Delhi HC directs to hold meeting on issue of funding of clinical trial for rare diseases

New Delhi [India], March 6 : The Delhi High Court on Monday directed the national consortium of concerned departments to hold a meeting and give its recommendations on the funding of clinical trials for rare diseases including Duchenne Muscular Dystrophy (DMD).
The High court has also sought a status report from AIIMS on the treatment of children suffering from rare diseases.
Justice Prathiba M Singh directed the National Consortium for Research, Development, and Therapeutics for rare diseases to hold a meeting by March 26 and said that the recommendations would be comprehensive in nature and the consortium is free to call upon the participation of agencies and people required for this purpose.
The bench said during the meeting the consortium shall consider the age of children suffering from rare diseases and the expenses incurred on the treatment.
The court asked the consortium to explore the possibility and feasibility of indigenous therapies in the already-approved trials as it would be a cost-effective option.
The high court also said the consortium shall also deal with the companies who already have approved therapies for rare diseases in India for any negotiation and agreement.
During the hearing, the doctor from AIIMS was also present, they informed the bench that 4 children have been found capable to be included in the clinical trial. The requisite examination and test will be done on these children on Thursday.
It was also informed that the trial will commence only if the parents agree. One of the petitioners is also included in the few patients upon whom the trial is being conducted by the company M/s Sarepta. The company may induct some more patients and permission for this has been sought.
The Delhi High Court last week had pulled up the central government, AIIMS, and even the counsel for petitioners for not informing it about the beginning of clinical trials for rare disease medicine. The court was hearing the batch of petitions by the children affected by the rare diseases.
Justice Prathiba M Singh going expressed her displeasure and said the court was "kept in dark" by all parties about an ongoing trial here for Duchenne Muscular Dystrophy (DMD).
The court asked the AIIMS to examine the possibility of the children participating in the trial after their evaluation and file a report by Monday.
Dr. Sheffali Gulati informed the court that trials are going on upon 69 patients in the country out of which 11 are in AIIMS. She informed the court she has all the details and would file it before the court. Sarepta is conducting these trials.
The bench asked the doctors why it was not informed prior to the trials were approved. "Why was this court kept in the dark about this trial? Neither government is telling nor is AIIMS. Government, DGCI, Health Ministry, petitioners, everyone kept the court in the dark," justice expressed her displeasure.