Delhi HC Directs National Consortium For Rare Diseases To Test Developing Indigenous Therapies

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.

A single bench of Justice Prathiba M Singh was hearing a bunch of petitions concerning children suffering from rare diseases like Duchenne Muscular Dystrophy (DMD), Hunter’s syndrome. The petitions ask for free treatment for the patients, which would otherwise be exceedingly expensive.

Justice 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.

She also directed the National Consortium to provide suggestions to the court on funding clinical studies for the development of indigenous medicines for DMD and other rare diseases, as well as how the court’s earlier order directing the flow of monies for treatment should be executed.

The bench mandated that the National Consortium’s recommendations be thorough and take the following factors into account:

• The age of the children, whose lives may be shortened if therapy is not started as soon as possible.
• The costs that may be incurred if the drugs are distributed to all of the youngsters who have approached the Centers of Excellence for treatment.
• The viability and feasibility of investigating indigenous medicines in already approved trials.
• Any negotiations or arrangements to be made with firms that already have treatments licenced for administration to children with rare disorders in India.

The court further mandated that, in accordance with an earlier directive, Rs. 5 crores be made available as an ad hoc sum within a week, subject to future judgments.

The All India Institute of Medical Sciences (AIIMS) had previously been ordered to receive an immediate payment of Rs. 5 crores by the Union of India on February 15 in order to ensure that the treatment of children with rare diseases, which had already begun, would not be suspended for lack of funds.

The matter has been scheduled for further consideration on April 13,2023.