Master Medhansh Jhawar 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) (56) 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 2023/DHC/000698 W.P.(C) 5315/2020 & connected matters and Ms. Arshya Singh, Advocates for R-2 (M:9891363718). Mr. Ripu Daman Bhardwaj (CGSC) for UOI. (57) 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 R-1 (M:9971579687). (58) 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, Advocates for R-1 (M:9560806614). W.P.(C) 5315/2020 & connected matters (59) 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, Advocate for respondent (AIIMS) (60) 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.

VERSUS

UNION OF INDIA & ANR...... Respondents Through: Mr. Siddharth Khattna, Advocate for UOI. (M:9811132326) (61) 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. W.P.(C) 5315/2020 & connected matters versus UNION OF INDIA & ANR...... Respondents Through: Mr. Tanveer Oberoi, Advocate for respondent (AIIMS) (62) 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) (63) 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 Suri and Ms. Arshya Singh Advocates for R-1 to 5 (M:9891363718). (64) WITH + W.P.(C) 4045/2021 & CM APPL. 12213/2021 W.P.(C) 5315/2020 & connected matters 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). (65) WITH + W.P.(C) 4067/2021 & CM APPL. 12306/2021 ANSHU, 10 YEARS OLD, THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

VERSUS

UNION OF INDIA & ANR...... Respondents Through: Mr. Tanveer Oberoi, Advocate for respondent (AIIMS). (66) 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). W.P.(C) 5315/2020 & connected matters versus UNION OF INDIA & ANR...... Respondent Through: Mr. Tanveer Oberoi, Advocate for respondent (AIIMS). (67) 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.

VERSUS

UNION OF INDIA & ANR...... Respondents Through: Mr. Satya Ranjan, (Sr. Panal Counsel) with Mr. Kautilya Birat, Advocates for UOI. (68) 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) W.P.(C) 5315/2020 & connected matters (69) WITH + W.P.(C) 4812/2021 & CM APPL. 14844/2021 NIKHIL YOGENDERSINGH CHOUDARY, 17 YEARS OLD, THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

VERSUS

UNION OF INDIA & ANR...... Respondents Through: Mr. Ranvir Singh (CGSC) for R-1. (70) 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, Advocate for respondent (AIIMS). (71) WITH + W.P.(C) 5395/2021 & CM APPL. 16686/2021 MASTER AYUSHMAN CHATURVEDI..... Petitioner Through: Mr. Ashok Agarwal, Mr. Kumar W.P.(C) 5315/2020 & connected matters 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. (72) 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. (73) 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) W.P.(C) 5315/2020 & connected matters for UOI. (74) 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 Utkarsh and Mr. Manoj Kumar,

VERSUS

UNION OF INDIA & ORS...... Respondent Through: Mr. Sanjeev Uniyal & Mr. Dhawal Uniyal, Advocates for R-1. (79) 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. (82) 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 Through: Mr. Ashok Agarwal, Mr.Kumar 2023/DHC/000698 W.P.(C) 5315/2020 & connected matters 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 (M: 9818030700). Mr. Tanveer Oberoi, Advocate 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 is that the medicines and therapies for the said 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 to the Petitioners. Indigenous Development of Treatment, Therapies & Medicines for Rare Diseases

4. In terms of the Memorandum of Understanding dated 8th January, 2021 signed between M/s Hanugen Therapeutics Private Limited (hereinafter ‘Hanugen’) and the Biotechnology Industry Research W.P.(C) 5315/2020 & connected matters Assistance Council (hereinafter ‘BIRAC’), Hanugen was to conduct a multicentric study for the therapeutic evaluation in respect of DMD patients. The total approved amount for the project was Rs.9.24 crores. As per the MoU, 50% of the said amount was to be provided by BIRAC and the other 50% was to be contributed by Hanugen.

5. On 9th December, 2022, this Court was apprised that the commencement of clinical trials was delayed due to lack of funds. In view of the said submission, the Court had directed the ld. CGSC to seek instructions as to whether a sum of Rs. 5 crores can be released from the Rare Diseases Fund in favour of Hanugen in order to enable the commencement of clinical trial.

