Centre releases Rs 40 cr for treatment of rare diseases, AIIMS gets Rs 10 crore

New Delhi [India], May 10 : The Central Government on Wednesday said that Rs 40 crore has been released to 11 centres of excellence including Rs 10 crore to All India Institute of Medical Sciences (AIIMS) for treatment of rare diseases.
The funds have been released by the Ministry of Health and Family Welfare (Rare Disease Cell).
A short affidavit was filed on behalf of the Ministry of Health in the batch of petitions filed by children Suffering from Rare diseases who sought direction for free treatment. Justice Prathiba M Singh said, "The ongoing treatment of the children should not be stopped due to funds."
The Central Government standing counsel (CGSC) submitted that Rs 10 crores has been released to AIIMS for treatment of Rare diseases.
The affidavit has also stated that the ICMR is committed to supporting the clinical trial of the drugs.
The CGSC also submitted that the full plan of action would be placed before the court by Monday. Thereafter the court listed the matter for further hearing on May 15.
The CGSC also informed the court that two orders for releasing funds passed by the court have been challenged before the division bench.
It was also informed that the division bench has modified the order of May 6 directing the Union Health Secretary to appear before the court. The division bench has modified the order to the effect that the joint secretary shall remain present during the hearing.
It is also submitted in the affidavit that the Court may consider the fact that even after spending a significant amount of money, patients suffering from certain rare diseases such as DMD etc. cannot be cured and this will only mitigate their sufferings. Therefore, the rational use of limited resources by the Centre of Excellence (CoEs) is of crucial importance.
The affidavit also stated that the Department of Health & Family Welfare is fully committed towards the expeditious clinical trial of drugs, generation of clinical trial data, its submission to the national regulator Drug Controller General of India (DCGI), its consideration and approval by DCGI for treatment of Rare Diseases.
In addition, the Biotechnology Industry Research Assistance Council (BIRAC) under the Department of Bio-Technology (DBT) has already committed on record, before this Hon'ble Court to fund 50 pc of the funds required for research and trial of such drugs, the affidavit stated.
It is also stated that ICMR has committed to fully supporting on-site trials as multi-centric trials shall be essential for assessing the efficacy as well as contraindications of the drugs.
Once the clinical trial progresses and data are generated, the Department of Health & Family Welfare as well as ICMR shall get the data analysed by a scientific institution of repute for submission before DCGI, the affidavit submitted.
Hence, even the data analysis cost will be borne by the Government, it added.
"This all will cover a major part of the proposed expenditure for the clinical trial of drugs. The promoter companies, since they would be selling the drug (once approved), as a commercial enterprise, would need to invest the balance of financial resources", it further stated.
Therefore, the High Court may like to direct the promoter company i.e. Hanugen to fund the cost of the drug material, drug manufacturing/drug import etc, the Centre has submitted.
On May 6, the Delhi High Court summoned the Union Health Secretary over non-compliance with orders passed for the release of funds of Rs 5 crore for the treatment of children suffering from rare diseases. The court said that it cannot put a blind eye to the treatment of 40 children.
Justice Prathiba M Singh said in the order of May 3, "On February 15, 2023, a further amount of Rs.5 crores was directed to be released by the Ministry of Health and Family Welfare. The said direction was reiterated in an order dated March 6, 2023. However, the said amount has not been released till date."
The bench is hearing a batch of Petitions by children suffering from rare diseases seeking free treatment.
Justice Singh expressed her displeasure and said, " Under such circumstances, the Court cannot turn a blind eye to the medical condition of 40 children who are Petitioners before the Court. The medicines which have already been administered and their effectiveness would
also be completely obliterated if further doses are not continued for the said children.29.
Under these circumstances, the Secretary, Ministry of Health & Family Welfare shall physically remain present in Court on the next date of hearing, Justice Singh had directed.