Advocates appeared:
CONT.CAS(C) 415/2022 & CM APPL. 18280/2022
Mr. Rahul Malhotra & Ms. Tanya Kumari, Ms. Shyel Trehan, Mr. Rohan Poddar & Ms. Shivalika Rudrabatla, Advocates, for the Petitioner.
Mr. Kirtiman Singh, CGSC, Ms. Vidhi Jain, Advocate for UOI.
Mr. Rajiv Manjhi, Joint Secretary, Ministry of Health and Family Welfare in person.
Mr. Divyam Nandrajog, Panel Counsel, GNCTD with Mr. Mayank Kamra, Advocate for R-2.
Mr. Tanveer Oberoi and Mr. Jaswinder Singh, Advocates, for the Petitioner.
Dr. Madhulika Kabra and Dr. Shefali Gulati in person.
W.P.(C) 5315/2020 & CM APPL. 19189/2020, 4237/2023, 7519/2023
Mr. Rahul Malhotra & Ms. Tanya Kumari, Advocates, Ms. Shyel Trehan, Mr. Rohan Poddar & Ms. Shivalika Rudrabatla, Advocates, Mr. Sidharth Luthra, Senior Advocate with Mr. Asif Ahmed, Mr. Akshat Kumar, Mr. Karanvir Gogia, Mr. Kushagra Raghuvanshi, Advocates, for the Petitioner.
Ms. Nidhi Raman CGSC with Mr. Rudra Paliwal, Advocates,
Mr. Kirtiman Singh, CGSC, Ms. Vidhi Jain, Advocate for UOI.
Mr. Ripu Daman Bhardwaj, CGSC for UOI.
Mr. Tanveer Oberoi, Advocate for (AIIMS).
Mr. Abhishek Yadav and Mr. Amit Kumar, Advocates for BIRAC.
Dr. Kanika, AIIMS.
Dr. Madhulika Kabra, (AIIMS).
Dr. Sheffali Gulati, (AIIMS).
Mr. Rajiv Manjhi, Joint Secretary, Ministry of Health and Family Welfare.
Mr. Arvind Singh Tanwar, Official from the Ministry.
W.P.(C) 11610/2017 & CM APPL. 27637/2018, 44016/2022
Mr. Ashok Agarwal, Mr.Kumar Utkarsh & Mr. Manoj Kumar, Advocates, Ms. Shyel Trehan, Mr. Rohan Poddar & Ms. Shivalika Rudrabatla, Advocates, for the Petitioner.
Mr. Vanshay Kaul, Advocate for Mr. Sameer Vashisht, ASC, Civil GNCTD.
Mr. Vijay Joshi, Senior Panel Counsel of UOI with Mr. Kuldeep Singh, Advocate, for the Respondents.
Mr. Tanveer Oberoi, Advocate for (AIIMS).
Mr. Saurabh Chauhan, Mr. Varun Jain, Advocates for the Intervenors
W.P.(C) 2943/2020 & CM APPLs. 10227/2020, 6633/2022, 7534/2023
Mr. Rahul Malhotra & Ms. Tanya Kumari, Advocates, Ms. Shyel Trehan, Mr. Rohan Poddar & Ms. Shivalika Rudrabatla, Advocates, for the Petitioner.
Mr. Anuj Aggarwal, ASC, GNCTD, Ms. Ayushi Bansal, Mr. Sanyam Suri and Ms. Arshya Singh, Advocates for R-2 and 4.
Mr. Tanveer Oberoi, Advocate for (AIIMS).
W.P.(C) 10782/2020 & CM APPL. 33828/2020
Mr. Ashok Agarwal, Mr. Kumar Utkarsh & Mr. Manoj Kumar, Advocates, Ms. Shyel Trehan, Mr. Rohan Poddar & Ms. Shivalika Rudrabatla, Advocates, for the Petitioner.
Mr. Amrita Prakash, CGSC and Mr. Vishal Ashwani Mehta, Advocates, for Respondents.
Mr. Tanveer Oberoi, Advocate for (AIIMS).
W.P.(C) 322/2021 & CM APPL. 812/2021
Mr. Ashok Agarwal, Mr. Kumar Utkarsh & Mr. Manoj Kumar, Advocates, Ms. Shyel Trehan, Mr. Rohan Poddar & Ms. Shivalika Rudrabatla, Advocates, for the Petitioner.
