Master Arnesh Shaw v. Union of India & Anr.

Delhi High Court · 05 Jan 2024 · 2024:DHC:98
Prathiba M. Singh
W.P.(C) 5315/2020
2024:DHC:98
constitutional petition_allowed Significant

AI Summary

The Delhi High Court directed immediate provision of free treatment for children with rare diseases, mandated fund release and regulatory transparency, and upheld the State's obligation to ensure uninterrupted access to essential medicines.

Full Text
Translation output
W.P.(C) 5315/2020 & connected matters
HIGH COURT OF DELHI
Date of Decision: 05th January, 2024 (3)
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. Saurabh Kripal, Sr. Advocate
WITH
Mr. Anish Chawla, Advocate for
Sarepta Therapeutics.
Mr. Tanveer Oberoi & Mr. Jaswinder Singh, Advs. for (AIIMS).
Mr. 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, Adv.
WITH
Mr Navneet Pratap Singh, Deputy Drugs
Controller General of India & Mr. Arunachalam C., ACD (I). (M:
9990755693)
JUDGMENT

(2) 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. Waize Ali Noor, Ms. Vidhi Jain & Ms. Anvi Garg Adv., Advs for UOI. 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. (4) 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. Tanveer Oberoi, Adv. Mr. Anand Grover, Sr. Adv. with Mr. Saurabh Chauhan, Mr. Varun Jain, Mr. Rohin Bhatt, Ms. Reny Chauhan, Advs. with Ms. Archana Panda, AR. (M:9971540730) (5) 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, Advocates for R-2 and 4 (M:9891363718). Mr. Tanveer Oberoi, Adv. for (AIIMS). Mr. Kirtiman Singh CGSC, Mr. (6) WITH + W.P.(C) 7756/2023 & CM APPL. 29934/2023 MASTER PUSPENDER THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

PAWAN KUMAR..... Petitioner Through: Mr. Ashok Agarwal, Mr. Kumar versus UNION OF INDIA & ANR...... Respondent Through: Mr. Tanveer Oberoi, Adv. for (AIIMS). (7) 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). (8) 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). (9) 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). (10) 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. Vedansh Anand (GP), for UOI. Mr Neeraj, Mr Sahaj Garg, Mr. Deepanshu Badiwal & Mr Vedansh Anand, Advocates for UOI. (11) WITH + W.P.(C) 8986/2023 & CM APPL. 34083/2023 LAKSHAY AGARWAL..... Petitioner versus Through: Mr. Anurag Ahluwalia, CGSC, Mr. Abhigyan Siddhant, Advocate. (AIIMS). (12) 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. Vedansh Anand (GP), for UOI. (AIIMS). Mr Abhishek Sharma, Miss Kritya Sinha, Mr. Pranshul Kulshreshtha, Advs. for R-5. (M: 8294621791) (13) 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 (14) 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 Mr. Kamal Digpaul with Ms. Swati Kwatra, Advocates for UOI. (AIIMS). (15) WITH + W.P.(C) 1491/2021 & CM APPLs. 4291/2021, 8671/2022 MASTER MEDHANSH JHAWAR @ MADHAV..... Petitioner versus (AIIMS). (16) 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. W.P.(C) 5315/2020 & connected matters Mr. Ghanshyam Mishra, Advocate with Mr. Babli Chauhan, Adv. for R-1. (M: 9899794006) (AIIMS). (17) WITH + 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 versus Through: Ms. Bharathi Raju, Sr. Panel Counsel with Mr. Rohit Singh, for UOI. (M:9868895906) (AIIMS). (18) 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, Advocates for R-2 (M:9891363718). Mr. Ripudaman Bhardwaj CGSC for UOI. (AIIMS). (19) WITH + W.P.(C) 3682/2021 & CM APPL.11153/2021 HARSHIT SONI, 16 YEARS OLD, THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

