Arnesh Shaw v. Union of India & Anr.

Delhi High Court · 01 Aug 2024 · 2024:DHC:5694
Prathiba M. Singh
W.P.(C) 5315/2020
2024:DHC:5694
constitutional appeal_allowed Significant

AI Summary

The Delhi High Court directed enrollment of eligible DMD patients in clinical trials, release of medicines, and transparency in trial recruitment and pricing under the National Rare Diseases Policy.

Full Text
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W.P.(C) 5315/2020 & connected matters
HIGH COURT OF DELHI
Date of Decision: 1st August, 2024 (2)
W.P.(C) 5315/2020 & CM APPL. 19189/2020, 4237/2023
MASTER ARNESH SHAW ..... Petitioner
Through: Mr. Rahul Malhotra, Advocate.
Ms. Shyel Trehan, Mr. Rohan Poddar & Ms. Shivalika Rudrabatla, Advs.
Mr. Asif Ahmed, Advocate. (M:
9560995495)
VERSUS
UNION OF INDIA & ANR. ..... Respondents
Through: Mr Saurabh Kirpal, Sr. Adv and Mr Anish Chawla Adv. for Sarepta.
Mr. Kirtiman Singh CGSC, Mr. Waize Ali Noor, Ms. Vidhi Jain &
Ms. Anvi Garg Adv., Advs for UOI.
Mr. Ripudaman Bhardwaj CGSC and Mr. Kushagra Kumar, Ms. Manaswini Kondepudi, Adv. for UOI.
Mr. Tanveer Oberoi& Mr. Jaswinder Singh, Advs. for (AIIMS).
Mr. Dharmender Verma and Mr. Vishal Singh, Advs. for BIRAC. Dr. Sheffali Gulati, (AIIMS).
Mr Dharmender Verma Adv., Mr. Vishal Singh Adv., Mr. Shantanu Garg Advocate for BIRAC (M:
9625777607).
Mr. Sudarshan Rajan, Mr. Hitain Bajaj and Mr. Mahesh Kumar, Advocates for R-3.
Ms. Shyel Trehan, Mr. Rohan Poddar, Ms. Shivalika Rudrabatla
Dr. Arun Shastry Mr. Dinesh Kumar and Mr. Prakash Raj Thakur, Advs. for DGCI. (M:
17:19
JUDGMENT

9990755693) (IN ALL THE MATTERS) Mr G. Narendra Kumar, Mr. C. Manivillavan Mr Arun Pradhan, adv Dinesh Kumar (IN ALL THE MATTERS) (1) WITH + CONT.CAS(C) 415/2022 & CM APPL. 18280/2022 MASTER MEDHANSH JHAWAR @ MADHAV THROUGH HIS NATURAL GUARDIAN..... Petitioner (M: 6370344354)

VERSUS

RAJESH BHUSHAN & ORS...... Respondent Through: Mr. Kirtiman Singh CGSC, Mr. Mr. Divyam Nandrajog, Panel Counsel, GNCTD with Mr. Mayank Kamra, Adv. for R-2. Mr. Tanveer Oberoi(M:9958935556) and Mr. Jaswinder Singh, Advocate (M:9811232066) Mr. Ripudaman Bhardwaj CGSC with Mr. Kushagra Kumar Adv. for UOI. (3) WITH + CONT.CAS(C) 678/2024 MASTER RAKSHAN REPRESENTED BY HIS FATHER V. MANIKNANDAN..... Petitioner Through:

VERSUS

REMA CHANDRAMOHAN & ANR...... Respondents Through: Mr. T. Singhdev Amicus with Mr. Abhijit Chakravarty and Mr. Tanishq Srivastava, Advocates. (4) WITH 17:19 + CONT.CAS(C) 687/2024 MASTER RAKSHAN REPRESENTED BY HIS FATHER V. MANIKNANDAN..... Petitioner Through:

VERSUS

SUDHANSHP PANT & ORS...... Respondents Through: Mr. T. Singhdev Amicus with Mr. Abhijit Chakravarty and Mr. Tanishq Srivastava, Advocates. (5) WITH + W.P.(C) 11610/2017 & CM APPL.27637/2018 FSMA INDIA CHARITABLE TRUST..... Petitioner Through: Mr. Ashok Agarwal, Mr. Kumar Utkarsh & Mr. Manoj Kumar, Advs. (M: 9811101923)

VERSUS

UNION OF INDIA AND ANR...... Respondents Through: Mr. Sameer Vashisht, ASC (Civil), GNCTD and Mr. Vanshay Kaul, Adv. for R-2. Mr. Vijay Joshi, Sr. Panel Counsel for UOI. Mr Pravin Anand Mr Shrawan Chopra Ms Prachi Agrawal Mr Achyut Tewari, Advocates for Roche India (M. 860463357) Mr. Tanveer Oberoi, Adv. Mr. Anand Grover, Sr. Advocate with Mr. Saurabh Chauhan, Mr. Varun Jain, Mr. Rohin Bhatt, Ms. Reny Chauhan, Mr. Sadeeq Ur Rahman Advs. along with Ms. Archana Panda, AR. (M:9971540730) (6) WITH + W.P.(C) 2943/2020 & CM APPLs.10227/2020, 6633/2022, 7534/2023 17:19 ALISHBA KHAN..... Petitioner versus UNION OF INDIA AND ORS...... Respondents Through: Mr. Anuj Aggarwal, ASC, GNCTD, Ms. Ayushi Bansal, Mr. Sanyam Suri and Ms. Arshya Singh, Mr. Siddhant Dutt, Advocates for R-2 and 4 (M:9891363718). Mr. Tanveer Oberoi, Adv. for (AIIMS). (7) WITH + W.P.(C) 7756/2023 & CM APPL. 29934/2023 MASTER PUSPENDER THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

