Arnesh Shaw v. Union of India & Anr.

VIPIN KUMAR..... 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. Bharathi Raju, Sr. Panel Counsel W.P.(C) 5315/2020 & connected matters UOI. (52) WITH + W.P.(C) 3662/2021 & CM APPLs. 11103/2021, 25590/2021, 32504/2021 PAYEL BHATTACHARYA..... Petitioner Through: Mr. Ishaan Karki, Advocate.

VERSUS

UNION OF INDIA & ORS...... Respondents Through: Mr. Anuj Aggarwal, ASC, GNCTD, Ms. Ayushi Bansal, Mr. Sanyam Suri and Ms. Arshya Singh, Advocates for respondents no.2 (M:9891363718). Mr. Ripu Daman Bhardwaj (CGSC) for UOI. (53) 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. Counsel for respondent no.1 (M:9971579687). (54) WITH + W.P.(C) 3689/2021 & CM APPL.11179/2021 W.P.(C) 5315/2020 & connected matters 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, Mr. Dhawal Uniyal, Mr. Sachin Chandela, Advocates for R-1 (M:9560806614). (55) 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.

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UNION OF INDIA & ANR...... Respondents Through: Mr. Tanveer Oberoi, Advocate for respondent (AIIMS) (56) 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 Ms. Shyel Trehan, Amicus Curiae with Mr. Rohan Poddar, Adv. W.P.(C) 5315/2020 & connected matters UNION OF INDIA & ANR...... Respondents Through: Mr. Tanveer Oberoi, Advocate for respondent (AIIMS) (57) 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 Through: Mr. Ashok Agarwal, Mr. Kumar Utkarsh & Mr. Manoj Kumar Ms. Shyel Trehan, Amicus Curiae with Mr. Rohan Poddar, Adv.

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UNION OF INDIA & ANR...... Respondents Through: Mr. Tanveer Oberoi, Advocate for respondent (AIIMS) (58) 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.

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UNION OF INDIA & ANR...... Respondents Through: Mr. Ranvir Singh (CGSC) for R-1. (59) WITH + W.P.(C) 3859/2021 & CM APPL. 11647/2021 SIDDHARTH SWARNKAR, 9 YEARS OLD, FATHER SH.

DINESH KUMAR SWARNKAR..... Petitioner Through: Mr. Ashok Agarwal, Mr. Kumar Utkarsh & Mr. Manoj Kumar W.P.(C) 5315/2020 & connected matters Ms. Shyel Trehan, Amicus Curiae with Mr. Rohan Poddar, Adv.

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UNION OF INDIA & ANR...... Respondents 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). (60) WITH + W.P.(C) 4045/2021 & CM APPL. 12213/2021 UTKARSH INDRAJIT PAWAR, 10 YEARS OLD, THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

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UNION OF INDIA & ANR...... Respondents Through: Mr. Sanjeev Sabharwal, Sr. Panel Counsel with Ms. Shweta, Advocate for UOI. Mr. Harish Kumar Garg, Advocate for UOI (M:9810150029). (61) 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 W.P.(C) 5315/2020 & connected matters UNION OF INDIA & ANR...... Respondents Through: Mr. Tanveer Oberoi, Advocate for respondent (AIIMS). (62) 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 Through: Mr. Ashok Agarwal, Mr. Kumar Utkarsh and Mr. Manoj Kumar, Advocates (M:9662778086).

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UNION OF INDIA & ANR...... Respondent Through: Mr. Tanveer Oberoi, Advocate for respondent (AIIMS). (63) 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 Through: Mr. Ashok Agarwal, Mr. Kumar Utkarsh and Mr. Manoj Kumar, Ms. Shyel Trehan, Amicus Curiae with Mr. Rohan Poddar.

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UNION OF INDIA & ANR...... Respondents Through: Mr. Satya Ranjan (Sr. Panal Counsel) with Mr. Kautilya Birat, Advocates for UOI. (64) WITH + W.P.(C) 4551/2021 & CM APPL. 13949/2021 SHAURYA DAHIYA, 7 YEARS OLD, THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

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UNION OF INDIA & ANR...... Respondents Through: Mr. Avnish Singh, (SCGC) and Mr. Aditya Vikram Dembela, Advocates Mr. Tanveer Oberoi, Advocate for respondent (AIIMS). (65) WITH + W.P.(C) 4812/2021 & CM APPL. 14844/2021 NIKHIL YOGENDERSINGH CHOUDARY, 17 YEARS OLD, THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

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UNION OF INDIA & ANR...... Respondents Through: Mr. Ranvir Singh (CGSC) for R-1. (66) WITH + W.P.(C) 5394/2021 & CM APPL. 16683/2021 UDAYVEER SINGH GULERIA, 7 YEARS OLD, THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

