Recently, in the matter of Master Arnesh Shaw v. Union of India & Anr., The High Court of Delhi has directed National Consortium to hold an urgent meeting on the Clinical Trials for developing indigenous therapies for Duchenne Muscular Dystrophy (DMD) and Gaucher with DART or Hanugen Therapeutics Private Limited.

The Bench of Justice Prathiba M Singh hearing a petition concerning children suffering from rare diseases like Duchenne Muscular Dystrophy (DMD), and Hunter's syndrome, the Court ordered National Consortium to do Research and Development on the disease and also order them to consult other centres under the National Policy for Rare Diseases (NPRD) on an estimate of candidates who may be requiring medicines and therapies across India.

“The meeting of the national consortium shall be held on or before 20th March 2023 and a report shall be put up by the next date of hearing,” the court said in its order passed on March 06.

“Let an affidavit be filed by the next date of hearing as to the various research and development activities carried out by the National Consortium/DHR till date in respect of rare diseases and their current status,” it ordered.

The Court gives freedom to National Consortium to whose participation would be required to make effective recommendations, in the meeting.

The recommendations shall consider the following aspects:

• The expenses may be incurred if the medicines are to be provided to all the children which have approached the Centres of Excellence seeking treatment.
• The possibility and feasibility of exploring indigenous therapies in the already approved trials.
• Any negotiations or arrangements to be entered into with the companies, that already have approved therapies for administration to children with rare diseases in India.
• The age of the children, whose life may be curtailed if the treatment is not commenced on priority.

The Next date of the hearing is on 13 April, 2023