BIDDERS’ SELECTION / REJECTION LIST AFTER FINAL EVALUATION … list RNA... · BIDDERS’ SELECTION / REJECTION LIST AFTER FINAL EVALUATION OF BID RECEIVED AGAINST THE SHORT TENDER
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Phone No. : (0674) 2380608, Website:www.osmcl.nic.in,
E-mail: proc.osmcl.od@nic.in
ODISHA STATE MEDICAL CORPORATION LTD. (A Govt. of Odisha Undertaking)
(ASSURING QUALITY, SAVING LIVES)
1 | P A G E
Notification No. 9076 Dated 10.07.2020
BIDDERS’ SELECTION / REJECTION LIST AFTER FINAL EVALUATION OF BID
RECEIVED AGAINST THE SHORT TENDER CALL NOTICE PUBLISHED VIDE
NOTIFICATION NO-6515/ DATED 11/05/2020 FOR SUPPLY OF RNA
EXTRACTION KIT
Brief Note
At the outset, the chairman of the committee welcomed all the members and apprised of the
short tender call notice cited above for procurement of RNA Extraction Kit. Under this tender enquiry, the
technical bids of 36 nos. of bidders were opened on dtd.09/06/2020. In the meantime the guideline
regarding validation and batch testing of COVID-19 diagnostic kit of ICMR has been revised on
dtd.04/06/2020 and as per the criteria laid down in the revised guideline CE-IVD approved/Non USFDA
approved/ Indigenous Kits will require validation from any of the ICMR identified validation centres prior
to DCGI approval.
Based on the said revised guideline, the technical evaluation committee in its earlier meeting
dtd.24.06.2020 had recommended to seek clarifications regarding submission of validation report from any of
the ICMR approved validation centers along with other clarifications such as submission of technical data
sheet, authorization certificate from OEM, DCGI approval and confirmation of required technical
specifications etc. based on the compliance statement and other relevant documents furnished by the
bidders in their uploaded bid document. Accordingly, clarifications were asked to the respective bidders with
a timeline of 7 days from the issue of clarification letter for submission of the same.
Based on the compliance statement and other relevant documents furnished by the bidders in
their uploaded bid document and as per the decision taken in the previous committee meeting held on
dtd.24.06.2020, three (3) bidders namely 1. M/s ODISHA SMALL INDUSTRIES CORPORATION LTD., 2. M/s
INSTRU PHARMA, CHANDIGARH & 3. BROAD CAST ENGINEERING CONSULTANTS INDIA LTD. had already been
rejected due to non-submission of EMD.
Discussions:
With this background, the chairman welcomed all the committee members. The clarifications
received from the bidders was presented to the committee and discussed point to point as briefed
underneath:
Phone No. : (0674) 2380608, Website:www.osmcl.nic.in,
E-mail: proc.osmcl.od@nic.in
ODISHA STATE MEDICAL CORPORATION LTD. (A Govt. of Odisha Undertaking)
(ASSURING QUALITY, SAVING LIVES)
2 | P A G E
1. POCT SERVICES PVT, LTD., LUCKNOW (Make- Mico Biomed Co. Ltd., Model-Veri-Q Manuprep-CV19)
Points on which clarifications sought as per committee recommendations
Response to the clarifications sought Recommendation
(I) Submission of validation
report of the quoted
product from any of the
ICMR approved validation
centres.
(II) Confirmation regarding
provision of carrier RNA on
free of cost along with the
quoted RNA extraction kit.
(I) Requested 2 days extension for
submission of the same since the
validation is under process & report will
be received by them in next two days.
(II) Submitted the confirmation regarding
provision of carrier RNA on free of cost
along with the quoted RNA Extraction
Kit.
Not qualified due to non
submission of validation
report of the quoted
product from any of the
ICMR approved validation
centres.
2. SIEMENS HEALTHCARE PVT. LTD. (Make- Bogar Bio Bee Store Pvt. Ltd., Model-Bio Bee Spin Expure)
Points on which clarifications sought as per committee recommendations
Response to the clarifications sought Recommendation
(I) Submission of DCGI approval
for the quoted product
(II) Submission of technical data
sheet indicating the
technical specifications as
asked for the quoted
product
(III) Confirmation regarding the
quoted kit should use spiking
with carrier RNA and
provision of carrier RNA on
free of cost along with the
quoted RNA extraction kit.
