Harshil Mehandiratta & ANR. v. Union Of India & ANR.
$~1 (SB) to 106 (SB) * IN THE HIGH COURT OF DELHI AT NEW DELHI Date of Decision: 22nd March, 2024 (2) W.P.(C) 5315/2020 & CM APPL. 19189/2020, 4237/2023 MASTER ARNESH SHAW Mr. Rahul Malhotra, Advocate.
Mr. Asif Ahmed, Advocate. (M:
9560995495) Mr Saurabh Kirpal, Sr. Adv and Mr Anish Chawla Adv. for Sarepta.
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:
9990755693) (IN ALL THE
MATTERS) (1) CONT.CAS(C) 415/2022 & CM APPL. 18280/2022 MASTER MEDHANSH JHAWAR @ MADHAV THROUGH HIS NATURAL GUARDIAN Mr. Rahul Malhotra, Advocate.
(M: 6370344354) 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) W.P.(C) 11610/2017 & CM APPLs. 27637/2018 FSMA INDIA CHARITABLE TRUST Kumar, Advs. (M: 9811101923) UNION OF INDIA AND ANR.
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) W.P.(C) 2943/2020 & CM APPLs.10227/2020, 6633/2022, 7534/2023 ALISHBA KHAN Mr. Rahul Malhotra, Advocate.
UNION OF INDIA AND ORS.
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) W.P.(C) 7756/2023 & CM APPL. 29934/2023 MASTER PUSPENDER THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. PAWAN KUMAR ..... Respondent
Mr.
Tanveer Oberoi, Adv.
for (AIIMS).
(6) W.P.(C) 8200/2023 & CM APPL. 31454/2023 MASTER DRASHTANT JHALA THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. JAYDEEP SINGH JHALA ..... Respondent Mr.
Tanveer Oberoi, Adv.
for (AIIMS).
(7) W.P.(C) 8947/2023 & CM APPL. 33930/2023 DIVYANSH KARNANI THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. RAJESH KUMAR KARNANI UNION OF INDIA & ORS.
..... Respondent Mr.
Tanveer Oberoi, Adv.
for (AIIMS).
(8) W.P.(C) 8948/2023 & CM APPL. 33931/2023
ARJUN SHARMA THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. SANJEEV SHARMA ..... Petitioner UNION OF INDIA & ANR.
Mr.
Tanveer Oberoi, Adv.
for (AIIMS).
(9) W.P.(C) 8973/2023 & CM APPL. 34025/2023 ADVIK RAYAKAWAR THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. PIYUSH RAYAKAWAR ..... Petitioner UNION OF INDIA & ANR.
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) W.P.(C) 8986/2023 & CM APPL. 34083/2023 LAKSHAY AGARWAL UNION OF INDIA & ANR.
..... Respondent
Mr. Anurag Ahluwalia, CGSC, Mr.
Abhigyan Siddhant, Advocate.
Mr.
Tanveer Oberoi, Adv.
for (AIIMS).
(11) W.P.(C) 8996/2023 & CM APPL. 34122/2023 ADARSH SONI THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. VIJAY KUMAR SONI Mr.
Ripudaman Bhardwaj CGSC with Mr. Kushagra Kumar Adv. for UOI Mr.
Tanveer Oberoi, Adv.
for (AIIMS).
Mr Vedansh Anand, Advocates for UOI.
Mr Abhishek Sharma, Miss Kritya Sinha, Mr. Pranshul Kulshreshtha, Advs. for R-5. (M: 8294621791) (12) 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
Mr. Siddharth Khatana, Adv. for R11. (M- 9811132326) Ms. Amrita Prakash, CGSC Mr.
Tanveer Oberoi, Adv.
for (AIIMS).
Ms. Anvi Garg Adv., Advs for UOI.s (13) W.P.(C) 322/2021 & CM APPL. 812/2021 KESHAV SHARMA AGE 12 YEARS THROUGH HIS NEXT FRIEND AND NATURAL FATHER SANJEEV KUMAR Mr. Ajay Digpaul and Ms. Ishita Pathak, Mr. Kamal Digpaul with Ms.
Swati Kwatra, Advocates for UOI.
Mr.
Tanveer Oberoi, Adv.
for (AIIMS).
(14) W.P.(C) 1491/2021 & CM APPLs. 4291/2021, 8671/2022 MASTER MEDHANSH JHAWAR @ MADHAV ..... Petitioner Mr. Rahul Malhotra, Advocate.