37,787 characters total

TIKAM CHAND SONI..... Petitioner versus Through: Mr. T.P. Singh, Sr. Central Govt. Counsel for R-1 (M:9971579687). (AIIMS). (20) 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, Advs for R-1 (M:9560806614). (AIIMS). (21) 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 Mr. Subesh K. Sahood, Adv. for R-1. (AIIMS). (22) 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). (23) 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). (24) 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). (25) 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). (26) 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). (27) 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). (28) 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. (29) 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). (30) 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, (SCGC) and Ms. Pushpalata Singh, Advocate. (M:8826437138) (AIIMS). Mr. Anurag Ahluwalia, CGSC with Tarveen Singh Nanda, Govt. Pleader. (M: 8826437138) (31) 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). (32) 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). Ms. Anvi Garg Adv., Advs for UOI. W.P.(C) 5315/2020 & connected matters (33) 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. Ms. Varsha Sharma on behalf of Mr. Parth Goyal for Mr. Jawahar Raja, ASC(C) GNCTD. (AIIMS). (34) 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). (35) 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 Through: Mr. Ripudaman Bhardwaj CGSC for UOI. (AIIMS). (36) 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, 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). (37) 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. Ripudaman Bhardwaj CGSC for UOI. (AIIMS) (38) 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. W.P.(C) 5315/2020 & connected matters Mr. Ripudaman Bhardwaj CGSC, for UOI. (39) 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 (M- 9810103680). Mr. Abhishek Khanna, Adv. for R-1. (AIIMS) (40) 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. (41) 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) (42) 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. Mr. Virender Pratap Singh Charak, Ms. Shubhra Parashar, Mr. Yash Hari Dixit, Mr. Akshay Kumar, Mr. Pushpender Singh Charak, Ms. Pinky Yadav, Advs. (M:

9958458448) (43) WITH + W.P.(C) 4535/2023 & CM APPL.17331/2023 MASTER CHINMAY BARUPAL THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

ASHOK KUMAR BARUPAL..... Petitioner versus Ms Monika Arora ( CGSC), Mr Yash Tyagi, Adv & Mr Subhrodeep, Adv. (44) 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. Mr. Sushil Raaja, SPC, UOI. (45) 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) (46) 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. (47) 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. (48) 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) (49) 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, Mr Sahaj Garg, Mr. Anand and Mr Rudra Paliwal Advocates for UOI. Mr. Tanveer Oberoi, Advocate for (AIIMS). Mr. Sudarshan Rajan, Mr. Hitain Bajaj and Mr. Mahesh Kumar, Advocates for R-4. (50) 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) Mr. Sudarshan Rajan, Mr. Hitain Bajaj and Mr. Mahesh Kumar, Advocates for R-2. (51) 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. Krishna Senior Panel Counsel, Mr Hardik Bedi GP. (M:

8010414123) Mr. Kirtiman Singh, CGSC with Ms. Vidhi Jain, Adv. for UOI. (52) 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) and Mr. Jaswinder Singh, Advs. Ms Prerna Dhall & Mr Ripu Dhiman, Advocates (M- 8920466138) Mr. Ripudaman Bhardwaj CGSC, for UOI. (53) 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 UOI with Ms Prerna Dhall, Adv. (54) 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. (55) 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 (56) 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 Mr. Ripudaman Bhardwaj CGSC with Mr. Vedansh Anand (GP), for UOI. (57) 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 (58) 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) (59) WITH + W.P.(C) 10867/2023 & CM APPL. 42110/2023 PARTH KAMBOJ THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

PARDEEP KUMAR..... Petitioner versus (60) WITH + W.P.(C) 10870/2023 & CM APPL. 42114/2023 PARV INSAN THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

WAZIR SINGH..... Petitioner versus (61) WITH + W.P.(C) 12222/2023 & CM APPL. 48011/2023 SAKSHAM JANGLA THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

PARVEEN KUMAR..... Petitioner versus (62) WITH + W.P.(C) 13172/2023 & CM APPL. 52098/2023 TANUJ THROUGH HIS NEXT FRIEND AND NATURAL FATHER MR.

SUDHIR KUMAR & ANR...... Petitioners versus (63) 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 UOI. (64) WITH + W.P.(C) 13174/2023 & CM APPL. 52100/2023 HARSHIT RAJPUT THROUGH HIS NEXT FRIEND AND NATURAL MOTHER SMT.

MEENA RAJPUT..... Petitioner versus (65) WITH + W.P.(C) 13175/2023 & CM APPL. 52102/2023 PARMARTH KAPOOR THROUGH HIS NEXT FRIEND AND NATURAL MOTHER MS.

