Back
IN THE HIGH COURT OF DELHI AT NEW DELHI
Prathiba M.Singh, J.
Aviraj Garg - Appellant
Versus
Union Of India & Anr. - Respondents
W.P. (C) No. 10782 of 2020, 1611 of 2021, 1511 of 2021, 1491 of 2021, 322 of 2021, 5315 of 2020
Decided On : 02-03-2021
Crowdfunding - Rare Diseases - [Drugs and Cosmetics Act, 1940, Drugs and Cosmetics Rules, 1945] - The court examined the feasibility of accelerated approval processes for therapies for rare diseases and directed the Union of India to explore a confidential proposal for making therapy available for children suffering from Duchenne Muscular Dystrophy (DMD). A committee was constituted to recommend immediate treatment options, steps for indigenizing therapy development, consideration of accelerated approval processes, and concrete proposals for crowdfunding. The committee was required to submit a report by a specified date.
Fact of the Case:
The court examined the efforts made by the Ministry of Health and other organizations in providing treatment and therapy options for patients suffering from rare diseases, particularly Duchenne Muscular Dystrophy (DMD).
Finding of the Court:
The court found that there are ongoing clinical trials for DMD therapies in India and directed the Union of India to explore accelerated approval processes and a confidential proposal for therapy. It constituted a committee to recommend immediate treatment options and propose concrete crowdfunding measures.
Issues: Efforts by the Ministry of Health in providing treatment for rare diseases, feasibility of accelerated approval processes, and availability of funding for therapy.
Ratio Decidendi: The court emphasized the need to explore accelerated approval processes and crowdfunding for the treatment of rare diseases, particularly DMD, in India.
Final Decision: The court constituted a committee to recommend immediate treatment options, steps for indigenizing therapy development, consideration of accelerated approval processes, and concrete proposals for crowdfunding. The committee was required to submit a report by a specified date and the matter was listed for further hearing.
JUDGMENT
Prathiba M. Singh, J. - This hearing has been done through video conferencing.
CM APPL. 4332/2021 (for exemption) in WP(C) 1511/2021
2. Allowed, subject to all just exceptions. Application is disposed of.
WP(C) 10782/2020 & CM APPL. 33828/2020 (for interim direction)
WP(C) 5315/2020 & CM APPL. 19189/2020 (for interim direction)
WP(C) 322/2021 & CM APPL. 812/2021 (for interim direction)
WP(C) 1491/2021 & CM APPL. 4291/2021 (for interim direction)
WP(C) 1511/2021 & CM APPL. 4331/2021 (for interim direction)
WP(C) 1611/2021 & CM APPL. 4600/2021 (for interim direction)
3. The Court has perused the two affidavits filed by Central Drugs Standard Control Organisation (hereinafter, "CDSCO") and the Union of India. The Court has also heard the submissions of Dr. Shastry from Dystrophy Annihilation Research Trust, Bangalore (hereinafter, "DART") and on behalf of the Institute of Child Health, Kolkata.
4. Firstly, this Court is of the opinion that there ought to have been greater effort by the Ministry of Health by engaging with M/s Sarepta Therapeutics, which was willing to provide a confidential proposal; by exploring more concrete options for crowdfunding etc. The clear stand of the Union of India appears to be that until the policy gets notified and the eplatform for crowdfunding is created, there can be no crowdfunding which can be explored. However, orally Dr. Pulkesh Singh for the Ministry of Health, Union of India, has mentioned that he has written to four organisations to arrange for funding for treatment of the said patients.
5. From the submissions made by Dr. Shastry from DART as also from the affidavit filed on behalf of CDSCO, it appears that clinical trials are already underway in India for drugs/therapies for the treatment of DMD. The details of the same are set out in the affidavit filed by CDSCO. The said affidavit and the submissions made today shows that there are various organisations and companies which are conducting clinical trials in respect of DMD therapies. The same include :-
(i) M/s Medspace Clinical Research India Private Limited
(ii) M/s Muscular Dystrophy Patients Welfare Society
(iii) M/s Dystrophy Annihilation Research Trust
(iv) Institute of Child Health, Kolkata
(v) Nizam's Institute of Medical Sciences (non sense mutation DMD)
(vi) Child Trust Hospital, Chennai (non sense mutation DMD)
6. In view of the fact that there are various therapies for DMD which are already being researched upon in India and there are several children suffering from these diseases, the feasibility of accelerated approval processes ought to be examined. Further, the Union of India ought to explore the confidential proposal which is being put forward by M/s Sarepta Therapeutics for the purpose of making the therapy available for children who are suffering from DMD. In order to undertake a comprehensive assessment of the issues that have arisen and for recommending a time-line based solution, this Court constitutes the following Committee:
(i) Chairperson - Dr. Renu Swarup, Secretary of Department of Biotechnology, Govt. of India. (secy@dbt.nic.in)
(ii) Dr. (Prof.) Madhulika Kabra, Division of Genetics, Department of Paediatrics, AIIMS (madhulikakabra@hotmail.com)
(iii) Dr. IC Verma Director, Centre of Medical Genetics, Sir Ganga Ram Hospital (dr_icverma@yahoo.com)
(iv) Dr. P. Ramesh Menon, Associate Professor, Department of Paediatrics, AIIMS (M: 8800997737) (rpmaiims@gmail.com)
(v) Dr. Arun Shastry, Chief Scientific Officer, Dystrophy Annihilation Research Trust (DART) (M:9840219833) (arunshastry@dartindia.in)
(vi) Dr. Apurba Ghosh, Director, Institute of Child Health (apurbaghosh@yahoo.com)
(vii) Dr. Angamuthu Meena Kanikannan, Nizam's Institute of Medical Sciences (M:+914065863509) (meenaak@hotmail.com)
(viii) Dr. V, Viswanathan, Kanchi Karnakoti, CHILDS Trust Hospital (M: 9840100072) (vishneuro@gmail.com)
(ix) Dr. Pulkesh Kumar, Deputy Secretary, Ministry of Health and Family Welfare.
The Chairperson is free to consult or co-opt any other
The court emphasized the need to explore accelerated approval processes and crowdfunding for the treatment of rare diseases, particularly DMD, in India.
The court emphasized the necessity for timely medical treatment and therapies for rare diseases, directing proactive measures by government bodies to facilitate funding and expedite clinical trials.
The court mandated that the government ensure timely treatment and funding for patients suffering from rare diseases, establishing a comprehensive framework to facilitate compliance with health polic....
The fundamental right to health and healthcare under Article 21 of the Constitution necessitates ensuring treatment for Rare Diseases despite exorbitant costs, and the government's obligation to fina....
The government has an obligation to invest in research for indigenous therapies, and the court can direct the commencement of treatment and release of funds for rare diseases treatment under the Rare....
The central legal point established in the judgment is the need to ensure timely access to medications for patients and the importance of expediting the process of medicines procurement at the nation....
The court affirmed that the right to health, as part of the fundamental right to life under Article 21, requires timely access to treatment, especially for children with rare diseases.
Governments must ensure timely treatment for rare diseases, recognizing health as a fundamental right, while exploring funding solutions due to high treatment costs.
The fundamental right to health and healthcare under Article 21 of the Constitution encompasses the responsibility of the government to ensure the availability of treatment for rare diseases, despite....
An indispensable Tool for Legal Professionals, Endorsed by Various High Court and Judicial Officers
Please visit our Training & Support
Center or Contact Us for assistance
Scan Me!
India’s Legal research and Law Firm App, Download now!
For Daily Legal Updates, Join us on :
Back to top
