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ESIC e-TENDER ENQUIRY FORM FOR SUPPLY OF ORTHOPEDIC IMPLANTS
(Arthroplasty & Allied Items)
e-Tender Enquiry Form – Free of cost
CONTENTS Tender Letter
Terms & Conditions with Annexure
Check List of the Documents
Item Schedule
EMPLOYEES’ STATE INSURANCE CORPORATION
ROOM NO. 312 & 314 HQRS. OFFICE, PANCHDEEP BHAWAN
C.I.G. ROAD, NEW DELHI – 110 002
LAST DATE OF SUBMISSION OF ONLINE & MANUAL BID (EMD Envelope): 24th
October 2018
at 10:00 AM.
For any further clarifications/queries for e-Procurement Portal, please contact at:
Email id for Support / Helpdesk - https://esictenders.eproc.in/hlml/Support.asp
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EMPLOYEES' STATE INSURANCE CORPORATION ESIC Hqrs, Panchdeep Bhawan, C.I.G. ROAD, NEW DELHI
e-Tender Enquiry No.U-25/12/Orthopedic Implants (Arthroplasty)/2018-Med.V Dated: 25.09.2018
On behalf of the Director General, Dy. Medical Commissioner (RC) invites online e-Tender Enquiry
No. U-25/12/Orthopedic Implants (Arthroplasty)/2018-Med.V for DG ESIC Rate Contract for supply of
Orthopedic Implants (Arthroplasty), for use of ESI institutions all over India, through e-
procurement portal of ESIC - https://esictenders.eproc.in
SUMMARY OF DG-ESIC RATE CONTRACT
I. It is proposed to enter into a Running Rate Contract with bidder(s)/ firm(s) which fulfill the
eligibility criteria approved by ESI Corporation for supply of Orthopedic Implants (Arthroplasty)
enumerated in the schedule annexed. The eligibility criteria have been given in the terms and
conditions. Bidder(s)/ Firm(s) intending to participate in the rate contract should first
ensure that they fulfill all the eligibility criteria as prescribed under the terms and
conditions, otherwise the tenders will be summarily rejected.
II. The Rate Contract will be governed by the terms and conditions enclosed with this Tender
Enquiry and no modifications / alterations etc. are allowed in any case. If any modification /
alteration is proposed or any other condition advanced by the bidder, it shall be ignored and
the bid will be disqualified.
III. Bidder is therefore advised to tender rate quotations only if the terms and conditions as
prescribed by Corporation are acceptable to them in its entirety and they fulfill all the
eligibility criteria.
IV. To participate in e-tender, bidder should register at https://esictenders.eproc.in and send Bid
Processing Fee via online payment mode to the Service Provider at the earliest to ensure
timely registration and bid submission. The bidder(s) should complete all stages of online bid
submission through e-procurement portal of ESIC i.e. https://esictenders.eproc.in. Bidders
should not wait for the last date. They are requested to complete the process of online bid
submission well before the closing, in order to safeguard their own interest.
V. Evaluation & finalization of Rate Contract will be based on e- bid submitted by the
bidder. It is the sole responsibility of the bidder to scan and upload clear and legible
documents for the purpose of evaluation. Any deficiency in the document submitted by the
bidder shall lead to disqualification of the bidder and shall be the sole responsibility of the
bidder.
www.esic.nic.in
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VI. A SINGLE SEALED ENVELOPE : The bidder should put a separate sealed envelope in tender box containing
1) Original Demand Draft of EMD.
A single sealed envelope superscribed with the e-Tender for supply of Orthopedic Implants
(Arthroplasty) duly completed and addressed to Dy. Medical Commissioner (R.C.) should be
dropped in the tender box kept in R.C. Cell, Room No. 312, III Floor, ESIC Hqrs. Office,
Panchdeep Bhawan, C.I.G. Road, New Delhi – 110002 on or before 10.00 A.M. on 24th
October 2018.
VII. ONLINE TECHNICAL BID: The bidder should upload all the certificates / documents for the items tendered online in
Technical Bid.
The tender shall be liable to be rejected if complete documents/certificates/annexure are not
uploaded or EMD is not submitted in time
VIII. Online Technical Bid and a single sealed envelope will be opened on 24th
October 2018
at 03:00 PM at the Vth Floor, Committee Room, Hqrs. Office, ESI Corp., C.I.G. Road,
New Delhi – 110002 in presence of representatives of the bidder(s)/ firms having an
authority letter for representation from the firm alongwith their identity proof in support.
IX. If any representative of the bidder(s)/firm(s) fails to present and / or is absent from the bid
meeting, their presence will not be marked later in any circumstances. The absence of any
representative of the bidder(s)/firm(s) shall be the sole responsibility of the firm.
X. The bid meeting will be conducted by the ESIC in the manner and procedure as prescribed
and a certificate will be obtained from all the participant(s) / representative(s) of the
bidder(s)/firm(s) attending the bid meeting w.r.t. the same.
XI. If the date of opening of tender is declared a public holiday, the tenders shall be opened on
the next working day at the same venue and time.
XII. Technical Evaluation:- Technical evaluation of bid will be evaluated in two stages.
(i) Technical evaluation on the basis of documents to examine the eligibility and other
prescribed conditions.
(ii) Evaluation/Examination/Testing of samples of items quoted in tender. Sample(s) not
found technically fit in such evaluation will be declared rejected/non-responsive for that
quoted item.
XIII. PRICE BID ONLINE :
The Bidder has to fill Annexure 'P' online. Online Price Bid of only those bidder(s) who are
found technically eligible will be opened. The communication through email will be sent to the
technically eligible bidder(s).
NOTE:- 1) It is sole responsibility of participating bidder to check further notification(s) / update(s)/
corrigendum(s), if any on ESIC website - www.esic.nic.in & ESIC e-Procurement portal -
https://esictenders.eproc.in
2) After uploading all the documents/ certificates/ Annexure(s)/ Affidavits etc online, the
participating bidder should check by downloading themselves to see if documents are
uploaded correctly and they are legible to read.
Dy. Medical Commissioner (RC)
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Important Instructions for Bidders regarding Online Payment
All bidders/firms are required to procure Class-IIIB Digital Signature Certificate (DSC) with
Both DSC Components i.e. Signing & Encryption to participate in the E-Tenders.
Bidders should get Registered at https://esictenders.eproc.in.
Bidders should add the below mentioned sites under Internet Explorer Tools Internet
Options Security Trusted Sites Sites of Internet Explorer Trusted Sites
https://esictenders.eproc.in
https://www.tpsl-india.in
https://www4.ipg-online.com
Also, Bidders need to select “Use TLS 1.1 and Use TLS 1.2” under Internet Explorer Tools
Internet Options Advanced Security.
Bidder needs to submit Bid Processing Fee charges of Rs. 2495/- (non-refundable) in favour of
M/s. C1 India Pvt. Ltd., payable at New Delhi via Online Payment Modes such as Debit Card,
Credit Card or Net Banking for participating in the Tender.
Bidders can contact our Helpdesk at https://esictenders.eproc.in/html/Support.asp
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e-TENDER SCHEDULE
SNo. Details Dates & time
1. Period of availability of e-Tender Enquiry
document on ESIC website-
www.esic.nic.in and ESIC e-Procurement
portal- https://esictenders.eproc.in
26th
Sep. 2018 to 24th
October 2018 upto
10:00 AM
2. Last date of Online Technical Bid &
Manual Bid(EMD) submission
24th
October 2018 upto 10:00 AM
3. Pre-bid Meeting 09.10.2018 at 11:00 AM
at Vth Floor Conference Room,
ESIC Hqrs Office, Panchdeep Bhawan,
C.I.G. Road, New Delhi – 110002.