SURABHI BHARDWAJ..... Petitioner versus (66) WITH + W.P.(C) 13177/2023 & CM APPL. 52129/2023 HARSHIL MEHANDIRATTA & ANR...... Petitioners versus UOI. (67) WITH + W.P.(C) 13179/2023 & CM APPL. 52133/2023 MANVIK KHANGWAL THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

PARVEEN KUMAR..... Petitioner versus (68) WITH + W.P.(C) 13180/2023 & CM APPL. 52134/2023 GAURAV KAPOOR..... Petitioner versus Through: Mr. Ripudaman Bhardwaj CGSC, for UOI. (69) WITH + W.P.(C) 13186/2023 & CM APPL. 52141/2023 SOUMYA MISHRA THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

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

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

VINAY KAMAL..... Petitioner versus UOI. (73) WITH + W.P.(C) 13191/2023 & CM APPL. 52149/2023 YASH THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. MONU..... Petitioner versus UOI. (74) WITH + W.P.(C) 13192/2023 & CM APPL. 52152/2023 AARUSH PRITHWANI THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

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

AJAY KUMAR PALSANIA..... Petitioner versus Through: Mr. Ripudaman Bhardwaj, for UOI. (76) WITH + W.P.(C) 13196/2023 & CM APPL. 52158/2023 HIMANSHU SHARAMA THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

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

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

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

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

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

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

MANGLESH GOYAL..... Petitioner versus UOI. (84) WITH + W.P.(C) 13304/2023 & CM APPL. 52496/2023 VIHAAN GUPTA THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

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

HUSAIN ALI..... Petitioner versus Through: Mr. Shubham Prasad, G.P. for UOI. (M: 9712533333) Ms. Anvi Garg Adv., Advs for UOI. W.P.(C) 5315/2020 & connected matters (87) 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 UOI Mr. Shubham Prasad, G.P. for UOI. (88) WITH + W.P.(C) 13449/2023 & CM APPL. 53114/2023 HENILKUMAR PRAJAPATI THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

KANAIYALAL PRAJAPATI..... Petitioner versus Through: Mr. Shashank Garg, CGSC for UOI with Mr. Vanshul Pali, Adv. (89) WITH + W.P.(C) 13453/2023 & CM APPL. 53123/2023 TIRTH RAVI KHAIRNAR THROUGH HIS NEXT FRIEND AND NATURALFATHER SH.

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

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

PRAGNESHGIRI PRAVINGIRI GOSAI.... Petitioners versus (92) AND + W.P.(C) 13475/2023 ANUJ KUMAR..... Petitioners versus Ms Seema Singh, Adv. UOI R[1]. (M:

8588871365) Mr. Shashank Garg, CGSC with Mr. Vanshul Pali, Adv. for R-1. (93) WITH + W.P.(C) 14141/2023 & CM APPL. 55947/2023 TAKSH KAUSHIK THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH VED PRAKASH..... Petitioner versus Through: None. (94) WITH + W.P.(C) 15263/2023 & CM APPL. 61134/2023 MOHAMMAD AYAAN SHEIKH THROUGH HIS NEXT FRIEND AND NATURAL MOTHER MRS.

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

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

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

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

CHANDRAPRAKASH AGARWAL..... Petitioner versus (99) WITH W.P.(C) 15336/2023 & CM APPL. 61505/2023 RAHUL..... Petitioner versus Mr. Anurag Ahluwalia, CGSC with Mr. Tarveen Singh Nanda, GP. (100) 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, Adv. (M. 9968324260) (101) WITH W.P.(C) 15639/2023 & CM APPL. 62620/2023 KARAN SONI THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

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

DEEPAK SHARMA..... Petitioners versus Through: Mr Vedansh Anand, Adv. for R-1. (M: 8076802450) (105) WITH W.P.(C) 16267/2023 & CM APPL. 65509/2023 PRINCE PAREEK THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

PANKAJ PAREEK..... Petitioners versus Through: Mr. Tanveer Oberoi, Adv. for AIIMS. W.P.(C) 5315/2020 & connected matters (106) AND W.P.(C) 16361/2023 & CM APPL. 65805/2023 SARANSH KUMAR THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

SATISH KUMAR MANDAL..... Petitioners versus Through: Mr. Tanveer Oberoi Advs. 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 has been filed by the Petitioners who are children suffering from rare diseases. The Petitioners, who are in their tender years are facing hardships that are both physically daunting and emotionally taxing. The condition of the Petitioners is deepened by the rarity and complexity of their conditions. 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. In the present batch of cases, the Court is not only focused on providing immediate relief to the Petitioners in the form of access to necessary treatments and medications but is also attempting a holistic and comprehensive solution to ensure equitable access to drugs needed for persons with rare diseases. Communication from M/s. Sarepta Therapeutics

