MASTER ARNESH SHAW  Vs UNION OF INDIA & ANR.

W.P.(C) 53 15/2020 & 322/2021 Page 1 of 6
$~14 & 38
* IN THE HIGH COURT OF DELHI AT NEW DELHI
Date of de cision: 12th January , 2021.
+ W.P.(C) 53 15/2020 & CM APPL. 19189/2020

MASTER ARNESH SHAW ….. Petitione r
Through: Mr. Vivek Chib, Mr. Rahul Malhotra,
Mr. Asif Ahmed, Mr. Vikhyat Ober oi
and Mr. Manas Tripathi, Advocates.
(M:9899218215 )
versus

UNION OF INDIA & ANR. ….. Respondent s
Through: Mr. R ipudaman Bhardwaj, CGSC
with Mr. Kushagra Kumar, Advocate
for R -1.
Mr. Satvik V arma and Mr. Tanveer
Oberoi, Advocat es for R -2/AIIMS.
38 AND
+ W.P.(C) 3 22/2021 & CM APPL.812/2021
KESHAV SHARMA AGE 12 YEARS THROUGH:
HIS NEXT FRIEND AND NATURAL FATHER
SANJEEV KUMAR ….. Petitioner
Through: Mr. Ashok Agarwal, Advocate.
versus

UNION OF I NDIA & ANR. ….. Respondent s
Through: Mr. Aja y Digpaul , CGSC and Mr.
Kamal R. Digpaul, Advocate for R -1.
Mr. V.S.R. Krishna, Advocate for R –
2/AII MS.
CORAM:
JUSTICE PRATHI BA M. S INGH
Prathiba M. Singh, J.(Oral )

1. This h earing has been done by video confe rencing.
2. Both these matters concern children , who are suffe ring from a rare
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disease known as Duchenne Muscular Dystrophy (hereinafter refer red as
“DMD”). The drug for this particular condition is st ated to be at an
experimental stage and is currently be ing manufactured by a company called
Sarepta Th erapeutics, USA. The relief sought in t hese petitions is that the
government should be directed to ensu re that the Petitioners ar e provided
free trea tment for this disorder , as the d rug is exorbitantly expens ive and is
not af fordable by the Petition ers.
3. In W.P.(C) 5315/2020 , the Union of India through Ministry of Health
and Family Welfare has placed on record an affidavit giving details of the
various health policies, which are under con sideration in resp ect of such rare
diseases . As pe r the sa id affidavit , a Draft Health P olicy for Rare Diseases
has been released by the governme nt in 20 20, which is still in the sta ge of
consultation . T he earlier policy of 2017 was kept in ab eyance by th e
governm ent vide notification dated 18th December, 2018. This C ourt, vide
order dated 7th August, 2020, had directed the case of the Petitioners to All
India Institute of Medical Scienc es (hereinafter, “AIIMS”), which has
placed on rec ord a report along with an affidavit reiterating the report . The
first repo rt filed by AIIMS is to the effect t hat the child is unlikely to show
impro vement with Exondy s 51 therapy , however, a final re commendat ion in
this rega rd, is to be taken by the Central Technical Committee for Rare
Diseases, Ministry of Health and Family Welfare, Govt. of India . The said
report has been followed with another affidavit filed on behalf of AIIMS
supporting the said earlier report.
4. This Cour t is of the opinion that just because of the exorbitant price of
the drug or treatment, patients, especially children, suffering from a rare
disease ought not to be deprived of tr eatment for their conditi on. The draf t
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policy of the governme nt, which was introduced in 2020 for c onsul tation has
still not seen th e ligh t of the day. Considering the fact that `Right to Health
and Health care’ is a Fundamental Right which has been rec ognised by the
Supreme Court to be a part of the `Right to life ’ under Article 21 of the
Cons titution , it is incumbent on society in general and authorities in
particul ar to ensure that the life of such child ren is not compromised, even if
there is a sm all window of improving their chances of survival or even
providing a better quali ty of life.
5. In the Draft Health Policy for Rare Diseas es 2020, DMD is
recognised as b eing one of the rare diseases , the cost of treat ment of which
is very high . The said disease has been categori sed in group 3 of the Polic y,
which is extracted hereinb elow:
“Group 3: Diseases for which definitive treatment is
available but challenges are to make optimal pat ient
selection for benefit, very high cost and l ifelong therapy

3a) Bas ed on the literature sufficient evidence for good
long-term outcomes exists for the following disorders
1. Gaucher Disease (Ty pe I & III (without
significant neurological impairme nt)
2. Hurler Synd rome [Mucopolysaccharidosis
(MPS) Type I ] (attenuated forms)
3. Hunter Syndrome [MPS II ] (attenuated
form)
4. Pompe Disease diagnosed early (Both
infantile & late on set)
5. Fabry D isease diagnosed befo re
significa nt end organ d amage
6. Spinal Muscular Atrophy
7. MPS IVA
8. MPS VI

