It also asked the government to consider increasing the budget for rare diseases for the upcoming financial year 2021-22 and said the policy should deal with giving financial incentives for manufacturing drugs and contributing towards treatment of rare diseases.
Justice Prathiba M Singh, in an interim order on a batch of petitions concerning children suffering from rare diseases, said that as part of the policy, besides the NCRDT, a committee at AIIMS as well as a fund be set up for such ailments.
It said the consortium should consist of the Department of Biotechnology, Indian Council of Medical Research (ICMR), Council of Scientific and Industrial Research (CSIR), Drugs Controller General of India (DCGI) other related ministries and departments and look after research, the development of indigenous treatment, manufacturing of drugs and inclusion of persons in clinical trials.
“The National Health Policy for Rare Diseases, 2020 shall be finalised and notified by the Government of India on or before March 31,” the high court directed.
The high court passed the directions after considering a report filed by an expert committee set up by the court, an affidavit by the Ministry of Health and Family Welfare and also the earlier orders passed in the matter. It said these directions shall form part of the Policy.
It said the rare diseases committee shall be set up at All India Institute of Medical Sciences (AIIMS) for examination of applications and recommend the treatment and funding of the rare illnesses.
The court said when the application will be received by AIIMS, a decision has to be taken by the committee within two weeks and in case, an application is received through other institutions notified under the Policy, the decision on treatment and funding has to be taken by the panel within four weeks.
It directed that the entire unspent budget allocated for rare diseases for the past three years shall be immediately moved into the rare diseases fund, which shall be managed, supervised and utilised by nodal agency AIIMS.
The digital platform created under the Policy for receiving crowd funding shall be linked to the fund and those individuals and companies wishing to contribute shall make direct contributions into it.
The court said the Policy shall be placed before it and the petitioners shall make a representation to the Committee for further processes in terms of the directions and listed the matter for further hearing on April 19.
It also asked the petitioners, suffering from rare diseases, to make representations to the committee regarding the treatment.
The high court had earlier constituted an expert committee to assess and find solutions on various aspects, including how to immediately provide treatment and therapy options to patients suffering from rare diseases including Duchenne Muscular Dystrophy (DMD) and Hunter’s syndromes.
It had said the committee shall also discuss steps to be taken to indigenise the development of the therapies in India and reasonable timelines required to be followed thereof.
DMD, one of the various forms of muscular dystrophy, is a rare genetic disease that affects boys almost exclusively and causes progressive weakness.
The high court’s order came on various pleas filed on behalf of children suffering from rare diseases, including DMD and Mucopolysaccharidosis II or MPS II (Hunter Syndrome), and seeking direction to the Centre to provide them uninterrupted and free of cost treatment as the therapy is very expensive.
MPS II is a rare disease that is passed on in families and it mainly affects boys and their bodies cannot break down a kind of sugar that builds bones, skin, tendons and other tissues.
The high court had earlier also directed the Centre to finalise by March 31 its new National Health Policy for Rare Diseases of 2020 and make operational the digital platform envisaged under it for crowd funding of the expensive medicines and treatment for rare illnesses.
The court had also noted in its order that the earlier policy on rare diseases of 2017 was kept in abeyance from December 2018 onwards and the new policy was still awaiting comments from the public and other stakeholders.
