Master Medhansh Jhawar @ Madhav v. Rajesh Bhushan & Ors.

VERSUS

UNION OF INDIA & ANR...... Respondents Through: Mr. Bharathi Raju, Sr. Panel Counsel with Mr. Rohit Singh, Advocate for UOI. (M:9868895906) (38) 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. Ripu Daman Bhardwaj (CGSC) for UOI. (39) WITH + W.P.(C) 3682/2021 & CM APPL. 11153/2021 HARSHIT SONI, 16 YEARS OLD, THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

VERSUS

UNION OF INDIA & ANR...... Respondents Through: Mr. T.P. Singh, Sr. Central Govt. Signing Date:17.02.2023 23:35 2023/DHC/001159 W.P.(C) 5315/2020 & connected matters Counsel for R-1 (M:9971579687). (40) WITH + W.P.(C) 3689/2021 & CM APPL.11179/2021 DHANANJAY BHARDWAJ, 11 YEARS OLD, THROUGH HIS NEXT FRIEND ND NATURAL FATHER SH. AMIT KUMAR..... Petitioner Through: Mr. Ashok Agarwal, Mr. Kumar Utkarsh and Mr. Manoj Kumar, Advocates (M:9662778086).

VERSUS

UNION OF INDIA & ANR...... Respondents Through: Mr. Sanjeev Uniyal and Mr. Dhawal Uniyal, Advs for R-1 (M:9560806614). (41) 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 Through: Mr. Ashok Agarwal, Mr. Kumar Utkarsh & Mr. Manoj Kumar Ms. Shyel Trehan, Amicus Curiae with Mr. Rohan Poddar, Adv.

VERSUS

UNION OF INDIA & ANR...... Respondents Through: Mr. Tanveer Oberoi, Adv. for (AIIMS). (42) 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 Through: Mr. Ashok Agarwal, Mr. Kumar Utkarsh & Mr. Manoj Kumar

VERSUS

UNION OF INDIA & ANR...... Respondents Through: Mr. Siddharth Khattna, Advocate for Signing Date:17.02.2023 23:35 2023/DHC/001159 W.P.(C) 5315/2020 & connected matters UOI. (M:9811132326) (43) WITH + W.P.(C) 3729/2021 & CM APPL. 11269/2021 MANISH, 8 YEARS OLD, THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

VERSUS

UNION OF INDIA & ANR...... Respondents Through: Mr. Tanveer Oberoi, Adv. for (AIIMS). (44) WITH + W.P.(C) 3737/2021 & CM APPL. 11277/2021 SHOURYA MARU, 7 YEARS OLD, FATHER SH.

KAMAL KUMAR MARU..... Petitioner Through: Mr. Ashok Agarwal, Mr. Kumar Utkarsh & Mr. Manoj Kumar Ms. Shyel Trehan, Amicus Curiae with Mr. Rohan Poddar, Adv.

VERSUS

UNION OF INDIA & ANR...... Respondents Through: Mr. Ranvir Singh (CGSC) for R-1. (M:9818071061) (45) WITH + W.P.(C) 3859/2021 & CM APPL. 11647/2021 SIDDHARTH SWARNKAR, 9 YEARS OLD, FATHER SH.

VERSUS

UNION OF INDIA & ANR...... Respondents Through: Mr. Anuj Aggarwal, ASC, GNCTD with Ms. Ayushi Bansal, Mr. Sanyam Signing Date:17.02.2023 23:35 2023/DHC/001159 W.P.(C) 5315/2020 & connected matters Suri and Ms. Arshya Singh Advocates for R-1 to 5 (M:9891363718). (46) WITH + W.P.(C) 4045/2021 & CM APPL. 12213/2021 UTKARSH INDRAJIT PAWAR, 10 YEARS OLD, THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

VERSUS

UNION OF INDIA & ANR...... Respondents Through: Mr. Sanjeev Sabharwal, Sr. Panel Counsel with Ms. Shweta, Advocate for UOI. Mr. Harish Kumar Garg and Ms. Khushboo Sharma, Advocates for UOI (M:9810150029). (47) 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 Through: Mr. Ashok Agarwal, Mr. Kumar Utkarsh and Mr. Manoj Kumar, Advocates (M:9662778086).

VERSUS

UNION OF INDIA & ANR...... Respondents Through: Mr. Tanveer Oberoi, Adv. for (AIIMS). (48) 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 Signing Date:17.02.2023 23:35 2023/DHC/001159 W.P.(C) 5315/2020 & connected matters versus UNION OF INDIA & ANR...... Respondent Through: Mr. Tanveer Oberoi, Adv. for (AIIMS). Mr. Ripudam Bhardwaj, CGSC with Mr. Vinod Tiwari, Adv. for R-1 & 3. (49) 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 Ms. Shyel Trehan, Amicus Curiae with Mr. Rohan Poddar.