4. Opening of Online Technical Bid &
Manual Bid(EMD Envelope)
24.10.2018 at 03.00 PM
at Vth Floor Conference Room,
ESIC Hqrs Office, Panchdeep Bhawan,
C.I.G. Road,New Delhi – 110002.
5. Opening of Price Bid Will be communicated over Email to the
bidders who are found technically eligible
6. Validity of offer 180 days from the last date of submission of
e-Tender
If the date of opening of tenders is declared a public holiday, the tenders shall be opened on the next
working day at the same venue and time.
Pre-bid Meeting
The objective of the pre-bid meeting is to answer the doubts/queries related to the provision of this
e-tendering. It is requested to send Queries/doubts for Pre-bid meeting on e-mail address
[email protected] three days before the schedule date. So that solutions & clarifications can be
prepared timely.
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Earnest Money Deposit
a) The bidder must submit Earnest Money Deposit (EMD) along with this tender by means of
Demand Draft in favour of ESIC FUND ACCOUNT NO 1, New Delhi.
Bank guarantee/ Cheques / FDRs will not be accepted in any case.
b) EMD for a bidder is Rs.5000000/-(Rupees Fifty Lakh).
c) If the Firm/Bidder has participated in Group No. “b” (Arthroplasty & Allied Items) in
earlier tender No. U-25/12/Orthopedic Implants & Physiotherapy items/2018-Med.V, which was
opened on 03.05.2018, need not to submit the EMD again for this tender enquiry.
d) Please fill Annexure EMD.
e) Participating MSE Firms (having valid registration certificate as on date/date of
opening of the tender) are exempted from payment of Earnest Money Deposit (EMD).
f) The validity of the Demand Draft/Banker’s cheque submitted for Earnest Money
Deposit should be 60 Days from the opening date of the tender.
g) In case the bidder is unsuccessful/Bid of the bidder is not selected, the EMD which is
credited in ESIC account, will be refunded to the unsuccessful bidder within one month after
the award of the contract.
h) In case the bidder is successful/Bid of the bidder is selected, the EMD which is credited in
ESIC account, will be refunded to the successful bidder after they submit requisite
performance security.
i) In case bidder withdraws his bid within its validity or fails to deposit performance
security within the specified time after award of contract, the Earnest Money will be
forfeited and the bidder will be debarred/ de-registered for a period of three years.
j) E.S.I. Corporation will not pay any interest on deposited EMD and would be stand credited
to the E.S.I. Corporation Account.
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TERMS AND CONDITIONS FOR GOVERNING THE
RATE CONTRACT
1. This rate enquiry is for the purpose of executing Rate Contract for supply of Orthopedic
Implants (Arthroplasty) in ESI Hospitals/Dispensaries and other medical institutions run by the
ESI Corporation and ESIS PAN India. The rates quoted and accepted by the Director General,
ESI Corporation shall be valid for the quantities that may be purchased from time to time
during the course of the contract.
2. The quotations shall remain open for acceptance for 180 days (One hundred Eighty days)
from the date of opening of tenders.
3. The Director General, Employees' State Insurance Corporation, New Delhi reserves the right
to reject any or all offers including the lowest quotation without assigning any reasons
whatsoever. The Director General, ESI Corporation, New Delhi will also have the authority to
accept bidder's offer in respect of any one or more of the items for which bidders may have
quoted and his decision in this respect shall be final.
4. The Director General, ESI Corporation reserves the rights to invite separate quotations in his
sole discretion, to effect purchases outside this contract in the event of any urgent demand
arising in a locality where no stocks are held or otherwise.
5. ESIC will be entitled to proceed against the participating bidder/ firm before the court of law
or otherwise to protect its rights and remedies available under law.
6. The past performance of the bidder will be taken into consideration for award of a new Rate
Contract.
7. Bidder will have to furnish documents in support of the information given in the tender.
Original documents shall be submitted for verification as and when required
8. The bid submitted by bidder(s)/firm(s) debarred/blacklisted by the ESI Corporation/any other
Govt. Institution for participation in ESI Rate Contract/any other Govt. Institution will not be
considered for award of Rate Contract till the period of debarring and they need not apply.
9. In case of any attempt for cartelization by bidder with a view to hike up the prices, all bids
will be rejected and the bidders will be debarred for three years.
10. The bidder, if selected, will have to supply Orthopedic Implants (Arthroplasty) items directly to
the ESIC/ESIS through their registered office/C&F Depot/ C&F Agent/Authorized Dealer.
11. Validity of the Rate Contract is two years from the date of finalization of the contract, but in
case of exigencies, period can be extended.
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12. Rates for only such items, which can be supplied immediately on demand or latest within six
weeks of the placing of supply order through out of the period of contract as indicated above,
may be quoted
13. NOC for facility regarding import license for raw materials etc., will not be given by the
ESIC/ESIS.
14. ELIGIBILITY CRITERIA
A. Bidder shall be a manufacturer (holding valid manufacturing & marketing license) /direct
importer (holding valid import & sales license) issued by the State/Central Drug Controller
for all the items quoted and must submit an attested copy of the same. For the items other
than those defined as ‘drugs’ in the Drugs & Cosmetics Act 1940, the bidders shall possess
valid manufacturing/Import license(s) granted by appropriate authorities, local bodies,
industrial department etc. as applicable.
Distributors/agents/contract manufacturers are not eligible to participate in the tender. If
the item offered is planned to be manufactured in more than one factory, the drug
licenses/licenses of all such manufacturing units shall invariably be submitted. Bidders
should not offer products that are manufactured in factories, who were blacklisted by the
Corporation/any other State/Central Government agencies organizations or whose licenses
were suspended/cancelled or who have been convicted or against whom prosecution actions
are pending.
If above terms and conditions are not fulfilled tender will be liable for the cancellation.
(i) Participating bidder/ firm should not be blacklisted/deregistered and should not have been
blacklisted/deregistered by any other Govt. institution/ Organization during the last Three
years for manufacturing/Importing/supplying sub- standard Orthopedic Implants (Arthroplasty)
/Other items or on any other grounds(an affidavit duly notarized on stamp paper worth of Rs.
100/- in clear and unambiguous language must be submitted).
(ii)Participating bidder/ firm should not be convicted in an offence under the prevention of
Corruption Act,1988. Participating bidder/ firm should not be convicted in an offence under
the Indian Penal Code or any other law for the time being in force, for any cause of life or
property or causing a threat to public health as part of execution of a public procurement
contract. (an affidavit duly notarized on stamp paper worth of Rs. 100/- in clear and
unambiguous language must be submitted).
(iii) Participating bidder/ firm should not have been convicted by any court of law in any
matter related to manufacturing/importing/supplying sub- standard Orthopedic Implants
(Arthroplasty) or on any other grounds. Participating bidder/ firm should submit a non-
conviction certificate issued by the State/Central Drug Controller, to the effect that the
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manufacturer/importer has not been convicted under the Drugs and Cosmetics Act, 1940 and
rules there under during the preceding three years, for any of the item for which it has quoted
price. Non-Conviction Certificate must have been issued on or after 30.09.2017 from the
Drug Controller of the concerned State.
