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IN THE HIGH COURT OF DELHI AT NEW DELHI
Prathiba M. Singh, J.
Master Arnesh Shaw – Appellant
Versus
Union of India & Anr. – Respondents
W.P.(C) 5315 of 2020 & CM APPL. 19189 of 2020, 4237 of 2023
Decided On : 15-05-2023
Rare Diseases - Clinical Trials and National Rare Diseases' Committee - [ICMR Act, 1989 - Section 7; New Drugs and Clinical Trial Rules, 2019 - Section 13; National Policy for Treatment of Rare Diseases, 2017; National Policy for Rare Diseases, 2021] - The court discussed the conduct of clinical trials for rare diseases, funding arrangements, and the constitution of the National Rare Diseases' Committee. Key legal provisions such as the ICMR Act, 1989 and the New Drugs and Clinical Trial Rules, 2019 were referenced and interpreted to facilitate the clinical trials and indigenization of therapies. The court's decision was influenced by the need to streamline the manufacturing and trials process, and to ensure the implementation of the National Rare Disease Policy, 2021.
Fact of the Case:
The petitioners, children suffering from rare diseases, sought access to expensive medicines and therapies. The court oversaw the conduct of clinical trials, funding arrangements, and the constitution of the National Rare Diseases' Committee to address the challenges in treating rare diseases.
Finding of the Court:
The court found that the conduct of clinical trials and the constitution of the National Rare Diseases' Committee were essential to address the challenges in treating rare diseases and to ensure the implementation of the National Rare Disease Policy, 2021.
Issues: Access to expensive medicines and therapies for children suffering from rare diseases, conduct of clinical trials, funding arrangements, and the constitution of the National Rare Diseases' Committee.
Ratio Decidendi: The court's decision was based on the need to streamline the manufacturing and trials process, and to ensure the implementation of the National Rare Disease Policy, 2021.
Final Decision: The court directed the conduct of clinical trials, funding arrangements, and the constitution of the National Rare Diseases' Committee to address the challenges in treating rare diseases and to ensure the implementation of the National Rare Disease Policy, 2021.
The court directed that clinical trials by M/s Hanugen proceed further, BIRAC make its second tranche contribution without delay since funds were arranged by Hanugen, and a meeting be held between Hanugen, BIRAC, and ICMR representatives in the week commencing 22nd May 2023 to chalk out a timetable for clinical trials per approved protocols.[11000768370004] The court further directed the CGSC to file an updated status report by the next hearing after obtaining instructions from BIRAC and ICMR.[11000768370005] The court constituted the National Rare Diseases’ Committee with members including Dr. Nikhil Tandon (Professor-AIIMS), Secretary-Ministry of Health & Family Welfare or nominee, Director General-ICMR, DCGI, and Dr. Madhulika Kabra (Professor-AIIMS).[11000768370019] The Committee's mandate includes procuring therapies/drugs and creating logistical frameworks for treatment, recommending steps for indigenisation of therapies/medicines and accessibility, and periodic review of the National Rare Disease Policy, 2021 with recommendations to the Ministry.[11000768370020] The Committee must urgently address immediate needs of patients whose treatments stopped due to funding issues (per para 16 of 3rd May 2023 order) by contacting providers/manufacturers/distributors to recommence treatment.[11000768370021] The Committee may consult invitees, subject experts, or domain persons, and obtain patient/provider details from counsel/AIIMS/standing counsel as needed.[11000768370022] The Committee shall examine enrolled patients at AIIMS (DMD, SMA, other rare diseases) and modalities for commencing their treatment.[11000768370023][11000768370024] The issue of a wrong vial supplied for the petitioner in W.P.(C) 5395/2021 (to be replaced in next procurement) shall be brought to the Committee's notice.[11000768370025] The Committee's first meeting shall occur between 17th-21st May 2023, with a compilation of all court orders provided by Joint Secretary Mr. Rajiv Manjhi (Ministry of Health & Family Welfare), who shall coordinate as Officiating Secretary until otherwise appointed.[11000768370026] The matters are listed for 29th May 2023 at 2:30 pm.[11000768370026]
JUDGMENT
Prathiba M. Singh J. (Oral)--This hearing has been done through hybrid mode.
2. The present batch of petitions has been filed by the Petitioners who are children suffering from rare diseases. The case of the Petitioners is that medicines and therapies for the said diseases are exorbitantly expensive and if the same are not made available, the health and physical well-being of these children would be severely jeopardised. These matters have been heard by the Court from time to time and various directions have been issued for enabling treatment and making medicines available to the Petitioners.
Trials for Development of Indigenous Therapies
3. On 20th April, 2023, this Court was informed that ICMR is willing to fund the on-site trials of the therapies that are currently being developed by Hanugen-BIRAC. However, manufacturing of the drugs would have to be carried out by the company concerned, and the cost of manufacturing would also have to be borne by the company. On 3rd May, 2023, ld. Counsel for BIRAC submitted that Hanugen has informed BIRAC that it had arranged its share of funds in terms of the Grant-in-aid Letter Agreement (GLA), and that BIRAC is also willing to continue to honour the said agreement.
4. Today, Dr. Shastry from DART and Mr. Amit Kumar appearing for BIRAC submit that the second tranche of Rs.92 lakhs has been arranged by Hanugen and now, in terms of the GLA, contribution of BIRAC is to be made. It has further been brought to the attention of the Court that as per the affidavit dated 10th May, 2023, ICMR has agreed to provide full support, both technical and financial, to clinical trials at four trial sites. The relevant portion of the said affidavit reads as under:
"7. It is respectfully submitted that the present instance has provided an opportunity to encourage research & development of new drugs by way of augmenting and expediting clinical trials. In this connection, it is humbly submitted that the clinical trial protocol for conducting the regulatory clinical trial has specified the following 9 trial sites:
i. Indira Gandhi Institute of Child Health, Bengaluru
ii. Sir Ganga Ram Hospital, New Delhi;
iii. All India Institute of Medical Sciences, New Delhi;
iv. Postgraduate Institute of Medical Education & Research, Chandigarh;
v. SMS Medical College, Jaipur;
vi. All India Institute of Medical Science, Bhopal;
vii. CIMS Hospital, Ahmedabad;
viii. KEM Hospital, Pune &
ix. Nizam's Institute of Medical Sciences, Hyderabad.
Out of these 9 sites, ICMR has agreed to full support (both technically and financially), the clinical trials at the following 4 trial sites:
I) AIIMS, New Delhi.
II) PGIMER, Chandigarh
III) Indira Gandhi Institute of Child Health, Bangalore
IV) Sir Ganga Ram Hospital, New Delhi
8. It is respectfully submitted that Department of Health & Family Welfare is fully committed towards expeditious clinical trial of drugs, generation of clinical trial data, its submission to the national regulator i.e. Drug Controller General of India (DCGI), its consideration & approval by DCGI for treatment of Rare Diseases. In addition, 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% of the funds required for research and trial of such drugs.
9. ICMR has committed for fully supporting on site trial, as multi-centric trial shall be essential for assessing the efficacy as well as contra indications of the drugs. Once clinical trial progresses and data are generated, Department of Health & Family Welfare as well as ICMR shall get the data analysed by a scientific institution of repute for submission before DCGI. Hence, even the data analysis cost will be borne by the Government. 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
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