Mr. Tanveer Oberoi, Adv. for (AIIMS).
(15) W.P.(C) 1511/2021 & CM APPLs. 4331/2021, 8616/2022 MASTER KENIT JHAWAR @ KESHAV Mr. Rahul Malhotra, Advocate.
Mr. Rishabh Sahu, Central Govt Sr.
Counsel with Mr Sameer Sharma, Adv. for UOI.
Mr. Ghanshyam Mishra, Adv. for R-1. (M: 9899794006) Mr. Tanveer Oberoi, Adv. for (AIIMS).
(16) W.P.(C) 1611/2021 & CM APPL. 4600/2021 LAKSHYA KUMAR GOYAL, 8 YRS OLD, THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.
VIPIN KUMAR .... Petitioner Mr. Rahul Malhotra, Advocate.
Ms. Bharathi Raju, Sr. Panel Counsel with Mr. Rohit Singh, for UOI.
(M:9868895906) Mr.
Tanveer Oberoi, Adv.
for
(AIIMS).
(17) W.P.(C) 3662/2021 & CM APPLs. 11103/2021, 25590/2021, 32504/2021 PAYEL BHATTACHARYA Mr. Aditya Chatterjee and Mr. Ishaan Karki, Advocates.
UNION OF INDIA & ORS.
Mr. Anuj Aggarwal, ASC, GNCTD, Ms. Ayushi Bansal, Mr. Sanyam Suri and Ms. Arshya Singh, Mr. Siddhant Dutt Advocates for R-2 (M:9891363718).
Mr. Ripudaman Bhardwaj CGSC with Mr. Kushagra Kumar Adv. for UOI Mr.
Tanveer Oberoi, Adv.
for (AIIMS).
(18) 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 Mr. T.P. Singh, Sr. Central Govt.
Counsel for R-1 (M:9971579687).
Mr.
Tanveer Oberoi, Adv.
for (AIIMS).
(19) W.P.(C) 3689/2021 & CM APPL.11179/2021 DHANANJAY BHARDWAJ, 11 YEARS OLD, THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. AMIT KUMAR Mr. Sanjeev Uniyal and Mr. Dhawal Uniyal with Mr. Satyam Pandey Advs for R-1 (M:9560806614).
Mr.
Tanveer Oberoi, Adv.
for (AIIMS).
(20) W.P.(C) 3706/2021 & CM APPL. 11229/2021 KHUSHWANT BHARDWAJ, 7 YEARS OLD, THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. NIKHIL BHARDWAJ Mr. Sanjib Kumar Mohanty, Sr. Panel Counsel with Ms. Anushka Jakhodia,
Mr. Subesh K. Sahood, Adv. for R-1.
Mr.
Tanveer Oberoi, Adv.
for (AIIMS).
(21) W.P. (C) 3707/2021 & CM APPL. 11230/2021 AARAV GARG, 5 YEARS OLD, THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.
VIVEK Mr. Siddharth Khatana, Advocate for UOI. (M:9811132326) Mr.
Tanveer Oberoi, Adv.
for (AIIMS).
(22) 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 Mr.
Tanveer Oberoi, Adv.
for (AIIMS).
(23) W.P.(C) 3737/2021 & CM APPL. 11277/2021 SHOURYA MARU, 7 YEARS OLD, THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. KAMAL KUMAR MARU Mr. Ranvir Singh (CGSC) for R-1.
(M:9818071061) Mr.
Tanveer Oberoi, Adv.
for (AIIMS).
(24) W.P.(C) 3859/2021 & CM APPL. 11647/2021 SIDDHARTH SWARNKAR, 9 YEARS OLD, THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. DINESH KUMAR SWARNKAR ..... Petitioner Mr. Anuj Aggarwal, ASC, GNCTD with Ms. Ayushi Bansal, Mr. Sanyam Suri and Ms. Arshya Singh Advocates for R-1 to 5 (M:9891363718).
Mr.
Tanveer Oberoi, Adv.
for (AIIMS).
(25) 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 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).
Mr.
Tanveer Oberoi, Adv.
for (AIIMS).
(26) 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 Mr.
Tanveer Oberoi, Adv.
for (AIIMS).
(27) W.P.(C) 4259/2021 & CM APPL. 12948/2021 ISHAAN, 10 YEARS OLD, THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. RAJVIR SINGH ..... Respondent Mr.