B. Participating bidder/firm must have a valid Registration Certificate issued by Directorate
General of Quality Assurance (DGQA) Ministry of Defence, Govt. of India for manufacture
and supply of items for Defence, for the item(s) quoted in above said tender. (if applicable)
Or
Participating bidder/firm must have WHO-GMP certificate i.e., Good Manufacturing
Practices (GMP) Certificate in accordance with the WHO recommendations issued by
Central / State Drug Control Authorities/ FDA for each of the item quoted. If it is found
subsequently that the WHO-GMP certificate has not been issued in accordance with
the guidelines issued in this regard by the Drug Controller General of India (which
includes joint inspection of the manufacturing unit by central and state drug control
authorities), the certificate as well as the tender are liable to be rejected. (if applicable)
Or
GMP (Good Manufacturing Practice) Certificate as per the revised Schedule ‘M’ of the Drugs
& Cosmetics Rules issued by Central / State Drug Controller/ FDA for the item(s) quoted. (if
applicable)
C. Deleted.
D. i) For the quoted items covered under drugs, a certificate as per annexure B-1,from the
State Drug Controller (should not have been issued more than six months from the opening
of tender) that the Participating bidder/ firm has been manufacturing/ importing the product(s)
for which the bidder has quoted the price for the last three preceding years except for new
item(s). However for startup company of Indian origin, the above said certificate issued from
State Drug Controller for manufacturing and sales the product(s) for the last financial year
i.e.2016-17 will be acceptable for participation in ESI Tender Enquiry.
ii)For the quoted items not covered under drugs, a certificate (should not have been issued
more than six months from the opening of tender) issued by appropriate authorities, local
bodies, industrial department etc. that the participating bidder/ firm has been manufacturing/
importing the product(s) for which the bidder has quoted the price for the last three preceding
years or a declaration on letter head of the firm supported by documentary proof (Supply
order etc.), as per Annexure B-2 can be submitted.
However for startup company of Indian origin, the above said certificate either issued from
appropriate authorities, local bodies, industrial department etc. for manufacturing and sales of
the quoted product(s) for the last financial year i.e.2016-17 or on letter head of the firm
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supported by documentary proof (Supply order etc.). as per Annexure B-2 can be
submitted.
E. The Participating bidder/firm shall submit an unconditional undertaking to supply Orthopedic
Implants (Arthroplasty) of standard quality as prescribed under the provisions of Drug and
Cosmetic Act, 1940 (as amended) )/or any other provision issued by appropriate authorities,
local bodies, industrial department etc.. The bidder shall also undertake not to supply items
“Not of standard”, “Grossly sub-standard” and “Spurious and adulterated” as per the
guidelines issued by the Drug Controller of India from time to time.
F. In case of newly introduced item(s), the Participating bidder/firm will submit valid
certificate from the Drug Controller General of India in support of the claim and valid Drug
license from the concerned Licensing Authority.
G. In case of proprietary item(s), Participating bidder/ firm will submit valid certificate to this
effect from the State Drug Controller/Licensing Authority, else bidder’s claim will not be
considered.
H. For the item(s) which are being imported, the Participating bidder/firm will submit valid
import license issued by Drug Controller General of India.
I. The bidder must quote items which are either marked ISI/European CE/US FDA/Indian
FDA.For such items, the bidder will be eligible if it possesses and submits valid ISI/European
CE/US FDA/Indian FDA certificate/license issued by Bureau of Indian Standards/ European
CE/US FDA/Indian FDA for the last three preceding years(as applicable).
J. For the item(s) quoted in the tender enquiry, Participating bidder/ firm will have to submit:
i) Original Label of all quoted items.
ii) Literature/Brochures/Catalogue of all quoted items
K. Participating bidder/ firm will have to submit/Demonstrate (Implants) the samples on
demand. Every sample must be superscribed with the name of the bidder/firm, Tender No.,
Item No. in a separate envelope duly sealed and stamped by the bidder. If bidder fails to
submit the samples within the period specified, the bid of the firm for that item(s) will be
summarily rejected.
L. Participating bidder/ firm should submit an undertaking on an affidavit of Rs. 50/- (Rupees
Fifty only) stating that they will comply with all the statues & legislation regarding
manufacturing, import, sale and supply of items in India and in particular the following
Acts/Enactments viz., the Drugs and Cosmetics Act, 1940, The Drugs and Cosmetics Rules,
1945 (as amended), The Legal Metrology Act, 2009, The Drugs (Control) Act, 1950, The
Indian Statistical Institute Act, 1959, The Central Excise Act, 1944 etc.
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M. The participating bidder/ firm should submit a guarantee bond on a affidavit of Rs. 50/-
(Rupees Fifty only) duly signed by the Notary (Annexure T) as under:-
a. “The bidder/firm hereby declare that the items sold to the ESIC under this
contract shall be of best quality and workmanship and shall be strictly in
accordance with the specifications and particulars contained/mentioned in the
description clauses hereof and the bidder/firm hereby guarantees that the said
item(s) would continue to conforms to their description/ specification and the
provisions of law as stated in the contract and that notwithstanding the fact that
the purchaser (inspector) may have inspected and/or approved the said item(s). If
the same be discovered not to conform to the description and quality aforesaid or
have deteriorated, the decision of the ESIC in that behalf will be final and
conclusive. ESIC will be entitled to reject said item(s) or such portion thereof as
may be discovered not to conform to the said description and quality in the
manner as prescribed. Such rejection of the item(s) will be at the seller's risk and
all the provisions herein contained relating to rejection of item(s) etc. or such
portion thereof if is rejected by the purchaser. Nothing herein contained shall
prejudice any other right of ESIC in that behalf under this contract or
otherwise”.
N. Company/Authorised Signatory has to submit Employer Code No. & copy of last three
contributions towards ESI in case factory is covered under ESI Act.
OR
Company /Authorised Signatory has to submit an affidavit giving address of Manufacturing
unit with a declaration that this factory / manufacturing unit is outside the implemented area /
notified area by ESI Corporation
OR
Company /Authorised Signatory has to submit a certificate from the Regional Director that
the factory is not coverable under ESI Act, in case the factory is within the notified area.
O. The list of items for which the offer is being made should be given as per the format given in
Annexure-A. All the columns of Annexure-A should be properly filled up and no column
should be left blank.
P. Each and every page of the tender and Annexure if any, should be signed by the authorised
signatory of the bidder/ firm. The specimen signature of the authorised signatory should be
submitted to the Corporation along with the tender.
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Q. Information as per the proforma enclosed (Annexure-E) should be submitted with the tender.
Furnishing of wrong information and false documents will make the bidder ineligible and
liable to be debarred / blacklisted from participation in ESI Rate Contracts.
R. Non submission of Annexure “G”, Annexure “H”, not following all the terms & conditions
of Tender Enquiry, furnishing wrong information and false documents will make the bidder
ineligible and liable to be debarred / blacklisted from participation in future ESI Rate
Contracts for Three years along with forfeiture of the earnest money.
S. The Bidder should submit an affidavit on Stamp Paper, stating that the item(s), which are
being quoted, are not banned under Section 26 (A) of Drugs & Cosmetics Act. Or any other
provision of law prevailing in India.
T. All the Annexure’s (A, P and Detail of Licences) are to be properly filled and Annexure’s
(B-1/B-2, C, D, E, G,H,L, T, TO and EMD) to be uploaded, otherwise tender will liable to be
rejected.
15. Terms & Conditions for Micro & Small Enterprises (MSE) firms quoting items reserved
for exclusive procurement from them as per Govt. Circular No. 21(1)/2011-MA dated
25.04.2012 and 21(15)/2012-MA dated 24.05.2012
A. MSE Firms must have a valid registration certificate with any of the following:
District Industries Centre
Khadi & Village Industries Commission
Khadi & Village Industries Board
Coir Board
National Small Industries Corporation
Directorate of Handicraft & Handloom
Any other Body Specified by Ministry of MSME, Govt. of India.