(I) Claimed that the quoted product comes
under Class B category and manufactured in
India. So DCGI approval is not applicable and
enclosed the MSME certificate and the ICMR
approval letter.
(II) Submitted the technical data sheet for the
quoted product indicating the tender
specification which compiles to the tender
requirement
(III) Submitted the confirmation regarding the
kit use spike with carrier RNA and provision of
the same on free of cost along with the quoted
RNA Extraction Kit.
Not qualified due to non
submission of DCGI
approval for the quoted
product
3. TIRUMALA INFRASTURCTURE AND DEVELOPMENT PVT. LTD., BBSR (Make- OPRL Biosciences Pvt. Ltd. Model-Pro NuEx-mini Prep)
Points on which clarifications sought as per committee recommendations
Response to the clarifications sought Recommendation
(I) Submission of DCGI approval
for the quoted product
(II) Submission of authorization
from the OEM i.e. OPRL
Biosciences Pvt. Ltd. for the
quoted product
(III) Confirmation regarding
provision of carrier RNA on
(I) Claimed that for the quoted product DCGI
approval is not applicable. However requested to
submit the same before the supply.
(II) Not submitted.
(III)Submitted the confirmation regarding
provision of carrier RNA on free of cost along
with the quoted RNA Extraction Kit.
Not qualified due to non
submission of DCGI
approval and
authorization from the
OEM i.e. OPRL
Biosciences Pvt. Ltd. for
the quoted product.
Phone No. : (0674) 2380608, Website:www.osmcl.nic.in,
E-mail: proc.osmcl.od@nic.in
ODISHA STATE MEDICAL CORPORATION LTD. (A Govt. of Odisha Undertaking)
(ASSURING QUALITY, SAVING LIVES)
3 | P A G E
free of cost along with the
quoted RNA extraction kit.
4. KASTURI MARKETING, BHUBANESWAR (Make- GCC Biotech India Pvt. Ltd. Model- Gsure)
Points on which clarifications sought as per committee recommendations
Response to the clarifications sought Recommendation
(I) Submission of DCGI approval
for the quoted product
(II) Confirmation regarding the
quoted kit should use spiking
with carrier RNA and
provision of carrier RNA on
free of cost along with the
quoted RNA extraction kit.
(I) Submitted the MD-9 (Licence to
manufacture for Sale or for Distribution
of Class C or Class D medical devices) for
COVID-19 RT-PCR test Kit instead of RNA
Extraction kit.
(II) Submitted the confirmation regarding
provision of carrier RNA on free of cost
along with the quoted RNA Extraction Kit.
Not qualified due to non
submission of DCGI
approval.
5. FIT CARE PVT. LTD. , DELHI (Make- Zybio INC. Model-Nucleic Acid Extraction Kit (Magnetic Bead)
Points on which clarifications sought as per committee recommendations
Response to the clarifications sought Recommendation
(I) Submission of validation
report of the quoted product
from any of the ICMR
approved validation centres.
(II) Confirmation regarding the
quoted kit should use spiking
with carrier RNA and
provision of carrier RNA on
free of cost along with the
quoted RNA extraction kit.
(I) Submitted the validation report for the
quoted kit from VRDL, Dept. of
Microbiology, KG Medical University,
Lucknow, UP
(II) Claimed that they do not have carrier
RNA in kit and the same will not affect
reagent performance leading to >90%
recovery of RNA from the sample.
(Accepted by the committee since non-
availability of Carrier RNA will not affect
the recovery of RNA)
Qualified
6. SRI SRI TRADE CONTRACT, BANGLORE (Make- Hangzhou Bioer Technology Co. Ltd. Model-Biospin)
Points on which clarifications sought as per committee recommendations
Response to the clarifications sought Recommendation
(I) Submission of DCGI approval
for the quoted product
(II) Submission of authorization
from the OEM for the
quoted product
(III) Confirmation regarding the
quoted kit should use spiking
with carrier RNA and
provision of carrier RNA on
free of cost along with the
quoted RNA extraction kit.
(I)Submitted MD-15 (License to Import Medical
Device) for the quoted product.
(II)Not Submitted the authorization from the
OEM i.e. M/s Hangzhou Bioer Technology Co. Ltd.
for the quoted product.
