Kirtiman Singh, ld. CGSC that out of the allocated amount of Rs.34 crores, AIIMS has spent only Rs.9 crores as yet. Dr. Madhulika Kabra, appearing virtually, has clarified that the total spent amount on the procurement of medicines for patients suffering from rare diseases would be reflected only after the medicines have been procured. There are a number of patients for whom orders have already been placed and the amount has to be utilized for the said patients. Accordingly, she submits that the continuation of the treatment would not be possible without further allocation of money. In support of this submission, the affidavit st dated 21 July, 2024 is referred to and relied upon. In the said affidavit, AIIMS stated that approximately 227 children were allocated funds NPRD, 2021, and it further provided a detailed chart indicating the type of disorder, nature of treatment, funds allocated, expenditure incurred, and other W.P.(C) 5315/2020 & connected matters Page 36 of 39 Signature Not Verified Digitally Signed By:DHIRENDER KUMAR Signing Date:28.09.2024 18:00:11 relevant/important information pertaining to such cases. 8. Be that as it may, considering that the amount is being directed to be paid to AIIMS, Delhi, which is fully accountable for all the money spent, let th the amounts in terms of order dated 13 September, 2024 be released by the UOI. 9. CM APPL.56264/2024 is dismissed in the above terms. Directions qua Sarepta 10. In terms of the order dated 13th September, 2024, Mr. Anish Chawla, ld. Counsel appearing for M/s. Sarepta Therapeutics handed over to the Court an affidavit dated 19th September, 2024, and the same has been placed on record. Ms. Priyanka has appeared virtually today. 11. It is seen from the affidavit filed by M/s. Sarepta that the process for procurement currently proposed is as under: “4. It is humbly submitted that currently the medicines are not being produced in India by Sarepta. Sarepta has appointed a global distributor, Impatients (“myTomorrows”), to supply drugs on a named patient/early access basis, and myTomorrows has engaged a service provider in India to assist with the supply of Sarepta’s products to named patients. 5. It is humbly submitted that, as of the date of this document, the prices offered in India for the medicinal products eteplirsen, golodirsen, and casimersen are the lowest globally provided to any national healthcare system. 6. It is humbly submitted that for the purchase and supply process to be smooth, the following particulars of the patient should be provided at the time of placing the purchase order by the concerned Ordering Health Institute / Centre for Excellence and/or Rare Disease Committee: a. Name of patient W.P.(C) 5315/2020 & connected matters Page 37 of 39 Signature Not Verified Digitally Signed By:DHIRENDER KUMAR Signing Date:28.09.2024 18:00:11 b. Name of the medicinal product c. Weight d. Height e. Quantity / vials f. Gender g. Year of birth h. Relevant medical information and condition A Confidential Disclosure Agreement (CDA) will be executed by myTomorrows and the Ordering Health Institute / Centre for Excellence and/or Rare Disease Committee before sharing the aforementioned patient details . 7. The concerned Ordering Health Institute / Centre for Excellence and/or Rare Disease Committee shall also provide the following documents along with the email for purchase of the medicines: a) Signed Confidential Disclosure Agreement (CDA) b) Custom duty and IGST exemption certificate, preferably simultaneously, in order to expedite the supply c) Application Form 12A and the corresponding Permit Form 12B d) Institute/hospital name, address, and contact details e) Treating physician name f) Pharmacist name g) Signed and/or stamped Physician statement/Doctor’s declaration on unmet medical need h) Physician license i) Pharmacy license 8. Upon receipt of the purchase order and the patient particulars with the above information (mentioned in Points 6 and 7), the patient will be enrolled within 48 hours, and the order will be forwarded to myTomorrows for processing. 9. Within 24 hours of receipt of the purchase order and the above-mentioned documents, the Finance Team of myTomorrows will share the Invoice containing the instructions for Pre-Payment with the Ordering Health Institute. Once the pre-payment is received by myTomorrows, the order will be processed within 24 W.P.(C) 5315/2020 & connected matters Page 38 of 39 Signature Not Verified Digitally Signed By:DHIRENDER KUMAR Signing Date:28.09.2024 18:00:11 hours. 10. Once customs clearance is obtained, shipping to the Ordering Institute will take approximately 5 business days. 11. The tentative overall timeline for the delivery of the medicinal products will be about 11 days from the date of receipt of the purchase order and documents via the designated email.” 12. The above process is extremely cumbersome and long-drawn as an agreement is contemplated for each patient. Customs waivers have to be obtained for each patient. The proposed process is completely unrealistic in terms of efficiency of procurement and administration. 13. Thus, M/s. Sarepta shall place on record the general process for procurement of medicines on a bulk basis and not on a patient-to-patient basis so that upon orders being placed the same can be supplied without delay, in India itself. Let the same be done by the next date of hearing. 14. In addition, M/s. Sarepta Therapeutics is also directed to place on record a chart containing the details of all its granted patents and patent applications filed in India, along with the updated Form 3 as required by Section 8 of the Patents Act, 1970, in respect of the medicines currently being used for DMD patients, by the next date of hearing. 15. Let Ms. Priyanka be present in Court on the next date of hearing as well. rd 16. List on 3 October, 2024. 17. These are part-heard matters. PRATHIBA M. SINGH JUDGE dk/dn SEPTEMBER 27, 2024/ W.P.(C) 5315/2020 & connected matters Page 39 of 39 Signature Not Verified Digitally Signed By:DHIRENDER KUMAR Signing Date:28.09.2024 18:00:11