Master Arnesh Shaw v. Union of India & Anr.

Delhi High Court · 22 Mar 2024
Prathiba M. Singh
W.P.(C) 5315/2020
constitutional other Significant

AI Summary

The Delhi High Court directed facilitation of treatment and clinical trials for children with rare diseases under the National Policy for Rare Diseases, mandated customs duty exemption on medicines, and ordered negotiations between government and pharmaceutical companies to ensure therapy availability.

Full Text
Translation output
W.P.(C) 5315/2020 & connected matters
HIGH COURT OF DELHI
Date of Decision: 22nd March, 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
Mr. Dinesh Kumar and Mr. Prakash Raj Thakur, Advs. for DGCI. (M:
JUDGMENT

9990755693) (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 + W.P.(C) 11610/2017 & CM APPLs. 27637/2018 FSMA INDIA CHARITABLE TRUST..... Petitioner Through: Mr. Ashok Agarwal & 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) (4) WITH + W.P.(C) 2943/2020 & CM APPLs.10227/2020, 6633/2022, 7534/2023 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). (5) WITH + W.P.(C) 7756/2023 & CM APPL. 29934/2023 MASTER PUSPENDER THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

VERSUS

UNION OF INDIA & ANR...... Respondent Through: Mr. Tanveer Oberoi, Adv. for (AIIMS). (6) 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 (AIIMS). (7) 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). (8) 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). (9) WITH + W.P.(C) 8973/2023 & CM APPL. 34025/2023 ADVIK RAYAKAWAR THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

PIYUSH RAYAKAWAR..... Petitioner 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. (10) WITH + W.P.(C) 8986/2023 & CM APPL. 34083/2023 LAKSHAY AGARWAL..... Petitioner versus Through: Mr. Anurag Ahluwalia, CGSC, Mr. Abhigyan Siddhant, Advocate. (AIIMS). (11) WITH + W.P.(C) 8996/2023 & CM APPL. 34122/2023 ADARSH SONI THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

VIJAY KUMAR SONI..... Petitioner versus Through: Mr. Ripudaman Bhardwaj CGSC with Mr. Kushagra Kumar Adv. for UOI (AIIMS). Mr Vedansh Anand, Advocates for UOI. Mr Abhishek Sharma, Miss Kritya Sinha, Mr. Pranshul Kulshreshtha, Advs. for R-5. (M: 8294621791) (12) 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 (13) 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. (AIIMS). (14) WITH + W.P.(C) 1491/2021 & CM APPLs. 4291/2021, 8671/2022 MASTER MEDHANSH JHAWAR @ MADHAV..... Petitioner versus (AIIMS). (15) 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). (16) WITH + W.P.(C) 1611/2021 & CM APPL. 4600/2021 LAKSHYA KUMAR GOYAL, 8 YRS OLD, THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

VERSUS

34,407 characters total

Through: Ms. Bharathi Raju, Sr. Panel Counsel with Mr. Rohit Singh, for UOI. (M:9868895906) (AIIMS). (17) 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). (18) 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). (19) 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). (20) 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). (21) 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). (22) 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 versus (AIIMS). (23) 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). (24) WITH + W.P.(C) 3859/2021 & CM APPL. 11647/2021 SIDDHARTH SWARNKAR, 9 YEARS OLD, 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). (25) 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). (26) 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). (27) 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. (28) 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 versus Through: Mr. Satya Ranjan, (Sr. Panal Counsel) with Mr. Kautilya Birat, Advs for UOI. (AIIMS). (29) 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) (30) WITH + 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). (31) 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). (32) 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.

VERSUS

Through: Mr. Niraj Kumar, Sr. Central Govt. Counsel for UOI. Mr. Parth Goyal, Adv. for Mr. Jawahar Raja, ASC(C) GNCTD. (AIIMS). (33) 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). (34) 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.

KANCHAN KAMINI..... Petitioner versus (AIIMS). (35) 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). (36) WITH + W.P.(C) 1054/2023 and CM APPL. 4164/2023 MASTER TUSHAR THROUGH HIS NEXT FRIEND AND 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) (37) 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 (38) 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) (39) 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. (40) WITH + W.P.(C) 4502/2023 & CM APPL.17238/2023 SHREYANSH VERMA THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

DHEERAJ KANT VERMA..... Petitioner versus Through: Mr. Raj Kumar Yadav, Ms. Nitya Sharma, Ms. Jasmine Sheikh Advocate for UOI. (M:9818836222) (41) 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) (42) 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 versus Ms Monika Arora ( CGSC) & Ms. Jyoti Tiwari, Adv. for UOI. (43) 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. (44) WITH + W.P.(C) 4538/2023 & CM APPL.17337/2023 SANDEEP KALIA..... Petitioner versus Mr. Mukul Singh CGSC with Mr. Majjari Umesh, Ms. Ira Singh, Adv. for R-1. (M: 9971359513) (45) 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. (46) WITH + W.P.(C) 4591/2023 & CM APPL. 17548/2023 VANSH THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

VIPIN KUMAR..... Petitioner 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. (47) 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) (48) WITH + W.P.(C) 5726/2023 & CM APPL. 22436/2023 MASTER HARENDER THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

SUNDER SINGH & ANR...... Petitioners versus Through: Mr. Neeraj, SPC along with Mr. Mr. Tanveer Oberoi, Advocate for (AIIMS). Advocates for R-4. (49) 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 Hardik Bedi, GP for R[1] (50) 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. (51) 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) Ms Prerna Dhall & Mr Ripu Dhiman, Advocates (M- 8920466138) (52) 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 (53) 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. Mr. Ankit Verma, Advocate. (54) 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 (55) 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 versus Mr Vedansh Anand, Advocates for UOI. (56) 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 (57) 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 (58) WITH + W.P.(C) 10867/2023 & CM APPL. 42110/2023 PARTH KAMBOJ THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

PARDEEP KUMAR..... Petitioner versus (59) WITH + W.P.(C) 10870/2023 & CM APPL. 42114/2023 PARV INSAN THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

WAZIR SINGH..... Petitioner versus (60) WITH + W.P.(C) 12222/2023 & CM APPL. 48011/2023 SAKSHAM JANGLA THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

PARVEEN KUMAR..... Petitioner versus (61) WITH + W.P.(C) 13172/2023 & CM APPL. 52098/2023 TANUJ THROUGH HIS NEXT FRIEND AND NATURAL FATHER MR.

SUDHIR KUMAR & ANR...... Petitioners versus (62) 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. (63) WITH + W.P.(C) 13174/2023 & CM APPL. 52100/2023 HARSHIT RAJPUT THROUGH HIS NEXT FRIEND AND NATURAL MOTHER SMT.

MEENA RAJPUT..... Petitioner versus (64) WITH + W.P.(C) 13175/2023 & CM APPL. 52102/2023 PARMARTH KAPOOR THROUGH HIS NEXT FRIEND AND NATURAL MOTHER MS.

SURABHI BHARDWAJ..... Petitioner versus (65) WITH + W.P.(C) 13177/2023 & CM APPL. 52129/2023 HARSHIL MEHANDIRATTA & ANR...... Petitioners versus (66) WITH + W.P.(C) 13179/2023 & CM APPL. 52133/2023 MANVIK KHANGWAL THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

PARVEEN KUMAR..... Petitioner versus (67) WITH + W.P.(C) 13180/2023 & CM APPL. 52134/2023 GAURAV KAPOOR..... Petitioner versus (68) 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 (69) WITH + W.P.(C) 13187/2023 & CM APPL. 52142/2023 SUMIT VERMA THROUGH HIS NEXT FRIEND AND NATURAL MOTHER SMT.

KRISHNA DEVI..... Petitioner versus (70) WITH + W.P.(C) 13188/2023 & CM APPL. 52145/2023 VIKASH MEENA..... Petitioner versus (71) WITH + W.P.(C) 13190/2023 & CM APPL. 52148/2023 REHAN THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

VINAY KAMAL..... Petitioner versus (72) WITH + W.P.(C) 13191/2023 & CM APPL. 52149/2023 YASH THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. MONU..... Petitioner versus (73) WITH + W.P.(C) 13192/2023 & CM APPL. 52152/2023 AARUSH PRITHWANI THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

BHISHAM PRITHWANI..... Petitioner versus (74) 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 (75) WITH + W.P.(C) 13196/2023 & CM APPL. 52158/2023 HIMANSHU SHARAMA THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

VISHAL SHARAMA..... Petitioner (76) WITH + W.P.(C) 13197/2023 & CM APPL. 52159/2023 MRADUL MISHRA..... Petitioner versus (77) WITH + W.P.(C) 13236/2023 & CM APPL. 52311/2023 YASH RAJ SINGH THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

DHARMENDER SINGH..... Petitioner versus (78) WITH + W.P.(C) 13237/2023 & CM APPL. 52314/2023 PARMEET SINGH THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

KULDEEP SINGH..... Petitioner versus (79) WITH + W.P.(C) 13239/2023 & CM APPL. 52319/2023 MOHIT THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

SURENDER SINGH..... Petitioner versus (80) WITH + W.P.(C) 13240/2023 & CM APPL. 52321/2023 MOHAMMAD ARSHAD THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

MOHAMMAD HANIF..... Petitioner (81) WITH + W.P.(C) 13259/2023 & CM APPL. 52378/2023 SAHIL THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

MAHESH YADAV..... Petitioner versus (82) 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. (83) WITH + W.P.(C) 13304/2023 & CM APPL. 52496/2023 VIHAAN GUPTA THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

GAURAV KUMAR..... Petitioner versus (84) WITH + W.P.(C) 13379/2023 & CM APPL. 52805/2023 SAMEER LAMBA THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. HANSRAJ..... Petitioner versus (85) 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) (86) WITH + 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) (87) 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) (88) 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 (89) 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 (90) 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 (91) AND + W.P.(C) 13475/2023 ANUJ KUMAR..... Petitioners versus Ms Seema Singh, Adv. UOI R[1]. (M:

8588871365) Mr. Shashank Garg, CGSC with Mr. Vanshul Pali, Adv. for R-1. (92) 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. (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 versus Through: Mr. Tanveer Oberoi(M:9958935556) (94) WITH W.P.(C) 15301/2023 & CM APPL. 61316/2023 SHRESHTH SHARMA THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

DHEERAJ SHARMA..... Petitioner versus (95) WITH W.P.(C) 15302/2023 & CM APPL. 61317/2023 SHIVAM THROUGH HIS NEXT FRIEND AND NATURAL MOTHER SMT.

SWATI LOHIA..... Petitioner (96) WITH W.P.(C) 15315/2023 & CM APPL. 61386/2023 NIKUNJ GUPTA THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

ASHWANI GUPTA..... Petitioner versus (97) WITH W.P.(C) 15334/2023 & CM APPL. 61502/2023 DEVANSH AGARWAL THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

CHANDRAPRAKASH AGARWAL..... Petitioner versus Mr. Anurag Ahluwalia, CGSC, for R- (98) WITH W.P.(C) 15336/2023 & CM APPL. 61505/2023 RAHUL..... Petitioner versus Ms. Purva Chugh & Ms. Pooja Arora, Advs. (99) WITH W.P.(C) 15618/2023 & CM APPL. 62576/2023 KULDEEP SINGH NARUKA & ANR...... Petitioners versus Through: Ms. Pratima N Lakra CGSC with Vanya Bajaj, Advs. (M. 9968324260) (100) 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. (101) 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. (102) WITH W.P.(C) 16267/2023 & CM APPL. 65509/2023 PRINCE PAREEK THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

PANKAJ PAREEK..... Petitioners versus (103) AND W.P.(C) 16361/2023 & CM APPL. 65805/2023 SARANSH KUMAR THROUGH HIS NEXT SH.

SATISH KUMAR MANDAL..... Petitioners versus (104) AND W.P.(C) 55/2024 & CM APPL. 187/2024 BUSHRA KHAN THROUGH HER NEXT SH.

ASHRAT ALI KHAN..... Petitioner versus (105) AND W.P.(C) 436/2024 & CM APPL. 2013/2024 VIKASH KUMAR THROUGH HIS NEXT SH. SANDEEP..... Petitioner (106) 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. 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. 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 2 DMD Petitioners who have been enrolled in clinical trials 3 DMD Petitioners found amenable to treatment 19+16+15=50 4 DMD Petitioners evaluated as non-amenable to treatment 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

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. 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.

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.

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.

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. 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:

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.

PRATHIBA M. SINGH JUDGE MARCH 22, 2024 Rahul/dn