B. In tender, for general category of item - eligible Micro and Small Enterprises quoting
price within price band of L1 + 15% shall also be allowed to supply a portion of
requirement by bringing down their price to L1 price in a situation where L1 price is from
someone other than a Micro and Small Enterprise and such Micro and Small Enterprise
shall be allowed to supply upto 20% of the total tendered value.
C. Out of 20% target of annual procurement from Micro and Small Enterprises, a sub-target
of 20% (4% out of 20%) shall be earmarked for eligible Micro and Small Enterprises
owned by Scheduled Caste or Scheduled Tribe entrepreneurs.
D. Further in event of failure of such Micro and Small Enterprises to participate in tender
process or meet tender requirements and L1 price, 4% sub-target of procurement
earmarked for Micro and Small Enterprises owned by SC/ST entrepreneurs shall be met
from other eligible MSE units.
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16. Terms & Conditions for Startup Companies of Indian Origin as defined by Department
of Industrial policy and Promotion
Startup Company/firm of Indian Origin having a valid registration certificate can participate
in the bidding process. Inception year of Startup companies of Indian Origin should not be
prior to F.Y. 2014-2015.
17. TURNOVER CRITERIA
(a) Turnover for schedule Item(s)
(i) *Participating bidder/ firm should have minimum annual turnover of Rs. 60 crores
each of the last three preceding financial years (2014-15, 2015-16, 2016-17).
(ii) Participating Bidder(s)/ Firm(s) will have to submit audited financial statement by
registered Chartered Accountant for last three preceding financial years (i.e. 2014-15,
2015-16 and 2016-17) in support of the annual turnover.
(iii) Fifty Percent or more of the annual turnover shall be from the trading of the item(s) in
the open market i.e exclusive of supply to ESI/ Government Departments/Third party. A
certificate from the Chartered Accountant with reference to sale in the open market should
be submitted.
(iv)Group turnover (other than Orthopedic Implants) will not be considered for determining
the eligibility of the bidder and such tenders will be rejected summarily.
(v) Please fill and submit Annexure TO.
b) Turnover For MSE Firms
Participating MSE firms quoting for items them shall have to fulfill the turnover
criteria as defined for non MSE vendors specified in 17 (a).
c) Turnover for Startup Company(s)/firm of Indian Origin
Participating Startup firm/company should have a minimum annual turnover of Rs. Ten
Crores for the last financial year i.e.2016-17 to be eligible for participation in ESI Tender
Enquiry.
18. Undertaking For Performance
The participating Bidder/firm shall furnish an undertaking with respect to timely and
efficient supply of the quoted item(s) as per the tender in all the locations where ESIC / ESIS
Hospital and State ESI Directorates are located, through their Registered Office/C&F Depot
C&F Agent/Authorized Dealer. Participating bidder/firm would submit in the tender the List of the
Reg.Office /C&F Depot/ C&F Agent/Authorized Dealer address, email ID & Telephone number
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located in the State(s) along with the name of the person Incharge, as per Annexure L. Aforesaid
person Incharge will also be responsible for managing the supply in the stipulated time at the ESI
location under its jurisdiction and other matters, if any. In normal circumstances, the bidder(s) shall
not be allow to change C&F Agent/Authorized Dealer during the currency of the Rate Contract.
However in extreme exigency ,on the request of selected bidder the C&F Agent/Authorized Dealer
may be allowed to change, if Director General, ESI Corporation permits/approve.
19. Performance Security
All Successful bidders including MSE /Start up bidder(s) for L-1 (1st Preference ) or L-2/L-
3 (2nd
Preference/3rd
Preference) will have to deposit the performance Security in the form of
Performance Bank Guarantee of Scheduled Commercial Bank.
a) Performance security for a bidder having selected item at L-1 (1st Preference ) will be
Rupees 110 Lakhs.
b) Performance security for a bidder having selected item at L-2/L-3 (2nd
Preference/3rd
Preference) only will be Rs.500000/-(Rupees Five Lakh),in case any item of the bidder is not
selected for L-1 (1st Preference ).
c) However the bidder having selected item(s) at L-1 (1st Preference ) need not to submit any
separate performance security for item at L-2/L-3 (2nd
Preference/3rd
Preference).
d) Director General, ESI Corporation will be at liberty to apportion any amount due and payable
by the bidder to ESIC in respect of Non Supply / Non Performance/ Risk Purchase by the
ESIC/ against item(s) of “Not of Standard Quality” or any other amount which becomes
payable by the bidder in favour of ESIC by virtue of the terms and conditions agreed herein
and recover the same from the Performance Security. No appeal shall lie with any authority
against the decision taken by him in pursuance of this clause.
e) EMD of the successful bidder will not be adjusted as part of performance security.
20. MARKING/LABELLING:
Each packing shall be printed with nomenclature of the item and shall be labelled in
accordance with the requirement of the Drugs and Cosmetics Act, 1940 and the rules made
there under. Packing & packaging of the each drug must comply with the procedure provided
under the Legal Metrology Act, 2009 and rules made there under.
21. PACKING:
a) Participating bidder/ firm must quote for the packing specified against each item in the
schedule annexed the rate enquiry, as any other packing may not be accepted.
b) Where the size/quantity of the pack is not specified in tender enquiry, bidders may quote
for standard packs available in the market.
c) It should be ensured that all labels of cartons, item(s), etc., should be stamped "For
ESI supply, Not to be sold" with non washable/indelible ink clearly.Any consignment
without such stamping will not be considered valid and will be rejected.
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d) Loose supplies/damaged packing/tempered or damaged labeled supplies shall not be
accepted under any circumstances.
e) Participating bidder(s)/firm(s) shall quote the net price per unit for the item(s)
quoted in the tender in detail under a tabular format. Rates quoted for any other
packing will not be accepted and the same shall result in rejection of the bid
submitted by the bidder.
f) Supplies to be made in proper packing in boxes conforming to Pharmacopoiea / Drugs &
Cosmetics Act etc.
g) It should be ensured that only first use packaging material of uniform size should be
used for making supplies on the basis of ESI Rate Contract.
h) All primary packing containers should be strictly conforming to the specifications
described/ mentioned in the relevant pharmacopoeia/ Drugs & Cosmetics Act.
i) Packing should be able to prevent damage or deterioration during transit.
j) All containers are required to be secured with pilfer-proof seals to ensure genuineness of
the products packed and the correctness of the contents.
22. SHELF LIFE AS ON DATE
a. For item(s) having shelf life of Two years or less: As on the date of delivery, item
should not be older than one fourth(1/4) of its shelf life from the date of manufacture.
b. For item(s) having shelf life more than Two years: As on the date of delivery, item
should not be older than one sixth (1/6) of its shelf life from the date of manufacture.
c. For Imported Items: As on the date of delivery, item should have a minimum 50% of its
shelf life from the date of manufacture.
23. TESTING OF ITEMS
a. Regular and random testing of item(s) will also be undertaken by ESI from Govt./Govt.
approved laboratories at the time of supply and at any time during the shelf life or
whenever any defect is noticed.