Tanveer Oberoi, Adv.
for (AIIMS).
Mr. Ripudam Bhardwaj, CGSC with Mr. Vinod Tiwari, Adv. for R-1 & 3.
(28) W.P.(C) 4304/2021 & CM APPL. 13108/2021 TANAV HANDOO, 6 YEARS OLD, THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. AMIT HANDOO Mr. Satya Ranjan, (Sr. Panal Counsel) with Mr. Kautilya Birat, Advs for UOI.
Mr.
Tanveer Oberoi, Adv.
for (AIIMS).
(29) W.P.(C) 4551/2021 & CM APPL. 13949/2021 SHAURYA DAHIYA, 7 YEARS OLD, THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. SATBIR DAHIYA Mr. Avnish Singh, SPC Along with Mr. Mahendra Vikram Singh & Ms.
Kanchan Kumari, Advocate.
(M:8826437138) Mr.
Tanveer Oberoi, Adv.
for (AIIMS).
Mr. Anurag Ahluwalia, CGSC with Tarveen Singh Nanda, Govt. Pleader.
(M: 8826437138) (30) 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 Mr. Ranvir Singh (CGSC) for R-1.
Mr.
Tanveer Oberoi, Adv.
for (AIIMS).
(31) 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 Mr. Tanveer Oberoi, Adv. for (AIIMS).
(32) W.P.(C) 5395/2021 & CM APPL. 16686/2021, 63399/2023 MASTER AYUSHMAN CHATURVEDI Mr. Anurag Ojha, Advocate.
Mr. Deepak Somani, Advocate.
UNION OF INDIA & ORS.
Mr. Niraj Kumar, Sr. Central Govt.
Counsel for UOI.
Mr. Parth Goyal, Adv. for Mr.
Jawahar Raja, ASC(C) GNCTD.
Mr.
Tanveer Oberoi, Adv.
for (AIIMS).
(33) W.P.(C) 9684/2021
AADHYAN JAISWAL 11 YEARS OLD THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH ANIL KUMAR JAISWAL UNION OF INDIA & ORS.
Mr.
Divyam Nandrajog, Panel Counsel, GNCTD with Mr. Mayank Kamra, Adv. for R-2.
Mr.
Tanveer Oberoi, Adv.
for (AIIMS).
(34) 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 Mr. Ripudaman Bhardwaj CGSC with Mr. Kushagra Kumar Adv. for UOI Mr.
Tanveer Oberoi, Adv.
for (AIIMS).
(35) W.P.(C) 1182/2022 & CM APPL. 3442/2022 INSHA MINOR THROUGH HER NEXT FRIEND AND
NATURAL FATHER SH IRSHAD AHMAD SOFI..... Petitioner UNION OF INDIA & ORS.
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) Mr.
Tanveer Oberoi, Adv.
for (AIIMS).
(36) W.P.(C) 1054/2023 and CM APPL. 4164/2023 MASTER TUSHAR THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. JAI PRAKASH Mr. Kirtiman Singh, CGSC with Ms.
Vidhi Jain, Advocate for UOI.
Mr. Ripudaman Bhardwaj CGSC and Mr. Hardik Bedi, GP for UOI.
Mr.
Tanveer Oberoi, Adv.
for (AIIMS)
(37) W.P.(C) 1079/2023 and CM APPL. 4248/2023 MASTER RUDRA PAWAR THROUGH HIS NEXT FRIEND AND NATURAL MOTHER SMT. ANU VISHNOI Dr. Nabendu Sekhar Chatterjee, from ICMR.
Mr. Ripudaman Bhardwaj CGSC and Mr. Hardik Bedi, GP for UOI (38) W.P.(C) 2614/2023 KARAN, 14 YEARS OLD THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. VIJAY KUMAR Ms. Purva Chugh & Ms. Pooja Arora, Advs.
Mr. Nitinjya Chaudhry, Sr Panel Counsel with Mr. Abhishek, GP, Mr.
Rahul Mourya, Adv.
(M9810103680).
Mr. Abhishek Khanna, Adv. for R-1.
Mr. Tanveer Oberoi, Adv. for (AIIMS)
(39) W.P.(C) 4495/2023 & CM APPL.17190/2023 PARAS JAIN THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. SANDEEP JAIN Mr. Raj Kumar, Advocate, SPC, UOI.
Mr. Kirtiman Singh, CGSC with Ms.
Vidhi Jain, Adv. for UOI.