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UNION OF INDIA & ANR...... Respondents 2022/DHC/005474 W.P.(C) 5315/2020 & connected matters Through: Mr. Tanveer Oberoi, Advocate for respondent (AIIMS). (67) WITH + W.P.(C) 5395/2021 & CM APPL. 16686/2021 MASTER AYUSHMAN CHATURVEDI..... Petitioner Through: Mr. Ashok Agarwal, Mr. Kumar

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UNION OF INDIA & ORS...... Respondents Through: Mr. Niraj Kumar, Sr. Central Govt. Counsel for UOI. Mr. Jawahar Raja, ASC (C), GNCTD for respondent no.2. Mr. G.D. Sharma, Advocate for Respondent no.4. (68) 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

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UNION OF INDIA & ORS...... Respondents Through: Mr. Divyam Nandrajog, Panel Counsel, GNCTD, Mr. Mohd. Shahid Khan, Mr. Bhrigu Pamidi Ghantam, Advocate. W.P.(C) 5315/2020 & connected matters (69) WITH + W.P.(C) 14317/2021 & CM APPL. 45148/2021 SHREYANSH AARAV, 11 YEARS OLD, THROUGH HIS NEXT FRIEND AND NATURAL MOTHER SMT.

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UNION OF INDIA & ANR...... Respondents Through: Mr. Ripu Daman Bhardwaj (CGSC) for UOI. (70) WITH + W.P.(C) 1182/2022 & CM APPL. 3442/2022 INSHA MINOR THROUGH HER NEXT FRIEND AND NATURAL FATHER SH IRSHAD AHMAD SOFI..... Petitioner

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UNION OF INDIA & ORS...... Respondent Through: Mr. Sanjeev Uniyal, Mr. Dhawal Uniyal and Mr. Sachin Chandela, Advocates for R-1. 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 W.P.(C) 5315/2020 & connected matters are mostly children suffering from Rare Diseases. The case of the Petitioners is that the medicines and therapies for the said Rare Diseases are exorbitantly expensive, and directions ought to be issued to the Respondents i.e., the Union of India and its Ministry of Health and Family Welfare, All India Institute of Medical Science (hereinafter, “AIIMS”), as well as, the GNCTD, to provide continuous and uninterrupted treatment to the Petitioners, free of cost.

3. These matters have been heard by the Court from time to time and various directions have been issued for enabling treatment and for making available medicines for the Petitioners.

4. Vide previous order dated 29th November, 2022, the Department of Biotechnology (hereinafter, “DBT”) and Dystrophy Annihilation Research Trust (hereinafter, “DART”), were impleaded as Respondent Nos. 3 and 4 respectively in W.P.(C) 5315/2020. Affidavit dated 28th November, 2022 on behalf of the Ministry of Health and Family Welfare, Union of India was also directed to be placed on record, along with the agreement between the DBT and DART in respect of the funding of clinical studies.

5. Today, submissions have been made in part in these matters, in respect of the following directions issued by this Court, vide order dated 23rd March, 2021:

6. As recorded in the order dated 19th April, 2021, the Union of India has finalized and notified the National Policy for Rare Diseases (NPRD), 2021 on 30th March, 2021, for the treatment of patients suffering from rare diseases. The consortium of Centres of Excellence for the prevention and treatment of Rare Diseases, under the leadership of AIIMS, has also been made a part of the policy as per paragraph 12(a) of the policy. A ‘Rare Diseases Committee’ was also constituted within AIIMS. Creation of Digital Crowdfunding Platform

7. Vide order dated 23rd March, 2021, a crowdfunding platform had been directed to be set up by the Government under the National Policy for Rare Diseases.

8. It is submitted that the said crowdfunding platform is now operational. However, it appears that the same requires to be publicized in order to attract funding from the general public and corporate entities, including Public Sector Undertakings (“PSUs”).

9. Accordingly, it is directed that the details of the crowdfunding W.P.(C) 5315/2020 & connected matters platform be communicated by the Respondent No.1 to all the Navratna PSUs, as also, at least ten of the top business houses / private companies in India, so as to enable them to consider contribution to the said platform as part of CSR (corporate social responsibility) endeavours. There shall be proper follow up to this communication by the Respondent No.1. Any responses received to the said communication shall be placed on record. Rare Diseases Fund

10. It is clarified by ld. CGSC that the ‘Rare Diseases Fund’ is currently being managed by the Ministry of Health and Family Welfare, Union of India.

