The Delhi High Court on Wednesday pulled up the central government, All India Institute of Medical Sciences (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 said that even the counsel for the petitioners did not inform the court, otherwise the petitioners could have participated in the trial.
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 68 patients in the country, 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 being 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.
The central government standing counsel submitted that these are global trials and the intention was never to not inform the court.
The bench pointed out that there was a lack of coordination between all the authorities and they were passing the blame to each other’s, instead of adopting a solution-driven approach.
The doctors said that everyone could not be enrolled in the trial. There is a criterion for the enrollment for trial.
The court was also informed that the treatment of Alishba has been stopped as the sanctioned amount of Rs 50 lakh has been consumed.
The court, on the last date, had directed the Ministry of Health to release the further amount.