3b) For the following disorders for which the cos t of
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treatment is very high and either long term follow up
literature is awaited or has been done on s mall number
of patient s

1. Wolman Disease
2. Hypo phosphatasia
3. Neuronal ceroid lipofuscinosis
4. Cystic Fibrosis
5. Duchenne Muscular Dystrophy ”

6. Insof ar as group 3 diseases are concerned, the relevant propos al in the
Draft Health Policy is contained in paragraph 9, which read s as under:
“9. Volunt ary crowd -funding for tr eatme nt

9.1 Keeping in view t he resource c onstraint and
competing h ealth priorities, it will be dif ficult for
the Gove rnment to fully finance treatment of high
cost rate diseases. The gap can h owever be filled
by creating a d igital platform for bringing togeth er
notified hospitals where such patients are
receiving trea tment or come for treatment, on the
one hand, and prospecti ve individual or corpora te
donors willing to support treatment of such
patients. The n otified hospital s will share
informa tion r elating to the patients, diseases from
which they are suffering, prognosis, estima ted cost
of treatment and d etails of bank ac counts for
donation/ contribution t hrough online syste m.
Dono rs will be able to view the details of pati ents
and donate funds to a particul ar hospi tal. This will
enable donors from various sections of the society
to donate funds, which will be utilized for
treat ment of pa tients suff ering f rom rare diseases,
especially those un der category III.

9.2 The Gover nment will notify selected Centres of
Excellence, which will be prem ier Governmen t
tertiary hospitals with facilities for tr eatment of
rare d iseases . To begin with the following
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institutes would be noti fied as Cen ters of
Excellence for Ra re Dise ases:
1. A ll India Instit ute of Medical Scie nces, New
Delhi.
2. Maulana Aza d Medic al College, New Delh i.
3. Sanjay Gandhi Pos t Graduate Institut e of
Medic al Sciences, Lu cknow.
4. Post Graduate Institute of Medical Education
and Resear ch, Chandigarh .
5. Centre for D NA F inger printi ng & Diagnostics ,
Hyderabad
6. King Edward Medical Hospital, Mumbai
7. Institute of Post-Graduate Medical Educa tion
and Research, Kolk ata
8. Center f or Human Genetics (CHG) with Indi ra
Gandhi Hospital , Bengaluru
The cost o f treatme nt of pat ient in these c entres of
excellen ce will be met out of donations received
through the online digi tal platform, mentioned in
Para 8.1 above ”

7. As per the above draft policy, in view of the constraint of
governmental resour ces, and competing health priori ties, the gove rnment
proposes that it cannot fully financ e the treatment of all high co st rare
diseases, but the gap can be filled by seeking donations from prospective
individuals or corporate donors, who are willing to sup port the cost of such
diseases . Thus, the gove rnment has recognised that DMD is a rare disease
and has also recognized the fact that patients in general may not be able to
afford its treatment. The Government thus propose s that it shall explore
crowd fund ing as an option to address affo rdability concerns.
8. This c ourt is of the opinion that the finalisation of the Draft Health
Policy for Rare Diseases cannot be k ept pending indefi nitely, especially
when common hu man li ves are at stake . The earlier P olicy having been kept
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in abey ance, it is inc umbent for the Governme nt to finalise and notify the
Policy at the earliest. Acco rdingly, i t is directed as under:
(1) A specific timeli ne shall be provided by the Secretary , Minis try of
Heal th and Family Welfare , in re spect of the finalisation and
notificatio n of the Draft Health Policy for Rare Diseases, 2020 .
(2) Insofar as the Petition ers, who are suffe ring from DMD , are
concerned, the Secretary – Ministry of Health and Family Welfare
would proceed in terms of the draft policy and explore crowd
fundin g, includ ing through prospective individuals , corporate
donors a nd independent foundations, which exist to fund such
treatments . The Ministry shall in addition also contac t the
compan y M/s Sarepta Th erape utics, USA, which publicly
advertises that it provid es financ ial support / medication in
deserving cases, as is evident from their website. The Ministry
shall come u p with a proposa l, with respect to the same, within the
next 1 0 days.
9. Let a report in respect of the above two direc tions be p laced on reco rd
at lea st 2 days be fore the next date.
10. List on 28th January , 2021.
PRATHIBA M. SINGH
JUDGE
JANUAR Y 12, 2021 /dk/Ak
2021:DHC:122