Executive Summary:
This document outlines the approved formula for compensation to patients implanted with ASR Hip devices, as determined by the Ministry of Health & Family Welfare. It instructs State/UT Drug Controllers to constitute State Level Committees to examine patient documents and issue advertisements regarding the matter. The final report for each patient must be submitted to the Central Expert Committee within 60 days of application receipt by the State Level Committee.
Key Points / Main Content:
* **Compensation Formula:**
* The Ministry of Health & Family Welfare has approved a formula for compensating patients implanted with ASR Hip devices: B x R x F = Compensation + ₹10,00,000.
* B = Base amount (₹20,00,000)
* R = Risk Factor/Disability (Annexure A)
* F = Age Factor (Annexure B)
* **State Level Committee:**
* State/UT Drug Controllers must constitute State Level Committees (if not already done) to:
* Examine documents from patients.
* Evaluate patients to ascertain ASR Hip implantation status and revision surgery details.
* Issue advertisements to inform affected patients.
* State/UTs with existing committees should inform the Central Expert Committee of cases received.
* The State Level Committee must furnish its report to Central Level Expert Committee in a specified Performa.
* **Patient Examination Modalities:**
* State Level Committees must evaluate patients to determine:
* If an ASR metal-on-metal hip replacement from DePuy International Ltd/Johnson & Johnson was implanted.
* Date of implantation.
* If revision surgery was performed, the date and percentage of disability.
* If revision surgery was not performed, results of blood evaluation for metal ion toxicity and MRI.
* Whether revision surgery is required or follow-up is needed.
* **Reporting Deadline:**
* The State Level Committee must submit a final report for each patient to the Central Expert Committee within 60 days of receiving the patient's application.
* **Patient Undertaking:**
* Patients must submit self-attested copies of authentic documents and undertake to submit original documents for verification when required.
* Patients bear legal responsibility if documents are fabricated or tampered with.
Impact Analysis:
* **State/UT Drug Controllers:**
* *Impact:* Responsible for forming State Level Committees, ensuring patient evaluation, and issuing advertisements.
* *Action Required:* Constitute State Level Committees (if not already done), ensure patient evaluation, issue advertisements, and inform the Central Expert Committee of cases received.
* **State Level Committees:**
* *Impact:* Responsible for evaluating patient documents, examining patients, and furnishing reports to the Central Expert Committee.
* *Action Required:* Evaluate patients, examine documents, and furnish reports to the Central Expert Committee within 60 days of application receipt.
* **Patients Implanted with ASR Hip Devices:**
* *Impact:* Eligible for compensation based on the approved formula.
* *Action Required:* Submit required documents to the State Level Committee and undergo evaluation.
* **Central Expert Committee:**
* *Impact:* Responsible for receiving reports from State Level Committees and determining final compensation amounts.
* *Action Required:* Review reports from State Level Committees and determine compensation amounts.
Key Entities Referenced
Central Drugs Standard Control Organisation: A regulatory body under the Directorate General of Health Services, Ministry of Health Family Welfare, Government of India, responsible for regulating medical devices and pharmaceuticals.
StateUT Drug Controllers: The drug regulatory authorities in the States and Union Territories of India.
ASR Hip: Articular Surface Replacement (ASR) Hip Implants, the subject of compensation due to reported defects.
Ministry of Health Family Welfare: The Indian government ministry responsible for health policy and family welfare programs.
Central Expert Committee: A committee constituted by the Ministry of Health Family Welfare to finalize the compensation formula for patients implanted with ASR Hip.
State Level Committee: Committees to be constituted in each State/UT to examine patient documents and issue reports to the Central Expert Committee regarding ASR Hip cases.
FDA Bhawan, Kotla Road, New Delhi: Address of Central Drugs Standard Control Organisation Medical Device Division office
DePuy International Ltd Now Johnson and Johnson: Manufacturer of the ASR Hip metal on metal Implant.
No. 29/MISC/03/2018-DC (388)
Government of India
Directorate General of Health Services
Central Drugs Standard Control Organisation
(Medical Device Division)
FDA Bhawan, Kotla Road,
New Delhi-110002
Dated: JQ NOV 218
To
All State/UT Drug Controllers,
Subject: Formula for grant of compensation to the patients who were
implanted with ASR Hip and constitution of the State Level Committee-
reg
Sir/Madam,
This is to inform you that the Central Expert Committee constituted
by the Ministry of Health & Family Welfare had finalised a formula for
grant of compensation to the patients who were implanted with ASR Hip.
This formula was sent to the Ministry of Health & Family Welfare for their
approval.
Now, the Ministry of Health & Family Welfare had approved the
formula and the same is enclosed for your reference and further action
in the matter.
That the Ministry of Health & Family Welfare vide letter
X.11035/25/2015-DFQC dated 30.08.2018 and this office vide letter No.
