Delhi High Court
Master Arnesh Shaw vs Union Of India & Anr. on 2 March, 2021
Signature Not Verified
Digitally Signed By:DINESH
SINGH NAYAL
Signing Date:03.03.2021
21:36:23
$~10, 18, 20 to 23
* IN THE HIGH COURT OF DELHI AT NEW DELHI
Date of decision: 2nd March, 2021
+ W.P.(C) 10782/2020
AVIRAJ GARG, AGE 4 YEARS, THROUGH HIS NEXT FRIEND
AND NATURAL FATHER SH. ABHINAV GARG ..... Petitioner
Through: Mr. Ashok Aggarwal and Mr. Kumar
Utkarsh, Advocates. (M:9811101923)
versus
UNION OF INDIA & ANR. ..... Respondents
Through: Ms. Amrita Prakash, CGSC for
Respondent/UOI
Mr. Tanveer Oberoi & Mr. Satvik
Verma, Advocates for Respondent
No.2/AIIMS
Mr. Rajdeep Bhattacharya, Advocate
for Respondent No.5/Institute of
Child Health (M: 9163329688)
Dr. Arun Shastry, Chief Scientific
Officer, DART, Bangalore
(M: +91 8023412725/9840219833)
18 WITH
+ W.P.(C) 5315/2020
MASTER ARNESH SHAW ..... Petitioner
Through: Mr. Vivek Chib, Mr. Rahul Malhotra,
Mr. Asif Ahmed & Mr. Manas
Tripathi, Advocates.
versus
UNION OF INDIA & ANR. ..... Respondents
Through: Mr. Chetan Sharma, ASG with Mr.
Ripudaman Bhardwaj, CGSC with
Mr. Kushagra Kumar, Advocates for
Respondent No.1/UOI
(M: 9818030700)
Mr. Tanveer Oberoi & Mr. Satvik
Verma, Advocates for Respondent
No.2/AIIMS
Signature Not Verified
Digitally Signed
Signing Date:03.03.2021 20:25
Signature Not Verified
Digitally Signed By:DINESH
SINGH NAYAL
Signing Date:03.03.2021
21:36:23
Dr. Pulkesh Kumar, Deputy
Secretary, MoHFW.
20 WITH
+ W.P.(C) 322/2021
KESHAV SHARMA AGE 12 YEARS THROUGH HIS NEXT
FRIEND AND NATURAL FATHER SANJEEV
KUMAR ..... Petitioner
Through: Mr. Ashok Agarwal & Mr. Kumar
Utkarsh, Advocates
versus
UNION OF INDIA & ANR. ..... Respondents
Through: Mr. Ajay Digpaul, CGSC with Mr.
Kamal R. Digpaul, Advocate for UOI.
Mr. Tanveer Oberoi & Mr. Satvik
Verma, Advocates for R-2/AIIMS.
Dr. Arun Shastry, DART, Bangalore
Mr. Rajdeep Bhattacharya, Advocate
for Respondent No.5/Institute of
Child Health (M: 9163329688)
21 WITH
+ W.P.(C) 1491/2021
MASTER MEDHANSH JHAWAR @ MADHAV ..... Petitioner
Through: Mr.Vivek Chib, Mr. Rahul Malhotra
and Mr. Manas Tripathi, Advocates
versus
UNION OF INDIA & ANR. ..... Respondents
Through: Mr. Tanveer Oberoi & Mr. Satvik
Verma, Advocates for Respondent
No.2/AIIMS.