Mr. Ajay Digpaul and Mr. Kamal Digpaul with Ms. Swati Kwatra, Advocates for UOI.
Mr. Tanveer Oberoi, Advocate for (AIIMS).
W.P.(C) 1491/2021 & CM APPLs. 4291/2021, 8671/2022
Mr. Rahul Malhotra & Ms. Tanya Kumari, Advocates, Ms. Shyel Trehan, Mr. Rohan Poddar & Ms. Shivalika Rudrabatla, Advocates, for the Petitioner.
Mr. Kirtiman Singh & Ms. Vidhi Jain, Advocates, for the Respondents.
Mr. Tanveer Oberoi, Advocate for (AIIMS).
W.P.(C) 1511/2021 & CM APPL. 4331/2021, 8616/2022
Mr. Rahul Malhotra, Advocate, Ms. Shyel Trehan, Mr. Rohan Poddar & Ms. Shivalika Rudrabatla, Advocates, for the Petitioner.
Mr. Rishabh Sahu, Central Govt Senior Counsel with Mr Sameer Sharma, Advocate for UOI.
Mr. Ghanshyam Mishra, Advocate for R-1.
Mr. Tanveer Oberoi, Advocate for (AIIMS).
W.P.(C) 1611/2021 & CM APPL. 4600/2021
Mr. Ashok Agarwal, Mr. Kumar Utkarsh & Mr. Manoj Kumar, Advocates, Ms. Shyel Trehan, Mr. Rohan Poddar & Ms. Shivalika Rudrabatla, Advocates, for the Petitioner.
Mr. Bharathi Raju, Senior Panel Counsel with Mr. Rohit Singh, Advocate for UOI.
Mr. Tanveer Oberoi, Advocate for (AIIMS).
W.P.(C) 3662/2021 & CM APPLs. 11103/2021, 25590/2021, 32504/2021
Mr. Aditya Chatterjee and Mr. Ishaan Karki, Advocates, Ms. Shyel Trehan, Mr. Rohan Poddar & Ms. Shivalika Rudrabatla, Advocates, for the Petitioner.
Mr. Anuj Aggarwal, ASC, GNCTD, Ms. Ayushi Bansal, Mr. Sanyam Suri and Ms. Arshya Singh, Advocates for R-2.
Mr. Ripu Daman Bhardwaj (CGSC) for UOI.
Mr. Tanveer Oberoi, Advocate for (AIIMS).
W.P.(C) 3682/2021 & CM APPL. 11153/2021
Mr. Ashok Agarwal, Mr. Kumar Utkarsh & Mr. Manoj Kumar, Advocates, Ms. Shyel Trehan, Mr. Rohan Poddar & Ms. Shivalika Rudrabatla, Advocates, for the Petitioner.
Mr. T.P. Singh, Senior Central Govt. Counsel for R-1.
Mr. Tanveer Oberoi, Advocate for (AIIMS).
W.P.(C) 3689/2021 & CM APPL.11179/2021
Mr. Ashok Agarwal, Mr. Kumar Utkarsh & Mr. Manoj Kumar, Advocates, Ms. Shyel Trehan, Mr. Rohan Poddar & Ms. Shivalika Rudrabatla, Advocates, for the Petitioner.
Mr. Sanjeev Uniyal and Mr. Dhawal Uniyal, Advs for R-1.
Mr. Tanveer Oberoi, Advocate for (AIIMS).
W.P.(C) 3706/2021 & CM APPL. 11229/2021
Mr. Ashok Agarwal, Mr. Kumar Utkarsh & Mr. Manoj Kumar, Advocates, Ms. Shyel Trehan, Mr. Rohan Poddar & Ms. Shivalika Rudrabatla, Advocates, for the Petitioner.
Mr. Tanveer Oberoi, Advocate for (AIIMS).
W.P. (C) 3707/2021 & CM APPL. 11230/2021
Mr. Ashok Agarwal, Mr. Kumar Utkarsh & Mr. Manoj Kumar, Advocates, Ms. Shyel Trehan, Mr. Rohan Poddar & Ms. Shivalika Rudrabatla, Advocates, for the Petitioner.
Mr. Siddharth Khatana, Advocate for UOI.
Mr. Tanveer Oberoi, Advocate for (AIIMS).
