[Treatment of Children with Rare Diseases] “Kept in dark”: Delhi HC pulls up AIIMS, Centre for failing to inform about clinical trials

The Delhi High Court on Wednesday pulled up the Central Government, the All India Institute of Medical Sciences (AIIMS), and the petitioners' counsel for failing to notify the court of the start of clinical trials for rare disease medication for children.

A single-judge bench comprising Justice Prathiba M. Singh was hearing a batch of petitions filed mostly by children suffering from rare diseases stating that the medicines and therapies for the said diseases are exorbitantly expensive.

The court expressed displeasure and stated, "The court was 'kept in dark' by all the parties, including the petitioners, about an ongoing trial for Duchenne Muscular Dystrophy (DMD) by Sarepta Therapeutics".

Expressing concern for the other petitioner children who could have participated in the trial, the court asked the AIIMS to examine the possibility of the other children that can be enrolled in the trial. The court directed the AIIMS to evaluate, prepare a chart and submit the report by February 6.

During the hearing, Dr. Sheffali Gulati appearing from AIIMS apprised the court that trials for 68 patients in the country were ongoing by Sarepta, out of which 11 patients were from AIIMS, Delhi.

Advocate Kirtiman Singh for the central government contended that the Sarepta trials were part of a global trial and it was never an intention to not inform the court.

To this, the court orally remarked, “There is a lack of coordination between all the authorities and that we cannot blame each other, instead we need to adopt a solution-driven approach”. Accordingly, the court listed the matter for further consideration on February 6.

Notably, Justice Singh on February 15, ordered the Centre to release Rs. 5 crore funds to the All Indian Institute of Medical Sciences (AIIMS), Delhi, to ensure that treatment of children with rare diseases does not halt due to a lack of funds.

It is to be noted that earlier this month, the court had sought an explanation from the AIIMS on the allegations of its "grossly negligent behavior" for not placing purchase orders of therapeutics for the treatment of rare diseases like Duchenne Muscular Dystrophy (DMD), Hunter's Syndrome, etc.

 "The amount having been released by the Ministry of Health & Family Welfare way back in September 2022, the non-placing of purchase orders/supply orders on M/s Sarepta would be a grossly negligent attitude adopted by the concerned persons at AIIMS. There cannot be any justification for this attitude”, the court had said.

The high court in December 2022, directed the Centre to release Rs. 5.35 crore to fund clinical trials for the treatment of rare diseases like Duchenne Muscular Dystrophy (DMD), Hunter's Syndrome, etc.

Case Title: Master Arnesh Shaw v. Union of India &Anr. (a batch of petitions)