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Guidelines and Procedures DT 11.08.2022
Guidelines and Procedures DT 11.08.2022
2783305/2022/GRANT
To
The Directors/ Nodal Officers,
All the Centres of Excellence
(as per list attached).
Madam/Sir,
IncontinuationtothisMinistry'so.M.ofevennumberdatedl9.05.2022(copy
Procedures for giving
enclosed), I am directed to inform that the Guidelines and
Diseases have been
financial assistance to the patients suffering from various Rare
approvedbytheCompetentAuthority.Thesameareenclosedherewithforfurther
necessary action.
Yours laithfullY,
Encl: As above
Copy to:
l.DGHSandChairmanofCTCRD,DirectorateGeneralofHealthServices'
Nirman Bhawan' New Delhi.
116
2783305/2022/GRANT
The National Policy for Rare Diseases (NPRD), 2021 was published on 30th March
2021 with aims to lower the incidence and prevalence of rare diseases based on integrated
and comprehensive prevention strategy and providing financial assistance to the patients
suffering from these diseases within the constraints on resources and competing health
care priorities. Details of guidelines and procedures for giving financial assistance, as per
the policy, to the patients suffering from various Rare Diseases are as under:
1. General Conditigns
(i) Financial assistance will be provided to the patients suffering from Rare
(ii) Financial assistance will be provided to the patients suffering from any of the
(iii) Financial support will be provided to the patient (through coE) suffering from
(iv) The list of diseases under Group 1, Group 2 and Group 3, as mentioned in
Annexure-|, are not exhaustive and will be reviewed periodically based on updated
(v) Patients will be provided financial assistance for their treatment at eight (08)
centres of Excellence (coE). The details of the coEs are given at Annexure-ll.
(vi) More Centres of Excellence shall be added for regional outreach if they are
found to be suitable in terms of infrastructure and human resources based on
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2783305/2022/GRANT
Welfare (MoHFW).
Bodies/Statutory Bodies and their family, who are beneficiary under any Central
Government scheme, such as CGHS/EHS etc., State Government health scheme and
any other scheme of PSUs/Autonomous Bodies/Statutory Bodies, will not be eligible
(ix) Families covered under Ayushman Bharat - Pradhan Mantri Jan ArogyaYojna
(AB-PMJAY) will also be eligible for financial assistance as per NPRD,2021, if the
disease is not covered under AB-PMJAY packages.
2- Financial Assistance
2.1
(i) Maximum financial assistance admissible under the scheme will be upto Rs.
50 lakh per patient. The financial assistance per patient will be given to the
concerned coE, where the patient is getting treatment/admitted for treatment. The
lstaarered
Jeoulrement ot tund
tn a case, where the total cost of the treatment estimated by the Rare oisease committee of the coE
ii Rs. 45 lakh However, the
is over few years vit four to five years. ln such cases, the fund will b€
requirement of fund for the treatment of the disease spread
lakh
released for the treatment of the patient based on the requirement till i! reaches Rs 45
tn another situation, suppose the cost of the treatment of the rare disease egtimated by the committee
of the coE is R5 20 lakh After
term outcome not known in resp€ct ofthetreatment provided to the patients
treatment, the patient is recovered. However, asthe lon8 ls
patient will be eliSible for financial assistance upto the
and in case of ie-occurrence of the disease in the sub!€quent year, the Settint
remaining amount i.e. in this case upto Rs 30 lalh (Ri. 50 Lakh_Rs, 20 l-akh).
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2783305/2022/GRANT
(iii) ln cases where the cost of treatment is less than Rs. 50 Lakh, the financial
assistance received under Prime Minister's National Relief Fund (PMNRF) or CM
Relief Fund or from any other source by the patient for treatment, shall be deducted
(iv) ln cases where the cost of the treatment is more than Rs. 50 Lakh, the
financial assistance of Rs. 50 Lakh only will be provided under NPRD-2021'
(v) The coEs shall be given one-time financial support up to a ceiling of Rs.5
crore for procurement of equipment for strengthening patients care services for
screening, diagnosis and prevention (parental diagnosis) for rare diseases based on a
gap analysis. The list of equipment which is likely to be useful for these activities is
given at Annexure-llt.
(vi) As the cost of the consu ma bles/kits is also high, provisions may be made for
providing fund to the CoEs for the procurement of consumables and kits wherever
required.
(v) The coEs may also have option for outsourcing wet labs work as per their
requirement.
such rare diseases (listed in Group 2) that can be managed with special diets or
hormonal supplements or other relatively low cost interventions.
will be difficult for the Government to fully finance the treatment of high cost rare
diseases. The gap will be filled up by providing financial assistance through
(ii) The coEs will share information relating to the patients, diseases from which
they are suffering and estimated cost of treatment on the crowdfunding portal.
