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2023 Supreme(Del) 4643

PRATHIBA M. SINGH
Master Arnesh Shaw – Appellant
Versus
Union of India – Respondent


Advocates appeared:
Ms. Shyel Trehan, Mr. Rohan Poddar & Ms. Shivalika Rudrabatla, Advocates, for the Petitioner in W.P.(C) 5315 of 2020 & CM APPL. 19189 of 2020, 4237 of 2023 & CONT.CAS(C) 415/2022 & CM APPL. 18280/2022 & W.P.(C) 11610/2017 & CM APPL. 27637/2018, 44016/2022 & W.P.(C) 2943/2020 & CM APPLs. 10227/2020, 6633/2022, 7534/2023 & W.P.(C) 10782/2020 & CM APPL. 33828/2020 & W.P.(C) 322/2021 & CM APPL. 812/2021 & W.P.(C) 1491/2021 & CM APPLs. 4291/2021, 8671/2022 & W.P.(C) 1511/2021 & CM APPL. 4331/2021, 8616/2022 & W.P.(C) 3662/2021 & CM APPLs. 11103/2021, 25590/2021, 32504/2021 & W.P.(C) 3682/2021 & CM APPL. 11153/2021 & W.P.(C) 3689/2021 & CM APPL.11179/2021 & W.P. (C) 3707/2021 & CM APPL. 11230/2021 & W.P.(C) 3729/2021 & CM APPL. 11269/2021 & W.P.(C) 3737/2021 & CM APPL. 11277/2021 & W.P.(C) 3859/2021 & CM APPL. 11647/2021 & W.P.(C) 4045/2021 & CM APPL. 12213/2021 & W.P.(C) 4067/2021 & CM APPL. 12306/2021 & W.P.(C) 4259/2021 & CM APPL. 12948/2021 & W.P.(C) 4304/2021 & CM APPL. 13108/2021 & W.P.(C) 4551/2021 & CM APPL. 13949/2021 & W.P.(C) 4812/2021 & CM APPL. 14844/2021 & W.P.(C) 5394/2021 & CM APPL. 16683/2021 & W.P.(C) 9684/2021 & W.P.(C) 14317/2021 & CM APPL. 45148/2021, 14521/2023 & W.P.(C) 1182/2022 & CM APPL. 3442/2022 & W.P.(C) 1054/2023 and CM APPL. 4164/2023 & W.P.(C) 1079/2023 and CM APPL. 4248/2023 & W.P.(C) 2614/2023 & W.P.(C) 4495/2023 & CM APPL.17190/2023 & W.P.(C) 4502/2023 & CM APPL.17238/2023 & W.P.(C) 4526/2023 & CM APPL.17321/2023 & W.P.(C) 4535/2023 & CM APPL.17331/2023 & W.P.(C) 4536/2023 & CM APPL.17333/2023 & W.P.(C) 4538/2023 & CM APPL.17337/2023 & W.P.(C) 4539/2023 & CM APPL.17340/2023 & W.P.(C) 4591/2023 & CM APPL. 17548/2023 & W.P.(C) 5102/2023 & CM APPL.19968/2023.
Mr. Asif Ahmed, Advocate, for the Petitioner in W.P.(C) 5315 of 2020 & CM APPL. 19189 of 2020, 4237 of 2023.
Mr. Kirtiman Singh, CGSC, Ms. Vidhi Jain, Advocate, for the UOI in W.P.(C) 5315 of 2020 & CM APPL. 19189 of 2020, 4237 of 2023 & CONT.CAS(C) 415/2022 & CM APPL. 18280/2022 & W.P.(C) 1491/2021 & CM APPLs. 4291/2021, 8671/2022 & W.P.(C) 1054/2023 and CM APPL. 4164/2023 & W.P.(C) 1079/2023 and CM APPL. 4248/2023 & W.P.(C) 4495/2023 & CM APPL.17190/2023 & W.P.(C) 4502/2023 & CM APPL.17238/2023 & W.P.(C) 4526/2023 & CM APPL.17321/2023 & W.P.(C) 4535/2023 & CM APPL.17331/2023 & W.P.(C) 4536/2023 & CM APPL.17333/2023 & W.P.(C) 4538/2023 & CM APPL.17337/2023 & W.P.(C) 4539/2023 & CM APPL.17340/2023 & W.P.(C) 4591/2023 & CM APPL. 17548/2023.
Mr. Ripudaman Bhardwaj CGSC with Mr. Kushagra Kumar Advocates, for the UOI in W.P.(C) 5315 of 2020 & CM APPL. 19189 of 2020, 4237 of 2023 & W.P.(C) 3662/2021 & CM APPLs. 11103/2021, 25590/2021, 32504/2021 & W.P.(C) 14317/2021 & CM APPL. 45148/2021, 14521/2023.