The Director General, ESI Corporation shall be at liberty to undertake regular and random
testing of the item(s) supplied by the RC holder at regular interval to maintain and ensure
the quality of item(s) supplied.
b. The report of the Govt./Govt. approved laboratory shall be accepted by the RC holder
firm. In case the same is disputed by the RC holder firm, the report of the Appellate
Laboratory only will be accepted as final. However the same should be submitted within
three months, from the date of communication of the disputed test report to the RC holder
firm. For this, the RC holder firm should approach the concerned Drug Control
Authorities for getting the items tested, as per procedure, from the Appellate Laboratory.
16
24. Quality Control
i) The Bidder shall guarantee that item delivered to the purchaser are brand new and not
refurbished one. Consistency in quality shall be maintained for the entire lot of product
offered.The Firm shall be responsible for the quality of supply.
ii) The stores offered should comply with the provisions of the Drugs and Cosmetics Act,
1940 and the Rules made there under .
iii) While quoting against items with ISI/European CE/US FDA Mark, it should be ensured
by the bidder/firm that ISI/European CE/US FDA code number is/are indicated on
quotation and at the time of making of the supplies, it should be ensure by the RC holder
that the items supplied has ISI/ European CE/US FDA Mark as well as Code Number, as
is the statutory requirement of the Bureau of Indian Standards /European/American
Standards. The attested copy of the valid ISI Marking/ European Marking/American
Marking license, issued by concerned statutory body should be enclosed alongwith the
quotation.
iv) If any item supplied against this Rate Contract are found to be not of standard quality on
inspection by Competent Authority, the RC holder firm will be liable to replace the entire
quantity and the cost of testing will be recovered from the supplier.
v) If at any stage, the quality of articles is found of poor quality/different technical
specification, the supplied item shall be rejected and no payment shall be made for this
rejected item supplied. The rejected items must be removed by the firm within Two weeks
of date of intimation of rejection at their own cost. In case rejected items are not removed;
it will be destroyed at the risk, responsibility & cost of the Firm.
vi) If single item/ Batch of item is declared NSQ under DGESIC Rate Contract/s.
Recall of the NSQ item immediately from all ESIC/ ESIS User Units. Replacement of
the qty of NSQ item to ESIC/ ESIS User Units by RC holder. Recovery to be initiated
by the DDO’s wherever payment had been made already.
Rate Contract Holder/ firm will be debarred for further supply of the said NSQ item
in the currency of the Rate contract.
Rate Contract Holder/firm will be liable to pay damages/ compensation (if any) to
individual/ individuals arising due to consumption of item declared NSQ and in case
of any adverse reaction reported in the Hospital during administration of the item(s).
vii) If more than one item/ Batch of item belonging to any individual Bidder/firm is
declared NSQ within a year in DGESIC Rate Contract.
Recall of the NSQ item immediately from all ESIC/ ESIS User Units. Replacement of
the qty of NSQ item to ESIC/ ESIS User Units by RC holder. Recoveries to be
initiated by the DDO’s wherever payment had been made already.
Rate Contract Holder/ firm will be debarred for further supply of the said NSQ item
in the currency of the Rate contract.
Debarring of Rate Contract Holder/firm immediately from current and all future
DGESIC Rate Contracts for a period of three years
17
Rate Contract Holder/ firm will be liable to pay damages/ compensation (if any) to
individual/ individuals arising due to consumption of item declared NSQ and in case
of any adverse reaction reported in the Hospital during administration of the item(s).
Forfeiture of performance security of the Rate Contract holder in respective DGESIC
Rate Contract.
25. Purchase Order
a) After the quotations have been accepted by the Director General, ESI Corporation,
purchase orders will be placed by the Director Medical Delhi/MS of ESIC/ESIS
hospitals/Directors of ESI Scheme of various States as per Schedule attached, who for the
purpose of this Rate Contract, shall be designated as Chief Direct Demanding Officer and
will exercise the powers of Director General, ESI Corporation in all matters connected
with the execution of supplies and/or wherever specifically provided in the terms and
conditions of the Rate Contract. The Chief Direct Demanding Officer can also designate
any of his subordinate Officer as Direct Demanding Officer (DDO) to operate this
contract.
b) Purchase order(s) will be placed from time to time during the currency of the contract in
which the exact quantities required on each occasion together with the date of delivery
shall be specified by the Direct Demanding Officer(s).
c) No guarantee can be given as to the minimum quantity which will be drawn against this
contract but the RC holder firm will supply quantity as may be ordered by the Direct
Demanding Officer(s) during the currency of the contract.
d) Purchase order(s) against the contract will be accepted as long as these reach the RC
Holder/ firm on or before last date of the currency of the contract. Purchase order(s)
received during the closing days should be complied with in due course, in accordance
with the contract, even though in some cases owing to contract having expired, supplies
are to be executed after the expiry of the last date of contract.
e) The ESI Corporation has the right to purchase the contracted items from other
tenderer/manufacturer/supplier/market if needed and the firm shall not object or claim to
make the purchase from him/her only.
26. Delivery Period of the Purchase Order
a) DDOs will send scanned copy of the Purchase order(s) through an email followed by
Registered AD post.
18
b) Delivery Period will be of six weeks from the date of receiving of the purchase order
by RC holder and the RC holder/ firm shall, execute the purchase order within
stipulated time.
c) During transit RC Holder/ firm should maintain the recommended temperature of
the item(s) (wherever indicated), otherwise if on checking it is found that
temperature has not been maintained, supply against the said order is liable to be
rejected and cancelled. It will be counted as a non-supply.
d) In case of failure to supply, the Corporation reserves the right to purchase the stocks from
other sources as risk purchase, i.e. purchase from any other RC Holder/firm or firms, in
the rate contract or from outside the contract at the discretion of the Direct Demanding
Officer concerned at a competitive rate.
e) In all contracts, for the items which are labelled with 'ESI SUPPLY' mark, including
rejected items, it is a condition of the contract that such items will not be sold by the RC
Holder to the public / open market.
f) In case the ESIC decides to cancel the contract, the mode of repurchase will be at the
discretion of the ESIC only.
27. Penalty for non supply/late supply
a) If the RC Holder/firm fails to execute the supply order within the stipulated period of six
weeks, a penalty of two (2) per cent of the value of the order calculated at the contract rate
per week or a part of a week will be levied. The maximum penalty for late supply shall
not exceed 10% of the total value of the order/orders. The RC Holder/firm can seek
extension of the delivery period with the prior consent of the concerned Director
Demanding Officer(s), if it is not in a position to execute the order in time. Such extension
is permissible for a maximum period of 5 weeks only, but penalty will be levied. The
extension of delivery period cannot be claimed as a matter of right but will be at the
discretion of concerned Director Demanding Officer.
b) If the items are not supplied by the schedule date (as indicated above or by the extended
date) full or in part, the order in respect of the quantity not supplied is liable to be
cancelled at the risk and expense of RC Holder/firm. The extra expenditure involved in
procuring supplies from elsewhere will, in that case, be recoverable from the RC
Holder/firm, in full at discretion of Direct Demanding Officer(s). The recoveries thus due
will be deducted from any sum payable by the Direct Demanding Officer or which at any
time thereafter may become payable under this contract or any other contract placed with
bidder by the Direct Demanding Officers. He will be deemed to be exercising the powers
19
of Director General, ESI Corporation in case any such contingency arises. Apart from risk
purchase action, the bidder's the Performance security deposit may be forfeited and shall
invite other penal action like debarring from participating in ESI Corporation Rate
Contract present and future for a period of not less than Three years.
c) If the RC Holder/firm fails to execute the supply order three times at any location of ESIC
/ ESIS in any part of the country during the period of rate contract, it shall be debarred for
the next Three years with effect from the last failure and forfeiting of Performance
Security.
