ILNS: The Centre has informed the Delhi High Court that it has notified the National Policy for Rare Diseases, 2021 on March 31 and Rs 4.10 crore has been transferred to AIIMS, while approving the budget estimate for 2021-22 to the tune of Rs 25 crore.
An affidavit placed before the Bench of Justice Prathiba M Singh by the Ministry of Health said that the consortium of centres of excellence for the prevention and treatment of rare diseases under the leadership of All India Institute of Medical Sciences has also been made a part of the policy.
The Union of India (UoI) and the Ministry of Home Affairs (MHA) have placed on record an affidavit dated April 16, 2021, in compliance with the previous order dated March 23, passed in a matter related to children suffering from rare diseases and whose parents were unable to bear the costs of the expensive treatment they required.
The affidavit has set out the following compliances, which have been undertaken:
1. The National Policy for Rare Diseases 2021, has been notified on March 30, 2021.
2. The consortium of centers of excellence for the prevention and treatment of rare diseases under the leadership of AIIMS has also been made a part of the policy, as per paragraph 12 A. The communications in this regard have already been sent by the Ministry to AIIMS for constituting the consortium. The letters dated April 7, 2021 in this regard have been placed on record.
3. As far as funding is concerned, as per the affidavit, the budgeted estimates of the previous years have lapsed as the same was not utilised. However, the current year’s available funds under the rare diseases component, of Rs 4.10 crore under the umbrella scheme of RAN is stated to have been transferred to AIIMS to the RAN account.
4. The budget estimate for 2021-22, to the tune of Rs 25 crore, based on the utilisation, the Ministry has deposed that the amounts can be enhanced. In addition, it is stated that the crowd funding option is also expected to provide supplemental financial resources.
5. There are eight centres of excellence, each of which would be managing a digital crowd-funding platform. The ministry has written a letter to each centre of excellence for opening a bank account for the rare diseases fund.
6. For the research development technology transfer and indigenisation of therapeutics, the national consortium would be convened by the department of health research with ICMR as a member. The CSIR and DBT, as also DOPP, are part of the said consortium. The further approvals for new drugs in the rare disease category would be provided by the Drug Controller of India under The New Drugs and Clinical trial Rules the said committee and a status report shall be filed in respect of the decisions taken for each of the petitioners for the next date of hearing.
7. It has also been highlighted that if the amount has been transferred in the RAN account, limit of Rs 20 lakh may be applicable. In respect of this limit, Mr Bharadwaj shall seek instructions for the next date of hearing and make submissions. It was further submitted by Mr Bharadwaj that the Solicitor General appearing is not available and the matter be adjourned.
Mr Ashok Agarwal, who appeared for the petitioner, brought to the notice of the court that DMD is a recognised form of disability under the Rights of Persons with Disabilities Act, 2016. He accordingly submitted under Section 86 of the said Act, the national fund for persons with disabilities has already been set up.
Accordingly, in view of the fact that such a fund is a part of the statute, the ministry shall file an affidavit as to whether the national fund for persons with disabilities has been set up and if so, what is the amount that has been allocated for the said fund.
The Delhi High Court had earlier constituted a committee with Dr Renu Swarup as its Chairperson and directed the committee to file a detailed report on major aspects of the said subject.
The Single Judge Bench of the Delhi High Court had also directed the Centre that The National Health Policy for Rare Diseases shall be finalised and notified on or before March 31, 2021.
The court had also earlier declared that
“Right to health and healthcare was a fundamental right, and therefore, finalisation of the policy on rare diseases could not be kept pending indefinitely”.
The court directed to file the report in 10 days. The matter is listed for further proceedings on May 17.