Mr. Tanveer Oberoi, Advocate, for the (AIIMS) in W.P.(C) 5315 of 2020 & CM APPL. 19189 of 2020, 4237 of 2023 & CONT.CAS(C) 415/2022 & CM APPL. 18280/2022 & W.P.(C) 11610/2017 & CM APPL. 27637/2018, 44016/2022 & W.P.(C) 10782/2020 & CM APPL. 33828/2020 & W.P.(C) 322/2021 & CM APPL. 812/2021 & W.P.(C) 1491/2021 & CM APPLs. 4291/2021, 8671/2022 & W.P.(C) 1511/2021 & CM APPL. 4331/2021, 8616/2022 & W.P.(C) 1611/2021 & CM APPL. 4600/2021 & W.P.(C) 3662/2021 & CM APPLs. 11103/2021, 25590/2021, 32504/2021 & W.P.(C) 3682/2021 & CM APPL. 11153/2021 & W.P.(C) 3689/2021 & CM APPL.11179/2021 & W.P.(C) 3706/2021 & CM APPL. 11229/2021 & W.P. (C) 3707/2021 & CM APPL. 11230/2021 & W.P.(C) 3729/2021 & CM APPL. 11269/2021 & W.P.(C) 3737/2021 & CM APPL. 11277/2021 & W.P.(C) 3859/2021 & CM APPL. 11647/2021 & W.P.(C) 4045/2021 & CM APPL. 12213/2021 & W.P.(C) 4067/2021 & CM APPL. 12306/2021 & W.P.(C) 4259/2021 & CM APPL. 12948/2021 & W.P.(C) 4304/2021 & CM APPL. 13108/2021 & W.P.(C) 4551/2021 & CM APPL. 13949/2021 & W.P.(C) 4812/2021 & CM APPL. 14844/2021 & W.P.(C) 5394/2021 & CM APPL. 16683/2021 & W.P.(C) 5395/2021 & CM APPL. 16686/2021 & W.P.(C) 9684/2021 & W.P.(C) 14317/2021 & CM APPL. 45148/2021, 14521/2023 & W.P.(C) 1182/2022 & CM APPL. 3442/2022 & W.P.(C) 1054/2023 and CM APPL. 4164/2023 & W.P.(C) 1079/2023 and CM APPL. 4248/2023 & W.P.(C) 2614/2023 & W.P.(C) 5726/2023 & CM APPL. 22436/2023.
Mr Dharmender Verma Advocate, Mr. Vishal Singh Advocate, Mr. Shantanu Garg Advocate for BIRAC with AR Mr. Amit Kumar in W.P.(C) 5315 of 2020 & CM APPL. 19189 of 2020, 4237 of 2023.
Mr. Rahul Malhotra & Ms. Shruti Gupta, Advocates, for the Petitioner in CONT.CAS(C) 415/2022 & CM APPL. 18280/2022 & W.P.(C) 2943/2020 & CM APPLs. 10227/2020, 6633/2022, 7534/2023 & W.P.(C) 1491/2021 & CM APPLs. 4291/2021, 8671/2022 & W.P.(C) 1511/2021 & CM APPL. 4331/2021, 8616/2022 & W.P.(C) 3682/2021 & CM APPL. 11153/2021.
Mr. Divyam Nandrajog, Panel Counsel, GNCTD with Mr. Mayank Kamra, Advocate, and Mr. Jaswinder Singh, Advocate, for the Respondent-2 in CONT.CAS(C) 415/2022 & CM APPL. 18280/2022 & W.P.(C) 9684/2021.
Dr. Shefali Gulati in person in CONT.CAS(C) 415/2022 & CM APPL. 18280/2022.
Mr. Ashok Agarwal, Mr. Kumar Utkarsh, Ms. Nishtha Jain & Mr. Manoj Kumar, Advocates, for the Petitioner in W.P.(C) 11610/2017 & CM APPL. 27637/2018, 44016/2022 & W.P.(C) 3682/2021 & CM APPL. 11153/2021 & W.P.(C) 3689/2021 & CM APPL.11179/2021.
Mr. Sameer Vashisht, ASC (Civil), GNCTD and Mr. Vanshay Kaul, Advocates, for the Respondent-2 in W.P.(C) 11610/2017 & CM APPL. 27637/2018, 44016/2022.
Mr. Vijay Joshi, Senior Panel Counsel, for the UOI in W.P.(C) 11610/2017 & CM APPL. 27637/2018, 44016/2022.
Mr. Saurabh Chauhan & Mr. Varun Jain, Advocates, for the intervenors in W.P.(C) 11610/2017 & CM APPL. 27637/2018, 44016/2022.
Mr. Anuj Aggarwal, ASC, GNCTD, Ms. Ayushi Bansal, Ms. Arshya Singh, Advocates, for the Respondetn-2 and 4 in W.P.(C) 2943/2020 & CM APPLs. 10227/2020, 6633/2022, 7534/2023 & W.P.(C) 3662/2021 & CM APPLs. 11103/2021, 25590/2021, 32504/2021.
