Calcutta High Court (Appellete Side)
Welfare Society & Anr vs Ministry Of Health & Family Welfare on 19 September, 2024
Author: Hiranmay Bhattacharyya
Bench: Hiranmay Bhattacharyya
19.09.2024
Item Nos.20-22
gd/ssd
WPA(P)/20/2020
CAN/1/2023, CAN/2/2023
MUSCULAR DYSTROPHY PATIENT
WELFARE SOCIETY & ANR.
VS
MINISTRY OF HEALTH & FAMILY WELFARE,
GOVERNMENT OF INDIA & ORS.
with
WPA/6300/2023
YUVAAN SINGH & ORS.
VS
UNION OF INDIA & ORS.
with
WPA(P)/9/2023
PARIVAAR BENGAL & ANR.
VS
STATE OF WEST BENGAL & ORS.
Ms. Nandini Mitra,
Mr. Samim Ahammed,
Ms. Saloni Bhattacharya,
Ms. Gulsanwara Pervin,
Mr. Arka Ranjan Bhattacharya,
Ms. Ambiya Khatoon
..for the Petitioners in
WPA(P) 20 of 2020.
Mr. Siddhartha Sankar Mandal,
Ms. Arunima Das Sharma
..for the Petitioners in
WPA 6300 of 2023.
Mr. Kaushik Gupta,
Ms. Srimoyee Mukherjee
..for the Petitioners in
WPA(P) 9 of 2023.
Mr. Asok Kumar Chakraborti,
ld. Additional Solicitor General,
Mr. Tirtha Pati Acharya,
Mr. Arijit Majumdar
..for the Union of India.
Md. T.M. Siddiqui,
Mr. Suddhadev Adak
..for the State in
WPA(P) 20 of 2020 and
WPA(P) 9 of 2023.
2
Mr. Somnath Naskar
..for the State in
WPA 6300 of 2023.
1.
Reference may be made to the order dated
12.09.2024 in which several directions were issued.
2. The first was with regard to the camp to be
conducted for online demonstration as to how UDID
cards have to be downloaded.
2. Mr. Siddique, learned Government counsel
has submitted that the camp will be organized on 30th
September, 2024.
3. We would request the petitioners in WPA(P) 9
of 2023 to intimate all these stakeholders with regard
to the conduct of the camp in addition to the intimation
given by the State vide communication dated 18th
September, 2024.
4. The second aspect was with regard to the
amount to be paid by the State of West Bengal to each
of the persons suffering from rare disease which is
presently Rs.1,000/-.
5. The learned Government counsel has produced
a communication sent by the Deputy Director of Health
Services (NCD-I), Health and Family Welfare
Department, Government of West Bengal addressed to
the Principal Secretary, Department of Women & Child
Development & Social Welfare by memo dated 18th
September, 2024 and they are awaiting appropriate
instructions in the matter.
6. On the next date the instructions given by the
concerned department be placed before this court.
7. The third aspect was with regard to the drug
given to persons suffering from rare disease.
8. The court in its order dated 12.09.2024 had
taken note of the cost calculation done by the Head of
the Department, Department of Neonatology and Nodal
Officer of COE of Rare Disease, IPGME & R, SSKM
Hospital, Kolkata. We had noted that in the said order
that the Drug Controller of India is yet to approve the
said drug.
9. In the light of the same, the learned Additional
Solicitor General was requested to get instructions from
the concerned authority as to whether the approval of
the drug is being processed or as to any other decision
taken by the Drug Controller of India.
10. The learned Additional Solicitor General has
also produced the written instruction given by the Legal
Cell, Central Drugs Standard Control Organisation
(HQ), Directorate General of Health Services, Ministry of
Health and Family Welfare, New Delhi vide e-mail dated
September 19, 2024. The contents of the mail is
extracted hereunder:
"Respected Sir,
This is with reference to enclosed Court Order
dated 12.09.2024 wherein, Paragraph 11 is
referred to share the report / information
regarding approval of oral non-steroidal drug i.g.