(III) Claimed that they do not have provision of
carrier RNA in quoted kit and the same will not
affect reagent performance leading to >90%
recovery of RNA from the sample. (Accepted by
the committee since non-availability of Carrier
RNA will not affect the recovery of RNA)
Not qualified due to non
submission of
authorization from the
OEM for the quoted
product
Phone No. : (0674) 2380608, Website:www.osmcl.nic.in,
E-mail: proc.osmcl.od@nic.in
ODISHA STATE MEDICAL CORPORATION LTD. (A Govt. of Odisha Undertaking)
(ASSURING QUALITY, SAVING LIVES)
4 | P A G E
7. MAA MANGALA AGENCIES, BBSR (Make- Genetix Biotech Asia Pvt. Ltd. Model-RNAsure Nucleopore)
Points on which clarifications sought as per committee recommendations
Response to the clarifications sought Recommendation
(I) Submission of DCGI approval
for the quoted product
(II) Submission of validation
report of the quoted product
from any of the ICMR
approved validation centres.
(III) Submission of
technical data sheet
indicating the technical
specifications as asked for
the quoted product i.e. RNA
Sure Virus Kit of Nucleo-Pore
(Genetix Brand)
(IV) Confirmation
regarding the quoted kit
should use spiking with
carrier RNA and provision of
carrier RNA on free of cost
along with the quoted RNA
extraction kit.
Submitted reply regarding non submission of
requisite clarifications due to no response from
their supplier i.e. Genetix Biotech Asia Pvt. Ltd.
Not qualified due to non
submission of requisite
clarification.
8. NEOSANTE, BANGLORE (Make- Genetix Biotech Asia Pvt. Ltd. Model-RNAsure Nucleopore)
Points on which clarifications sought as per committee recommendations
Response to the clarifications sought Recommendation
(I) Submission of DCGI approval
for the quoted product i.e.
RNA Sure Virus Kit of
Nucleo-Pore
(II) Submission of technical data
sheet indicating the
technical specifications as
asked for the quoted
product i.e. RNA Sure Virus
Kit of Nucleo-Pore
(III) Submission of relevant
document establishing the
relation between Genetix
Biotech Asia Pvt. Ltd. and
365 Medical
(IV) Confirmation regarding the
quoted kit should use spiking
with carrier RNA and
(I) Submitted MD-13 (Licence to Manufacture
Medical Devices for the purpose of Testing) for
the quoted product. (Accepted by the committee
as DCGI approval)
(II) Submitted the technical data sheet for the
quoted product indicating the tender
specification which compiles to the tender
requirement
(III) The OEM i.e. Genetix Biotech Asia Pvt. Ltd.
gave direct authorization to Neosante for the
quoted kit i.e. RNA Sure Virus Kit of Nucleopore.
(IV) As per the technical data sheet furnished,
Carrier RNA is included as one of the component
of the quoted kit. (Accepted by the committee
based on the furnished brochure)
Qualified
Phone No. : (0674) 2380608, Website:www.osmcl.nic.in,
E-mail: proc.osmcl.od@nic.in
ODISHA STATE MEDICAL CORPORATION LTD. (A Govt. of Odisha Undertaking)
(ASSURING QUALITY, SAVING LIVES)
5 | P A G E
provision of carrier RNA on
free of cost along with the
quoted RNA extraction kit.
9. BANGALORE SURGICAL TRADERS, BANGALORE (Make- Chromgene Biotech Pvt. Ltd Model-Viral RNA extraction kit)
Points on which clarifications sought as per committee recommendations
Response to the clarifications sought Recommendation
(I) Submission of DCGI approval
for the quoted product
(II) Submission of technical data
sheet indicating the
technical specifications as
asked for the quoted
product
(III) Confirmation regarding the
quoted kit should use spiking
with carrier RNA and
provision of carrier RNA on
free of cost along with the
quoted RNA extraction kit.
(I) Requested 7 days extension for submission of
the same for the quoted product.
(II) Not submitted
(III) Not submitted
Not qualified due to non
submission of DCGI
approval, technical data
sheet and confirmation
regarding provision of
carrier RNA for the
quoted product.
10. BISWAL TRADELINK PVT. LTD., BBSR (Make- Phase Scientific Intl. Ltd., Hong Kong Model- Phasify Viral RNA extraction Kit)
Points on which clarifications sought as per committee recommendations
Response to the clarifications sought Recommendation
(I) Submission of DCGI approval
for the quoted product
(II) Submission of technical data
sheet indicating the
technical specifications as
asked for the quoted
product
(III) Confirmation regarding the
quoted kit should use spiking
with carrier RNA and
provision of carrier RNA on
free of cost along with the
quoted RNA extraction kit.