Mr. Ashok Agarwal, Mr. Kumar Utkarsh & Mr. Manoj Kumar, Advocates, for the Petitioner in W.P.(C) 10782/2020 & CM APPL. 33828/2020 & W.P.(C) 322/2021 & CM APPL. 812/2021 & W.P.(C) 3706/2021 & CM APPL. 11229/2021 & W.P. (C) 3707/2021 & CM APPL. 11230/2021 & W.P.(C) 3729/2021 & CM APPL. 11269/2021 & W.P.(C) 3737/2021 & CM APPL. 11277/2021 & W.P.(C) 3859/2021 & CM APPL. 11647/2021 & W.P.(C) 4045/2021 & CM APPL. 12213/2021 & W.P.(C) 4067/2021 & CM APPL. 12306/2021 & W.P.(C) 4259/2021 & CM APPL. 12948/2021 & W.P.(C) 4304/2021 & CM APPL. 13108/2021 & W.P.(C) 4551/2021 & CM APPL. 13949/2021 & W.P.(C) 4812/2021 & CM APPL. 14844/2021 & W.P.(C) 5394/2021 & CM APPL. 16683/2021 & W.P.(C) 9684/2021 & W.P.(C) 14317/2021 & CM APPL. 45148/2021, 14521/2023 & W.P.(C) 1182/2022 & CM APPL. 3442/2022 & W.P.(C) 1054/2023 and CM APPL. 4164/2023 & W.P.(C) 1079/2023 and CM APPL. 4248/2023 & W.P.(C) 4495/2023 & CM APPL.17190/2023 & W.P.(C) 4502/2023 & CM APPL.17238/2023 & W.P.(C) 4526/2023 & CM APPL.17321/2023 & W.P.(C) 4535/2023 & CM APPL.17331/2023 & W.P.(C) 4536/2023 & CM APPL.17333/2023 & W.P.(C) 4538/2023 & CM APPL.17337/2023 & W.P.(C) 4539/2023 & CM APPL.17340/2023 & W.P.(C) 4591/2023 & CM APPL. 17548/2023 & W.P.(C) 5102/2023 & CM APPL.19968/2023 & W.P.(C) 5726/2023 & CM APPL. 22436/2023 & W.P.(C) 5753/2023 & CM APPL. 22528/2023 & W.P.(C) 6089/2023 and CM APPL. 23902/2023.
Ms. Amrita Prakash, CGSC and Mr. Vishal Ashwani Mehta, Advocates, for the Respondent in W.P.(C) 10782/2020 & CM APPL. 33828/2020.
Mr. Ajay Digpaul and Mr. Kamal Digpaul with Ms. Swati Kwatra, Advocates, for the UOI in W.P.(C) 322/2021 & CM APPL. 812/2021.
Mr. Rishabh Sahu, Central Govt Senior Counsel with Mr Sameer Sharma, Advocate, for the UOI in W.P.(C) 1511/2021 & CM APPL. 4331/2021, 8616/2022.
Mr. Ghanshyam Mishra, Advocate with Mr. Babli Chauhan, Advocate, for the Respondent-1 in W.P.(C) 1511/2021 & CM APPL. 4331/2021, 8616/2022.
Mr. Bharathi Raju, Senior Panel Counsel, for the UOI in W.P.(C) 1611/2021 & CM APPL. 4600/2021.
Mr. Aditya Chatterjee and Mr. Ishaan Karki, Advocates, for the Petitioner in W.P.(C) 3662/2021 & CM APPLs. 11103/2021, 25590/2021, 32504/2021.
Mr. T.P. Singh, Senior Central Govt. Counsel, for the Respondent-1 in W.P.(C) 3682/2021 & CM APPL. 11153/2021.
Mr. Sanjeev Uniyal and Mr. Dhawal Uniyal, Advocates, for the Respondent-1 in W.P.(C) 3689/2021 & CM APPL.11179/2021.
Mr. Sanjib Kumar Mohanty, Senior Panel Counsel with Mr. Subesh K. Sahood, Advocates, for the Respondent-1 in W.P.(C) 3706/2021 & CM APPL. 11229/2021.
Mr. Siddharth Khatana, Advocate, for the UOI in W.P. (C) 3707/2021 & CM APPL. 11230/2021.
Mr. Ranvir Singh (CGSC), for the Respondent-1 in W.P.(C) 3737/2021 & CM APPL. 11277/2021.
Mr. Anuj Aggarwal, ASC, GNCTD with Ms. Ayushi Bansal, Mr. Sanyam Suri and Ms. Arshya Singh Advocates, for the Respondent-1 to 5 in W.P.(C) 3859/2021 & CM APPL. 11647/2021.