W.P.(C) 3729/2021 & CM APPL. 11269/2021
Mr. Ashok Agarwal, Mr. Kumar Utkarsh & Mr. Manoj Kumar, Advocates, Ms. Shyel Trehan, Mr. Rohan Poddar & Ms. Shivalika Rudrabatla, Advocates, for the Petitioner.
Mr. Tanveer Oberoi, Advocate for (AIIMS).
W.P.(C) 3737/2021 & CM APPL. 11277/2021
Mr. Ashok Agarwal, Mr. Kumar Utkarsh & Mr. Manoj Kumar, Advocates, Ms. Shyel Trehan, Mr. Rohan Poddar & Ms. Shivalika Rudrabatla, Advocates, for the Petitioner.
Mr. Ranvir Singh (CGSC) for R-1.
Mr. Tanveer Oberoi, Advocate for (AIIMS).
W.P.(C) 3859/2021 & CM APPL. 11647/2021
Mr. Ashok Agarwal, Mr. Kumar Utkarsh & Mr. Manoj Kumar, Advocates, Ms. Shyel Trehan, Mr. Rohan Poddar & Ms. Shivalika Rudrabatla, Advocates, for the Petitioner.
Mr. Anuj Aggarwal, ASC, GNCTD with Ms. Ayushi Bansal, Mr. Sanyam Suri and Ms. Arshya Singh Advocates for R-1 to 5.
Mr. Tanveer Oberoi, Advocate for (AIIMS).
W.P.(C) 4045/2021 & CM APPL. 12213/2021
Mr. Ashok Agarwal, Mr. Kumar Utkarsh & Mr. Manoj Kumar, Advocates, Ms. Shyel Trehan, Mr. Rohan Poddar & Ms. Shivalika Rudrabatla, Advocates, for the Petitioner.
Mr. Sanjeev Sabharwal, Senior Panel Counsel with Ms. Shweta, Advocate for UOI.
Mr. Harish Kumar Garg and Ms. Khushboo Sharma, Advocates for UOI.
Mr. Tanveer Oberoi, Advocate for (AIIMS).
W.P.(C) 4067/2021 & CM APPL. 12306/2021
Mr. Ashok Agarwal, Mr. Kumar Utkarsh & Mr. Manoj Kumar, Advocates, Ms. Shyel Trehan, Mr. Rohan Poddar & Ms. Shivalika Rudrabatla, Advocates, for the Petitioner.
Mr. Tanveer Oberoi, Advocate for (AIIMS).
W.P.(C) 4259/2021 & CM APPL. 12948/2021
Mr. Ashok Agarwal, Mr. Kumar Utkarsh & Mr. Manoj Kumar, Advocates, Ms. Shyel Trehan, Mr. Rohan Poddar & Ms. Shivalika Rudrabatla, Advocates, for the Petitioner.
Mr. Tanveer Oberoi, Advocate for (AIIMS).
Mr. Ripudam Bhardwaj, CGSC with Mr. Vinod Tiwari, Advocate for R-1 & 3.
W.P.(C) 4304/2021 & CM APPL. 13108/2021
Mr. Ashok Agarwal, Mr. Kumar Utkarsh & Mr. Manoj Kumar, Advocates, Ms. Shyel Trehan, Mr. Rohan Poddar & Ms. Shivalika Rudrabatla, Advocates, for the Petitioner.
Mr. Satya Ranjan, (Senior Panal Counsel) with Mr. Kautilya Birat, Advs for UOI.
Mr. Tanveer Oberoi, Advocate for (AIIMS).
W.P.(C) 4551/2021 & CM APPL. 13949/2021
Mr. Ashok Agarwal, Mr. Kumar Utkarsh & Mr. Manoj Kumar, Advocates, Ms. Shyel Trehan, Mr. Rohan Poddar & Ms. Shivalika Rudrabatla, Advocates, for the Petitioner.
Mr. Avnish Singh, (SCGC) and Mr. Aditya Vikram Dembela, Advocates.
Mr. Tanveer Oberoi, Advocate for (AIIMS).
W.P.(C) 4812/2021 & CM APPL. 14844/2021
Mr. Ashok Agarwal, Mr. Kumar Utkarsh & Mr. Manoj Kumar, Advocates, Ms. Shyel Trehan, Mr. Rohan Poddar & Ms. Shivalika Rudrabatla, Advocates, for the Petitioner.