Mr. Tanveer Oberoi& Mr. Jaswinder Singh, Advs. for (AIIMS).
(40) W.P.(C) 4502/2023 & CM APPL.17238/2023 SHREYANSH VERMA THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. DHEERAJ KANT VERMA ..... Petitioner Mr. Raj Kumar Yadav, Ms. Nitya Sharma, Ms.
Jasmine Sheikh Advocate for UOI. (M:9818836222) Mr. Tanveer Oberoi& Mr. Jaswinder Singh, Advs. for (AIIMS).
(41)
W.P.(C) 4526/2023 & CM APPL.17321/2023 MASTER LAKSHYAVED KALISHARAN THROUGH HIS NEXT FRIEND AND NATURAL MOTHER SHILPA RAMESH .... Petitioner 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) Mr. Tanveer Oberoi& Mr. Jaswinder Singh, Advs. for (AIIMS).
(42) W.P.(C) 4535/2023 & CM APPL.17331/2023 MASTER CHINMAY BARUPAL THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. ASHOK KUMAR BARUPAL Ms Monika Arora ( CGSC) & Ms.
Jyoti Tiwari, Adv. for UOI.
Mr. Tanveer Oberoi& Mr. Jaswinder Singh, Advs. for (AIIMS).
(43) W.P.(C) 4536/2023 & CM APPL.17333/2023 MADHAV SHARMA THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. NEERAJ SHARMA Mr. Sushil Raaja, SPC, UOI.
Mr. Tanveer Oberoi& Mr. Jaswinder Singh, Advs. for (AIIMS).
(44) W.P.(C) 4538/2023 & CM APPL.17337/2023 SANDEEP KALIA Mr. Mukul Singh CGSC with Mr.
Majjari Umesh, Ms. Ira Singh, Adv.
for R-1. (M: 9971359513) Mr. Tanveer Oberoi& Mr. Jaswinder Singh, Advs. for (AIIMS).
(45) W.P.(C) 4539/2023 & CM APPL.17340/2023 RAJVEER SRIVASTAVA THROUGH HIS
NEXT FRIEND AND NATURAL FATHER SH. RAJESH KUMAR SRIVASTAVA UNION OF INDIA & ORS.
Mr Mukul Singh (CGSC) with Ms.
Ira Singh, Adv. for UOI. (M:
9971359512) Mr. Mukul Singh CGSC, Ms. Ira Singh, Advocate for R-1.
Mr. Tanveer Oberoi& Mr. Jaswinder Singh, Advs. for (AIIMS).
(46) W.P.(C) 4591/2023 & CM APPL. 17548/2023 VANSH THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. VIPIN KUMAR UNION OF INDIA & ORS.
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.
Mr. Tanveer Oberoi& Mr. Jaswinder
Singh, Advs. for (AIIMS).
(47) W.P.(C) 5102/2023 & CM APPL.19968/2023 PRANSHU NAMDAR THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. PARIXIT NAMDHAR ..... Petitioner Ms. Ritu Reniwal (SPC UOI).
Ms Prerna Dhall & Mr Ripu Dhiman, Advocates (M- 8920466138) Mr. Tanveer Oberoi& Mr. Jaswinder Singh, Advs. for (AIIMS).
(48) W.P.(C) 5726/2023 & CM APPL. 22436/2023 MASTER HARENDER THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. SUNDER SINGH & ANR. ..... Petitioners UNION OF INDIA & ORS.
Mr. Neeraj, SPC along with Mr.
Vedansh Anand and Mr. Mahesh Kumar Rathore, Advs. UOI.
Mr. Tanveer Oberoi, Advocate for (AIIMS).
Mr. Sudarshan Rajan, Mr. Hitain Bajaj and Mr. Mahesh Kumar, Advocates for R-4.
(49) W.P.(C) 5753/2023 & CM APPL. 22528/2023 VINAY THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. MEHAR SINGH UNION OF INDIA & ORS.
Mr Atul Sai Krishna Senior Panel Counsel, Mr Hardik Bedi GP. (M:
8010414123) Mr. Tanveer Oberoi& Mr. Jaswinder Singh, Advs. for (AIIMS).
Mr. Sudarshan Rajan, Mr. Hitain Bajaj and Mr. Mahesh Kumar, Advocates for R-2.
Mr Atul Krishna, SPC with Mr Hardik Bedi, GP for R1 (50) W.P.(C) 6089/2023 & CM APPL. 23902/2023 MASTER SAIANSH THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. AVTAR SINGH MALHOTRA. Petitioner UNION OF INDIA & ORS.