Givinostat for administering the patients of DMD
in India or any other decision taken by the
DCG(I).
In this regard, it is informed that as per the
available information with CDSCO (Central Drugs
Standard Control Organisation), the subject drug
is neither approved and nor any application is
pending before CDSCO for its approval.
This is for your kind information and further
necessary action.
Regards
Legal Cell,
Central Drugs Standard Control Organisation
(HQ),
Directorate General of Health Services, Ministry
of Health and Family Welfare,
FDA Bhawan, Kotla Road, New Delhi 110002
Tele - 011-23502916"
11. As could be seen from the above
communication the oral non-steroidal drug, namely,
Givinostat is neither approved by the CDSCO nor any
application is pending before the said authority for
approval.
12. The learned advocate appearing for the
petitioners submitted that drug is being prescribed by
certain hospital. As of now the drug is not available in
India and the parent of one of the children suffering
from rare disease, who is present in court, submitted
that if the drug is prescribed, they will have to import
the drug.
13. As of now it appears that there is no clarity
as to whether the person, who is desirous of taking
the said oral non-steroidal drug would be free to
import the same from any other foreign country
despite the fact that the CDSCO has not approved the
drug.
14. In this regard, the learned Additional Solicitor
General is requested to obtain additional instructions
from the said authority as to what would be the
procedure for import of the drug in the event the
patient party or the patient himself is willing to
administer/consume the said drug.
15. With regard to the direction given to the
learned advocate for the petitioners to get in touch
with the Chamber of Commerce in West Bengal, the
learned advocate for the petitioners seeks some more
time to inform the concerned.
16. The learned advocate appearing for the
petitioners has placed before us the reasoned order
passed by the High Court of Delhi dated 13th
September, 2024 in WP(C) 5315 of 2020 etc.
17. The Hon'ble Court in paragraph 10 of the
order has noted that when there are large number of
DMD patients in India, it is expected that a company
like M/s. Sarepta, which also claims to hold patents in
respect of the concerned medicinal/pharmaceutical
products, ought to have adequate measures in place
to ensure its availability for Indian patients,
considering the provisions under the Patents Act,
1970 to ensure that medicinal products which are
patented, that too those which are completely
unaffordable, are available at reasonably affordable
price to the public. Certain directions have been
issued to the said company in this regard.
18. With regard to the doses of certain medicines
for 14 patients, the Hon'ble Court opined that since
treatment of the 14 patients has already commenced,
a direction was issued to the Ministry of Health and
Family Welfare for grant of approval to AIIMS to place
orders on M/s. Sarepta for supply of necessary
medicines and release the corresponding funds based
on the price list quoted by M/s. Sarepta to the
National Rare Diseases Committee (NRDC). There has
been other directions issued qua the doses to patients
suffering from Gaucher's and MPS.
19. We find a direction has been issued to the
Ministry of Health and Family Welfare to release a
sum of Rs.10 Crores to AIIMS so that even the non-
DMD patients may be provided with the requisite
treatment till the final judgment is passed.
20. A present status report has been called for in
respect of all the directions which have been issued.
The question which falls for consideration is whether
the procedure which has been adopted in AIIMS, New
Delhi can be replicated in the Centre of Excellence at
Kolkata, namely, the SSKM Hospital. In order to do so
the first aspect is release of the funds by the Ministry
of Health and Family Welfare, Government of India
and other Departments of the Government of India
which would permit/approve the import of drugs
through proper channel.
21. In order to get a better clarity on this issue,
we request the learned Additional Solicitor General to
obtain an appropriate instruction from the concerned
authority and place the same before this court for
consideration.
22. List these matters on 7th November, 2024.
(T. S. SIVAGNANAM)
CHIEF JUSTICE
(HIRANMAY BHATTACHARYYA, J.)