28. Quoting Of Price
a. The price charged for the stores supplied under the agreement or the rate quoted by bidder
for supply of item(s) to the DG-ESIC, whichever is lower, shall in no event exceed the
lowest price at which the bidder sells the stores of identical description to any other
person(s) during the said period of agreement. If at any time during the said period, the
bidder reduces the sales price of such stores or sells such stores to any other person at a
price lower than the price chargeable under the agreement, he shall forthwith notify such
reduction in sale price to the Director General, E.S.I. Corporation and Direct Demanding
Officers and the price payable under the agreement for the stores supplied after the date of
its coming in to force will be the reduced price. The approved price in Rate Contract
shall stand correspondingly reduced. The preference in the Rate contract will not be
changed till any further fresh instructions.
b. The price must be quoted F.O.R Destination per unit as shown in the schedule annexed
and should be exclusive of GST Tax but inclusive of all charges for packing and
forwarding.
c. GST Taxes, if extra, where legally leviable and intended to be claimed, should be
distinctly shown separately alongwith the price quoted. Where this is not done, no claim
of GST taxes will be admitted at any later stage and on any ground whatsoever.
d. The purchaser will not pay separately for transit insurance and the bidder will be
responsible for delivery of items covered by the supply order in good condition at the
specified destination and for this purpose freight, insurance, octroi etc., if any, will have to
be borne by the bidder.
e. The consignee will, as soon as possible, but not later than 30 days of the date of arrival of
stores at destination, notify the RC Holder/firm, of any loss damage to the stores, that may
have occurred during the transit.
29. Payment
20
a. Payment for the supply will be made within 4 to 6 weeks (after receipt and acceptance of the
items) directly by the Direct Demanding Officer(s) or through nominees to whom bills are
submitted. Notwithstanding any omission or shortcoming in the supply order it is incumbent
upon the RC Holder/ firm to supply the items as per the specifications of the relevant rate
contract.
b. Any dues or payments that have arisen to the Corporation from the RC Holder /firm for which
no specific time limit has been laid down in the terms and conditions shall be payable by the
bidder/firm within such time limit as may be prescribed in the letters/orders addressed to the
RC Holder /firm.
c. Any payments that have been demanded as per the provisions of above clause b or under any
other clause shall be payable within the time laid down.
d. Payment shall be released after deducting TDS/GST as per Income Tax Rules and any other
deductions as per Government Rules and payment shall be released only after it is ensured
that the items/ quantity and quality supplied are to the entire satisfaction of the ESIC. If any
time it is found to be defective, or not of the desired quality etc., the same shall be replaced by
the firm,for which no extra payment shall be made by ESIC.
e. The payment of the bills shall be made after deducting Government dues, if any.
f. The payment of the bills shall be withheld in the following circumstances:
i. The goods are found sub-standard or in non-acceptable conditions.
ii. Breach of condition of any terms of the contract by firm.
iii.Previous Government dues of the firm.
g. On failure to do so: -
i) The RC Holder /firm shall be liable to be debarred for supplying items etc. to the
Corporation for a period not exceeding three years.
ii) The RC Holder /firm is liable to be prosecuted in court of law.
30. ARBITRATION
a. In the event of any dispute or difference arising under these conditions or any special
conditions or contract or in connection with this contract, except as to any matters the
decision on which is specially provided for by these or special conditions the same shall
be referred to a sole arbitrator duly appointed as per the provisions of The Arbitration &
Conciliation Act, 1996 (As amended in the year 2016) and the Rules made thereunder and
for the time being in-force shall apply to the arbitration proceeding under this clause.The
venue of the Arbitration will be Delhi only. The Arbitration will be conducted in English
Language. The award of the Arbitral Tribunal shall be final, conclusive and binding on
the parties to the agreement.
21
b. Work under the contract shall, if reasonably possible, continue during the arbitration
proceedings and no payment due to or payable by the purchaser shall be with-held, on
account of such proceedings.
c. Notwithstanding any omission or shortcoming in the supply order it is incumbent upon
the RC Holder /firm to supply the items as per the specifications of the relevant rate
contract.
31. JURISDICTION
All the disputes relating to this tender enquiry and Rate Contract shall be subject to the
territorial jurisdiction of Courts at Delhi only.
32. GOVERNING LAWS
The contract shall be governed in accordance with the law prevailing in India, Act, Rules,
Amendments and orders made thereon from time to time.
33. INDEMNIFICATION
The RC holder/Tenderer shall indemnify the purchaser against all actions,suit,claims and
demand or in respect of anything done or omitted by RC holder/Tenderer in connection with
the contract and against any losses or damages to the purchaser/ESIC in consequence of any
action or suit being brought against the RC holder/Tenderer.
34. SAVING CLAUSE
In case this contract or any portion thereof shall be invalidated on any ground by any court of
competent jurisdiction, no suits, no prosecution or any legal proceedings shall lie against the
officials of ESIC and or any person associated with the ESI C for anything that is done in
good faith or intended to be done in pursuance of tender.
35. RATE REVISION
Successful bidders shall not be entitled to any rate revision for any reason except that allowed
by Government of India.
36. INSPECTION
The Director General, ESI Corporation, reserve the right for Inspection of the Bidder(s)/
firm(s) participating in the tenders, by the officer(s) appointed. They can carry out inspection
for assessing the quality /capacity/capability/eligibility of the Bidder/ firm to make supplies
on the basis of ESI Rate Contract and to ensure that the provisions of the Drugs and Cosmetic
Act, 1940 and the good manufacturing practices are being followed by firm. The decision of
the Director General shall be final in this regard.
37. PHARMACOPOEIA SPECIFICATION
22
IP/BP/USP etc. should be clearly mentioned against each item/constituent of the formulation
quoted as per the provisions of Drug and Cosmetics Act/Any other Act.
38. GENERAL INSTRUCTIONS
a. Signing of the tender:
The tender is liable to be rejected if complete information is not given therein or if the
particulars and date (if any) asked for in the schedule to the tender are not filled in.
Individual signing the tenders or other documents connected with the contract must
specify whether he signs as:-
i) A sole proprietor of the firm or constituted attorney of such sole proprietor.
ii) A partner of the firm, if it be a partnership firm in which case he must have
authority to refer to arbitration disputes concerning the business of the
partnership/agreement or a power of attorney.
iii) Authorised Attorney of the firm if it is a company.
b. Any concealment, misrepresentation on the part of the firm shall warrant strict action
which may extend to cancellation of the tender or subsequent award. Such cancellation
shall be at the sole risk of the firm / individual signing the tender or submitting any other
document.
c. In case of 34( a) (ii) a copy of partnership agreement attested by a Notary Public should
be furnished unless the same has been previously furnished to the Corporation, or an
affidavit on stamped paper by all the partners admitting execution of the partnership of the
general power of attorney should be furnished.
d. In the case of partnership firms, where no authority to refer disputes concerning the
business of the partnership has been conferred on any partner, the tender and all other
related documents must be signed by each partner of the firm.
e. A person signing the tender form or any documents forming part of the contract on behalf
of another shall be deemed to warrant that he has authority to sign the same and, if on
enquiry it appears that the person so signing had no authority to do so, the purchaser may
without prejudice to other civil and criminal remedy cancel the contract and hold the
signatory liable for all costs and damages.
f. The tender will be rejected if:-
i. The bidder/ firm submits conditional tender.
ii. "No tax" quotations are not supported by a proof.
iii. All the papers are not complete.
iv. More than one type of rates are quoted for one product.