3. Vide order dated 2nd November, 2023, this Court recorded the stand of the Union of India, wherein the Court was informed of a positive development regarding the treatment of children with Duchenne muscular dystrophy (hereinafter, ‘DMD’). It was stated that M/s Sarepta Therapeutics had agreed to provide free therapy for 14 children who had already begun treatment, covering a three-month period. It was also understood that M/s Sarepta Therapeutics had committed to continue treating these patients for the next three months, and supply the medication free of cost. Accordingly, Dr. Madhulika Kabra, AIIMS was asked to expedite the procurement of medicines for these 14 patients to resume their treatment and place the order for therapies within one week. Additionally, the National Rare Diseases’ Committee (hereinafter, ‘NRDC’) was instructed to present its final proposal before the next hearing based on their ongoing discussions with companies.

4. Further, as per status report dated 6th December, 2023 filed by AIIMS, vide email dated 5th December 2023, M/s Sarepta Therapeutics communicated to Dr. Madhulika Kabra, AIIMS that M/s Sarepta Therapeutics would be willing to provide 3 months’ free treatment to the 14 DMD patients, if a path forward could be agreed upon for all the patients that were identified.

5. Thereafter, on 7th December 2023, Mr. Charles Gerrits from M/s Sarepta Therapeutics appeared online via the video-conferencing link. On the said date, it was clarified that if M/s Sarepta Therapeutics wished to be heard, they would need to engage a counsel for representation before this Court.

6. As recorded in the previous order, the NRDC submitted a note to the Court, containing quotations from various manufacturers for treatments of specific medical conditions. The said note, provided in a sealed cover, details the best prices offered to the Union of India for diseases like Gaucher’s Disease, Pompe’s Disease, Fabry’s Disease, and Spinal Muscular Atrophy (both drug and gene therapy). This Court further noted that M/s Sarepta Therapeutics had given a quotation to the NRDC for Duchenne Muscular Dystrophy (‘DMD’) treatment under the condition of confidentiality. Consequently, no financial figures for DMD treatment were available on the last hearing for the Court's consideration.

7. The said note prepared by the NRDC also stated that the final report has been prepared and is pending approval from competent authorities, and further time was sought to place the same on record. Thus, on the last date, this Court directed that the NRDC’s final report be submitted. The MoHFW and other competent authorities were also directed to expedite the processing and approval of the NRDC’s report.

8. Today, M/s Sarepta Therapeutics is represented before this Court. Mr. Saurabh Kripal, ld. Sr. Counsel, has handed over to the Court a communication/submission on behalf of M/s. Sarepta Therapeutics, as sent by Mr. Charles Gerrits, through its counsel- Mr. Anish Chawla.

9. The court has perused the terms contained in the said email. In terms thereof, the following directions are issued: i. Let the said communication/submission, including two emails dated 4th January, 2024 be placed before the NRDC on 8th January, 2024, when the next meeting is scheduled. ii. Representatives of M/s. Sarepta Therapeutics, along with ld. Counsel Mr. Anish Chawla, may attend the meeting either online or physically or through hybrid mode.

10. The final report of the NRDC has been handed over to the Court by Mr. Kirtiman Singh, ld. Counsel in a sealed cover. The Court has also perused through the final report. In respect of the above development, and communication from M/s. Sarepta Therapeutics, the NRDC is free to conduct its negotiations with M/s. Sarepta Therapeutics, and thereafter, place its report in respect of DMD as well.

11. In view of the order passed above, the Court defers orders on the final report. Orders shall be passed after perusing the same and after the NRDC holds negotiations with M/s. Sarepta Therapeutics.

12. In the meantime, it is directed that the NRDC shall place before the Court on record, the final negotiated price for each of the rare diseases negotiated by them, with the respective companies, in a sealed cover at least two days before the next date of hearing.