(I) Claimed that application has already been
submitted for obtaining the DCGI approval which
shall be submitted after receipt of the same.
(II) Submitted the technical data sheet for the
quoted product indicating the tender
specification which compiles to the tender
requirement
(III) Claimed that they do not have carrier RNA in
kit and the same will not affect reagent
performance. (Accepted by the committee since
non-availability of Carrier RNA will not affect the
recovery of RNA)
Not qualified due to non
submission of DCGI
approval for the quoted
product.
Phone No. : (0674) 2380608, Website:www.osmcl.nic.in,
E-mail: proc.osmcl.od@nic.in
ODISHA STATE MEDICAL CORPORATION LTD. (A Govt. of Odisha Undertaking)
(ASSURING QUALITY, SAVING LIVES)
6 | P A G E
11. BHARAT PARENTERALS LIMITED, GUJURAT (Make- KH Medical Co Ltd. Model- RADI PREP Swab and Stool DNA/RNA Kit)
Points on which clarifications sought as per committee recommendations
Response to the clarifications sought Recommendation
(I) Submission of validation
report of the quoted product
from any of the ICMR
approved validation centres.
(II) Confirmation regarding
provision of carrier RNA on
free of cost along with the
quoted RNA extraction kit.
(I) Submitted the validation report for the quoted
kit from ICMR NIV, Pune.
(II) Submitted the confirmation regarding
provision of carrier RNA on free of cost along with
the quoted RNA Extraction Kit.
Qualified
12. HI-MEDICA EQUIPMENT INDIA PVT. LTD., BANGLORE (Make-Bhat Biotech Model- Gene easy Viral RNA isolation Kit)
Points on which clarifications sought as per committee recommendations
Response to the clarifications sought Recommendation
(I) Submission of DCGI approval
for the quoted product
(II) Confirmation regarding
provision of carrier RNA on
free of cost along with the
quoted RNA extraction kit.
(I) Claimed that application has already been
submitted through MD-7 for obtaining the DCGI
approval which shall be submitted after receipt of
the same.
(II) Submitted the confirmation regarding
provision of carrier RNA on free of cost along with
the quoted RNA Extraction Kit.
Not qualified due to non
submission of DCGI
approval for the quoted
product.
13. MYLAB DISCOVERY SOLUTIONS PVT. LTD., PUNE (Make-MYLAB Model- Maverick Magnetic Bead
Nucleic Acid Extraction Kit)
Points on which clarifications sought as per committee recommendations
Response to the clarifications sought Recommendation
(I) Submission of DCGI approval
for the quoted product
(II) Submission of technical data
sheet indicating the
technical specifications as
asked for the quoted
product
(III) Confirmation regarding the
quoted kit should use spiking
with carrier RNA and
provision of carrier RNA on
free of cost along with the
quoted RNA extraction kit.
(I) Submitted MD-13 (Licence to Manufacture
Medical Devices for the purpose of Testing) for
the quoted product. (Accepted by the committee
as DCGI approval)
(II) Submitted the technical data sheet for the
quoted product indicating the tender
specification which compiles to the tender
requirement
(III) Submitted the confirmation regarding the kit
use spike with carrier RNA and provision of the
same on free of cost along with the quoted RNA
Extraction Kit.
Qualified
Phone No. : (0674) 2380608, Website:www.osmcl.nic.in,
E-mail: proc.osmcl.od@nic.in
ODISHA STATE MEDICAL CORPORATION LTD. (A Govt. of Odisha Undertaking)
(ASSURING QUALITY, SAVING LIVES)
7 | P A G E
14. SHYAM SHREE RESIDENCY PVT. LTD., BBSR (Make-PerkinElmer Inc. Model-Nucleic Acid Extraction
Kit)
Points on which clarifications sought as per committee recommendations
Response to the clarifications sought Recommendation
(I) Submission of technical data
sheet indicating the
technical specifications as
asked for the quoted
product
(II) Confirmation regarding the
quoted kit should use spiking
with carrier RNA and
provision of carrier RNA on
free of cost along with the
quoted RNA extraction kit.