6. Thereafter, an affidavit dated 17th December, 2022 was filed on behalf of Hanugen stating that the total budget for clinical trial involving 54 patients would be Rs.13.50 crores. Out of the said amount, Rs.1.41 crore each was already put in by Hanugen and BIRAC. Thus, the total outstanding amount was Rs.10.67 crores. The affidavit further stated that for the first 6 months only 50% of the patients would receive the drug, so to begin the trial, an amount of Rs.5.35 crores was needed by Hanugen.

7. Upon hearing the parties, the Court had passed the following order on 22nd December, 2022:

24. For the said purpose, the first meeting between W.P.(C) 5315/2020 & connected matters the BIRAC and M/s Hanugen Therapeutics Private Limited for finalizing the said agreement shall be held on 12th January, 2023. Ms. Trehan, ld. Amicus Curiae may also assist the parties in finalizing the said agreement, if required. Mr. Amit Kumar, Legal Officer of BIRAC, who is present in Court today, shall also remain present in the said meeting. Let the draft agreement in this regard be placed before this Court, on the next date of hearing.”

8. As per the above order, Rs. 5.35 crores were directed to be released by BIRAC to Hanugen. An agreement was also to be negotiated between BIRAC and Hanugen for vesting of all intellectual property in the data, therapies, products/processes.

9. Further to the previous order dated 22nd December, 2022, it appears that there is a complete stalemate between Hanugen and BIRAC. No effective meeting has taken place between BIRAC and Hanugen in terms of the order dated 22nd December, 2022.

10. Today, CM No.4237/2023 filed by Hanugen is listed before the Court. The said application has been filed by Hanugen seeking orders from the Court clarifying that the amount of Rs.5.35 crores directed to be released is only the first tranche of payment for the commencement of the clinical trial. Hanugen’s cause of anxiety are the following two emails sent by BIRAC on 13th January, 2023: "Dear Dr. Arun, With reference to the High Court Order, an amount of Rs.5.35 crores is to be released by BIRAC in favour of Hanugen. The order also states that the total cost of the study (after subtracting the sum already released by BIRAC and also put in by Hanugen) is Rs. 10.6725 Cr. With reference to this, kindly clarify the source of the remaining funds… " W.P.(C) 5315/2020 & connected matters XXX "Dear Dr. Arun, In continuation to the trail mail, Project Division and the fund recipient (Hanugen) may please note that the total cost of the project will remains Rs. 936.70 Lakhs as per the GLA. The Court had directed BIRAC to consider further funding of Rs. 5.35 Cr. over and above the already released amount. Hence, the company shall ignore the total project cost as mentioned in trail mail. and the company may please do the following needful: (by 14th January 2023)

1. to arrange a meeting on top priority as directed by the Hon'ble Court.

BIRAC had already requested for that, and now the meeting may be arranged in upcoming week on top priority i.e., from 16 January 2023 to 18 January 2023.

2. to provide revised Clause 7 of the GLA."

11. The above emails show that order dated 22nd December, 2022 has been completely misinterpreted by BIRAC. Vide the said order, the Court had acceded to the request of Hanugen to release the payment of Rs.5.35 crores to it in order to ensure that the trial is commenced. The said amount was computed by the Court upon a submission of Hanugen that the total estimated cost of the clinical trial was to the tune of Rs.13.[5] crores, out of which 10.67 crores was yet to be paid. Since, Hanugen had submitted that for the first six months only 50% of the patients would receive the drug, the Court had directed that half of the project amount, i.e., 5.35 crores be released to Hanugen.

12. There are a large number of writ petitions filed by children suffering from DMD. The Government has agreed to release a maximum of Rs. 50 lakhs per patient. The intention was that the entire research for the indigenous therapy for DMD could be funded by BIRAC/Government, W.P.(C) 5315/2020 & connected matters which would also own IP rights in the data and therapy/drug that may be developed. Considering the total cost of Rs.13.50 crores as against the allotted amount of Rs. 50 lakhs being invested into each patient for medicines from the US, the indigenous development of therapies for DMD ought to be explored, in the opinion of the Court. A similar view had been expressed by the Court vide order dated 5th August, 2022, in the following words:

13. Let the present order along with order dated 22nd December, 2022 be placed before Ms. Alka Sharma, Managing Director, BIRAC and Mr. Rajesh Gokhale, Secretary, Department of Biotechnology (DBT). Ms. Alka Sharma and Mr. Rajesh Gokhale, or any senior official from DBT nominated by Mr. Gokhale, are requested to hold a meeting with the representatives of Hanugen in order to explore the framework in which funding for clinical trial for DMD can be done, in the larger interest. Previous orders passed by this Court would show that the budgets which were kept aside for rare diseases have not even been completely utilised. Relevant portion of the order dated 23rd March, 2021 reads as under:

18. Secondly, the affidavit of Ministry of Health and Family Welfare, Union of India, also reveals that almost Rs. 200 crores were budgeted for the purpose of expenditure in respect of Rare Diseases. The affidavit shows that the expenditure that has already been incurred is only to the tune of Rs.[7] crores over W.P.(C) 5315/2020 & connected matters the last three years.

