JUDGMENT :

Prathiba M. Singh, J.

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 Assistance Council (hereinafter ‘BIRAC’), Hanugen was to conduct a multi-centric 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:

“17. At this point in time, the clear position of Hanugen and DART is that they are unable to fund their portion of the amount as per the Memorandum of Understanding dated 8th January, 2021 signed between the Biotechnology Industry Research Assistance Council (BIRAC) and M/s. Hanugen Therapeutics Private Limited (hereinafter, “Hanugen”). It is submitted that if the clinical trial is conducted by administering the medicines in respect of half of the total of 54 patients, the total budgetary requirement for commencing the said trial, would be a sum of approximately Rs.5.35 crores that would be required by Hanugen. It was in this background that the Court had issued the directions relating to release of Rs.5 crores, as extracted hereinabove.

18. Upon a query put by the Court, insofar as the direction for disbursement of Rs.5 crores to Hanugen is concerned, it is submitted that a sum of Rs.1.41 crores has already been released by BIRAC, in favour of Hanugen. The remaining amount which is to be released by BIRAC, in terms of the said MoU, would be approximately Rs.3.2 crores.

19. Keeping all the above factors in mind, it is directed that the clinical trials, in the manner as specified in its affidavit dated 17th December, 2022, ought to be commenced and conducted by Hanugen.

Under such circumstances, considering the part funding which has already been disbursed, as also, the lack of funds with Hanugen at this point in time, it is deemed appropriate to direct that an amount to the tune of Rs.5.35 crores shall be released by BIRAC