13. In a positive development, M/s. Sarepta Therapeutics has also agreed to provide free treatment for 14 patients for three months. The following are the 14 patients suffering from DMD for whom free treatment shall be provided:

S. No. Case No. Petitioner Name

1 W.P.(C) 5315/2020 Master Arnesh Shaw 2 W.P.(C) 322/2021 Keshav Sharma 3 W.P.(C) 1611/2021 Lakshya Kumar Goyal 4 W.P.(C) 3682/2021 Harshit Soni 5 W.P.(C) 3689/2021 Dhananjay Bhardwaj 6 W.P.(C) 3729/2021 Manish 7 W.P.(C) 3729/2021 Chirag 8 W.P.(C) 3859/2021 Siddharath Swarankar 9 W.P.(C) 4067/2021 Anshu 10 W.P.(C) 4259/2021 Ishaan 11 W.P.(C) 4812/2021 Nikhil Yogender Singh 12 W.P.(C) 5394/2021 Udayveer Singh Guleria 13 W.P.(C) 5395/2021 Master Ayushman Chaturvedi 14 W.P.(C) 14317/2021 Shreyansh Aarav

14. Accordingly, let Dr. Kabra proceed, place the required order on M/s. Sarepta Therapeutics. Mr. Anish Chawla is directed to provide all necessary assistance to Dr. Kabra and the Petitioners, so as to enable them to receive the required treatment.

15. In terms of the orders dated 7th December, 2023 and 2nd November, 2023, the supplies of the drugs shall, therefore, be made within a period of two weeks by M/s. Sarepta Therapeutics.

16. Let the electronic record of W.P.(C) 5315/2020 titled “Master Arnesh Shaw v. Union of India” be obtained by the counsels appearing for M/s. Sarepta Therapeutics. If they wish to make any submissions on the next date they may do so.

17. The email dated 4th January, 2024 which has been handed over to the Court by M/s. Sarepta Therapeutics’ counsel shall be kept in safe custody of the Court Master. The email dated 4th January, 2024 shall be communicated to the Committee by tomorrow i.e., 6th January, 2024. Continuation of treatment

18. On 2nd November 2023, this Court directed, inter alia, that AIIMS shall commence the procurement of medicines for all those patients/Petitioners whose evaluations had been completed and were amenable to treatment. The said directions were to be carried out as per the fund allocation of Rs.50 lakhs per patient, in accordance with the Rare Diseases Policy, 2021.

19. Vide order dated 7th December, 2023, this Court directed that AIIMS shall continue the treatment of patients suffering from rare diseases, except DMD, for whom treatment had already commenced. Further, the MoHFW was directed to release the necessary funds to AIIMS, to ensure that there was no interruption in the ongoing treatment.

20. Today, an affidavit dated 4th January, 2024 has been placed before the Court. As per the said affidavit, subsequent to the last hearing, AIIMS, New Delhi, received Rs. 25 Crores for the financial year 2023-24, specifically for treating patients with rare diseases. The said fund is in addition to Rs. 10 Crores already released for the same financial year. The said affidavit reads as follows:

“3. The Answering Respondent further respectfully submits that subsequent to the last date of hearing an amount of Rs. 25 Crores has been remitted to AIIMS, New Delhi for the Financial Year 2023-24 subject to the condition that the funds are to be utilized for the treatment of rare diseases patients by AIIMS in a manner as deemed appropriate by the Medical Experts at AIIMS, New Delhi. Copy of letter dated 11.12.2023 and sanction order dated 22.12.2023 are annexed herewith and marked as Annexure - 2 (COLLY). It is relevant to mention that this amount is in addition to the amount of Rs. 10 Crores that had already been released for the Financial Year 2023-24 and in respect of which an affidavit dated 10.05.2023 was filed placing the same on record. 4. It is respectfully submitted that in terms of the order dated 07.12.2023 passed by this Hon'ble Court, it was directed that the issue of unspent amount from the budget for Rare Diseases be dealt with in the final report of the NRDC. The relevant portion of the order dated 07.12.2023 is reproduced hereunder: - “23. In so far as the Rare Diseases Fund (hereinafter, 'RDF') is concerned, this Court has repeatedly observed that more than Rs. 200 crores of unspent amount from the
budget for rare diseases continues to remain with the MoHFW and the same has not been released. The said issues shall be dealt with in the final report of the NRDC."
5. In terms of the directions of this Hon'ble Court, it is respectfully submitted that in regard to transferring the entire unspent funds from the previous years' budgetary allocation to provide treatment for eligible patients diagnosed with treatable conditions, it is stated that unspent balance of the previous year's budget in respect of each and every Ministry/Department, attached and subordinate bodies of Government of India is governed by the provisions of the General Financial Rules (GFR), 2017, which prohibit accumulation of the funds across financial years. It is further stated that the funds provided during the financial year and not utilized before the close of that financial year, shall stand lapsed at the close of the financial year in terms of Rule No. 62(1) of GFR.
6. In view of the afore mentioned facts and circumstances, it is most respectfully prayed that this Hon'ble Court may be pleased to pass such other and further orders as it may deem fit and proper.” Clinical Trials