19. Considering the fact that budgets have already been sanctioned for dealing with Rare Diseases, it is directed that such budgets ought to be now utilized efficiently for the purposes of both funding of treatments, as well as Research and Development activities.”

14. The Government thus has an obligation to invest in this research to enable development of indigenous therapies.

15. The officials ought to bear in mind that there are 28 writ petitions which have been filed before the Court seeking funding for medicines and therapies. As per the Rare Diseases policy of the Government itself, a sum of Rs.50 lacs per patient has to be set aside for providing medicines per patient. This would involve a substantial amount of money being spent.

16. In this background, let the meeting for negotiating an agreement for the development of indigenous therapies for DMD and vesting the intellectual property and other rights with the Government be held on 2nd February, 2023 at 5:00 pm.

17. The representatives of DART/Hanugen, who are present in Court, shall also attend the said meeting.

18. In order to enable effective discussions, Ms. Shyel Trehan, ld. Counsel and Mr. Kirtiman Singh, ld. CGSC shall also join the said meeting.

19. Mr. Amit Kumar from BIRAC, who is present in Court today shall brief the concerned officials about the events that have transpired in these proceedings in order to ensure that effective deliberations can take place.

20. It is made clear that the amount of Rs.5.35 crores, which was directed to be released to M/s. Hanugen vide order dated 22nd December, 2022 for the purpose of conducting phase-2/3 trials is not the upper limit and the W.P.(C) 5315/2020 & connected matters terms and conditions of the agreement are still to be negotiated between the parties. Further directions for release of funds to each of the patients would be passed, if no progress is made, by the next date of hearing. Commencement of Treatment

21. Mr. Oberoi, ld. counsel for AIIMS had submitted under instructions that purchase orders have already been placed on M/s Sarepta. This submission of the ld. Counsel is controverted by ld. Counsel appearing for the Petitioner.

22. At this stage, Dr. Kanika from AIIMS, who has joined the Court virtually, has revealed that the supply orders have not been placed on M/s Sarepta yet. She submits the funds were released in respect of few patients in September, 2022, however, the tender process took time. The earlier tender had to be cancelled and a fresh tender had to be placed.

23. On 9th December, 2022, the Court was informed that, in respect of DMD patients, tenders have been called and purchase orders have also been placed, which is completely contrary to what is being submitted today in Court by Dr. Kanika. The relevant portion of the order reads as under:

24. Since the inception of these cases, it is well known to all the parties and stakeholders concerned that for DMD, M/s Sarepta is the only one W.P.(C) 5315/2020 & connected matters company which is supplying therapeutics across the world.

25. The amount having been released by the Ministry of Health & Family Welfare way back in September, 2022, the non-placing of purchase orders/supply orders on M/s Sarepta would be a grossly negligent attitude adopted by the concerned persons at AIIMS. There cannot be any justification for this attitude.

26. Let an affidavit be filed by AIIMS within one week explaining its position.

27. Mr. Oberoi, ld. Counsel also seeks a clarification in respect of the constitution of the Rare Disease Committee. Let an application be filed if any clarification is needed.

28. Dr. Kanika to remain present in Court on the next date.

29. List on 15th February, 2023. W.P.(C) 1054/2023 & W.P.(C) 1079/2023

30. These are writ petitions filed by two minors, who are suffering from Duchenne Muscular Dystrophy (DMD). The prayer in the petitions is to consider the case of the Petitioners for treatment through administration of Antisense Oligonucleotide (AON) therapy and other treatment free of cost.

31. Issue notice.

32. Ld. counsel for the Union of India to take instructions for release of funds in respect of these patients to AIIMS.

33. List on 15th February, 2023.

PRATHIBA M. SINGH JUDGE JANUARY 30, 2023/dk/mr/sk (corrected & released on 1st February, 2023)