29/MISC/03/2018-DC (389) dated 28.09.2018 has already requested
you to ensure the formation of Central Level Committee and get the
matter advertised in the newspapers. Also vide letter No. F. No.
DCGI/Legal/Misc-68/2018-DC dated 09.11.2018, a copy of the draft
advertisement for publication in newspaper was forwarded to you.
You are further requested to ensure that the State level Committee
are constituted in your respective State/UT to examine the documents
as received from the patients and also the patients as well as the
advertisement is issued. The State/UTs where the State Level
Committees have already been constituted may apprise the Central
Expert Committee (through email at leqgalcell@cdsco.nic.in or by post at
Legal Cell, CDSCO, FDA Bhawan, Kotla Road, New Delhi-110002)about the cases received so far. With respect to the modalities of the
examination of the patient and their documents, a detailed format is
enclosed herewith for the ready reference of State Level Committee.
It is important to mention herein that as per the recommendations
approved by the Central Government, the final report with respect to
each individual patient has to be submitted to the Central Expert
Committee within a period of 60 days from the date of receipt of the
application by the State Level Committee.
Ast
(Dr. S. Eswara Reddy)
Drugs Controller General (India)
Enclosures:
1) Formula as approved
2) Modalities including undertaking
Copy to:
Principal/ Health Secretaries of all States/UTsBrief Procedure for State Level Committee
State Level Expert Committee shall evaluate the Patient and ascertain:
If, ASR metal on metal hip replacement from DePuy International Ltd
(Now Johnson and Johnson) is actually implanted& if, yes date of
implantation vide document (discharge sheet etc) with implant
stickers.
A. If revision surgery is done......cccecccecee
a. The date of revision surgery.
b. The percentagedisabilities vide the certificate no.......... dated
a & issued as per rule is......... % by competent
authorities (As guided by Ministry of Social justice and
Empowerment)
B. If the revision surgery is not done.
a. The result of blood evaluation for metal ion toxicity i.e. levels of
Cobalt, Chromium by Accredited path. Lab.
b. MRI (Metal Artefact reduction technique)
c. Based on (a) & (b) above whether condition of patient requires
revision surgery orneed to be kept under follow up observation.
After ascertaining the above facts the State Level Expert Committee
Shallfurnish its report to Central Level Expert Committeein following
Performa.
I. If revision surgery is undertaken:
Mr/Mrs‘XYZ’was implanted ASR Hip (metal on metal) Implant of
DePuy International Ltd (Now Johnson and Johnson).
a. On date........... when his/her age waS........... vide
COCUITIONE, ...c0cisxecamss
b. And he /she has undergone revision surgery on date
whenhis / her ag@ WAS ...ceceeseeceeeeeee (vide document like
discharge sheet etc).c. And his/her verified percentage disability as on date is........
%.
Submitted the verified copies of all relevant documents along with this.
Signature of Member Secretary
Date :-
II. If revision surgery is not undertaken:
The report shall be given in following format
Mr / Mrs‘XYZ’ was implanted with ASR Hip(metal on metal)
Implant of DePuy International Ltd (Now Johnson. and
Johnson)ondated ........... & his Clinical Examination of blood, X-
ray & MRI suggest revision surgery/ does not suggestrevision
surgery at this stage but follow up at six monthly interval is
advised.
Signature of Member Secretary
Date: -Undertaking
|, Mr/Mrs...................S/0 or D/o resident of......... Aadhar card/ voter card
— hereby submitting self-attested true copies of document which are authentic.
| undertake to submit the original documents for verification to State level
Committee/Central Expert Committee whenever required. In case the documents are
found to be fabricated/tampered with, | undertake to bear the legal responsibility of
the same.The formula for the payment of compensation to the ASR patients is as mentioned
herein below:
BXRXF
99.37
4.
Rupees Ten lakhs (Rs 10,00,000) towards non-pecuniary damages
B is the base amount that is Rupees Twenty Lakhs (Rs 20,00,000)
R is the Risk Factor-Disability as per Annexure A
F is the Age Factor as per Annexure B
The Government of India, MoHFW_ has approved the formula for determining the
compensation.
Annexure A
Percentage Disability 7 a
20% - 30%
30% - 40%
40% - 50%
50% & above
ae
ce on
16
228.54
17 | 227.49
eC (std SCS 226.38
Pa
225.22
200 : jo 224.00
’
221.37
219.95
218.47 |
216.9138 7 189.56
390 - 186.90
40 7 184.17
41 oe oe 181.37
42 178.49
43 175.54
44 172.52
45 169.44
46 _| 166.29
AT on _ 7 163.07
AB - 159.80
49 156.47
50 153.09
51 149.67
52 146.20
53 142.68
54 139.13
55 i 135.56
56 131.95
57 128.33
58 124.70
59 oe ee 121.05
60 117.41
61 113.77
62 110.14
63 106.52
64 102.93
65&more | 99.37