(I) Submitted the technical data sheet for the
quoted product indicating the tender
specification which compiles to the tender
requirement
(II) Submitted the confirmation regarding the kit
use spike with carrier RNA and provision of the
same on free of cost along with the quoted RNA
Extraction Kit.
Qualified
15. KRISHGEN BIOSYSTEM, MUMBAI (Make-Kreative Technolabs Model-KREATIVE Viral RNA Extraction Kit)
Points on which clarifications sought as per committee recommendations
Response to the clarifications sought Recommendation
(I) Submission of DCGI approval
for the quoted product
(II) Confirmation regarding
provision of carrier RNA on
free of cost along with the
quoted RNA extraction kit.
(III) Submission of validation
report of the quoted product
from any of the ICMR
approved validation centres.
(I) Submitted MD-14 (Application for issue of
import license to import medical device) for the
quoted product.
(II) Submitted the confirmation regarding
provision of carrier RNA on free of cost along with
the quoted RNA Extraction Kit.
(III) Submitted the validation report for the
quoted kit from ICMR NIV, Pune.
Not qualified due to non
submission of DCGI
approval for the quoted
product.
16. ALMIGHTY TECHSERV PVT. LTD., NEW DELHI (Make- Genome Diagnostics Pvt. Ltd Model- Genosens
Viral RNA Extraction Kit)
Points on which clarifications sought as per committee recommendations
Response to the clarifications sought Recommendation
(I) Submission of DCGI approval
for the quoted product
(II) Confirmation regarding the
quoted kit should use spiking
with carrier RNA and
provision of carrier RNA on
free of cost along with the
quoted RNA extraction kit.
(I) Submitted copy of application for grant of NOC
to manufacturer DNA/RNA Extraction Kit issued
from CDSCO (Central Drug Standard Control
Organization) and claimed that DCGI approval not
required.
(II) Submitted the confirmation regarding the kit
use spike with carrier RNA and provision of the
same on free of cost along with the quoted RNA
Extraction Kit.
Not qualified due to non
submission of DCGI
approval for the quoted
product.
Phone No. : (0674) 2380608, Website:www.osmcl.nic.in,
E-mail: proc.osmcl.od@nic.in
ODISHA STATE MEDICAL CORPORATION LTD. (A Govt. of Odisha Undertaking)
(ASSURING QUALITY, SAVING LIVES)
8 | P A G E
17. TRIVITRON HEALTHCARE PVT. LTD. MUMBAI (Make-Trivitron Healthcare Pvt. Ltd., Model-RNA sure)
Points on which clarifications sought as per committee recommendations
Response to the clarifications sought Recommendation
(I) Confirmation regarding
provision of carrier RNA on
free of cost along with the
quoted RNA extraction kit.
(I) Submitted the confirmation regarding provision
of carrier RNA on free of cost along with the
quoted RNA Extraction Kit.
Qualified
18. NARAYANI ALLIANCE, BBSR (Make- Genuine Bio system Private Limited, Model- Viral RNA
Extraction Miniprep System of Biolinkk)
Points on which clarifications sought as per committee recommendations
Response to the clarifications sought Recommendation
(I) Submission of DCGI approval
for the quoted product
(II) Confirmation regarding
provision of carrier RNA on
free of cost along with the
quoted RNA extraction kit.
(I) Submitted the MD-9 (Licence to manufacture
for Sale or for Distribution of Class C or Class D
medical devices) for the quoted kit i.e. Viral RNA
Extraction Miniprep System of Biolinkk
mentioning Genuine Biosystem Private Limited as
manufacturer and also furnished necessary
agreement between Biolinkk & Genuine
Biosystem Private Limited for branding &
distribution of the quoted kit i.e. Viral RNA
Extraction Miniprep System.
(II) Submitted the confirmation regarding
provision of carrier RNA on free of cost along
with the quoted RNA Extraction Kit.
Qualified
19. AGAM PHARMACEUTICALS, GUWAHATI (Make-Kilpest India Ltd., Model-True PCR RNA extraction Kit)
Points on which clarifications sought as per committee recommendations
Response to the clarifications sought Recommendation
(I) Submission of DCGI approval
for the quoted product
(II) Confirmation regarding the
quoted kit should use spiking
with carrier RNA and
provision of carrier RNA on
free of cost along with the
quoted RNA extraction kit.
Not submitted the requisite clarifications
Not qualified due to non
submission of requisite
clarification.