Mr. Kirtiman Singh CGSC, Mr Hardik Bedi GP Mr. Waize Ali Noor,
Ms. Vidhi Jain & Ms. Anvi Garg Adv., Advs for UOI.
Mr. Tanveer Oberoi& Mr. Jaswinder Singh, Advs. for (AIIMS).
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) W.P.(C) 7549/2023 and CM APPL. 29273/2023 MASTER CHUNNU YADAV THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. SANJEEV KUMAR ..... Petitioner Mr. Gokul Sharma (GP) for R-1. (M9045885304) Mr. Tanveer Oberoi(M:9958935556) and Mr. Jaswinder Singh, Advocate (M:9811232066) Ms Prerna Dhall & Mr Ripu Dhiman, Advocates (M- 8920466138) Mr. Ripudaman Bhardwaj CGSC with Mr. Kushagra Kumar Adv. for UOI (52) W.P.(C) 7553/2023 and CM APPL. 29299/2023 MASTER HARSHIT PAWAR THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. PRAVEEN KUMAR ..... Petitioner
Mr. Ripudaman Bhardwaj CGSC with Mr. Kushagra Kumar Adv. for UOI.
Mr. Tanveer Oberoi(M:9958935556) and Mr. Jaswinder Singh, Advocate (M:9811232066) (53) W.P.(C) 7644/2023 and CM APPLS. 29628-29/2023 MASTER SATYAKI ADAK THROUGH HIS NATURAL GUARDIAN Mr. Rahul Malhotra, Advocate.
Mr. Ripudaman Bhardwaj, CGSC with Mr. Kushagra Kumar, and Mr.
Abhinav Bhardwaj, Advs. for UOI.
Mr. Tanveer Oberoi(M:9958935556) and Mr. Jaswinder Singh, Advocate.
Mr. Ankit Verma, Advocate.
(54) W.P.(C) 10031/2023 and CM APPL. 38666/2023 ADITYA KUMAR YADAV THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. PREM SHANKAR
Mr. Rahul Malhotra, Advocate.
Mr. Ripudaman Bhardwaj, CGSC with Mr. Kushagra Kumar, and Mr.
Abhinav Bhardwaj, Advs. for UOI.
Mr. Tanveer Oberoi(M:9958935556) and Mr. Jaswinder Singh, Advocate (M:9811232066) (55) W.P.(C) 10063/2023 and CM APPL. 38727/2023 SUMIT KUMAR SINGH THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. AMARJIT SINGH Mr. Ripudaman Bhardwaj CGSC with Mr. Kushagra Kumar Adv. for UOI Mr. Tanveer Oberoi(M:9958935556) and Mr. Jaswinder Singh, Advocate (M:9811232066) Mr Vedansh Anand, Advocates for UOI.
(56) W.P.(C) 10064/2023 and CM APPL. 38728/2023 ADITYA SONI THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. MUKESH KUMAR SONI..... Petitioner
Mr. Ripudaman Bhardwaj, CGSC with Mr. Kushagra Kumar, and Mr.
Abhinav Bhardwaj, Advs. for UOI.
Mr. Tanveer Oberoi(M:9958935556) and Mr. Jaswinder Singh, Advocate (M:9811232066) (57) W.P.(C) 10606/2023 & CM APPL. 41165/2023 UMANAND KUMAR SONI THROUGH HIS NEXT FRIEND AND NATURAL GRANDFATHER SH. NANDU PRASAD SONI Mr. Vineet Dhanda, CGSC Mr. Tanveer Oberoi(M:9958935556) and Mr. Jaswinder Singh, Advocate (M:9811232066) (58) W.P.(C) 10867/2023 & CM APPL. 42110/2023
PARTH KAMBOJ THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. PARDEEP KUMAR ..... Petitioner ..... Respondent Mr. Tanveer Oberoi(M:9958935556) and Mr. Jaswinder Singh, Advocate (M:9811232066) (59) W.P.(C) 10870/2023 & CM APPL. 42114/2023 PARV INSAN THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. WAZIR SINGH ..... Respondent Mr. Tanveer Oberoi(M:9958935556) and Mr. Jaswinder Singh, Advocate (M:9811232066) (60) W.P.(C) 12222/2023 & CM APPL. 48011/2023 SAKSHAM JANGLA THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. PARVEEN KUMAR ..... Petitioner
UNION OF INDIA & ANR.