(iii) The fund received through crowdfunding will be used primarily for the
treatment of the patients suffering from rare diseases. Any leftover fund after
meeting treatment cost can be utilized for research purposes also'
(iv) CoEs have option to explore the possibility of getting financial assistance from
The content of the MoU may be finalized by the Committee of the COE and
approved by the Director of the COE'
the coE where he/she approached for the treatment. The proforma should be duly
signed by the treating Doctor of COE (Annexure - V).
(ii) A Rare Disease Committee to be constituted in each COE. The Nodal Officer
for Rare Disease of the CoE will be the Member Secretary of the Committee. COE
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2783305/2022/GRANT
(iii)
The application received from the Patients/Parents/guardians may be first
scrutinized by the Nodal Officer and thereafter placed before the Committee for
(iv) The committee of the coE will take decision for treatment and fund
allocation within 04 weeks of receiving the application.
(vi) COEs may demand fund for treatment of Rare Disease patients from MoHFW'
coEs will send their demands based on the recommendation of its Rare Disease
committee and with the approval of the Director of the concerned coE to the Under
Secretary (Rare Disease), Ministry of Health & Family Welfare, Nirman Bhawan, New
(c) A copy of the recommendation given by the Rare Disease Committee of the
concerned CoE.
(vii) On receipt of such request, the Programme Division i.e. Rare Disease Cell in
the Ministry will release the fund as per the procedure followed for release of such
fund with the concurrence of the lntegrated Finance Division (lFD) of the Ministry.
(viii) The CoEs will utilize the fund received by them under NPRD-21 with the
approval of its competent authority and Financial Advisor and by following all the
provisions of GFR.
(ix) After full utilization of the released fund or for the treatment of the new
patients, the CoE may demand additional fund' The same may be released by the
Ministry on receipt of Utilization certificate duly signed by the Nodal officer for Rare
disease of the COE.
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RARE DISEASE CELt
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2783305/2022/GRANT
(x)ln case of any dispute/interpretation of any clause of the Policy or any issue
arising out of implementation of the above p rocedu re/guidelines, the same may be
4.
TheRegistryisexpectedtoyieldinformationonhospitalbaseddataanddisease
burden. To streamline the process of capturinE data related to
various Rare Diseases,
. TheNodalofficershouldregisterthedetailsofthepatientonthelcMR
Registry.
lncase,theCoEhasreceivedapatientsufferingfromararedisease,whichis
CICRD for
not mentioned in Annexure I of this guideline, they should intimate
justification and
its inclusion in any of the three categories along with full
scientific data.
ii, RenolTronsqlontotion'
o. Fobry diseose
b. Autosomol recessive Polycystic Kidney Diseose (ARPKD),
c. Autosomol dominont Polycystic Kidney Diseose (ADPKD) etc'
iii. potients requiring combined liver and kidney tronsplonts con olso be considered if the
same ceiling of funds is mointoined. (Rorely Methyl Molonicociduria moy require
combined liver & Kidney tronsplant) etc.
Group 2: Dlseases requiring long term / lifelong treatment having relatively lower cost of
treatment and beneflt has been documented in literature and annual or more frequent
surveillance ls required:
a,f Disorders managed with special dietary formulae or Food for special medical purposes
(FsMPl
i) Phenylketonurio(PKU)
ii) Non-PKU hyperphenyloloninemio conditions
lii) Mople Syrup Urine Diseose (MSUD)
iv) Tyrosinemio tYPe 1 ond 2
v) Homocvstinuria
vi) Ureo CYcle EnzYme defects
vll) Glutoric Acidurio tYPe 7 ond 2
viii) Methyl Molonic Acidemio
ix) Propionic Acidemio
RARE DIsEASE CELL
'(\l',J\
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2783305/2022/GRANT x) lsovoleric Acidemio
xi) Leucine sensitive hypoglycemio
xii) Goloctosemio
xiii) Glucose goloctose molobsorbtion
xiv)Severe Food Protein ollergy
b) Disorders that are amenable to other forms of therapy (hormone/ specific drugs)
3,spinolMusculorAtrophy(Antisenseoligonucleotidesbothintravenous&orol&gene
theroPY)
4. Wolman Diseose
5. Hypophosphotosio
6. Neuronol ceroid lipofuschinosis
RARE DISEAsE CELL
rtte
124
2783305/2022/GRANT Annexure-ll
Details of 08 (Eiehtl Centres of Excellence
4. Post Graduate lnstitute of Dr. Ranjit Pal Singh Bhogal, Assistant Professor,
Medical Education and Deputy Medical Superintendent,
Research, Chandigarh Department of Hospital Administration,
Contact No. 7087002089
majorbhogal1984@gmail.com
6. Centre for Human Genetics Dr. Sanjeeva GN, Associate Professor, lndira
(CHG) with lndira Gandhi Gandhi lnstitute of Child Health, Bengaluru
Hospital, Bengaluru Mob:9945657034
Email: sanju.gn26@Bmail.com
*u-
125
2783305/2022/GRANT Annexure-lll
-,{e-
126
2783305/2022/GRANT
Alrslcrd
Aoolication for Financial Assistance under National Policv for Rare Disease. 2021
2 Date of Birth
Age
OECLARATION
2. Though tam covered under PMJAY, the amount offinancial assistance required, indicated at
Column 10 above, is only for packages not covered under PMJAY-
-t^fi\
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2783305/2022/GRANT
Annexure-V
RECEIVING TREATMENT
-,ru-
29
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2783305/2022/GRANT
266147512022/GRANT
of
The undersigned is directed to state that the following provision envisaged under Para 10(i)
National Policy for Rare Diseases (NPRD), 2021:
.Finonciol support upto P$. 20 lokh under the umbrello scheme ol Rashtriyo Arogoyo Nidhi
sholl be provided by the centrol Government lor treotment, ol those rure diseoses
thot rcquie
o one-time treotment (diseoses tisted under Group 1). Seneliciories lor such finonciol
populotion'
ossistonce would not be limited to BPL fomilies, but extended to obout 40% ol the
in
who ore eligible os per notms of Prodhon Montti Jon Arogyo Yoiono, for theh treatment
Government teftiary hospitols only.'