Mr. Ranvir Singh (CGSC) for R-1.
Mr. Tanveer Oberoi, Advocate for (AIIMS).
W.P.(C) 5394/2021 & CM APPL. 16683/2021
Mr. Ashok Agarwal, Mr. Kumar Utkarsh & Mr. Manoj Kumar, Advocates, Ms. Shyel Trehan, Mr. Rohan Poddar & Ms. Shivalika Rudrabatla, Advocates, for the Petitioner.
Mr. Tanveer Oberoi, Advocate for (AIIMS).
W.P.(C) 5395/2021 & CM APPL. 16686/2021
Mr. Anurag Ojha & Deepak Somani, Advocate, Ms. Shyel Trehan, Mr. Rohan Poddar & Ms. Shivalika Rudrabatla, Advocates, for the Petitioner.
Mr. Niraj Kumar, Senior Central Govt. Counsel for UOI.
Ms. Varsha Sharma, Advocate for Mr. Jawahar Raja, ASC (C) for GNCTD.
Mr. Tanveer Oberoi, Advocate for (AIIMS).
Mr. G.D. Sharma, Advocate for R-4.
W.P.(C) 9684/2021
Mr. Ashok Agarwal, Mr. Kumar Utkarsh & Mr. Manoj Kumar, Advocates, Ms. Shyel Trehan, Mr. Rohan Poddar & Ms. Shivalika Rudrabatla, Advocates, for the Petitioner.
Mr. Divyam Nandrajog, Panel Counsel, GNCTD, Mr. Mohd. Shahid Khan, Mr. Mayank Kamra, Advocates, for the Respondents.
Mr. Tanveer Oberoi, Advocate for (AIIMS).
W.P.(C) 14317/2021 & CM APPL. 45148/2021
Mr. Ashok Agarwal, Mr. Kumar Utkarsh & Mr. Manoj Kumar, Advocates, Ms. Shyel Trehan, Mr. Rohan Poddar & Ms. Shivalika Rudrabatla, Advocates, for the Petitioner.
Mr. Ripu Daman Bhardwaj (CGSC) for UOI.
Mr. Tanveer Oberoi, Advocate for (AIIMS).
W.P.(C) 1182/2022 & CM APPL. 3442/2022
Mr. Ashok Agarwal, Mr. Kumar Utkarsh & Mr. Manoj Kumar, Advocates, Ms. Shyel Trehan, Mr. Rohan Poddar & Ms. Shivalika Rudrabatla, Advocates, for the Petitioner.
Mr. Sanjeev Uniyal & Mr. Dhawal Uniyal, Advs for R-1.
Mr. Tanveer Oberoi, Advocate for (AIIMS).
W.P.(C) 1054/2023 and CM APPL. 4164/2023
Mr. Ashok Agarwal, Mr. Kumar Utkarsh & Mr. Manoj Kumar, Advocates, Ms. Shyel Trehan, Mr. Rohan Poddar & Ms. Shivalika Rudrabatla, Advocates, for the Petitioner.
Mr. Kirtiman Singh, CGSC with Ms. Vidhi Jain, Advocate for UOI.
Mr. Ripu Dhawan Bhardwaj, CGSC with Mr. Hardik GP for UOI.
Mr. Tanveer Oberoi, Advocate for (AIIMS)
W.P.(C) 1079/2023 and CM APPL. 4248/2023
Mr. Ashok Agarwal, Mr. Kumar Utkarsh & Mr. Manoj Kumar, Advocates, Ms. Shyel Trehan, Mr. Rohan Poddar & Ms. Shivalika Rudrabatla, Advocates, for the Petitioner.
Mr. Kirtiman Singh, CGSC with Ms. Vidhi Jain, Advocate for UOI.
Mr. Ripu Dhawan Bhardwaj, CGSC with Mr. Hardik GP for UOI.
Mr. Tanveer Oberoi, Advocate for (AIIMS)
W.P.(C) 2614/2023
Ms. Sonia Sharma with Ms. Neha Chug, Mr. Vijay Chandra and Mr. Tushant, Advocates, Ms. Shyel Trehan, Mr. Rohan Poddar & Ms. Shivalika Rudrabatla, Advocates, for the Petitioner.