Phone No. : (0674) 2380608, Website:www.osmcl.nic.in,
E-mail: proc.osmcl.od@nic.in
ODISHA STATE MEDICAL CORPORATION LTD. (A Govt. of Odisha Undertaking)
(ASSURING QUALITY, SAVING LIVES)
9 | P A G E
20. BILCARE LIMITED, PUNE (Make- FAVORGEN, Model- FavorPrep Viral RNA/ Nucleic Acid Mini Kit)
Points on which clarifications sought as per committee recommendations
Response to the clarifications sought Recommendation
(I) Submission of DCGI approval
for the quoted product
(II) Confirmation regarding the
quoted kit should use spiking
with carrier RNA and
provision of carrier RNA on
free of cost along with the
quoted RNA extraction kit.
(I) Claimed that they take the product under OEM,
hence DCGI approval is not applicable for their
quoted kit.
(II) Submitted the confirmation regarding the kit
use spike with carrier RNA and provision of the
same on free of cost along with the quoted RNA
Extraction Kit.
Not qualified due to non
submission of DCGI
approval for the quoted
product.
21. BIOAPPS, KOLKATA (Make-Thermo Fisher Scientific /Invitrogen Bio services India Pvt. Ltd. Model-MagMax Viral/ Pathogen II(MVP II) Nucleic Acid isolation Kit)
Points on which clarifications sought as per committee recommendations
Response to the clarifications sought Recommendation
(I) Confirmation regarding the
quoted kit should use spiking
with carrier RNA and
provision of carrier RNA on
free of cost along with the
quoted RNA extraction kit.
(II) Confirmation on the
compatibility of the quoted
kit for the manual RNA
extraction procedure.
(I) Claimed that they do not have provision of
carrier RNA in quoted kit and the protocol without
the provision of carrier RNA has been approved
by USFDA for the quoted RNA extraction kit.
(Accepted by the committee since non-
availability of Carrier RNA will not affect the
recovery of RNA)
(II) Claimed that the quoted kit i.e. Magmax Viral
Pathogen II may be used for manual DNA/RNA
extraction procedure.
Qualified
22. DSS TAKARA BIO INDIA PVT. LTD. New Delhi.(Make- Takara Bio Inc. , Model-Takara mini BEST viral
RNA/DNA extraction Kit, Ver. 5)
Points on which clarifications sought as per committee recommendations
Response to the clarifications sought Recommendation
(I) Submission of DCGI approval
for the quoted product
(II) Submission of technical data
sheet indicating the
technical specifications as
asked for the quoted
product
(III) Confirmation regarding the
quoted kit should use spiking
with carrier RNA and
Not submitted the requisite clarifications
Not qualified due to non submission of requisite clarification.
Phone No. : (0674) 2380608, Website:www.osmcl.nic.in,
E-mail: proc.osmcl.od@nic.in
ODISHA STATE MEDICAL CORPORATION LTD. (A Govt. of Odisha Undertaking)
(ASSURING QUALITY, SAVING LIVES)
10 | P A G E
provision of carrier RNA on
free of cost along with the
quoted RNA extraction kit.
23. BRAVO PHARMACEUTICALS PVT. LTD., NEW DELHI (Make-HiMedia Laboratories Pvt. Ltd. ,Model-HipurA RNA Extraction Kit)
Points on which clarifications sought as per committee recommendations
Response to the clarifications sought Recommendation
(I) Submission of DCGI approval
for the quoted product
(II) Submission of technical data
sheet indicating the
technical specifications as
asked for the quoted
product
(III) Confirmation regarding the
quoted kit should use spiking
with carrier RNA and
provision of carrier RNA on
free of cost along with the
quoted RNA extraction kit.
(I) Submitted the MD-9 (Licence to manufacture
for Sale or for Distribution of Class C or Class D
medical devices) for the quoted kit
(II) The technical data sheet not furnished,
however submitted the compliance statement
confirming the availability of the technical
specifications as asked for the quoted product
(Accepted by the committee based on the
compliance statement)
(III) Submitted the confirmation regarding the kit
use spike with carrier RNA and provision of the
same on free of cost along with the quoted RNA
Extraction Kit.
