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The Delhi High Court on Friday asked the Centre whether funds can be released urgently to enable clinical trials for medicines that can treat rare diseases like duchenne muscular dystrophy (DMD).
A single judge bench of Justice Prathiba Singh was hearing a batch of pleas pertaining to children suffering from rare diseases, such as DMD and hunter’s syndrome. A genetic disorder, DMD affects the muscles, leading to muscle wasting that gets worse over time. It occurs primarily among males, though in rare cases may affect females, according to National Institutes of Health, the US medical research agency. The treatment of the diseases being expensive, plea seeks directions to provide the children with free treatment.
With respect to “indigenous development of therapies for rare diseases”, the HC was informed that a MoU between Biotechnology Industry Research Assistance Council (BIRAC) and Hanugen Therapeutics Private Limited was signed on January 8, 2021.
According to the MOU, Hanugen is to conduct a multicentric study for therapeutic evaluation with respect to DMD patients. The HC noted that as per the agreement 50% of the study would be funded by the Centre while the remaining will come from the company. The HC was also informed that the total approved amount for the study is Rs 9.24 crore and only Rs 1.41 crore has been released till now.
Hanugen’s representatives informed the HC that phase 2 and phase 3 trials of the therapy has been approved by the DGCI and 54 patients have been enrolled for the trials, however commencement of trial has been delayed due to shortage of funds. The HC noted that DMD is a rare disease which is prevalent in many patients, and indigenous development of therapies is extremely crucial to avoid investment on expensive medication which is not easily available in the country.—please add this observation
The HC directed the counsel for Centre to obtain appropriate instructions on whether Rs 5 crore can be released urgently to enable Hanugen to commence its clinical trials. Hanugen’s officials were directed to file an affidavit within one week, giving the “details of the funding, the patients, DCGI approval, and the manner in which phase two and phase three trials” will be conducted. The matter is next listed on December 22.
The HC in March 2021 had directed the Centre to institute a Crowd funding platform under the National Rare Diseases Policy. On the platform, the HC on Friday said that although it is operational, the same requires to be “publicised in order to attract funding from the general public and corporate entities and PSU’s”.
The HC directed the Centre to prepare a detailed plan for publicising the platform and details relating to the same be sent to “Navratna Public Sector units and top 10 private companies in order to enable them consider contributing to the said platform”.
It was directed that there shall be proper follow up of such communication and any responses received by the companies and PSUs will be placed before the HC.
The Centre informed the HC that the rare diseases fund is being managed by the Ministry of Health. The HC further sought from the Centre the data on the number of patients who have been recommended treatment for such disorders by centres of excellence. The HC has also sought data on the amount disbursed and the timeline being followed by the Health ministry in approving these recommendations.
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