Mr. Sanjeev Sabharwal, Senior Panel Counsel with Ms. Shweta, Advocate, for the UOI in W.P.(C) 4045/2021 & CM APPL. 12213/2021.
Harish Kumar Garg and Ms. Khushboo Sharma, Advocates, for the UOI in W.P.(C) 4045/2021 & CM APPL. 12213/2021.
Mr. Ripudam Bhardwaj, CGSC with Mr. Vinod Tiwari, Advocates, for the Respondent-1 & 3 in W.P.(C) 4259/2021 & CM APPL. 12948/2021.
Mr. Satya Ranjan, (Senior Panal Counsel) with Mr. Kautilya Birat, Advocates, for the UOI in W.P.(C) 4304/2021 & CM APPL. 13108/2021.
Mr. Avnish Singh, (SCGC) and Ms. Pushpalata Singh, Advocate, for the Respondent in W.P.(C) 4551/2021 & CM APPL. 13949/2021.
Mr. Ranvir Singh (CGSC), for the Respondent-1 in W.P.(C) 4812/2021 & CM APPL. 14844/2021.
Mr. Deepak Somani, Advocate, for the Petitioner in W.P.(C) 5395/2021 & CM APPL. 16686/2021.
Mr. Niraj Kumar, Senior Central Govt. Counsel, for the UOI in W.P.(C) 5395/2021 & CM APPL. 16686/2021.
Ms. Varsha Sharma for Mr. Jawahar Raja, ASC(C), GNCTD in W.P.(C) 5395/2021 & CM APPL. 16686/2021.
Mr. Sanjeev Uniyal & Mr. Dhawal Uniyal, Advocates, for the Respondent-1 in W.P.(C) 1182/2022 & CM APPL. 3442/2022.
Mr Rishikesh Kumar ASC, GNCTD with Ms. Sheenu Priya, Mr Sudhir Mr. Sumit Choudhary, Mr. Sudhir Kumar Shukla, Mr Mohammed Zaid Mr Aditya Raj and Ms. Roshni Haldhar, Advocates, for the Respondent in W.P.(C) 1182/2022 & CM APPL. 3442/2022.
Ripudaman Bhardwaj CGSC with Mr Hardik Bedi GP, for the UOI in W.P.(C) 1054/2023 and CM APPL. 4164/2023 & W.P.(C) 1079/2023 and CM APPL. 4248/2023.
Dr. Nabendu Sekhar Chatterjee, from ICMR in W.P.(C) 1079/2023 and CM APPL. 4248/2023.
Ms. Sonia Sharma, Ms. Neha Chugh, Mr. Vijay Chandra jha & Mr. Tushant, Advocates, for the Petitioner in W.P.(C) 2614/2023.
Mr. Nitinjya Chaudhry, Sr Panel Counsel with Mr. Abhishek, GP, for the Respondent in W.P.(C) 2614/2023.
Mr. Abhishek Khanna, Advocate, for the Respondent-1 in W.P.(C) 2614/2023.
Mr. Raj Kumar, Advocate, SPC, UOI in W.P.(C) 4495/2023 & CM APPL.17190/2023.
Mr. Raj Kumar Yadav, Advocate, for the UOI in W.P.(C) 4502/2023 & CM APPL.17238/2023.
Mr. Virender Pratap Singh Charak and Ms.Shubhra Parashar Advocates, for the UOI in W.P.(C) 4526/2023 & CM APPL.17321/2023.
Ms Monika Arora (CGSC), Mr Yash Tyagi, Advocates, for the Respondent in W.P.(C) 4535/2023 & CM APPL.17331/2023 & W.P.(C) 4591/2023 & CM APPL. 17548/2023.
Mr. Sushil Raaja, SPC, UOI in W.P.(C) 4536/2023 & CM APPL.17333/2023.
Mr. Mukul Singh CGSC, Ms. Ira Singh, Advocates, for the Respondent-1 in W.P.(C) 4538/2023 & CM APPL.17337/2023 & W.P.(C) 4539/2023 & CM APPL.17340/2023 & W.P.(C) 4591/2023 & CM APPL. 17548/2023.
Ms. Ritu Reniwal (SPC UOI) in W.P.(C) 5102/2023 & CM APPL.19968/2023.
Ms. Prerna Dhall, Advocate of UOI in W.P.(C) 5102/2023 & CM APPL.19968/2023.
Mr Neeraj, SPC with Mr. Sahaj Garg & Mr Vedansh Anand, Advocates, for the UOI in W.P.(C) 5726/2023 & CM APPL. 22436/2023.
Mr Atul Krishna Senior Panel Counsel, Mr Hardik Bedi GP, for the Respondent in W.P.(C) 5753/2023 & CM APPL. 22528/2023 & W.P.(C) 6089/2023 and CM APPL. 23902/2023.