23
v. Sealed envelope containing Manual Bid (EMD) is not sealed properly.
vi. If it is not legible and cuttings/over writings are not attested by the authorised
signatory alongwith seal.
vii. The rates quoted are not found both in figures and words. The unit for which rate
is quoted should be clearly specified.
viii. If a firm quotes NIL charges/consideration, the bid shall be treated as
unresponsive and will not be considered.
g. Each page of photocopy of various papers/certificates attached/uploaded should be self
attested by authorised signatory.
h. It is mandatory for all bidders to submit the tender online through e-procurement portal
of esic-https://esic.eproc.in. The terms & conditions of the present e-Tender Enquiry
Form for Rate Contract are binding upon the firms / Bidders. The submissions of the
online tender and the tender(EMD) under sealed envelope respectively shall construe a
concluded agreement for the purpose of invocation and enforcement of the terms &
conditions of the online tender.
39. The sealed envelope of Manual Bid containing EMD as calculated of the quoted item(s)
should be addressed to:
Dy. Medical Commissioner (R.C.) ESI Corporation, New Delhi-110002.
Such sealed cover should be delivered by the specific time and date.
A sealed cover containing EMD and Online Technical Bid will be opened
manually/online on the specified date and time. Online Price Bid of only those
bidders, who are found technically eligible will be opened. The date and time of
opening of the price bid in respect of bidders who fulfill eligibility criteria will be
intimated to such bidders.
40. Withdrawal of Bid:
i. Once a tender is submitted, it will be responsibility of the tenderer not to
escape half way directly or indirectly by way of raising any problem.
ii. withdrawal of tender along with the earnest money will be allowed before the
date of opening of tenders.
41. After opening of tenders: -
a) withdrawal of the complete tender can be allowed but in such cases, the earnest money
shall be forfeited in full;
24
b) no change/alteration in rate or other terms & conditions in the tender will be permitted
under any circumstances;
c) Partial withdrawal (in respect of one or more items quoted) will not be allowed under any
circumstances.
42. No claim for the payment from RC Holder/Firm shall be entertained after the lapse of three years of
arising of the claim.
43. FORCE MAJEURE:
i. For purposes of this contract, force majeure means at any time during subsistence of contract an event
beyond the control of the supplier and not involving the suppliers fault or negligence and not foreseeable.
Such event may include, but are not limited to, acts of the purchaser either in its sovereign or contractual
capacity ,war or revolutions, fires ,floods, epidemics, quarantine restrictions and freight embargoes.
ii. If a force majeure situation arises the supplier shall promptly but not later than 30 days notify the purchaser
in writing of such condition and the cause thereof. Unless otherwise directed by the purchaser in writing ,the
supplier shall continue to perform its obligations under the Contract as far as is reasonably practical and shall
seek all reasonable alternative means for performance not prevented by the Force Majeure event. Force
Majeure will be accepted on adequate proof thereof.
iii. if contingency continues beyond 30 days,both parties will discuss and decide the course of action to be
adopted.Even otherwise ,if the contingency continues beyond 60 days then the purchaser may consider for
termination of the contract on equitable terms.
Dy. Medical Commissioner (RC)
25
Annexure A
Item Name and
Description of the
product Packing
Offered
Drug
License
No. and
Date of
issue
for the
product
Date of
Mfg. of
1st
batch
of the
product
S. No. in
Annexure
B/Page
No.
Brand
Name, if
any
Was the firm debarred
in the past for the item
if so, period of
debarring
Manufactured by
Marketed
by
Type of Drug License
Self mfg. / loan
license / 3rd party Remarks (Put NA if Not Applicable)
26
DETAILS OF LICENSES
For Indigenous Items`
Details of
License (s)
for quoted
Items
Minimum 1 rows entry required. Number of Rows To Add:
S.
No.
Item
No.
Drug License Site GMP GLP No
Conviction
Proprietary
Certificate
New item
Certificate
Num
ber
Valid
Upto
Page
No.
Valid
Upto
Page
No.
Valid
Upto
Page
No.
Date
of
Issue
Page
No.
Number Date
of
Issue
Number Date
of
issue
For Imported Items
Details of
License(s)
for
Imported
Items
Minimum 1 rows entry required. Number of Rows To Add:
S.
No.
Item
No. Import License Form
10
Country
of
Origin
COPP Form 20B/21B Form 41 No
Conviction
Proprietary
Certificate
New item
Certificate
Number Valid
Upto
Page
No.
Valid
Upto
Number Date of
Issue
Valid
Upto
Page
No.
Number Valid
Upto
Page
No.
Date
of
Issue
Page
No.
Number Date
of
Issue
Number Date
of
issue
27
ANNEXURE B-1
MANUFACTURING/Importing & MARKETING CERTIFICATE
(For the items covered under drugs)
This is to certify that M/S_________________________ are holding valid manufacturing/Import licenses No.______________________________ date____ of the State and they are manufacturing/ Importing, the following products since the last three years. It is further certified that the following products are also being marketed for the last three years.
The products are as follows:-
S.No. Item No. Item Name and description
1
2
3
Note :
1. This certificate is to be signed by the Drug Controller of State. Certificate issued by Inspector of Drugs/Drug Inspector will not be accepted unless their authorization by the State Drug Controller to this effect is supported by documentary proof.
2. Firm should have three completed years experience of manufacturing/Importing and marketing
as on date of opening of the tender.
Dated:
Signature and seal of
Drug Controller of the State
28
ANNEXURE B-2
MANUFACTURING/Importing & MARKETING CERTIFICATE
(For the items not covered under drugs)
This is to certify that M/S_________________________ is/are holding valid manufacturing/Import licenses No.______________________________ date____ and are manufacturing/importing and marketing the following products since the last three years. The products are as follows:-
S.No. Item No. Item Name and description
1
2
3
Note :
1. This certificate is to be signed by the Authorized signatory. 2. Bidder/Firm should have three completed years experience of manufacturing/Importing and
marketing as on date of opening of the tender. It should be supported by documentary proof
(Supply order etc.)
Dated:
Signature of Authorized signatory
Stamp and seal of firm
29
Annexure 'C'
TO BE FILLED IN BY BIDDER AND RETURNED WITH THE TENDER (On the letter head of the bidder/firm)
To,
Dy. Medical Commissioner (R.C.),
Room No. 312 & 314, III Floor,
Hqrs. Office, ESI Corporation, Panchdeep Bhawan
C.I.G. Road, New Delhi – 110 002
Dear Sir / Madam,
We return herewith your e-Tender Enquiry No. U-25/12/ Orthopedic Implants (Arthroplasty)/2018-
Med.V for supply of Orthopedic Implants (Arthroplasty) dated: ___________ with our quotation against
respective items. We have carefully perused the Terms and Conditions of the tender enquiry and
accept the same.
For and on behalf of the firm
(Firms Name & Address)
(Signature of Authorized signatory)
WITNESS:
Signed in my presence:
Name:
Designation:
Seal:
Notary Public/Gazetted Officer
( Name & Complete Address)
30
Annexure - 'D'
PRODUCTION/Import CERTIFICATE
Indicate details of production/Import of the items quoted, for the last three preceding
years.
S. No. Item No. Item Name &
Description
Date of issue of
Mfg. License for
the product
Date of marketing
the 1st batch
1. 2. 3. 4. 5.
6. ACTUAL PRODUCTION/Import DETAILS
Year – 2014-15 Year 2015-16 Year 2016-17 Remarks
Batch No. Batch size Batch No. Batch
size
Batch
No.
