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Judgment
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 mostly 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.
The following doctors from AIIMS have appeared:
Dr. Madhulika Kabra
Dr. Sheffali Gulati
Dr. Kanika
Pursuant to the previous order dated 15th February, 2023, affidavits have been filed by the Drugs Controller General of India (DCGI) and the Ministry of Health and Family Welfare, Union of India.
Mr. Rajiv Manjhi Joint Secretary, Ministry of Health and Family Welfare, Union of India submits that as per the Ministry’s policy only Rs.50,00,000/- can be released per patient.
As per the queries raised and the submissions made, it appears to the Court that a number of clinical trials have been approved by the DCGI in India for Duchenne Muscular Dystrophy (DMD) and for Gaucher disease and candidates in India, have been enrolled. In fact some trials are also stated to have been completed. Dr. Gulati has informed that some of the candidates for the trials have been enrolled at AIIMS, Delhi itself. However, the said information about the trials was not informed to the Court over the last two years when these matters have been under consideration. It is noted with some consternation that even the DCGI has not placed all the facts before the Court in respect of the approved trials or the trials pending consideration.
The Court is currently in the process of ascertaining all the facts relating to clinical trials and the requirements of the Petitioners who are almost 30 in number and are suffering from rare diseases etc.
Today, the hearing was inconclusive. In order to have an effective further hearing the following directions are issued:
The team from AIIMS who is present before the Court today shall place on record a complete chart of all the clinical trials in which AIIMS is involved for the two medical conditions i.e. DMD and Gaucher. The said chart shall deal with the feasibility of enrolment of all the Petitioners in the said clinical trials.
The DCGI shall also place on record a complete chart of all the trials which have been approved or are pending approval in respect of DMD and Gaucher.
The Ministry of Health and Family Welfare, Union of India shall specifically consider the case of Alishba Khan who has already started treatment for DMD but her treatment has been stopped due to non-release of further funds and place its stand on record on the next date of hearing.
All officials from DCGI, Ministries, lawyers and doctors from AIIMS shall appear physically on the next date of hearing as due to the large number of issues and the number of lawyers appearing, a virtual hearing is not feasible.
List on 6th March, 2023 at 4 pm.