PAWAN KUMAR..... Petitioner versus UNION OF INDIA & ANR...... Respondent Through: Mr. Tanveer Oberoi, Adv. for (AIIMS). (8) WITH + W.P.(C) 8200/2023 & CM APPL. 31454/2023 MASTER DRASHTANT JHALA THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

JAYDEEP SINGH JHALA..... Petitioner versus 17:19 (AIIMS). (9) WITH + W.P.(C) 8947/2023 & CM APPL. 33930/2023 DIVYANSH KARNANI THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

RAJESH KUMAR KARNANI..... Petitioner versus UNION OF INDIA & ORS...... Respondent (AIIMS). (10) WITH + W.P.(C) 8948/2023 & CM APPL. 33931/2023 ARJUN SHARMA THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

SANJEEV SHARMA..... Petitioner versus (AIIMS). (11) WITH + W.P.(C) 8973/2023 & CM APPL. 34025/2023 ADVIK RAYAKAWAR THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

VERSUS

Through: Mr. Ripudaman Bhardwaj CGSC with Mr. Kushagra Kumar Adv. for UOI Mr. Neeraj, SPC along with Mr. Vedansh Anand and Mr. Mahesh Kumar Rathore, Advs. UOI. (12) WITH + W.P.(C) 8986/2023 & CM APPL. 34083/2023 LAKSHAY AGARWAL..... Petitioner versus Through: Mr. Anurag Ahluwalia, CGSC, Mr. Abhigyan Siddhant, Advocate. (AIIMS). (13) WITH + W.P.(C) 8996/2023 & CM APPL. 34122/2023 ADARSH SONI THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

29,712 characters total

VIJAY KUMAR SONI..... Petitioner versus (AIIMS). Mr Vedansh Anand, Advocates for UOI. 17:19 Mr Abhishek Sharma, Miss Kritya Sinha, Mr. Pranshul Kulshreshtha, Advs. for R-5. (M: 8294621791) (14) WITH + W.P.(C) 10782/2020 & CM APPL.33828/2020 AVIRAJ GARG, AGE 4 YEARS, THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

ABHINAV GARG..... Petitioner versus Through: Mr. Siddharth Khatana, Adv. for R1-

1. (M- 9811132326) Ms. Amrita Prakash, CGSC (AIIMS). Ms. Anvi Garg Adv., Advs for UOI.s (15) WITH + W.P.(C) 322/2021 & CM APPL. 812/2021 KESHAV SHARMA AGE 12 YEARS THROUGH HIS NEXT FRIEND AND NATURAL FATHER SANJEEV KUMAR..... Petitioner versus Through: Mr. Ajay Digpaul and Ms. Ishita Pathak, Mr. Kamal Digpaul with Ms. Swati Kwatra, Advocates for UOI. 17:19 (AIIMS). (16) WITH + W.P.(C) 1491/2021 & CM APPLs. 4291/2021, 8671/2022 MASTER MEDHANSH JHAWAR @ MADHAV..... Petitioner versus (AIIMS). (17) WITH + W.P.(C) 1511/2021 & CM APPLs. 4331/2021, 8616/2022 MASTER KENIT JHAWAR @ KESHAV..... Petitioner versus Through: Mr. Rishabh Sahu, Central Govt Sr. Counsel with Mr Sameer Sharma, Adv. for UOI. Mr. Ghanshyam Mishra, Adv. for R-1. (M: 9899794006) (AIIMS). (18) WITH + W.P.(C) 1611/2021 & CM APPL. 4600/2021 17:19 LAKSHYA KUMAR GOYAL, 8 YRS OLD, THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

VERSUS

Through: Ms. Bharathi Raju, Sr. Panel Counsel with Mr. Rohit Singh, for UOI. (M:9868895906) (AIIMS). (19) WITH + W.P.(C) 3662/2021 & CM APPLs. 11103/2021, 25590/2021, 32504/2021 PAYEL BHATTACHARYA..... Petitioner Through: Mr. Aditya Chatterjee and Mr. Ishaan Karki, Advocates.