Judgement Key Points

The court directed that clinical trials by M/s Hanugen proceed further, BIRAC make its second tranche contribution without delay since funds were arranged by Hanugen, and a meeting be held between Hanugen, BIRAC, and ICMR representatives in the week commencing 22nd May 2023 to chalk out a timetable for clinical trials per approved protocols.[11000768370004] The court further directed the CGSC to file an updated status report by the next hearing after obtaining instructions from BIRAC and ICMR.[11000768370005] The court constituted the National Rare Diseases’ Committee with members including Dr. Nikhil Tandon (Professor-AIIMS), Secretary-Ministry of Health & Family Welfare or nominee, Director General-ICMR, DCGI, and Dr. Madhulika Kabra (Professor-AIIMS).[11000768370019] The Committee's mandate includes procuring therapies/drugs and creating logistical frameworks for treatment, recommending steps for indigenisation of therapies/medicines and accessibility, and periodic review of the National Rare Disease Policy, 2021 with recommendations to the Ministry.[11000768370020] The Committee must urgently address immediate needs of patients whose treatments stopped due to funding issues (per para 16 of 3rd May 2023 order) by contacting providers/manufacturers/distributors to recommence treatment.[11000768370021] The Committee may consult invitees, subject experts, or domain persons, and obtain patient/provider details from counsel/AIIMS/standing counsel as needed.[11000768370022] The Committee shall examine enrolled patients at AIIMS (DMD, SMA, other rare diseases) and modalities for commencing their treatment.[11000768370023][11000768370024] The issue of a wrong vial supplied for the petitioner in W.P.(C) 5395/2021 (to be replaced in next procurement) shall be brought to the Committee's notice.[11000768370025] The Committee's first meeting shall occur between 17th-21st May 2023, with a compilation of all court orders provided by Joint Secretary Mr. Rajiv Manjhi (Ministry of Health & Family Welfare), who shall coordinate as Officiating Secretary until otherwise appointed.[11000768370026] The matters are listed for 29th May 2023 at 2:30 pm.[11000768370026]


JUDGMENT

Prathiba M. Singh J. (Oral)--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 case of the Petitioners is that medicines and therapies for the said diseases are exorbitantly expensive and if the same are not made available, the health and physical well-being of these children would be severely jeopardised. 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.

Trials for Development of Indigenous Therapies

3. On 20th April, 2023, this Court was informed that ICMR is willing to fund the on-site trials of the therapies that are currently being developed by Hanugen-BIRAC. However, manufacturing of the drugs would have to be carried out by the company concerned, and the cost of manufacturing would also have to be borne by the company. On 3rd May, 2023, ld. Counsel for BIRAC submitted that Hanugen has informed BIRAC that it had arranged its share of funds in terms of the Grant-in-aid Letter Agreement (GLA), and that BIRAC is also willing to cont

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