Qualified
24. VIBGYOR ENTERPRISES, KOLKATA (Make-OPRL Biosciences Pvt. Ltd. Model-Pro NuEx-Mini Prep Viral RNA Extraction Kit)
Points on which clarifications sought as per committee recommendations
Response to the clarifications sought Recommendation
Submission of DCGI approval
for the quoted product
Confirmation regarding
provision of carrier RNA on
free of cost along with the
quoted RNA extraction kit.
(I) Claimed that the OEM i.e. M/s OPRL
Biosciences Pvt. Ltd, Chennai has already applied
for the DCGI approval and the same is expected
shortly.
(II) Submitted the confirmation regarding carrier
RNA and provision of the same on free of cost
along with the quoted RNA Extraction Kit.
Not qualified due to non
submission of DCGI
approval for the quoted
product.
Phone No. : (0674) 2380608, Website:www.osmcl.nic.in,
E-mail: proc.osmcl.od@nic.in
ODISHA STATE MEDICAL CORPORATION LTD. (A Govt. of Odisha Undertaking)
(ASSURING QUALITY, SAVING LIVES)
11 | P A G E
25. IMPERIAL LIFE SCIENCES PVT. LTD., HARYANA (Make-Maccura Biotechnology Co. Ltd. Model-Mag-Bind RNA Extraction kit)
Points on which clarifications sought as per committee recommendations
Response to the clarifications sought Recommendation
(I) Confirmation regarding the
quoted kit should use spiking
with carrier RNA and
provision of carrier RNA on
free of cost along with the
quoted RNA extraction kit.
(I) Claimed that the Carrier RNA Spike is not required with kits based on Magnetic Bead based technology as the recovery rate of Viral RNA from these kits are high (more than >95%) as compared to kits based on Silica membrane column technology. However, submitted the confirmation that Carrier RNA would be provided Free of Cost in sufficient quantity along with the quoted Viral RNA extraction Kit. (Accepted by the committee since non-availability of Carrier RNA will not affect the recovery of RNA)
Qualified
26. OM SURGICAL AND CHEMICALS (Make-Hangzhou Bioer technology Ltd. Model-Biospin Virus Nucleic
acid extraction Kit)
Points on which clarifications sought as per committee recommendations
Response to the clarifications sought Recommendation
(I) Confirmation regarding the
quoted kit should use spiking
with carrier RNA and
provision of carrier RNA on
free of cost along with the
quoted RNA extraction kit.
(I) Claimed that they do not have provision of
carrier RNA in quoted kit and the same will not
affect reagent performance leading to >90%
recovery of RNA from the sample. (Accepted by
the committee since non-availability of Carrier
RNA will not affect the recovery of RNA)
Qualified
27. TUSHI VENTURES LLP, BHUBANESWAR. (Make-Aura Biotechnologies Pvt. Ltd., Model-AURA PURE)
Points on which clarifications sought as per committee recommendations
Response to the clarifications sought Recommendation
(I) Submission of DCGI approval
for the quoted product
(II) Confirmation regarding
provision of carrier RNA on
free of cost along with the
quoted RNA extraction kit.
(I) Submitted MD-9 (Licence to Manufacture for
Sale or for Distribution of Class C or Class D
medical device) issued in favour of M/s Genuine
Biosystem Private Limited. However, There is no
authorization furnished from M/s Genuine
Biosystem Private Limited to previously quoted
product of M/s Aura Biotechnologies Pvt. Ltd.
(II) Submitted the confirmation regarding carrier
RNA and provision of the same on free of cost
along with the quoted RNA Extraction Kit.
Not qualified due to non
submission of
authorization from M/s
Genuine Bio system
Private Limited to
previously quoted
product of M/s Aura
Biotechnologies Pvt.
Ltd.
Phone No. : (0674) 2380608, Website:www.osmcl.nic.in,
E-mail: proc.osmcl.od@nic.in
ODISHA STATE MEDICAL CORPORATION LTD. (A Govt. of Odisha Undertaking)
(ASSURING QUALITY, SAVING LIVES)
12 | P A G E
28. INNVOLUTION HEALTHCARE PVT. LTD., GHAZIABAD (Make-General Biological Corporation, Model- Lab Prep Viral RNA/DNA Nucleic Acid Kit)
Points on which clarifications sought as per committee recommendations
Response to the clarifications sought Recommendation
(I) Confirmation regarding
provision of carrier RNA on
free of cost along with the
quoted RNA extraction kit.
