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General
The information has been reviewed in year :
Organisation name:
DKMS BMST Foundation India
Organisation ION:
ION-9935
Country:
India
Year the registry started operations:
November 2015
Products
comment
Do you provide HPC, Marrow?
no
Do you provide HPC, Apheresis?
yes
Do you provide HPC, Cord Blood?
no
Do you provide MNC, Apheresis?
yes
Donors are not allowed to donate any type of donation within 6 months after a peripheral stem cell harvest due to Indian law.
Do you provide NC, Whole Blood?
no
Product quantity
Data valid for year
2020
Number of products
National
International
HPC, Marrow products:
0
0
HPC, Apheresis:
7
3
HPC, Cord:
0
0
License
Organisation is licensed/accredited by the Health Authority:
no
Comment:
Not applicable in India
Name of Health Authority:
Date of last inspection:
Link to website of Health Authority:
Can you provide the Legal documentation from the Competent Authority that your organisation is allowed to operate as a registry ?
The registry is accredited by any other organisation:
no
If yes, by which organisation?
Donor policy
All donors are unpaid volunteers:
yes
All donors are informed about donation process and associated risks:
yes
Donors sign a valid informed consent to donate in the presence of a medical doctor/health care personnel/registry staff:
yes
The registry has systems in place to protect and control access to donor/patient records:
yes
The registry maintains donor anonymity:
yes
The registry has detailed donor evaluation and exclusion criteria in place:
yes
The registry has donor evaluation and exclusion criteria that do meet or exceed the WMDA guidelines:
yes
IDM
IDM
Tested
Method
Days between test and sampling/workup
ALT/ASTALT/AST ratio, De-Ritis-Quotient
Yes
Biochemistry
<30 days
ChagasChagas, T. cruzi
-
CMV IgGCytomegalovirus (CMV) Antibody testing IgG
Yes
ELISA
<30 days
CMV IgMCytomegalovirus (CMV) Antibody testing IgM
Yes
ELISA
<30 days
CMV TotalCytomegalovirus Total
On request
ELISA
<30 days
EBV IgGEpstein-Barr Virus Antibody testing IgG
Yes
ELISA
<30 days
EBV IgMEpstein-Barr Virus Antibody testing IgM
Yes
ELISA
<30 days
HAV (NAT)Anti-hepatitis A virus nucleic acid testing
-
HBV (NAT)Hepatitis B nucleic acid testing
Yes
PCR/TMA
<30 days
HBc AbHepatitis B core antibody testing
Yes
ELISA / CLIA
<30 days
HBs AgHepatitis B Surface antigen testing
Yes
ELISA / CLIA
<30days
HCV (NAT)Hepatitis C nucleic acid testing
Yes
PCR/TMA
<30 days
HCV AbHepatitis C antibody testing
Yes
ELISA /CLIA
<30 days
HEV (NAT)Hepatitis E Virus nucleic acid testing
-
HIV (NAT)Human Immunodeficiency Virus nucleic acid testing
HIV p24Human Immunodeficiency Virus p24 antigen testing
No
HTLV-IHuman T-Lymphotropic Virus type I testing
Yes
ELISA
<30 days
HTLV-IIHuman T-Lymphotropic Virus type II testing
Yes
ELISA
<30 days
MalariaMalaria
Yes
Quantitative Buffy Coat (QBC)
<30 days
HSVHerpes Simplex Virus
-
STSSerological tests for syphilis
Yes
TPHA
<30 days
STS FTA-ABSSerological test for syphilis
On request
FTA
<30 days
ToxoplasmosisToxoplasmosis
Yes
ELISA
<30 days
VZVVaricella Zoster Virus
-
WNV-NATWest Nile Virus nucleic acid testing
No
Other tests performed
Yes
irregular AB
<30 days
Regulatory information section 2
Relevant documents will be uploaded by the organisation to the documents page.
Testing
The physical and medical exam at donor workup is performed by a medical doctor:
yes
All donor testing (at workup) for infectious disease is performed in a laboratory certified/licensed by a Competent Authority:
yes
HLA typing for patient specific request is performed in an appropriately accredited laboratory:
yes
Sterility testing is performed on the adult donor product:
yes
Sterility testing is performed on the cord blood product:
no
Screening questionnaire to exclude communicable disease:
yes
Screening questionnaire to exclude donors with 'high risk' lifestyles:
yes
Donor reliability identified by a medical doctor:
yes
Donor clearance to donate is confirmed by a medical doctor, following as a minimum the donor exclusion criteria in Annex 1 of EU Directive 2006/17/EC :
The party providing the cell product must exclude donors when:
They are pregnant;
They are breastfeeding;
There is the potential for transmission of inherited conditions;
There is evidence of any other risk factors for transmissible diseases on the basis of a risk assessment, taking into consideration Donor travel and exposure history and local infectious disease prevalence;
There is presence on the donor’s body of physical signs implying a risk of transmissible disease(s);
There is a history of a disease of unknown aetiology;
There is a risk of transmission of diseases caused by prions;
There is systemic infection which is not controlled at the time of donation, including bacterial diseases, systemic viral, fungal or parasitic infections, or significant local infection in the tissues and cells to be donated;
There is history of chronic, systemic autoimmune disease that could have a detrimental effect on the quality of the Cell Product;
There is recent history of vaccination with a live attenuated virus where a risk of transmission is considered to exist;
There is ingestion of, or exposure to, a substance (such as cyanide, lead, mercury, gold) that may be transmitted to recipients in a dose that could endanger their health.
yes
Customs regulations
Are there any customs regulations to follow or customs paperwork required needed to import cell products into the country of the affiliated transplant centres?
Transplant centre has to provide 12-B form (Permit for the import of small quantities of drugs for personal use), entry letter for the courier, workup forms and information about person who will meet the courier at the airport.
Are there any customs regulations to follow or customs paperwork required needed to export cell products from the country of the affiliated organisation?
Basic paperwork, Statement of Necessity, Authorization and Declaration Letter
Are there any import national regulations to follow or paperwork required needed to import the cell products into the country of the affiliated transplant centre?
Are there any export regulations to follow or paperwork required needed to export cell products from the country of the affiliated organisation?
Reporting of Serious Adverse Events
Please indicate which of the following schemes for reporting Serious Adverse Events relating to either the Donor or the product the Registry participates in:
- Mandatory National Reporting Scheme
- Voluntary National Reporting Scheme
- WMDA SEAR/SPEAR Reporting Scheme
yes
The registry will notify the receiving Registry within 24 hours of receiving information relating to any serious adverse event that could be considered to affect the patient receiving the product:
yes
Quality management
The organisation does maintain Standard Operating Procedures for its work:
yes
Please indicate if your organisation/country has any specific requirements that should be communicated in advance to the requesting entity (e.g., financial sanctions, specific regulatory forms, etc.) :
Donor records relating to the medical exam and cell product collection process are the following number(s) of year(s) retained: