Arnesh Shaw v. Union of India & Anr.

Delhi High Court · 26 Feb 2024 · 2024:DHC:1687
Prathiba M. Singh
W.P.(C) 5315/2020
2024:DHC:1687
constitutional other Significant

AI Summary

Delhi High Court directs facilitation of clinical trials and supply of rare disease therapies, clarifies customs duty exemption on imported medicines, and mandates expeditious clearance to ensure timely treatment.

Full Text
Translation output
W.P.(C) 5315/2020 & connected matters
HIGH COURT OF DELHI
Date of Decision: 26th February, 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. 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.
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 Signing Date:01.03.2024 20:57 NATURAL GUARDIAN..... Petitioner (M: 6370344354)

VERSUS

RAJESH BHUSHAN & ORS...... Respondent 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. 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) (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). Mr. Kirtiman Singh CGSC, Mr. (5) 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). (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 and Kondepudi, Advs. for UOI. Mr Neeraj, Mr Sahaj Garg, Mr. Deepanshu Badiwal & Mr Vedansh Anand, Advocates for 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 and Mr. Kushagra Kumar, Ms. Manaswini Kondepudi, Advs. Mr. Vedansh Anand (GP), for UOI. (AIIMS). 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: Ms. Amrita Prakash, CGSC and Mr. Vishal Ashwani Mehta, Advocates (M:9818667963). (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, and Ms. Priyanka Verma, Advocate with Mr. Babli Chauhan, 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

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

33,039 characters total

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 (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 (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 and Mr. Deepak Somani, 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. (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. (38) WITH + W.P.(C) 2614/2023 KARAN, 14 YEARS OLD THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

VIJAY KUMAR..... Petitioner Through: Ms. Sonia Sharma, Ms. Neha Chugh, Mr. Vijay Chandra Jha, Adv. Ms. Purva Chugh & Mr. Tushant, Advs.

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.

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.

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), Mr Yash Tyagi, Adv & Mr Subhrodeep, Adv. (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, Advocate with Arani Chaudhary, Advocate for 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 Through: Mr. Ashok Agarwal, Mr.Kumar versus Through: Mr Neeraj, Mr Sahaj Garg, Mr. Anand and Mr Rudra Paliwal Advocates for UOI.. 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. (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 Kondepudi, Advs. for UOI with Ms Prerna Dhall, Adv. (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 THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

AMARJIT SINGH..... Petitioner versus Kondepudi, Advs. with Mr. Vedansh Anand (GP), 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 with Mr. Durga D. Vashist, Adv. for R-1. (M:9811013810) (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 (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 (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 Through: Mr. Ripudaman Bhardwaj, Mr. Kushagra Kumar, Ms. Manaswini Kondepudi, Advs for UOI. (75) WITH + W.P.(C) 13196/2023 & CM APPL. 52158/2023 HIMANSHU SHARAMA THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

VISHAL SHARAMA..... Petitioner versus (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 Through: Mr. Ripudaman Bhardwaj CGSC, Mr. Kondepudi for UOI. (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 versus (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 (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 Kondepudi for UOI 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: None. (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 versus (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 Through: Mr. Ripudaman Bhardwaj CGSC with (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 Mr. Anurag Ahluwalia, CGSC with Mr. Tarveen Singh Nanda, Govt Pleader. (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, Adv. for R-1. (M: 8076802450) Mr. Ripudaman Bhardwaj CGSC, Mr. (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 Utkarsh & Mr. Manoj Kumar, Advs versus (105) AND W.P.(C) 436/2024 & CM APPL. 2013/2024 VIKASH KUMAR THROUGH HIS NEXT SH. SANDEEP..... Petitioner versus (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. Developments qua M/s. Sarepta Therapeutics and M/s Hanugen Therapeutics

3. On previous occasions, such as on 10th July 2023, this Court directed M/s. Hanugen Therapeutics/DART to proceed with clinical trials, as the arrangement with ICMR had not materialized, and they sought to proceed on their own through third-party investment as per the contract with BIRAC. Thereafter, on 7th December 2023, this Court directed the ld. Amicus to contact M/s. Hanugen Therapeutics and DART to inquire about the progress of trials of the indigenous therapies for DMD.