VERSUS

UNION OF INDIA & ORS...... Respondents Through: Mr. Anuj Aggarwal, ASC, GNCTD, Ms. Ayushi Bansal, Mr. Sanyam Suri and Ms. Arshya Singh, Mr. Siddhant Dutt Advocates for R-2 (M:9891363718). (AIIMS). 17:19 (20) WITH + W.P.(C) 3682/2021 & CM APPL.11153/2021 HARSHIT SONI, 16 YEARS OLD, THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

TIKAM CHAND SONI..... Petitioner versus Through: Mr. T.P. Singh, Sr. Central Govt. Counsel for R-1 (M:9971579687). (AIIMS). (21) WITH + W.P.(C) 3689/2021 & CM APPL.11179/2021 DHANANJAY BHARDWAJ, 11 YEARS OLD, THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. AMIT KUMAR..... Petitioner versus Through: Mr. Sanjeev Uniyal and Mr. Dhawal Uniyal with Mr. Satyam Pandey Advs for R-1 (M:9560806614). (AIIMS). 17:19 (22) WITH + W.P.(C) 3706/2021 & CM APPL. 11229/2021 KHUSHWANT BHARDWAJ, 7 YEARS OLD, THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

NIKHIL BHARDWAJ..... Petitioner versus Through: Mr. Sanjib Kumar Mohanty, Sr. Panel Counsel with Ms. Anushka Jakhodia, Mr. Subesh K. Sahood, Adv. for R-1. (AIIMS). (23) WITH + W.P. (C) 3707/2021 & CM APPL. 11230/2021 AARAV GARG, 5 YEARS OLD, THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. VIVEK..... Petitioner versus Through: Mr. Siddharth Khatana, Advocate for UOI. (M:9811132326) (AIIMS). 17:19 (24) WITH + W.P.(C) 3729/2021 & CM APPL.11269/2021 MANISH, 8 YEARS OLD, THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

PHOOL CHAND JAT & ANR.... Petitioners Through: Mr. Ashok Agarwal Mr. Kumar versus (AIIMS). (25) WITH + W.P.(C) 3737/2021 & CM APPL. 11277/2021 SHOURYA MARU, 7 YEARS OLD, FATHER SH.

KAMAL KUMAR MARU..... Petitioner versus Through: Mr. Ranvir Singh (CGSC) for R-1. (M:9818071061) (AIIMS). (26) WITH + W.P.(C) 3859/2021 & CM APPL. 11647/2021 SIDDHARTH SWARNKAR, 9 YEARS OLD, 17:19 FATHER SH.

DINESH KUMAR SWARNKAR..... Petitioner versus Through: Mr. Anuj Aggarwal, ASC, GNCTD with Ms. Ayushi Bansal, Mr. Sanyam Suri and Ms. Arshya Singh Advocates for R-1 to 5 (M:9891363718). (AIIMS). (27) WITH + W.P.(C) 4045/2021 & CM APPL. 12213/2021 UTKARSH INDRAJIT PAWAR, 10 YEARS OLD, THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

INDRAJIT DAMAR PAWAR..... Petitioner versus Through: Mr. Sanjeev Sabharwal, Sr. Panel Counsel with Ms. Shweta, Advocate for UOI. Mr. Harish Kumar Garg and Ms. Palak Gupta, Ms. Khushboo Sharma, Advocates for UOI (M:9810150029). (AIIMS). 17:19 (28) WITH + W.P.(C) 4067/2021 & CM APPL. 12306/2021 ANSHU, 10 YEARS OLD, THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

NARENDRA KUMAR YADAV …... Petitioner versus (AIIMS). (29) WITH + W.P.(C) 4259/2021 & CM APPL. 12948/2021 ISHAAN, 10 YEARS OLD, THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

RAJVIR SINGH..... Petitioner versus (AIIMS). Mr. Ripudam Bhardwaj, CGSC with Mr. Vinod Tiwari, Adv. for R-1 & 3. (30) WITH + W.P.(C) 4304/2021 & CM APPL. 13108/2021 TANAV HANDOO, 6 YEARS OLD, THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. AMIT HANDOO..... Petitioner 17:19

VERSUS

Through: Mr. Satya Ranjan, (Sr. Panal Counsel) with Mr. Kautilya Birat, Advs for UOI. (AIIMS). (31) WITH + W.P.(C) 4551/2021 & CM APPL. 13949/2021 SHAURYA DAHIYA, 7 YEARS OLD, THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

SATBIR DAHIYA..... Petitioner versus Through: Mr. Avnish Singh, SPC Along with Mr. Mahendra Vikram Singh & Ms. Kanchan Kumari, Advocate. (M:8826437138) (AIIMS). Mr. Anurag Ahluwalia, CGSC with Tarveen Singh Nanda, Govt. Pleader. (M: 8826437138) (32) WITH 17:19 + W.P.(C) 4812/2021 & CM APPL. 14844/2021 NIKHIL YOGENDERSINGH CHOUDARY, 17 YEARS OLD, THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

YOGENDERSINGH P CHOUDARY..... Petitioner versus Through: Mr. Ranvir Singh (CGSC) for R-1. (AIIMS). (33) WITH + W.P.(C) 5394/2021 & CM APPL. 16683/2021 UDAYVEER SINGH GULERIA, 7 YEARS OLD, THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

RAMESH GULERIA..... Petitioner versus (AIIMS). (34) WITH + W.P.(C) 5395/2021 & CM APPL. 16686/2021, 63399/2023 MASTER AYUSHMAN CHATURVEDI..... Petitioner Through: Mr. Anurag Ojha, Advocate. Mr. Deepak Somani, Advocate. 17:19

VERSUS

Through: Mr. Niraj Kumar, Sr. Central Govt. Counsel for UOI. Mr. Parth Goyal, Adv. for Mr. Jawahar Raja, ASC(C) GNCTD. (AIIMS). (35) WITH + W.P.(C) 9684/2021 AADHYAN JAISWAL 11 YEARS OLD THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH ANIL KUMAR JAISWAL..... Petitioner versus Through: Mr. Divyam Nandrajog, Panel Counsel, GNCTD with Mr. Mayank Kamra, Adv. for R-2. (AIIMS). (36) WITH + W.P.(C) 14317/2021 & CM APPLs. 45148/2021, 14521/2023 SHREYANSH AARAV, 11 YEARS OLD, THROUGH HIS NEXT FRIEND AND NATURAL MOTHER SMT.

