The submissions were made in an affidavit filed before Justice Prathiba M Singh pursuant to her directions on March 23 to finalise and notify the National Health Policy for Rare Diseases by March 31 and to set up a National Consortium for Research, Development and Therapeutics (NCRDT) for such ailments.
The March 23 directions came on a batch of pleas concerning children suffering from rare diseases and whose parents are unable to bear the costs of the expensive treatments they require.
In its affidavit, filed through central government standing counsel Ripudaman Singh Bhardwaj, the ministry has said that it has also written to the Secretary of Department of Health Research to form the NCRDT which along with the Centres of Excellence are also part of the new policy on rare diseases.
The ministry further said that the policy also provides for setting up a committee on rare diseases in AIIMS and communication in this respect has been sent to the premier hospital and the Centres of Excellence.
Regarding funding of the treatment to be provided to the children suffering from rare diseases, the ministry said that funds allocated for the purpose in the financial year 2020-21 were unutilised and lapsed.
However, Rs 4.10 crore under the rare disease component of the umbrella scheme of Rashtriya Arogya Nidhi (RAN) for 2020-21 has been remitted to AIIMS, the ministry said and added that the budget estimate for 2021-22 for treating rare diseases was Rs 25 crore and this amount can be enhanced based on its utilisation.
Besides that there is an option of crowdfunding to supplement the funds, it told the court.
AIIMS told the court that the rare diseases committee has been set up and it shall examine the cases of the petitioners and others who suffer from such ailments.
Advocate Ashok Agarwal, who appeared for several of the petitioner children, said one of the rare diseases was muscular dystrophy which is considered as a disability under the Rights of Persons with Disabilities (RPWD) Act of 2016 and there is a fund available under the statute for its treatment.
The court asked AIIMS to file a report regarding the status of setting up Centres of Excellence pursuant to the ministry’s communication to it and also on the findings of the rare diseases committee.
The court also sought the ministry’s stand on Agarwal‘s contention of funds being available under the RPWD Act.
With regard to funds meant for 2020-21 going unutilised, the court said it will take up that issue on the next date of hearing on May 20.
The ministry in its affidavit also said, “It is submitted that manufacturing of drugs will be done by public and private sector pharmaceutical companies and further the approvals for new drugs are provided by Drugs Controller General of India under the New Drugs and Clinical Trial Rules, 2019”.
It further said that rare diseases patients are provided treatment under RAN, which is a specific scheme for poor patients living below threshold poverty line.
“Therefore, the amount marked under the RAN cannot be used for research due to an existing approved mandate. It is further submitted that the fund raised through crowdfunding, is to be utilized firstly for the treatment of rare diseases and further funds can be made available for research also after meeting treatment cost,” it said.
The high court was hearing 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.