4. In relation to M/s. Sarepta Therapeutics, it appeared before the Court on 5th January 2024, and on the said date, Mr. Saurabh Kirpal, the ld. Senior Counsel, presented to the Court a communication/submission on behalf of M/s Sarepta Therapeutics, as forwarded by Mr. Charles Gerrits through its counsel, Mr. Anish Chawla. This Court directed that the said communications be present before the National Rare Diseases’ Committee (hereinafter, ‘NRDC’) and representatives from M/s. Sarepta Therapeutics were also permitted to attend the meeting. A positive development was also noted that M/s. Sarepta Therapeutics had agreed to provide free treatment for 14 patients.

5. On the previous date, i.e., 19th January 2024, it was submitted on behalf of AIIMS that, in terms of the order dated 5th January 2024, AIIMS had placed an order for therapies for 14 children, which M/s. Sarepta has assured would be supplied. Further, the final report of the NRDC was received by the Court. The quotation given by M/s. Sarepta Therapeutics to the NRDC has also been placed on record in a sealed cover. This Court directed as follows:

“8. Today, the final report of the NRDC has been received by the Court. The quotation given by M/s. Sarepta Therapeutics to the NRDC has also been placed on record in a sealed cover.
9. Thus, to facilitate the conclusion of submissions in these writ petitions, let the report of the NRDC, submitted on 5th January 2024, along with the addendum handed over to the Court today, be provided to the ld. Amicus, Ms. Trehan, and Mr. Anand Grover, ld. Sr. Counsel by the Court Master. The said documents shall be handed over so as to enable them to make submissions at the next date of hearing. The said report(s) shall be retained exclusively by these two counsels, and all parties may present their submissions on the next date, referencing the report and the addendum. The said reports shall not be shared by the said counsels with anyone else.
10. Ld. Counsels for the Petitioners, ld. Amicus and the counsels for all the companies, as also the Union of India may make their submissions on the next date of hearing. 11. For the purpose of carrying out the final hearing in these petitions in a smooth manner, it is directed that all parties shall submit electronic copies of their written submissions, along with the copies of any judgments on the email address of the least two days before the next date of hearing.”

6. Ms. Trehan, ld. Amicus has commenced her final arguments.

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.

9. Furthermore, during the hearing, it was further clarified that the report submitted by the NRDC on 5th January 2024, already addresses the concerns of SMA, with specific allocations made for SMA.

10. In terms of the previous orders dated 5th January, 2024 and 19th January, 2024, regarding the treatment for the 14 patients that needed to commence, Mr. Kirpal, ld. Senior Counsel, submits that the orders have been complied with and the medications are being procured for delivery to AIIMS. However, he expresses concern over the potential imposition of custom duties and other charges by the Union of India.

11. On 30th March, 2023, the Ministry of Finance published the following press release[1]: “The Central Government has given full exemption from basic customs duty on all drugs and Food for Special Medical Purposes imported for personal use for treatment of all Rare Diseases listed under the National Policy for Rare Diseases 2021 through a general exemption notification. Ministry of Finance, ‘Customs duty full exemption for all imported drugs & Food for Special Medical Purposes for personal use for treatment of all Rare Diseases’ https://www.pib.gov.in/PressReleasePage.aspx?PRID=1912095#:~:text=The%20Central%20Government %20has%20given,through%20a%20general%20exemption%20notification. In order to avail this exemption, the individual importer has to produce a certificate from Central or State Director Health Services or District Medical Officer/Civil Surgeon of the district. Drugs/Medicines generally attract basic customs duty of 10%, while some categories of lifesaving drugs/vaccines attract concessional rate of 5% or Nil. While exemptions have already been provided to specified drugs for treatment of Spinal Muscular Atrophy or Duchenne Muscular Dystrophy, the Government has been receiving many representations seeking customs duty relief for drugs and medicines used in treatment of other Rare Diseases Drugs or Special Foods required for the treatment of these diseases are expensive and need to be imported. It is estimated that for a child weighing 10 kg, the annual cost of treatment for some rare diseases, may vary from ₹10 lakh to more than ₹1 crore per year with treatment being lifelong and drug dose and cost, increasing with age and weight. This exemption will result in substantial cost savings and provide much needed relief to the patients. The Government has also fully exempted Pembrolizumab (Keytruda) used in treatment of various cancers from basic customs duty.”

12. Further, the Ministry of Finance, Department of Revenue vide gazette notification bearing no. G.S.R. 235 (E) dated 29th March, 2023[2], 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.

16. List on 22nd March, 2024.

17. These are part-heard matters.

PRATHIBA M. SINGH JUDGE FEBRUARY 26, 2024 Rahul/dn https://static.pib.gov.in/WriteReadData/specificdocs/documents/2023/mar/doc2023330177401.pdf