VERSUS

(AIIMS). (37) WITH + W.P.(C) 1182/2022 & CM APPL. 3442/2022 INSHA MINOR THROUGH HER NEXT FRIEND AND NATURAL FATHER SH IRSHAD AHMAD SOFI..... Petitioner versus Through: Mr. Sanjeev Uniyal & Mr. Dhawal Uniyal with Mr. Satyam Pandey, Ms. Ritagya Mishra Advs for R-1. (M:9560806614) Mr. Rishikesh Kumar ASC-GNCTD, with Mr Aditya Raj, Mr. Muhammad Zaid, Mr. Sheenu Priya, Mr. Sudhir Kumar Shukla & Mr Sumit Choudhary, (Advocates) (AIIMS). (38) WITH + W.P.(C) 1054/2023 and CM APPL. 4164/2023 MASTER TUSHAR THROUGH HIS NEXT FRIEND AND 17:19 NATURAL FATHER SH. JAI PRAKASH..... Petitioner versus Through: Mr. Kirtiman Singh, CGSC with Ms. Vidhi Jain, Advocate for UOI. Mr. Hardik Bedi, GP for UOI. (AIIMS) (39) WITH + W.P.(C) 1079/2023 and CM APPL. 4248/2023 MASTER RUDRA PAWAR THROUGH HIS NEXT FRIEND AND NATURAL MOTHER SMT. ANU VISHNOI..... Petitioner versus Dr. Nabendu Sekhar Chatterjee, from ICMR. Mr. Hardik Bedi, GP for UOI (40) WITH + W.P.(C) 2614/2023 KARAN, 14 YEARS OLD THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

VERSUS

Through: Mr. Nitinjya Chaudhry, Sr Panel Counsel with Mr. Abhishek, GP, Mr. Rahul Mourya, Adv. (M- 9810103680). Mr. Abhishek Khanna, Adv. for R-1. (AIIMS) (41) WITH + W.P.(C) 4495/2023 & CM APPL.17190/2023 PARAS JAIN THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

SANDEEP JAIN..... Petitioner versus Through: Mr. Raj Kumar, Advocate, SPC, UOI. Mr. Kirtiman Singh, CGSC with Ms. Vidhi Jain, Adv. for UOI. (42) WITH + W.P.(C) 4502/2023 & CM APPL.17238/2023 SHREYANSH VERMA THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

VERSUS

Through: Mr. Raj Kumar Yadav, Ms. Nitya Sharma, Ms. Jasmine Sheikh Advocate for UOI. (M:9818836222) (43) WITH + W.P.(C) 4526/2023 & CM APPL.17321/2023 MASTER LAKSHYAVED KALISHARAN THROUGH HIS NEXT FRIEND AND NATURAL MOTHER SHILPA RAMESH …. Petitioner versus Mr. Virender Pratap Singh Charak and Ms.Shubhra Parashar Advocates for UOI. Ms. Shubhra Parashar, Mr. Yash Hari Dixit, Mr. Akshay Kumar, Mr. Pushpender Singh Charak, Ms. Pinky Yadav, Advs. (M: 9958458448) (44) WITH + W.P.(C) 4535/2023 & CM APPL.17331/2023 17:19 MASTER CHINMAY BARUPAL THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

ASHOK KUMAR BARUPAL..... Petitioner versus Ms Monika Arora ( CGSC) & Ms. Jyoti Tiwari, Adv. for UOI. (45) WITH + W.P.(C) 4536/2023 & CM APPL.17333/2023 MADHAV SHARMA THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

NEERAJ SHARMA..... Petitioner versus Through: Mr. Sushil Raaja, SPC, UOI. (46) WITH + W.P.(C) 4538/2023 & CM APPL.17337/2023 SANDEEP KALIA..... Petitioner 17:19

VERSUS

Mr. Mukul Singh CGSC with Mr. Majjari Umesh, Ms. Ira Singh, Adv. for R-1. (M: 9971359513) (47) WITH + W.P.(C) 4539/2023 & CM APPL.17340/2023 RAJVEER SRIVASTAVA THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

RAJESH KUMAR SRIVASTAVA..... Petitioner versus Through: Mr Mukul Singh (CGSC) with Ms. Ira Singh, Adv. for UOI. (M:

9971359512) Mr. Mukul Singh CGSC, Ms. Ira Singh, Advocate for R-1. (48) WITH + W.P.(C) 4591/2023 & CM APPL. 17548/2023 VANSH THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