(61) W.P.(C) 13172/2023 & CM APPL. 52098/2023 TANUJ THROUGH HIS NEXT FRIEND AND NATURAL FATHER MR. SUDHIR KUMAR & ANR.
..... Petitioners UNION OF INDIA & ANR.
(62) W.P.(C) 13173/2023 & CM APPL. 52099/2023 AMAN MEENA THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. SAMAY SINGH MEENA UNION OF INDIA & ANR.
..... Respondent Mr. Ripudaman Bhardwaj CGSC and Mr. Kushagra Kumar, Ms. Manaswini
Kondepudi, Advs. for UOI.
(63) W.P.(C) 13174/2023 & CM APPL. 52100/2023 HARSHIT RAJPUT THROUGH HIS NEXT FRIEND AND NATURAL MOTHER SMT. MEENA RAJPUT ..... Petitioner UNION OF INDIA & ANR.
(64) W.P.(C) 13175/2023 & CM APPL. 52102/2023 PARMARTH KAPOOR THROUGH HIS NEXT FRIEND AND NATURAL MOTHER MS. SURABHI BHARDWAJ..... Petitioner UNION OF INDIA & ANR.
(65) W.P.(C) 13177/2023 & CM APPL. 52129/2023 HARSHIL MEHANDIRATTA & ANR.
..... Petitioners
UNION OF INDIA & ANR.
Mr. Ripudaman Bhardwaj CGSC with Mr. Kushagra Kumar Adv. for UOI (66) W.P.(C) 13179/2023 & CM APPL. 52133/2023 MANVIK KHANGWAL THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. PARVEEN KUMAR ..... Petitioner UNION OF INDIA & ANR.
(67) W.P.(C) 13180/2023 & CM APPL. 52134/2023 GAURAV KAPOOR UNION OF INDIA & ANR.
Mr. Ripudaman Bhardwaj CGSC with Mr. Kushagra Kumar Adv. for UOI (68) W.P.(C) 13186/2023 & CM APPL. 52141/2023 SOUMYA MISHRA THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. VINOD KUMAR
MISHRA UNION OF INDIA & ANR.
(69) W.P.(C) 13187/2023 & CM APPL. 52142/2023 SUMIT VERMA THROUGH HIS NEXT FRIEND AND NATURAL MOTHER SMT. KRISHNA DEVI UNION OF INDIA & ANR.
(70) W.P.(C) 13188/2023 & CM APPL. 52145/2023 VIKASH MEENA UNION OF INDIA & ANR.
(71) W.P.(C) 13190/2023 & CM APPL. 52148/2023 REHAN THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. VINAY KAMAL Mr. Ripudaman Bhardwaj CGSC with Mr. Kushagra Kumar Adv. for UOI.
(72) W.P.(C) 13191/2023 & CM APPL. 52149/2023 YASH THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. MONU UNION OF INDIA & ANR.
Mr. Ripudaman Bhardwaj CGSC with Mr. Kushagra Kumar Adv. for UOI (73) W.P.(C) 13192/2023 & CM APPL. 52152/2023 AARUSH PRITHWANI THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. BHISHAM PRITHWANI ..... Petitioner
UNION OF INDIA & ANR.
Mr. Ripudaman Bhardwaj CGSC with Mr. Kushagra Kumar Adv. for UOI.
(74) W.P.(C) 13193/2023 & CM APPL. 52153/2023 MANAV PALSANIA THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. AJAY KUMAR PALSANIA..... Petitioner UNION OF INDIA & ANR.
Mr. Ripudaman Bhardwaj CGSC with Mr. Kushagra Kumar Adv. for UOI (75) W.P.(C) 13196/2023 & CM APPL. 52158/2023 HIMANSHU SHARAMA THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. VISHAL SHARAMA ..... Petitioner
UNION OF INDIA & ANR.
Mr. Ripudaman Bhardwaj CGSC with Mr. Kushagra Kumar Adv. for UOI (76) W.P.(C) 13197/2023 & CM APPL. 52159/2023 MRADUL MISHRA ..... Respondent (77) W.P.(C) 13236/2023 & CM APPL. 52311/2023 YASH RAJ SINGH THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. DHARMENDER SINGH ..... Petitioner UNION OF INDIA & ANR.
