BIDDERS’ SELECTION / REJECTION LIST AFTER FINAL EVALUATION … list RNA... · BIDDERS’...

Phone No. : (0674) 2380608, Website:www.osmcl.nic.in,

E-mail: [email protected]

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:





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)



(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




(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.


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)





(II) Submission of authorization

from the OEM i.e. OPRL

Biosciences Pvt. Ltd. for the

quoted product

(III) Confirmation regarding


(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.


submission of DCGI

approval and

authorization from the

OEM i.e. OPRL

Biosciences Pvt. Ltd. for

the quoted product.





3 | P A G E



4. KASTURI MARKETING, BHUBANESWAR (Make- GCC Biotech India Pvt. Ltd. Model- Gsure)





(II) Confirmation regarding the






(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.


provision of carrier RNA on free of cost

along with the quoted RNA Extraction Kit.


submission of DCGI

approval.

5. FIT CARE PVT. LTD. , DELHI (Make- Zybio INC. Model-Nucleic Acid Extraction Kit (Magnetic Bead)




report of the quoted product

from any of the ICMR

approved validation centres.







(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)





(II) Submission of authorization

from the OEM for the

quoted product







(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)


submission of

authorization from the

OEM for the quoted

product





4 | P A G E

7. MAA MANGALA AGENCIES, BBSR (Make- Genetix Biotech Asia Pvt. Ltd. Model-RNAsure Nucleopore)





(II) Submission of validation




(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.


submission of requisite

clarification.

8. NEOSANTE, BANGLORE (Make- Genetix Biotech Asia Pvt. Ltd. Model-RNAsure Nucleopore)




for the quoted product i.e.

RNA Sure Virus Kit of

Nucleo-Pore





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



(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)




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





5 | P A G E




9. BANGALORE SURGICAL TRADERS, BANGALORE (Make- Chromgene Biotech Pvt. Ltd Model-Viral RNA extraction kit)









product







(I) Requested 7 days extension for submission of

the same for the quoted product.

(II) Not submitted

(III) Not submitted


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)









product







(I) Claimed that application has already been

submitted for obtaining the DCGI approval which

shall be submitted after receipt of the same.




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)


submission of DCGI


product.





6 | P A G E

11. BHARAT PARENTERALS LIMITED, GUJURAT (Make- KH Medical Co Ltd. Model- RADI PREP Swab and Stool DNA/RNA Kit)











(I) Submitted the validation report for the quoted

kit from ICMR NIV, Pune.


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)










submitted through MD-7 for obtaining the DCGI

approval which shall be submitted after receipt of

the same.





submission of DCGI


product.

13. MYLAB DISCOVERY SOLUTIONS PVT. LTD., PUNE (Make-MYLAB Model- Maverick Magnetic Bead

Nucleic Acid Extraction Kit)









product







(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)




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





7 | P A G E

14. SHYAM SHREE RESIDENCY PVT. LTD., BBSR (Make-PerkinElmer Inc. Model-Nucleic Acid Extraction

Kit)



(I) Submission of technical data




product







(I) Submitted the technical data sheet for the



requirement

(II) Submitted the confirmation regarding the kit



Extraction Kit.

Qualified

15. KRISHGEN BIOSYSTEM, MUMBAI (Make-Kreative Technolabs Model-KREATIVE Viral RNA Extraction Kit)









(III) Submission of validation




(I) Submitted MD-14 (Application for issue of

import license to import medical device) for the

quoted product.




(III) Submitted the validation report for the

quoted kit from ICMR NIV, Pune.


submission of DCGI


product.

16. ALMIGHTY TECHSERV PVT. LTD., NEW DELHI (Make- Genome Diagnostics Pvt. Ltd Model- Genosens

Viral 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.




Extraction Kit.


submission of DCGI


product.





8 | P A G E

17. TRIVITRON HEALTHCARE PVT. LTD. MUMBAI (Make-Trivitron Healthcare Pvt. Ltd., Model-RNA sure)



(I) Confirmation regarding




(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)









(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.


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)











Not submitted the requisite clarifications


submission of requisite

clarification.





9 | P A G E

20. BILCARE LIMITED, PUNE (Make- FAVORGEN, Model- FavorPrep Viral RNA/ Nucleic Acid Mini Kit)











(I) Claimed that they take the product under OEM,

hence DCGI approval is not applicable for their

quoted kit.




Extraction Kit.


submission of DCGI


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)



(I) Confirmation regarding the






(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)









product




Not submitted the requisite clarifications

Not qualified due to non submission of requisite clarification.





10 | P A G E




23. BRAVO PHARMACEUTICALS PVT. LTD., NEW DELHI (Make-HiMedia Laboratories Pvt. Ltd. ,Model-HipurA RNA Extraction Kit)









product







(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



Extraction Kit.

Qualified

24. VIBGYOR ENTERPRISES, KOLKATA (Make-OPRL Biosciences Pvt. Ltd. Model-Pro NuEx-Mini Prep Viral RNA Extraction Kit)



Submission of DCGI approval


Confirmation regarding




(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



submission of DCGI


product.





11 | P A G E

25. IMPERIAL LIFE SCIENCES PVT. LTD., HARYANA (Make-Maccura Biotechnology Co. Ltd. Model-Mag-Bind 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)









(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)









(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.





submission of

authorization from M/s

Genuine Bio system

Private Limited to

previously quoted

product of M/s Aura

Biotechnologies Pvt.

Ltd.





12 | P A G E

28. INNVOLUTION HEALTHCARE PVT. LTD., GHAZIABAD (Make-General Biological Corporation, Model- Lab Prep Viral RNA/DNA Nucleic Acid Kit)







(I) Submitted the confirmation regarding carrier



Qualified

29. G.M.CONTRACTORS PVT. LTD., DELHI (Make-Karwa Enterprises Pvt. Ltd. Model-Virus DNA/RNA isolation Kit)







(I) Submitted the confirmation regarding carrier



Qualified

30. ARVIND AGENCY,PUNE (Make-Alchem Diagnostics, Model-Biopro)









product





(IV) Confirmation regarding the






Furnished documents against the sought

clarifications are not from the quoted OEM i.e.

Alchem Diagnostics.


submission of sought

clarifications from the

quoted OEM i.e. Alchem

Diagnostics





13 | P A G E

31. EZILT LIFESCIENCES, NEW DELHI. (Make-APS Lifetech ,Model-Mag Pure Viral RNA isolation Kit-MAGSPIN-73-MACS)









(I) Requested 5-6 days extension for submission of

the same for the quoted product.





submission of DCGI


product.

32. S.R. Enterprises, Rourkela (Make-Genuine Bio system Pvt. Ltd., Model-GB's Aura Pure COVID-19 Viral RNA isolation Kit)






quoted RNA extraction kit

(I)Submitted the confirmation regarding carrier



Qualified

33. BKC AGENCIES, HARYANA(Make-Alchem Diagnostics, Model-Biopro)









product




approved validation centres


submitted for DCGI approval (MD-5), submit the

same after approval within 4 days.




requirement.

(III) Submitted the validation report for the

quoted kit from ICMR NIV, Pune.


submission of DCGI


product.





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

BIDDERS’ SELECTION / REJECTION LIST AFTER FINAL EVALUATION … list RNA... · BIDDERS’...

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