VERSUS

Ms Monika Arora (CGSC), Mr. Kushal Mr. Subhrodeep Saha Mr Yash Tyagi, Adv & Mr Subhrodeep, Adv. Mr. Mukul Singh CGSC, Ms. Ira Singh, Advocate for R-1. (49) WITH + W.P.(C) 5102/2023 & CM APPL.19968/2023 PRANSHU NAMDAR THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

PARIXIT NAMDHAR..... Petitioner versus Through: Ms. Ritu Reniwal (SPC UOI). Ms Prerna Dhall & Mr Ripu Dhiman, Advocates (M- 8920466138) (50) WITH + W.P.(C) 5726/2023 & CM APPL. 22436/2023 MASTER HARENDER THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

VERSUS

Through: Mr. Neeraj, SPC along with Mr. Mr. Tanveer Oberoi, Advocate for (AIIMS). Advocates for R-4. (51) WITH + W.P.(C) 5753/2023 & CM APPL. 22528/2023 VINAY THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

MEHAR SINGH..... Petitioner versus Through: Mr Atul Sai Krishna Senior Panel Counsel, Mr Hardik Bedi GP. (M:

8010414123) Advocates for R-2. Mr Atul Krishna, SPC with Mr 17:19 Hardik Bedi, GP for R[1] (52) WITH + W.P.(C) 6089/2023 & CM APPL. 23902/2023 MASTER SAIANSH THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

AVTAR SINGH MALHOTRA. Petitioner versus Through: Mr. Kirtiman Singh CGSC, Mr Hardik Bedi GP Mr. Waize Ali Noor, Ms. Vidhi Jain & Ms. Anvi Garg Adv., Advs for UOI. Mr Atul Sai Krishna Senior Panel Counsel, Mr Hardik Bedi GP. (M:

8010414123) Mr. Kirtiman Singh, CGSC with Ms. Vidhi Jain, Adv. for UOI. (53) WITH + W.P.(C) 7549/2023 and CM APPL. 29273/2023 MASTER CHUNNU YADAV THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

SANJEEV KUMAR..... Petitioner versus Mr. Gokul Sharma (GP) for R-1. (M-

9045885304) 17:19 Ms Prerna Dhall & Mr Ripu Dhiman, Advocates (M- 8920466138) (54) WITH + W.P.(C) 7553/2023 and CM APPL. 29299/2023 MASTER HARSHIT PAWAR THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

PRAVEEN KUMAR..... Petitioner versus (55) WITH + W.P.(C) 7644/2023 and CM APPLS. 29628-29/2023 MASTER SATYAKI ADAK THROUGH HIS NATURAL GUARDIAN..... Petitioner versus Through: Mr. Ripudaman Bhardwaj, CGSC with Mr. Kushagra Kumar, and Mr. Abhinav Bhardwaj, Advs. for UOI. and Mr. Jaswinder Singh, Advocate. 17:19 Mr. Ankit Verma, Advocate. (56) WITH + W.P.(C) 10031/2023 and CM APPL. 38666/2023 ADITYA KUMAR YADAV THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. PREM SHANKAR..... Petitioner Mr. Rahul Malhotra, Advocate.

VERSUS

Mr. Ripudaman Bhardwaj, CGSC (57) WITH + W.P.(C) 10063/2023 and CM APPL. 38727/2023 SUMIT KUMAR SINGH THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

VERSUS

17:19 Mr Vedansh Anand, Advocates for UOI. (58) WITH + W.P.(C) 10064/2023 and CM APPL. 38728/2023 ADITYA SONI THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

MUKESH KUMAR SONI..... Petitioner versus Mr. Ripudaman Bhardwaj, CGSC (59) WITH + W.P.(C) 10606/2023 & CM APPL. 41165/2023 UMANAND KUMAR SONI THROUGH HIS NEXT FRIEND AND NATURAL GRANDFATHER SH.

NANDU PRASAD SONI..... Petitioner versus Through: Mr. Vineet Dhanda, CGSC 17:19 (60) WITH + W.P.(C) 10867/2023 & CM APPL. 42110/2023 PARTH KAMBOJ THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

PARDEEP KUMAR..... Petitioner versus (61) WITH + W.P.(C) 10870/2023 & CM APPL. 42114/2023 PARV INSAN THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

WAZIR SINGH..... Petitioner versus (62) WITH 17:19 + W.P.(C) 12222/2023 & CM APPL. 48011/2023 SAKSHAM JANGLA THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

PARVEEN KUMAR..... Petitioner versus (63) WITH + W.P.(C) 13172/2023 & CM APPL. 52098/2023 TANUJ THROUGH HIS NEXT FRIEND AND NATURAL FATHER MR.

SUDHIR KUMAR & ANR...... Petitioners versus (64) WITH + W.P.(C) 13173/2023 & CM APPL. 52099/2023 AMAN MEENA THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

SAMAY SINGH MEENA..... Petitioner versus Through: Mr. Ripudaman Bhardwaj CGSC and Mr. Kushagra Kumar, Ms. Manaswini Kondepudi, Advs. for UOI. 17:19 (65) WITH + W.P.(C) 13174/2023 & CM APPL. 52100/2023 HARSHIT RAJPUT THROUGH HIS NEXT FRIEND AND NATURAL MOTHER SMT.