..... Respondent Mr. Ripudaman Bhardwaj CGSC with Mr. Kushagra Kumar Adv. for UOI (78)
W.P.(C) 13237/2023 & CM APPL. 52314/2023 PARMEET SINGH THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. KULDEEP SINGH UNION OF INDIA & ANR.
(79) W.P.(C) 13239/2023 & CM APPL. 52319/2023 MOHIT THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. SURENDER SINGH UNION OF INDIA & ANR.
(80) W.P.(C) 13240/2023 & CM APPL. 52321/2023 MOHAMMAD ARSHAD THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. MOHAMMAD HANIF ..... Petitioner
UNION OF INDIA & ANR.
(81) W.P.(C) 13259/2023 & CM APPL. 52378/2023 SAHIL THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. MAHESH YADAV UNION OF INDIA & ANR.
(82) W.P.(C) 13260/2023 & CM APPL. 52379/2023 VISHWAS GOYAL THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. MANGLESH GOYAL ..... Petitioner UNION OF INDIA & ANR.
Mr.
Ripudaman Bhardwaj CGSC with Mr. Kushagra Kumar Adv. for UOI.
(83) W.P.(C) 13304/2023 & CM APPL. 52496/2023 VIHAAN GUPTA THROUGH HIS NEXT FRIEND AND
NATURAL FATHER SH. GAURAV KUMAR UNION OF INDIA & ANR.
(84) W.P.(C) 13379/2023 & CM APPL. 52805/2023 SAMEER LAMBA THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. HANSRAJ UNION OF INDIA & ANR.
(85) W.P.(C) 13389/2023 & CM APPL. 52855/2023 SALMAN KHAN THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. HUSAIN ALI UNION OF INDIA & ANR.
Mr. Shubham Prasad, G.P. for UOI.
(M: 9712533333)
(86) W.P.(C) 13417/2023 & CM APPL. 53006/2023 HENIL PATEL THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. PANKAJ KUMAR PATEL UNION OF INDIA & ANR.
Mr. Ripudaman Bhardwaj CGSC with Mr. Kushagra Kumar Adv. for UOI.
Mr. Shubham Prasad, G.P. for UOI.
(M: 9712533333) (87) W.P.(C) 13449/2023 & CM APPL. 53114/2023 HENILKUMAR PRAJAPATI THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. KANAIYALAL PRAJAPATI Mr. Shashank Garg, CGSC for UOI with Mr. Vanshul Pali, Adv. (M:
9711552649) (88) W.P.(C) 13453/2023 & CM APPL. 53123/2023 TIRTH RAVI KHAIRNAR THROUGH HIS NEXT FRIEND AND NATURALFATHER SH. KHAINAR RAVI BHAI..... Petitioners
(89) 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 (90) W.P.(C) 13469/2023 & CM APPL. 53236/2023 JEET GOSAI THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. PRAGNESHGIRI PRAVINGIRI GOSAI ..... Petitioners
(91) AND W.P.(C) 13475/2023 ANUJ KUMAR ..... Petitioners Ms Seema Singh, Adv. UOI R1. (M:
8588871365) Mr. Shashank Garg, CGSC with Mr.
Vanshul Pali, Adv. for R-1.
(92) W.P.(C) 14141/2023 & CM APPL. 55947/2023 TAKSH KAUSHIK THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH VED PRAKASH Mr. Neeraj, SPC along with Mr.
Vedansh Anand and Mr. Mahesh Kumar Rathore, Advs. UOI.
(93) W.P.(C) 15263/2023 & CM APPL. 61134/2023 MOHAMMAD AYAAN SHEIKH THROUGH HIS NEXT FRIEND
AND NATURAL MOTHER MRS. AYESHA SHEIKH..... Petitioner Mr. Tanveer Oberoi(M:9958935556) and Mr. Jaswinder Singh, Advocate (M:9811232066) (94) W.P.(C) 15301/2023 & CM APPL. 61316/2023 SHRESHTH SHARMA THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. DHEERAJ SHARMA ..... Petitioner Mr. Ripudaman Bhardwaj CGSC with Mr. Kushagra Kumar Adv. for UOI.
Mr. Tanveer Oberoi(M:9958935556) and Mr. Jaswinder Singh, Advocate (M:9811232066) (95) W.P.(C) 15302/2023 & CM APPL. 61317/2023 SHIVAM THROUGH HIS NEXT FRIEND AND NATURAL MOTHER SMT. SWATI LOHIA
Mr. Ripudaman Bhardwaj CGSC with Mr. Kushagra Kumar Adv. for UOI.
