Delhi High Court Directs National Consortium To Hold Meeting On Clinical Trials For Developing Indigenous Therapies For Rare Diseases

The Delhi High Court has directed the National Consortium for rare diseases to hold a meeting on clinical trials for developing indigenous therapies for Duchenne Muscular Dystrophy (DMD) and Gaucher with DART or Hanugen Therapeutics Private Limited.

Justice Prathiba M Singh also directed the National Consortium for Research and Development on therapeutics for Rare Diseases to consult other Centres of Excellence under the National Policy for Rare Diseases (NPRD) on estimate of candidates who may be requiring medicines and therapies across India and not just in the national capital.

“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.

The court was hearing a clutch of petitions concerning children suffering from rare diseases like Duchenne Muscular Dystrophy (DMD), Hunter's syndrome. The petitions seek free-of-cost treatment for the patients, which is otherwise very expensive.

Justice Singh directed the National Consortium to place its recommendations before the court on funding of clinical trials for development of indigenous therapies in respect of DMD and other rare diseases and also on the manner in which the court’s earlier order directing releases of funds for treatment is to be implemented.

“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 also said that the National consortium is free to call any other entity or person, whom it deems appropriate and whose participation would be required to make effective recommendations, in the meeting.

The court ordered that the recommendations of the National Consortium would be comprehensive in nature and shall consider the following aspects:

- The age of the children, whose life may be curtailed if the treatment is not commenced on priority.

- The expenses, which 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, who already have approved therapies for administration to children with rare diseases in India.

The court also ordered that as directed by it earlier, Rs.5 crores shall be released within one week as an ad hoc amount subject to further orders.

Earlier, the court on February 15 had directed Union of India to immediately release Rs. 5 crores to All India Institute Of Medical Sciences (AIIMS) to ensure that treatment of children with rare diseases, where it has already commenced, is not stopped due to lack of funds.

The matter will now be heard on April 13.

Previously, the court had asked the Central Government to consider publicising crowdfunding for treatment of rare diseases through television, radio or any other media platform in order to attract more voluntary donations from the public.

Earlier, the court had asked the Central Government to consider publicising crowdfunding for treatment of rare diseases through television, radio or any other media platform in order to attract more voluntary donations from the public.

Case Title: Master Arnesh Shaw v. Union of India & Anr.

Citation: 2023 LiveLaw (Del) 219

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