MEENA RAJPUT..... Petitioner versus (66) WITH + W.P.(C) 13175/2023 & CM APPL. 52102/2023 PARMARTH KAPOOR THROUGH HIS NEXT FRIEND AND NATURAL MOTHER MS.

SURABHI BHARDWAJ..... Petitioner versus (67) WITH + W.P.(C) 13179/2023 & CM APPL. 52133/2023 MANVIK KHANGWAL THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

PARVEEN KUMAR..... Petitioner 17:19 (68) WITH + W.P.(C) 13180/2023 & CM APPL. 52134/2023 GAURAV KAPOOR..... Petitioner versus (69) WITH + W.P.(C) 13186/2023 & CM APPL. 52141/2023 SOUMYA MISHRA THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

VINOD KUMAR MISHRA..... Petitioner versus (70) WITH + W.P.(C) 13187/2023 & CM APPL. 52142/2023 SUMIT VERMA THROUGH HIS NEXT FRIEND AND NATURAL MOTHER SMT.

KRISHNA DEVI..... Petitioner 17:19 (71) WITH + W.P.(C) 13188/2023 & CM APPL. 52145/2023 VIKASH MEENA..... Petitioner versus (72) WITH + W.P.(C) 13190/2023 & CM APPL. 52148/2023 REHAN THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

VINAY KAMAL..... Petitioner versus (73) WITH + W.P.(C) 13191/2023 & CM APPL. 52149/2023 YASH THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. MONU..... Petitioner 17:19

VERSUS

(74) WITH + W.P.(C) 13192/2023 & CM APPL. 52152/2023 AARUSH PRITHWANI THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

BHISHAM PRITHWANI..... Petitioner versus (75) WITH + W.P.(C) 13193/2023 & CM APPL. 52153/2023 MANAV PALSANIA THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

AJAY KUMAR PALSANIA..... Petitioner versus 17:19 Mr. N. Ganpathy, Sr. Advocate & Mr. Manpreet Lamba, Adv. for D-2. (76) WITH + W.P.(C) 13196/2023 & CM APPL. 52158/2023 HIMANSHU SHARAMA THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

VISHAL SHARAMA..... Petitioner versus (77) WITH + W.P.(C) 13197/2023 & CM APPL. 52159/2023 MRADUL MISHRA..... Petitioner versus (78) WITH + W.P.(C) 13236/2023 & CM APPL. 52311/2023 YASH RAJ SINGH THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

DHARMENDER SINGH..... Petitioner 17:19 (79) WITH + W.P.(C) 13237/2023 & CM APPL. 52314/2023 PARMEET SINGH THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

KULDEEP SINGH..... Petitioner versus (80) WITH + W.P.(C) 13239/2023 & CM APPL. 52319/2023 MOHIT THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

SURENDER SINGH..... Petitioner versus (81) WITH + W.P.(C) 13240/2023 & CM APPL. 52321/2023 MOHAMMAD ARSHAD THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

VERSUS

(82) WITH + W.P.(C) 13259/2023 & CM APPL. 52378/2023 SAHIL THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

MAHESH YADAV..... Petitioner versus (83) WITH + W.P.(C) 13260/2023 & CM APPL. 52379/2023 VISHWAS GOYAL THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

MANGLESH GOYAL..... Petitioner versus Through: Mr. Ripudaman Bhardwaj CGSC with Mr. Kushagra Kumar Adv. for UOI. (84) WITH + W.P.(C) 13304/2023 & CM APPL. 52496/2023 VIHAAN GUPTA THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

VERSUS

(85) WITH + W.P.(C) 13379/2023 & CM APPL. 52805/2023 SAMEER LAMBA THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. HANSRAJ..... Petitioner versus (86) WITH + W.P.(C) 13389/2023 & CM APPL. 52855/2023 SALMAN KHAN THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

HUSAIN ALI..... Petitioner versus Through: Mr. Shubham Prasad, G.P. for UOI. (M: 9712533333) (87) WITH 17:19 + W.P.(C) 13417/2023 & CM APPL. 53006/2023 HENIL PATEL THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

PANKAJ KUMAR PATEL..... Petitioner versus Mr. Shubham Prasad, G.P. for UOI. (M: 9712533333) (88) WITH + W.P.(C) 13449/2023 & CM APPL. 53114/2023 HENILKUMAR PRAJAPATI THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

KANAIYALAL PRAJAPATI..... Petitioner versus Through: Mr. Shashank Garg, CGSC for UOI with Mr. Vanshul Pali, Adv. (M:

9711552649) (89) WITH + W.P.(C) 13453/2023 & CM APPL. 53123/2023 TIRTH RAVI KHAIRNAR THROUGH HIS NEXT FRIEND AND NATURALFATHER SH.

KHAINAR RAVI BHAI..... Petitioners versus 17:19 (90) WITH + W.P.(C) 13456/2023 & CM APPL. 53134/2023 RUDRA KIRTI KUMAR PATEL THROUGH HIS NEXT FRIEND AND NATURALFATHER SH.