11. Let a status report be filed, jointly by the Ministry of Health and Family Welfare and the Department of Biotechnology, on the following aspects: i. Compliance of the directions issued under paragraph 21 of order dated 23rd March, 2021, which has been reproduced hereinabove. ii. Data shall be provided to the Court as to the number of patients in respect of whom Centres of Excellence have been granted the funding, as also, the number of patients in respect of whom the treatment has been commenced. iii. Timelines being followed by the Ministry of Health and Family Welfare in approving the recommendations for grant of funding and treatment. Commencement of Treatment

12. This Court is informed that the treatment for patients of Gaucher Disease is stated to have commenced. However, despite repeated orders, the W.P.(C) 5315/2020 & connected matters patients of Duchenne Muscular Dystrophy (“DMD”) have yet not started receiving treatment.

13. Mr. Oberoi, ld. Counsel for AIIMS submits that there is substantial development in this regard. The fund had been received qua few patients. Tenders have been called and the purchase orders have also been placed on the concerned manufacturers.

14. Let the expected timelines for receiving of the medicines and for the starting of administration of the medicines upon the DMD patients, be also provided by AIIMS, by way of affidavit on the next date of hearing.

AIIMS to file a detailed status report of the working of the Rare Diseases Committee functioning in the hospital and the work done till date. Indigenous Development of Treatment, Therapies & Medicines for Rare Diseases

15. Insofar as the indigenous development of treatment, therapies and medicines for rare diseases, especially DMD, is concerned, it has been pointed out that a Memorandum of Understanding dated 8th January, 2021 has been signed between the Biotechnology Industry Research Assistance Council (BIRAC) and M/s. Hanugen Therapeutics Private Limited (hereinafter, “Hanugen”). As per the said MoU, Hanugen was to conduct a multi-centric study for therapeutic evaluation in respect of DMD patients. In terms of the agreement, 50% of the fund for this study was to be contributed by the Government and the other 50% was to be contributed by Hanugen itself. The total approved amount was Rs.9.24 crores.

16. It is submitted by Ms. Trehan, the Ld. Amicus that the first tranche of Rs.1.41 crores was released. The same was matched by Hanugen. However, for the remaining tranches, there is shortage of funds. W.P.(C) 5315/2020 & connected matters

17. The representatives of Hanugen have appeared before the Court virtually. They have stated that Phase 2-3 trials of the therapy have been approved by DCGI, and they have enrolled 54 patients for conducting the said trials. However, the commencement of the said trials has been delayed due to lack of funds.

18. In the opinion of this Court, DMD is a rare disease which is prevalent in a considerable number of patients in India. The indigenous development of therapies for DMD is extremely crucial in order to avoid import of expensive medication. The medication for DMD is currently not manufactured and also not easily available in India. The same is, in fact, imported from the USA. Thus, the trials, which have already been approved, ought to be allowed to be completed. If the same prove to be successful, there could be the possibility of a solution for patients suffering from DMD in India.

19. Under such circumstances, it is directed as under: i. The officials from M/s. Hanugen Therapeutics Private Limited, who have joined the proceedings virtually today, shall place on record an affidavit giving the details of requirements of funding, patient enrolment, DCGI approval, and the manner in which the Phase 2-3 trials are to be conducted. The said affidavit shall be filed by M/s. Hanugen Therapeutics Private Limited, within one week. ii. Ld. CGSC shall seek instructions as to whether a sum of Rs.[5] crores could be released from the Rare Diseases Fund in favour of M/s. Hanugen Therapeutics Private Limited, on an urgent basis, in order to enable the commencement of the clinical trials. W.P.(C) 5315/2020 & connected matters

20. List on 22nd December, 2022. Cont. Cas(C) 722/2022

21. In the present contempt case, the Petitioner is suffering from the Gaucher disease. The allegation of the Petitioner was that AIIMS had not commenced the treatment, pursuant to the orders dated 19th January, 2022 and 2nd February, 2022 passed by the Court in W.P. (C) No.1182/2022 titled “Insha (Minor) through her next friend and natural father Sh. Irshad Ahmad Sofi v. Union of India & Ors.”. As per the said two orders, the Petitioner has to be provided free of cost Enzyme Replacement Therapy treatment.

22. Mr. Oberoi, ld. Counsel for AIIMS, under instructions, submits that the first infusion has been administered on the Petitioner on 2nd December,

2022. He submits that he has filed an affidavit to this effect.

23. Let the said affidavit filed by AIIMS be brought on record in the present contempt case. Copy of the said affidavit shall also be filed and placed on record in the writ petition being W.P.(C) 1182/2022.

24. Since the writ petition being W.P.(C) 1182/2022 is already pending, and the treatment has commenced, Cont. Cas(C) 722/2022 is, disposed of.

PRATHIBA M. SINGH JUDGE DECEMBER 09, 2022/DK/AD