VERSUS

UNION OF INDIA & ANR...... Respondents Through: Mr. Satya Ranjan, (Sr. Panal Counsel) with Mr. Kautilya Birat, Advs for UOI. (50) WITH + W.P.(C) 4551/2021 & CM APPL. 13949/2021 SHAURYA DAHIYA, 7 YEARS OLD, THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

VERSUS

UNION OF INDIA & ANR...... Respondents Through: Mr. Avnish Singh, (SCGC) and Mr. Aditya Vikram Dembela, Advocates. (M:8826437138) (51) 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 Signing Date:17.02.2023 23:35 2023/DHC/001159 W.P.(C) 5315/2020 & connected matters Through: Mr. Ashok Agarwal, Mr. Kumar

VERSUS

UNION OF INDIA & ANR...... Respondents Through: Mr. Ranvir Singh (CGSC) for R-1. (52) WITH + W.P.(C) 5394/2021 & CM APPL. 16683/2021 UDAYVEER SINGH GULERIA, 7 YEARS OLD, THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

VERSUS

UNION OF INDIA & ANR...... Respondents Through: Mr. Tanveer Oberoi, Adv. for (AIIMS). (53) WITH + W.P.(C) 5395/2021 & CM APPL. 16686/2021 MASTER AYUSHMAN CHATURVEDI..... Petitioner Through: Mr. Ashok Agarwal, Mr. Kumar Mr. Anurag ojha & Deepak Somani, Advocate.

VERSUS

UNION OF INDIA & ORS...... Respondents Through: Mr. Niraj Kumar, Sr. Central Govt. Counsel for UOI. Mr. Jawahar Raja, ASC (C) with Ms. Moksha Sharma, Adv. for GNCTD. Mr. G.D. Sharma, Advocate for R-4. Signing Date:17.02.2023 23:35 2023/DHC/001159 W.P.(C) 5315/2020 & connected matters (54) WITH + W.P.(C) 9684/2021 AADHYAN JAISWAL 11 YEARS OLD THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH ANIL KUMAR JAISWAL..... Petitioner Through: Mr. Ashok Agarwal, Mr. Kumar

VERSUS

UNION OF INDIA & ORS...... Respondents Through: Mr. Divyam Nandrajog, Panel Counsel, GNCTD, Mr. Mohd. Shahid Khan, Mr. Mayank Kamra, Advs. (55) WITH + W.P.(C) 14317/2021 & CM APPL. 45148/2021 SHREYANSH AARAV, 11 YEARS OLD, THROUGH HIS NEXT FRIEND AND NATURAL MOTHER SMT.

VERSUS

UNION OF INDIA & ANR...... Respondents Through: Mr. Ripu Daman Bhardwaj (CGSC) for UOI. (56) WITH + W.P.(C) 1182/2022 & CM APPL. 3442/2022 INSHA MINOR THROUGH HER NEXT FRIEND AND NATURAL FATHER SH IRSHAD AHMAD SOFI..... Petitioner Through: Mr. Ashok Agarwal, Mr. Kumar Signing Date:17.02.2023 23:35 2023/DHC/001159 W.P.(C) 5315/2020 & connected matters versus UNION OF INDIA & ORS...... Respondent Through: Mr. Sanjeev Uniyal & Mr. Dhawal Uniyal, Advs for R-1. (M:9560806614) (7) WITH + W.P.(C) 1054/2023 and CM APPL. 4164/2023 MASTER TUSHAR THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. JAI PRAKASH..... Petitioner Through: Mr. Ashok Agarwal, Mr. Kumar Utkarsh & Mr. Manoj Kumar Ms. Shyel Trehan, Amicus Curiae with Mr. Rohan Poddar, Adv.

VERSUS

UNION OF INDIA & ANR...... Respondents Through: Mr. Ripu Dhawan Bhardwaj, CGSC with Mr. Hardik GP for UOI. Mr. Tanveer Oberoi, Adv. for (AIIMS) (8) AND + 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

UNION OF INDIA & ANR...... Respondents Through: Mr. Ripu Dhawan Bhardwaj, CGSC with Mr. Hardik GP for UOI. Mr. Tanveer Oberoi, Adv. for (AIIMS) 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 mostly children suffering from Rare Diseases. The case of the Petitioners Signing Date:17.02.2023 23:35 2023/DHC/001159 W.P.(C) 5315/2020 & connected matters 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. Indigenous Development of Treatment, Therapies & Medicines for Rare Diseases

3. On the last date of hearing, the Court had directed Ms. Alka Sharma, Managing Director, BIRAC and Mr. Rajesh Gokhale, or any senior official from the Department of Biotechnology (DBT) nominated by Mr. Gokhale, to hold a meeting with the representatives of Hanugen to explore the framework under which funding for clinical study for therapeutic evaluation of indigenous treatment in respect of DMD patients can be done. The relevant portion of the said order reads as under:

4. Today, minutes of the meeting held on 2nd February, 2023 have been handed over to the Court. Unfortunately, the minutes of the meeting show that there has been no progress whatsoever in respect of the directions issued by the Court. A perusal of the minutes shows that BIRAC is bound by the Biotechnology Industry Partnership Programme (BIPP) under which the Grant-in-aid Letter Agreement was entered into with Hanugen Therapeutics Pvt. Ltd. The stand taken by BIRAC is that it is mandatory for Hanugen to contribute 50% of the total project cost.