22 WITH
+ W.P.(C) 1511/2021
MASTER KENIT JHAWAR @ KESHAV ..... Petitioner
Through: Mr. Vivek Chib, Mr. Rahul Malhotra
and Mr. Manas Tripathi, Advocates
versus
UNION OF INDIA & ANR. ..... Respondents
Through: Mr. Tanveer Oberoi & Mr. Satvik
Signature Not Verified
Digitally Signed
Signing Date:03.03.2021 20:25
Signature Not Verified
Digitally Signed By:DINESH
SINGH NAYAL
Signing Date:03.03.2021
21:36:23
Verma, Advocates for Respondent
No.2/AIIMS
23 AND
+ W.P.(C) 1611/2021
LAKSHYA KUMAR GOYAL, 8 YRS OLD, THROUGH HIS NEXT
FRIEND AND NATURAL FATHER SH. VIPIN
KUMAR ..... Petitioner
Through: Mr. Ashok Aggarwal and Kumar
Utkarsh, Advocates.
versus
UNION OF INDIA & ANR. ..... Respondents
Through: Mr. Shankar Kumar Jha, Senior Panel
Counsels (M-9811706171)
Mr. Tanveer Oberoi & Mr. Satvik
Verma, Advocates for R-2/AIIMS.
CORAM:
JUSTICE PRATHIBA M. SINGH
Prathiba M. Singh (Oral)
1. 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
Signature Not Verified
Digitally Signed
Signing Date:03.03.2021 20:25
Signature Not Verified
Digitally Signed By:DINESH
SINGH NAYAL
Signing Date:03.03.2021
21:36:23
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
Signature Not Verified
Digitally Signed
Signing Date:03.03.2021 20:25
Signature Not Verified
Digitally Signed By:DINESH
SINGH NAYAL
Signing Date:03.03.2021
21:36:23
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. ([email protected])
(ii) Dr. (Prof.) Madhulika Kabra, Division of Genetics, Department
of Paediatrics, AIIMS ([email protected])
(iii) Dr. IC Verma Director, Centre of Medical Genetics, Sir Ganga
Ram Hospital ([email protected])
(iv) Dr. P. Ramesh Menon, Associate Professor, Department of
Paediatrics, AIIMS (M: 8800997737) ([email protected])
(v) Dr. Arun Shastry, Chief Scientific Officer, Dystrophy
Annihilation Research Trust (DART) (M:9840219833)
([email protected])
(vi) Dr. Apurba Ghosh, Director, Institute of Child Health
([email protected])
(vii) Dr. Angamuthu Meena Kanikannan, Nizam's Institute of
Medical Sciences (M:+914065863509)
([email protected])
(viii) Dr. V, Viswanathan, Kanchi Karnakoti, CHILDS Trust
Hospital (M: 9840100072) ([email protected])
(ix) Dr. Pulkesh Kumar, Deputy Secretary, Ministry of Health and
Family Welfare.
The Chairperson is free to consult or co-opt any other member or
organisation, if deemed expedient, into the Committee.
Signature Not Verified
Digitally Signed
Signing Date:03.03.2021 20:25
Signature Not Verified
Digitally Signed By:DINESH
SINGH NAYAL
Signing Date:03.03.2021
21:36:23
7. The committee shall submit a report on the following major aspects:
(i) How to immediately provide treatment and therapy options to
the Petitioners and similarly situated patients suffering from
DMD, Hunter's syndromes and other rare diseases.
(ii) Steps to be taken to indigenize the development of the therapies
in India, and reasonable timelines required to be followed
thereof.
(iii) Whether accelerated approval processes can be considered
especially in view of the research currently being undertaken in
India for DMD?
(iv) Immediate concrete proposals for crowdfunding of the costs of
treatment for children with rare diseases.
8. The first meeting of the Committee shall be held on 5th March, 2021
at 3.00 p.m. A report be submitted to this Court on or before 12th March,
2021.
9. Further, a specific affidavit shall be filed by the Union of India
specifying the budget for health in the last five years, as also whether any
part of the budget has been unused and can be used for the purpose of
treatment of the Petitioners or the indigenous development of therapies for
the treatment of rare diseases.
10. List this matter on 15th March, 2021.
PRATHIBA M. SINGH
JUDGE
MARCH 2, 2021/mw/Ak
Signature Not Verified
Digitally Signed
Signing Date:03.03.2021 20:25
