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.

JUDGMENT

Prathiba M. Singh, J. (Oral)--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 e- platform 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@gma