.Finonciol support upto Rs. 50 lokhs sholt be provided to the potients suffering lrom ony
cotegory of the Rore Diseoses. The finoncial suppott wilt be provided to the
potients for the
treotment in any ol the centte ol Excetlence (coE) mentioned in NPRD'2021, outside the
Umbrello Scheme oJ Roshtriyo Arogoyo Nidhi."
3. These amendments come into effect from the date of issue ofthis office Memorandum.
per amended
4. The guidelines/procedure for providing financial asslstance to the patients as
provisions ire being finalized. However, till the finalization of guidelines and in orderto
provide
rare diseases
uninterrupted and enhanced financial assistance i.e. upto Rs. 50 lakhs to the patients of
irrespective of category of disease, funds may continued to be granted from the current budget head
of Umbrella Scheme of Rashtriya Arogya Nidhi (RAN).
,-;&
(Manish Rai)
Under Secretary to the Govt. of lndia
Tel. 011-23052068
To,
01 r.
30
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2661475120221GRANT
2783305/2022/GRANT
- 2-
', L.'''.i))h
'.-
i 1" , r) 3. Under Secretary (Grants), Ministry of Health & Family Welfare, Nirman Bhawan, New Delhi with
- 2 a request to make necessary provision under the Umbrella Scheme of Rashtriya Arogya Nidhi
i i
(RAN) acco.ding to the revised pro\risions in NPRD, 2021 mentioned in this oM till the
finalization of tuidelines and a separate budget head is created for providing increased financial
assist.nce to the patients of Rare Diseases.
6l) +. fne Nodal Officer, all the 08 CoEs (as per list attached) with a request to process the cases of
rare diseases as per revised provisions in NPRD, 2021 mentioned in this OM. - ljUt oSR.r:, I r"zz-
Finance Division; MoHFW; Co -P
Director (Budget); MoHFw;
The Dir€ctor General and chairman of crcRD, Directorate General of Heahh Services, Nirman
Bhawan, Neu, Delhi :'rd\(''
1. The s€cretary, Department of BiotechnoloSy, Ministry of Science and Technology, Government ' prosBt>
of lndia; ('] "
'?. The Secretary, Ministry of Corporate Affairs, Government of lndia;
-9.- The Secretary Department of Heahh Research/oirector General, lndian Council for
Medical
Reseerch, New Dclhl; t
lBqo5gr.rd:o:-r-f-o-t)
\ The Secretary, -
Department of Pharmaceuticals, Shastri Bhawan, New Delhl; ----.-
\ The Secretary, Department of Promouon of lndustry and lnternal Tnde, Udyog thawan'
Delhi;
lL'
''6 The Secretary, Oepartment of Revenue, Ministry of Finance, Government of lndia;
\. n" Chairman, National Pharmaceuticat Pricing Authority, Jdlss Floor, YMCA Cultural Centre
Building 1. Jai Singh Road, New Delhi;
The Drugs Controller General of lndia, FDA Shawan, New oelhi;
19' The oirector General, Directorate General of Health services, Nirman Bhawan, New Delhi;
Additional chief secretaries/Principal Secretaries/commissioner (Health) of all
state
Administration (as per list attached), - tl3qoSgzSl>o:-t- (o- 39
dun'
iI6 $$+ -
ll>birector/ln charge, Centres of Excetlence (as per list attachea] (lSq oSSsrblrt,-
(o -7)
I2; NH C,f Y
\\ $l
d\u