(I) Submitted the confirmation regarding carrier
RNA and provision of the same on free of cost
along with the quoted RNA Extraction Kit.
Qualified
29. G.M.CONTRACTORS PVT. LTD., DELHI (Make-Karwa Enterprises Pvt. Ltd. Model-Virus DNA/RNA isolation Kit)
Points on which clarifications sought as per committee recommendations
Response to the clarifications sought Recommendation
(I) Confirmation regarding
provision of carrier RNA on
free of cost along with the
quoted RNA extraction kit.
(I) Submitted the confirmation regarding carrier
RNA and provision of the same on free of cost
along with the quoted RNA Extraction Kit.
Qualified
30. ARVIND AGENCY,PUNE (Make-Alchem Diagnostics, Model-Biopro)
Points on which clarifications sought as per committee recommendations
Response to the clarifications sought Recommendation
(I) Submission of DCGI approval
for the quoted product
(II) Submission of technical data
sheet indicating the
technical specifications as
asked for the quoted
product
(III) Submission of validation
report of the quoted product
from any of the ICMR
approved validation centres.
(IV) Confirmation regarding the
quoted kit should use spiking
with carrier RNA and
provision of carrier RNA on
free of cost along with the
quoted RNA extraction kit.
Furnished documents against the sought
clarifications are not from the quoted OEM i.e.
Alchem Diagnostics.
Not qualified due to non
submission of sought
clarifications from the
quoted OEM i.e. Alchem
Diagnostics
Phone No. : (0674) 2380608, Website:www.osmcl.nic.in,
E-mail: proc.osmcl.od@nic.in
ODISHA STATE MEDICAL CORPORATION LTD. (A Govt. of Odisha Undertaking)
(ASSURING QUALITY, SAVING LIVES)
13 | P A G E
31. EZILT LIFESCIENCES, NEW DELHI. (Make-APS Lifetech ,Model-Mag Pure Viral RNA isolation Kit-MAGSPIN-73-MACS)
Points on which clarifications sought as per committee recommendations
Response to the clarifications sought Recommendation
(I) Submission of DCGI approval
for the quoted product
(II) Confirmation regarding
provision of carrier RNA on
free of cost along with the
quoted RNA extraction kit.
(I) Requested 5-6 days extension for submission of
the same for the quoted product.
(II) Submitted the confirmation regarding carrier
RNA and provision of the same on free of cost
along with the quoted RNA Extraction Kit.
Not qualified due to non
submission of DCGI
approval for the quoted
product.
32. S.R. Enterprises, Rourkela (Make-Genuine Bio system Pvt. Ltd., Model-GB's Aura Pure COVID-19 Viral RNA isolation Kit)
Points on which clarifications sought as per committee recommendations
Response to the clarifications sought Recommendation
(I) Confirmation regarding
provision of carrier RNA on
free of cost along with the
quoted RNA extraction kit
(I)Submitted the confirmation regarding carrier
RNA and provision of the same on free of cost
along with the quoted RNA Extraction Kit.
Qualified
33. BKC AGENCIES, HARYANA(Make-Alchem Diagnostics, Model-Biopro)
Points on which clarifications sought as per committee recommendations
Response to the clarifications sought Recommendation
(I) Submission of DCGI approval
for the quoted product
(II) Submission of technical data
sheet indicating the
technical specifications as
asked for the quoted
product
(III) Submission of validation
report of the quoted product
from any of the ICMR
approved validation centres
(I) Claimed that application has already been
submitted for DCGI approval (MD-5), submit the
same after approval within 4 days.
(II) Submitted the technical data sheet for the
quoted product indicating the tender
specification which compiles to the tender
requirement.
(III) Submitted the validation report for the
quoted kit from ICMR NIV, Pune.
Not qualified due to non
submission of DCGI
approval for the quoted
product.
Phone No. : (0674) 2380608, Website:www.osmcl.nic.in,
E-mail: proc.osmcl.od@nic.in
ODISHA STATE MEDICAL CORPORATION LTD. (A Govt. of Odisha Undertaking)
(ASSURING QUALITY, SAVING LIVES)
14 | P A G E
NOTE:
1) The date of price bid opening is scheduled on Dt.13-07-2020 at 03:30 PM.
2) All the technically qualifying bidders are requested to be present or send authorized representatives to be present during the price bid opening.
Sd/-
GM Operation (Equipment), OSMCL
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