5. In view of this position, the Court is of the opinion that the matter would have to be now referred to the Secretary, Ministry of Health and Signing Date:17.02.2023 23:35 2023/DHC/001159 W.P.(C) 5315/2020 & connected matters Family Welfare (MH&FW) to take a decision in respect of clinical trials that are to be conducted for testing the therapies for rare diseases including DMD.

6. Let the orders passed by this Court dated 18th October, 2022, 29th November, 2022, and 9th December, 2022 be communicated by Mr. Kirtiman Singh, ld. CGSC to the Secretary, MH&FW who shall file the stand of the Ministry on record by way of an affidavit by the next date of hearing.

7. MH&FW shall also depute a senior official, at least of the level of Joint Secretary, to join the Court proceedings on the next date of hearing. Commencement of Treatment

8. Each of the Petitioners may approach AIIMS, New Delhi or the respective Centres of Excellence, closer to their locations, for the commencement of their treatment in terms of the order dated 14th December, 2021, which contains the following directions:

9. Vide order dated 30th January, 2023, the Court had directed AIIMS to file an affidavit in respect of non-placing of purchase order/supply order of medicine on M/s Sarepta.

10. An affidavit dated 30th January, 2023 has been filed on behalf of AIIMS placing on record a copy of the invoice dated 31st January, 2023 issued upon M/s My Tomorrows Headquarters, Sarepta’s distributor for DMD medicines. Ld. Counsel for AIIMS, under instructions, submits that though the supply order notes the date of delivery as 17th March, 2023, the delivery of the medicines is expected by 28th February, 2023 on the basis of their correspondence with Sarepta.

11. At this stage, the Court has been informed that M/s Sarepta has registered for clinical trials in India for the same medicines which are being procured by AIIMS. Furthermore, AIIMS Delhi is stated to be one of the centres of Sarepta’s clinical trial.

12. In view of the same, let the DCGI file an affidavit as to the details of M/s Sarepta’s trial or any other trial which has been approved by it in respect of DMD, Gaucher, or Hunter’s Syndrome therapies.

13. A competent official from the office of the DCGI shall also remain present in Court on the next date of hearing.

14. Let the present order be communicated by Mr. Kirtiman Singh, ld. CGSC to the DCGI for compliance. Signing Date:17.02.2023 23:35 2023/DHC/001159 W.P.(C) 5315/2020 & connected matters W.P.(C) 2943/2020

15. In the case of Ms. Alishba Khan, who is suffering from Gaucher, it is submitted by the ld. Counsel that medicines were being provided by AIIMS till January, 2023. However, thereafter, the treatment has been stopped. In response, it is submitted by ld. Counsel for AIIMS that the treatment had to be stopped as the funds received in respect of the said patient were exhausted.

16. Considering the fact that AIIMS, Delhi is recognised as a Centre of Excellence for treating rare diseases and is also the nodal centre of the Consortium of Centres of Excellence under the National Policy for Rare Diseases, 2021, and bearing in mind the large number of patients who have filed petitions before this court, for whom medicines are needed, it is directed that a sum of Rs.[5] crores shall be immediately released by the Union of India to AIIMS, Delhi so as to ensure that the treatment of children, where it has already commenced, is not stopped due to lack of funds.

17. The said funds shall be released within a period of two weeks from today.

18. Complete account of the manner in which the funds are being expended shall be maintained by AIIMS, Delhi under the direct supervision of Dr. Kabra who is heading the Rare Diseases Committee, AIIMS, New Delhi. Upon funds being received, the medicines shall be immediately procured by AIIMS and the treatment shall be recommenced.

19. In respect of the Petitioners in W.P.(C) 1491/2021 and W.P.(C) 1511/2021, ld. Counsel submits that the treatment in respect of Petitioners, who are both suffering from Hunter Syndrome, is yet to commence. Signing Date:17.02.2023 23:35 2023/DHC/001159 W.P.(C) 5315/2020 & connected matters

20. Dr. Kanika, who is present in Court today, submits that orders have been placed with Takeda Pharmaceuticals and upon receiving the medicines, the treatment shall be commenced without delay.

21. Let the Union of India place on record an affidavit within a period of one week giving the complete information of the funds released from the Rare Diseases Fund to various Centres for Excellence and the number of patients for whom treatment has been approved till date.

22. Prof. (Dr.) Madhulika Kabra, is requested to join the proceedings virtually on the next date of hearing.

23. List on 1st March, 2023.

PRATHIBA M. SINGH JUDGE FEBRUARY 15, 2023 Rahul/dj/SK