Master Medhansh Jhawar @ Madhav vs Rajesh Bhushan & Ors.

Prathiba M. Singh J. (Oral)

This hearing has been done through hybrid mode.

The present batch of petitions has been filed by the Petitioners who are 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.

This is an application filed by AIIMS, New Delhi seeking permission to constitute the Centre of Excellence (COE) Rare Diseases Committee in place of the “two-member Rare Disease Committee” which was constituted pursuant to the directions passed by the Court on 23rd March, 2021.

It is submitted by Mr. Oberoi, ld. Counsel on behalf of AIIMS as also by Dr. Madulika Kabra, who has appeared virtually before the Court, that after the constitution of the two-member Rare Diseases Committee by this Court, since AIIMS was also notified as a Centre of Excellence under the National Policy for Rare Diseases, 2021, the Committee for Rare Diseases was constituted afresh within AIIMS, New Delhi. As on today, the proposed new COE Committee is as under:

Upon a query being put to the ld. Counsel and also to Dr. Kabra as to how such a large Committee would be efficient especially in treatment of urgent cases of children with rare diseases, an assurance has been given by Dr. Kabra that the working of this Committee would be efficient and the number of members in the Committee would not in any way act as an impediment in taking quick decisions.

It is made clear that the proposal which has been put up by AIIMS has been approved by the Court subject to the condition that the decisions to be taken by the Rare Diseases Committee shall not be delayed or impeded in any manner by the size of the Committee.

The Committee is approved in the above terms.

The application is disposed of.

Issue notice in these petitions. Let the said children be examined in AIIMS within the next one week and a report be filed by the next date of hearing as to the feasibility of providing treatment to them.

List on 10th May, 2023 at 3:30 p.m.

On 15th February, 2023, Minutes of Committee Meeting of BIRAC dated 2nd February, 2023 were placed on record of the Court. As per the said minutes, BIRAC was bound by the Biotechnology Industry Partnership Programme (BIPP) and the Grant-in-aid Letter Agreement (GLA) and that it was mandatory for Hanugen to contribute 50% of the total project cost. On 6th March, 2023, the Court had referred the entire matter for developing indigenous therapies for rare diseases with Hanugen to the National Consortium for Research and Development on Therapeutics for Rare Diseases and directed it to place its recommendations before the Court.

On 20th April, 2023, the Court was informed that the ICMR is willing to fund the on-site trials directly, however, the manufacturing of the drug would have to be carried out by the company concerned and the cost of the same would also have to be borne by the said company. Accordingly, the Court had directed Hanugen to place its stand on record. The relevant portion of the order dated 20^th April, 2023 reads as under:

Today, ld. Counsel appearing for BIRAC submits that Hanugen Therapeutics has contacted BIRAC and informed that it has arranged its share of the funds in terms of the GLA and that BIRAC is also willing to continue to honour the said agreement insofar as the trials and funding of the same by ICMR is concerned.

Ms. Trehan, ld. Amicus Curiae submits that Hanugen is intending to hold a meeting with ICMR in order to understand how the on-site trials can be funded by ICMR. The ld. Amicus Curiae also submits that Hanugen is in the process of arranging funds for its share of the amounts in terms of the GLA.

Accordingly, let Hanugen, BIRAC and ICMR file their respective affidavits by the next date of hearing as to how they intend to move forward both qua the GLA as also the funding by ICMR of the on-site trials.

A complete chart of the treatment which has been given to all the Petitioners in these cases is set out below:

As can be seen from the above chart, in respect of a large number of children, the treatment has commenced upon the release of the sum of Rs.50,00,000/- in terms of the National Policy for Rare Disease qua the said Petitioner. However, in respect of some of the children, even the initial sum of Rs.50,00,000/- has not been received yet. Accordingly, in respect of the Petitioners at serial nos.25 to 37, the sum of Rs.50,00,000/- each shall now be released within a period of one week to AIIMS, New Delhi.

In the meantime, order for the supply of medicines for these children shall be placed by AIIMS with the supplier so that by the time the funds are received, medicines can also be received and the treatment can be commenced immediately.

Insofar as those children for whom the funds are stated to have been exhausted, a number of parents and counsels have made submissions today. Illustratively, in respect of Alishba Khan, the Petitioner in W.P.(C) 2943/2020, it is submitted that since the treatment was stopped in January, 2023, she has lost her hearing capacity and had to undergo surgery in AIIMS.

In respect of Master Keshav Sharma, the Petitioner in W.P.(C) 322/2021, his father is present in Court and submits that he is now almost bed ridden and his mobility has been severely impaired and he can only walk with support now.

Insofar as the Petitioner in W.P.(C) 5395/2021, i.e., Master Ayushman Chaturvedi is concerned, his parents have complained that out of the entire doses that was to be administered, one vial has not been administered and the treatment has since stopped as of 11th April, 2023. Dr. Kabra and Dr. Kanika from AIIMS, who have appeared virtually, seek to explain the same by stating that there was a shortage in the vial which was received from the supplier and they are following up with the supplier for the same.

In the present batch of cases, the Court faces an extreme situation where almost 40 children who are before the Court, are likely to suffer physical and mental injury and deterioration of health if further funds are not released for their treatment.

It has been noticed vide orders dated 23rd March, 2021 and 30th January, 2023 that a large amount of funds were, in fact, allocated for rare diseases. However, the budgets lapsed and the amounts were not released. Repeated orders of this Court for release of further amounts have not been acceded to by the Ministry.

The budgeted amounts which had lapsed are discussed in order dated 23^rd March, 2021 which reads as under:

A perusal of the above would show that the lapse of budget has also been confirmed in the affidavit by Ministry of Health and Family Welfare, Union of India to the tune of almost Rs. 193 crores. The said affidavit also demonstrated that as against the elapsed budget, only a sum of Rs.7 crores was spent between 2018 till 2021.

Vide orders dated 15th February, 2023, further amount of Rs.5 crores was directed to be released by the Ministry of Health & Family Welfare, Union of India. The said direction was reiterated in order dated 6th March, 2023. However, the said amount has not been released till date.

The Union of India has also filed LPA 364/2023 titled Union of India v. Alishba Khan before the ld. Division Bench of this Court, challenging the above two orders. This Court has been informed that no stay on the said two orders has been granted and the ld. Division Bench has also clarified that the pendency of the LPA would not come in the way of this Court hearing the matters further.

Under such circumstances, the Court cannot turn a blind eye to the medical condition of 40 children who are Petitioners before the Court. The medicines which have already been administered, their effectiveness would also be completely obliterated if further doses are not continued for the said children.

Under these circumstances, the Secretary, Ministry of Health & Family Welfare shall physically remain present in Court on the next date of hearing.

On the next date, the Court shall consider whether notice of contempt ought to be issued in these matters.

Insofar as the case of Master Ayushman Chaturvedi is concerned, the Court is compelled to observed that the Rare Diseases Committee in AIIMS, New Delhi is expected to act with alacrity in all these matters and not to take matters in a cavalier manner.

Let the said vial be obtained from the supplier and be administered as expeditiously as possible.

All the children who have been administered the medicines shall also be physically evaluated and a status report of their medical condition shall be placed on record by the next date of hearing.

List on 10^th May, 2023 at 3:30 p.m.