21. Vide order dated 6th March, 2023, this Court noted that the DART trial had already been approved by the Drugs Controller General of India (hereinafter, ‘DCGI’), and therefore, directed the NRDC to hold a meeting on clinical trials for developing indigenous therapies for rare diseases including DMD and Gaucher with DART/ Hanugen Therapeutics Pvt. Ltd. Keeping this development in mind, on the last date, this Court directed as follows: “16. Today, given M/s Sarepta Therapeutics’ stance, insofar as status of Clinical trials for DMD, ld. Amicus is advised to contact Hanugen Therapeutics Pvt. Ltd. and DART to inquire about the progress of trials of the indigenous therapies for DMD.

17. Hanugen Therapeutics Pvt. Ltd and/or DART are free to appear before the Court on the next date for the provide the status of the said trials.

18. Insofar as the DGCI is concerned, there is no representation despite specific orders of the Court on 2nd November, 2023. Repeatedly, the DCGI has been asked to place on record the details of all the trials taking place in India for DMD, in respect of approvals for trials sought by different manufacturers. However, till date, no such affidavit is forthcoming by the DCGI.

19. Upon specific directions issued by the Court, during the hearing, Dr. Rajeev Raghuvanshi, DCGI joined online and submitted that the data in respect of all the pending trials for the rare diseases is available with the DCGI, and that the same would be placed on record within a week.

20. The Court notes the communication from M/s Sarepta Therapeutics dated 10th May, 2023, addressed to one of the Petitioners, stating that at least two clinical trials for the treatment of DMD are being conducted in India without a placebo control group.

21. Let the DCGI include details of all the Clinical trials for the treatment of DMD by Sarepta Therapeutics or any other entity in its report. Further, specific information shall be given in the said report, specifying if the said trials are ‘open to recruitment’ and, if so, the number of participants from India that can be enrolled in the said Clinical trial. The DCGI shall submit as to the manner in which the recruitment for the trials can be maximised.

22. Let the DCGI place on record a status report concerning all Clinical Trials concerning DMD as a last opportunity within two weeks.”

22. Today, the DCGI has filed its affidavit dated 21st December, 2023, stating that four trials are currently ongoing in respect of DMD. The said affidavit reads as under: Details of all the Clinical trials taking place in India for treatment of Duchenne Muscular Dystrophy (DMD) is as below:._

23. The ld. Amicus Curiae Ms. Trehan submits that there is no access to information for the patients suffering from rare diseases in respect of the companies conducting clinical trials. Patients often lack crucial information about these complex trials, hindering their decision-making process. To address this, the ld. Amicus suggests that the DGCI ought to take further steps to establishing a mechanism for expanded trials, which would allow more Petitioners to participate. Status Report on behalf of AIIMS:

24. Vide order dated 7th December, 2023, this Court directed the AIIMS, New Delhi to, inter alia, place on record a report as to the feasibility of providing treatment to the Petitioners in W.P.(C) 15263/2023, W.P.(C) 15301/2023, W.P.(C) 15302/2023, W.P.(C) 15315/2023, W.P.(C) 15334/2023, W.P.(C) 15336/2023, W.P.(C) 15618/2023, W.P.(C) 15639/2023.

25. The relevant extract of the status report dated 4th January, 2024 is as follows:

26. List for hearing on 19th W.P.(C) 16267/2023 & CM APPL. 65509/2023 W.P.(C) 16361/2023 & CM APPL. 65805/2023

27. These are fresh petitions filed by children who are suffering from rare diseases seeking directions to the Respondents to provide continuous and uninterrupted treatment to them.

28. Issue notice. Let AIIMS examine the case of these patients and place its report by the next date of hearing.

29. List for hearing on 19th PRATHIBA M. SINGH JUDGE JANUARY 05, 2024 dj/dn/am