KIRTI KUMAR HIRABHAI PATEL..... Petitioners versus (91) WITH + W.P.(C) 13469/2023 & CM APPL. 53236/2023 JEET GOSAI THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

PRAGNESHGIRI PRAVINGIRI GOSAI..... Petitioners versus (92) AND + W.P.(C) 13475/2023 ANUJ KUMAR..... Petitioners 17:19

VERSUS

8588871365) Mr. Shashank Garg, CGSC with Mr. Vanshul Pali, Adv. for R-1. (93) WITH + W.P.(C) 14141/2023 & CM APPL. 55947/2023 TAKSH KAUSHIK THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH VED PRAKASH..... Petitioner versus Through: Mr. Neeraj, SPC along with Mr. (94) WITH + W.P.(C) 15263/2023 & CM APPL. 61134/2023 MOHAMMAD AYAAN SHEIKH THROUGH HIS NEXT FRIEND AND NATURAL MOTHER MRS.

AYESHA SHEIKH..... Petitioner versus Through: Mr. Tanveer Oberoi(M:9958935556) (95) WITH + W.P.(C) 15301/2023 & CM APPL. 61316/2023 SHRESHTH SHARMA THROUGH HIS NEXT FRIEND AND 17:19 NATURAL FATHER SH.

DHEERAJ SHARMA..... Petitioner versus (96) WITH + W.P.(C) 15302/2023 & CM APPL. 61317/2023 SHIVAM THROUGH HIS NEXT FRIEND AND NATURAL MOTHER SMT.

SWATI LOHIA..... Petitioner versus (97) WITH + W.P.(C) 15315/2023 & CM APPL. 61386/2023 NIKUNJ GUPTA THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

ASHWANI GUPTA..... Petitioner versus 17:19 (98) WITH + W.P.(C) 15334/2023 & CM APPL. 61502/2023 DEVANSH AGARWAL THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

CHANDRAPRAKASH AGARWAL..... Petitioner versus Through: Mr. Ripudaman Bhardwaj & Mr. Anurag Ahluwalia, CGSCs with Mr. Kushagra Kumar Adv. for UOI. (99) WITH + W.P.(C) 15336/2023 & CM APPL. 61505/2023 RAHUL..... Petitioner versus Through: Mr Anurag Ahluwalia, CGSC with Mr Tarveen Singh Nanda, Adv. for R- Ms. Purva Chugh & Ms. Pooja Arora, Advs. (100) WITH + W.P.(C) 15618/2023 & CM APPL. 62576/2023 17:19 KULDEEP SINGH NARUKA & ANR...... Petitioners versus Through: Ms. Pratima N Lakra CGSC with Vanya Bajaj, Advs. (M. 9968324260) (101) WITH + W.P.(C) 15639/2023 & CM APPL. 62620/2023 KARAN SONI THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

JUGAL KISHOR SONI AND ANR..... Petitioners versus Ms. Pratima N Lakra CGSC with Ms Kashish G Baweja, Advocate. (102) WITH + W.P.(C) 14150/2023 & CM APPL. 55962/2023 TANVEER SHARMA THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

DEEPAK SHARMA..... Petitioners versus Through: Mr Vedansh Anand, Advocates for UOI. (103) WITH 17:19 + W.P.(C) 16267/2023 & CM APPL. 65509/2023 PRINCE PAREEK THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

PANKAJ PAREEK..... Petitioners versus Through: Mr. Tanveer Oberoi(M:9958935556) (104) AND + W.P.(C) 16361/2023 & CM APPL. 65805/2023 SARANSH KUMAR THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

SATISH KUMAR MANDAL..... Petitioners versus Through: Mr. Tanveer Oberoi, Adv. (M:9958935556) (105) AND + W.P.(C) 55/2024 & CM APPL. 187/2024 BUSHRA KHAN THROUGH HER NEXT FRIEND AND NATURAL FATHER SH.

ASHRAT ALI KHAN..... Petitioner versus Through: Mr. Tanveer Oberoi, Adv. (M:9958935556) (106) AND + W.P.(C) 436/2024 & CM APPL. 2013/2024 17:19 VIKASH KUMAR THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. SANDEEP..... Petitioner (M: 6370344354)

VERSUS

(107) AND + W.P.(C) 479/2024 & CM APPL. 2128/2024 PARTH SAH THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. RAMANAND..... Petitioner versus Through: None. CORAM: JUSTICE PRATHIBA M. SINGH Prathiba M. Singh, J. (Oral)

1. This hearing has been done through hybrid mode.

2. At the outset, the ld. Amicus Ms. Shyel Trehan handed over an email communication and informed the Court that Dystrophy Annihilation Research Trust, Bangalore (hereinafter, ‘DART’) and M/s. Hanugen Therapeutics Private Limited (hereinafter, ‘Hanugen’) are about to commence the clinical trials for Duchenne Muscular Dystrophy (hereinafter, ‘DMD’) at AIIMS from next week. Preparations for the same are stated to have been finalised, and the final meeting was also held on 25th July, 2024. 17:19

3. Dr. Arun Shastry from DART has also joined the Court proceedings virtually and has informed the Court that patients who are between 5 to 10 years of age, are ambulatory, and to whom EXON 45, EXON 51, and EXON 53 are to be prescribed, would be entitled to enrol in the DART trials. The details of the inclusion and exclusion criteria in the clinical DART are stated to have been finalised by AIIMS.