Mr. Tanveer Oberoi(M:9958935556) and Mr. Jaswinder Singh, Advocate (M:9811232066) (96) W.P.(C) 15315/2023 & CM APPL. 61386/2023 NIKUNJ GUPTA THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. ASHWANI GUPTA Mr. Ripudaman Bhardwaj CGSC with Mr. Kushagra Kumar Adv. for UOI.
Mr. Tanveer Oberoi(M:9958935556) and Mr. Jaswinder Singh, Advocate (M:9811232066) (97) W.P.(C) 15334/2023 & CM APPL. 61502/2023 DEVANSH AGARWAL THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. CHANDRAPRAKASH AGARWAL Mr. Ripudaman Bhardwaj CGSC with Mr. Kushagra Kumar Adv. for UOI.
Mr. Anurag Ahluwalia, CGSC, for R-
Mr. Tanveer Oberoi(M:9958935556) and Mr. Jaswinder Singh, Advocate (M:9811232066) (98) W.P.(C) 15336/2023 & CM APPL. 61505/2023 RAHUL Mr. Ripudaman Bhardwaj CGSC with Mr. Kushagra Kumar Adv. for UOI.
Mr. Tanveer Oberoi(M:9958935556) and Mr. Jaswinder Singh, Advocate (M:9811232066) Ms. Purva Chugh & Ms. Pooja Arora, Advs.
(99) W.P.(C) 15618/2023 & CM APPL. 62576/2023 KULDEEP SINGH NARUKA & ANR.
..... Petitioners Ms. Pratima N Lakra CGSC with Vanya Bajaj, Advs. (M. 9968324260) (100) 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
Mr. Ripudaman Bhardwaj CGSC with Mr. Kushagra Kumar Adv. for UOI.
Mr. Tanveer Oberoi(M:9958935556) and Mr. Jaswinder Singh, Advocate (M:9811232066) Ms. Pratima N Lakra CGSC with Ms Kashish G Baweja, Advocate.
(101) W.P.(C) 14150/2023 & CM APPL. 55962/2023 TANVEER SHARMA THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. DEEPAK SHARMA ..... Petitioners Mr Vedansh Anand, Advocates for UOI.
Mr. Ripudaman Bhardwaj CGSC with Mr. Kushagra Kumar Adv. for UOI (102) W.P.(C) 16267/2023 & CM APPL. 65509/2023 PRINCE PAREEK THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. PANKAJ PAREEK ..... Petitioners Mr. Tanveer Oberoi(M:9958935556)
(103) AND W.P.(C) 16361/2023 & CM APPL. 65805/2023 SARANSH KUMAR THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. SATISH KUMAR MANDAL ..... Petitioners Mr. Tanveer Oberoi(M:9958935556) (104) AND W.P.(C) 55/2024 & CM APPL. 187/2024 BUSHRA KHAN THROUGH HER NEXT FRIEND AND NATURAL FATHER SH. ASHRAT ALI KHAN Mr. Tanveer Oberoi(M:9958935556) (105) AND W.P.(C) 436/2024 & CM APPL. 2013/2024 VIKASH KUMAR THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. SANDEEP (M: 6370344354)
Mr. Ripudaman Bhardwaj CGSC with Mr. Kushagra Kumar Adv. for UOI (106) AND W.P.(C) 479/2024 & CM APPL. 2128/2024 PARTH SAH THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. RAMANAND (M: 6370344354) 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 DMD Petitioners who have received treatment of Rs. 50 lakhs and for whom further medicines are to be provided by M/s Sarepta DMD Petitioners who have been enrolled in clinical trials DMD Petitioners found amenable to treatment 19+16+15=50 DMD Petitioners evaluated as non-amenable to treatment Non-DMD Petitioners who have received treatment of Rs. 50 lakhs and are continuing to receive treatment under orders of this Hon'ble Court Non-DMD Petitioners who have received treatment of Rs. 50 lakhs Non-DMD Petitioners evaluated as nonamenable to treatment Petitioners still under evaluation Patients refused treatment/evaluation Total Meeting between DART and AIIMS 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, PlaceboControlled, 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.
(iii) 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.
(iv) 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/CT11/53/2020 dated 25.08.2020 is annexed herewith and marked as ANNEXURE R-3.
(v) CLINICAL TRIAL AGREEMENT 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.
(vi) 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