Mr. Nitinjya Chaudhry, Sr Panel Counsel with Mr. Abhishek, GP.
Mr. Tanveer Oberoi, Advocate for (AIIMS).
Rare Diseases - Clinical Trials - New Drugs and Clinical Trial Rules, 2019 - National Policy for Rare Diseases(NPRD), 2021 - [DMD, Gaucher] - [New Drugs and Clinical Trial Rules, 2019, National Policy for Rare Diseases(NPRD), 2021]
The petitioners, mostly children suffering from Rare Diseases, sought treatment and availability of expensive medicines. The court issued directions for clinical trials and funding for treatment.
The court directed AIIMS and DCGI to provide a complete chart of clinical trials, considered eligibility of candidates for trials, and referred the matter to the National Consortium for Research and Development on Therapeutics for Rare Diseases.
Issues: Availability of treatment and funding for rare diseases, clinical trials for developing indigenous therapies, and release of funds for treatment.
Ratio Decidendi: The court emphasized the need for immediate treatment, directed the release of funds for medicines, and referred the matter to the National Consortium for comprehensive recommendations.
Final Decision: The court directed the release of funds, examination of candidates for clinical trials, and referred the matter to the National Consortium for further recommendations.
JUDGMENT
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 mostly children suffering from Rare Diseases. The case of the Petitioners is that medicines and therapies for the said diseases are exorbitantly expensive. 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.
3. On the last date of hearing, Mr. Rajiv Manjhi, Joint Secretary, Ministry of Health and Family Welfare and a team of doctors from AIIMS had appeared before the Court and various submissions were made about clinical trials and the amount that can be released per patient. Since the hearing was inconclusive on the said date, the Court had issued the following directions:
"8. Today, the hearing was inconclusive. In order to have an effective further hearing the following directions are issued:
(i) The team from AIIMS who is present before the Court today shall place on record a complete chart of all the clinical trials in which AIIMS is involved for the two medical conditions i.e. DMD and Gaucher. The said chart shall deal with the feasibility of enrolment of all the Petitioners in the said clinical trials.
(ii) The DCGI shall also place on record a complete chart of all the trials which have been approved or are pending approval in respect of DMD and Gaucher.
(iii) The Ministry of Health and Family Welfare, Union of India shall specifically consider the case of Alishba Khan who has already started treatment for DMD but her treatment has been stopped due to non-release of further funds and place its stand on record on the next date of hearing.
(iv) All officials from DCGI, Ministries, lawyers and doctors from AIIMS shall appear physically on the next date of hearing as due to the large number of issues and the number of lawyers appearing, a virtual hearing is not feasible."
4. In view of the directions passed on the last date, today, a Report dated 4th March, 2023 has been handed over to the Court by ld. Counsel for AIIMS. The Report states that the following studies/trials are currently being undertaken in relation to rare diseases in India:
3. By Shaare Zedak Medical Center, Israel pertaining to Gaucher disease.
5. The Report, thereafter, goes on to assess the eligibility of children before the Court in participating in the said clinical trials. Dr. Kabra and Dr. Shefali Gulati, who are present in Court, submit that, the four candidates who were found to be eligible to be included on a preliminary assessment are Aviraj Garg, Shourya Maru, Chirag and Aarav Garg.
6. It is the submission of Dr. Gulati that insofar as Aviraj Garg is concerned, he has already been included in the clinical trials of Sarepta. Insofar as the other three candidates are concerned, Dr. Gulati submits that they have been preliminary examined over video conferencing and assures the Court that they would be physically examined and the requisite tests shall be conducted on 9th March, 2023.
7. On the said date, the said Petitioners shall also be informed of the fact that if they are agreeable to participate in the trials, then the medication for the duration of the trial cannot be administered upon them. Let the three candidates appear before Dr. Gulati on 9th March, 2023.
8. Let the assessment be carried out and upon being counselled of the above-mentioned fact, the parents and candidates who give their consent may be accommodated in the trials.
9. On behalf of the Drug Controller General of India (DCGI), Mr. B.K. Samantrai, Deputy Drug Controller submits that approval for 19 further subjects for the Sarepta clinical trial for DMD has been given by the DCGI on 2nd March, 2023. It is further submitted on behalf of DCGI that in respect of trial subjects who
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