4. In view of this, since the list of all the writ Petitioners before the Court, and their present medical condition is already available with AIIMS, such Petitioners who would benefit from this trial and who satisfy the inclusion and exclusion criteria—up to about 15 patients as agreed between AIIMS and DART—may be enrolled in this trial. Let a complete status report be placed on record by the next date of hearing in respect of the clinical trials conducted by DART and AIIMS, and any other details thereof. Directions in CONT.CAS(C) 678/2024 & CONT.CAS(C) 687/2024

5. Vide order dated 22nd July, 2024, this Court directed as follows:

“9. In CONT.CAS(C) 678/2024 & CONT.CAS(C)
687/2024 , it is submitted on behalf of ld. Amicus Mr.
T. Singh Dev that consultation for the child with AIIMS has taken place on 20th July, 2024. The soft copies of the MRI scans are to be handed over to the doctors at AIIMS. Additionally, Dr. Kabra and Dr. Shefali confirmed that the child has been examined. 10. It is further stated that treatment plans shall be emailed to the father today itself. The father shall also send copies of the MRI scans to the doctors at AIIMS within a period of one week. 11. In W.P.(C) 4539/2023, a status report has been handed over by ld. Counsel for AIIMS Mr. Oberoi that the Petitioner is amenable to Exon 51 Skipping.

17:19 The said status report is taken on record.”

6. It is submitted on behalf of ld. Amicus Mr. T. Singh Dev, ld. Counsel submits that the MRI reports are yet to be submitted to AIIMS, and is likely to be submitted tomorrow i.e., 2nd August, 2024.

7. Accordingly, let Dr. Kabra and her team at AIIMS proceed ahead with the decided plan in terms of the previous order as extracted above. Final Submissions and directions

8. Ms. Vidhi Jain, ld. Counsel from the office of Mr. Kirtiman Singh, ld. CGSC, commenced her submissions and took the Court through an affidavit filed by the Ministry of Health dated 19th July 2024, which shows that the total number of patients who have been given treatment in the last two years is 105 and 430, respectively, in 2022-2023 and 2023-2024.

9. The amounts that have been transferred to the various Centres of Excellence have also been filed by means of a chart, which shows that the amounts transferred are much less than the budgeted estimate approved by the Ministry of Health and Family Welfare towards the implementation of the National Rare Diseases’ Policy and towards the disbursal for the 50 lakhs amount under the said Policy.

10. Considering that there are large number of patients before the Court seeking treatment and the budgets are still available for their treatment, it is deemed appropriate to direct as under:i) Dr. Kabra shall immediately place a request for the release of the next dose of treatment for the 14 patients diagnosed with DMD who have already been administered the medicines, for the next three months. The names of the 14 patients has already 17:19 been provided in the order dated 5th January, 2024. The same is reproduced as follows: 1 W.P.(C) 5315/2020 Arnesh Shaw 2 W.P.(C) 322/2021 Keshav Sharma 3 W.P.(C) 1611/2021 Lakshya Kumar Goyal 4 W.P.(C) 3682/2021 Harshit Soni 5 W.P.(C) 3689/2021 Dhananjay Bhardwaj 6 W.P.(C) 3729/2021 Manish 7 W.P.(C) 3729/2021 Chirag 8 W.P.(C) 3859/2021 Siddharath Swarankar 9 W.P.(C) 4067/2021 Anshu 10 W.P.(C) 4259/2021 Ishaan 11 W.P.(C) 4812/2021 Nikhil Yogender Singh 12 W.P.(C) 5394/2021 Udayveer Singh Guleria 13 W.P.(C) 5395/2021 Ayushman Chaturvedi 14 W.P.(C) 14317/2021 Shreyansh Aarav ii) From the number of Petitioners before the Court in the various writ petitions, let a chart be prepared and placed before the Court by the next date, showing the budget that would be required for a period of three months, if the medicines are to be ordered in these writs.

11. Further, Ms. Jain, ld. Counsel, also submits that there are two trials currently approved by the DCGI in India for DMD therapies. The details of the two trials have been handed over to Mr. Chawla, who is appearing for 17:19 M/s Sarepta Therapeutics. Mr. Chawla, ld. Counsel, under instructions, submits that the recruitments for the said trials are closed. However, it appears from the document handed over by the DCGI that the total number of subjects recruited by M/s Sarepta Therapeutics is less than the approved number of Indian subjects to be enrolled.

12. Let an affidavit in this regard be filed by M/s Sarepta Therapeutic by the next date of hearing. In the affidavit, M/s. Sarepta shall also state as to whether the pricing of its medicines for DMD varies in different countries and if so a chart shall be filed giving the retail price at which the products are available both before and after discounts in at least 10 advanced countries and 10 developing countries including India’s neighbouring countries. Let the said affidavit be filed by 10th August 2024.

13. List on 21st August, 2024.

14. These are part-heard matters.

PRATHIBA M. SINGH JUDGE AUGUST 1, 2024 Mr/dn 17:19