Batch size
Signature of the
Manufacturer
Signature of Chartered Accountant
along with address & Seal.
Note: Firm will have to produce documentary evidence in respect of production/Import as
and when asked for.
31
Annexure -E
Proforma to be filled in by the Tenderer.
I GENERAL INFORMATION
a) Name of the firm:
b) (Information must be correct): -
Address for correspondence:
Telephone No.:
Working Fax No (Must be provided).:
Mobile No.
E-mail address for all Correspondences
including placing of Supply order :
c) Whether the firm is Indian / Multi-national.
d) Whether small/medium/ Large scale
company.
e) Whether Firm registered as Micro & Small
Enterprises Firm under the Ministry of Micro
Small and Medium enterprises
f) Whether Firm registered as Startup
enterprise
g) Person responsible for conduct of business
h) Particulars of Licenses held under Drugs &
Cosmetics Act & the details. (If the license is
under renewal, certificate from the Drug
Controller that the license is under renewal
and deemed to be enforced should be
enclosed.
i) Procurement agency with which registered
and the agencies to whom Item(s) quoted
supplied during last one year.
j) i.) Has the firm ever been convicted, if yes
give details.
ii.) Any case pending in Court with details.
k) Has the firm ever been black listed/debarred
by any procurement agency(Private/Govt.). If
yes, details thereof.
l) Has the firm ever been debarred/black listed
for supply of Orthopedic Implants (Arthroplasty)
by ESI Corporation: if yes, give details
32
II TECHNICAL
a) Equipments for material handling, manufacturing and quality control of Orthopedic Implants (Arthroplasty)/items.
b) Specialised testing facilities such as Microbiological testing and biological testing;
c) Details of Technical Staff: i.) Manufacturing Staff: ii.) Quality Control Staff:
d) Has the firm carried out stability study for Orthopedic Implants (Arthroplasty)/items quoted:
e) Is the firm basic manufacturer of the Orthopedic Implants (Arthroplasty)/items quoted, if yes, details:
f) Orthopedic Implants (Arthroplasty)/items declared sub-standard/recalled during the last three years. Give details with reasons and the remedial action taken:
III FINANCIAL
a) Annual Turn-over for formulations during the last three years (year wise) (Must be filled)
i. 2014-15 : _________ ii. 2015-16 : _________ iii. 2016-17 : _________
b) Name & Address of the Bankers to the firm ______________________ _________________________________________________________
_________________________________________________________
c) GSTIN No. NOTE: The bidder will submit an undertaking of GST ACT compliance on
a non-judicial stamp paper of Rs. 50/-. ESIC will not hold any responsibility including impact on price due to non-compliance of GST Act.
DECLARATION
I__________________________________ proprietor/partner/director of M/s.
__________________________________ hereby declare that the information given in this
form is true and correct to the best of my knowledge and belief.
Signature:
Name:
Designation:
Seal:
WARNING: If information furnished in this form is subsequently found to be incorrect the
tenderer will be black listed.
33
Annexure(G)
UNDERTAKING
We hereby undertake that rates offered by us in the DG-ESIC Rate Contracts for Orthopedic
Implants (Arthroplasty) are within the price ceiling. We further undertake that in case there is any
down-ward revision by the NPPA or by any other means , same will be passed on to the ESI
Corporation from the effective date during the currency of the contract and in case of failure to do
so we are liable to be debarred from future ESIC Tender Enquiry for a further period of three years
along with forfeiting the performance security..
For and behalf of the firm
(Firm Name & Address)
34
Annexure (H)
UNDERTAKING
Lowest Rate Certificate
(On letter head of the firm)
We hereby undertake that rates offered by me/us in the DGESIC Rate Contract for Orthopedic Implants
(Arthroplasty) are the lowest rates offered to any Government organization/Institution, and no other Government organization/Institution has been offered rates lower than those being offered herein. We further undertake that in case there is any down-ward revision, the same will be passed on to the ESI Corporation from the effective date during the currency of the contract and in case of failure to do so we are liable to be debarred from future ESIC Tender Enquiry for a further period of three years along with forfeiting the earnest money/security deposit.
For and behalf of the firm
(Firm Name & Address)
35
Annexure “L”
* Participating bidder/firm should have at least one Registered Office/C&F Depot/C&F
Agent/Authorized Dealer in each zone. The bidder may appoint one or more than one C&F
agent/Authorized Dealer in each zone.(should be supported by documentary evidence.)
S.N
o.
Zones States Postal Address of
Registered
Office/C&FDepot/C
&F
Agent/Authorized
Dealer in State
Person authorised
to handle the
Regd. office /C&F
Depot/C&F
Agent/Authorized
Dealer along
with telephone No.
ID of
the
person
incharge
01 Zone 1 Delhi, Haryana,Himachal
Pradesh, Punjab,Rajasthan
02 Zone 2 Bihar, Jharkhand, Odisha,West
Bengal ,Assam
03 Zone 3 Goa, Gujarat,Maharashtra
04 Zone 4 Andhra
Pradesh, Karnataka, Kerala, Tamil
Nadu, Telangana
05 Zone 5 Chhattisgarh,Madhya
Pradesh, Uttarakhand ,Uttar
Pradesh
36
Annexure - P
PRICE BID
S.
No
Item
No.
Item Name
& Description
Unit Net Rates /
Unit **
offered
(in figures)
Net Rates
offered/
Unit
(in words )
Applicable
GST
Brand
Name
Is Price
Notified by
NPPA, if yes,
Order No. &
Ceiling Price
*Retail
Sale
Price
1. 2. 3. 4. 7. 8. 9. 10. 11. 12.
1. AA AAA 1 2.6666
Upto Four
decimal
places
Rs. Two and
paise Six Six
Six Six only
1
* “Retail Sale Price” means the retail price displayed by the manufacturer under the provisions of the Drug (Prices Control) Order, 1995.
For Column No 9- Please enter 0 or 1
0 for NO GST
1 for GST as applicable
NOTE: ** Rate(s) shall be quoted for 1Unit of item (One Plate, Screw etc.).
37
Annexure T
Guarantee bond on a affidavit of Rs. 50/- (Rupees Fifty only) duly signed by the
Notary
“The bidder/ firm hereby declare that the Orthopedic Implants (Arthroplasty) /item(s) sold to the ESIC
under this contract shall be of best quality and workmanship and shall be strictly in accordance
with the specifications and particulars contained/mentioned in the description clauses hereof and
the firm/bidder hereby guarantees that the said Orthopedic Implants (Arthroplasty) /items would
continue to conforms to their description/ specification and the provisions of law as stated in the
contract and that notwithstanding the fact that the purchaser (inspector) may have inspected
and/or approved the said Orthopedic Implants (Arthroplasty) /items. If the same be discovered not to
conform to the description and quality aforesaid or have deteriorated, the decision of the ESIC in
that behalf will be final and conclusive. ESIC will be entitled to reject said Orthopedic Implants
(Arthroplasty) /items or such portion thereof as may be discovered not to conform to the said
description and quality in the manner as prescribed. Such rejection of the Orthopedic Implants
(Arthroplasty) /items will be at the seller's risk and all the provisions herein contained relating to
rejection of Orthopedic Implants (Arthroplasty) /items etc. or such portion thereof if is rejected by the
purchaser. Nothing herein contained shall prejudice any other right of ESIC in that behalf under
this contract or otherwise”.
Signature:
Name:
Designation:
Seal
38
Annexure EMD
Earnest Money Deposit Details Number of items
quoted EMD
(in Rs.) DD /BC detail(s)
Orthopedic Implants
(Arthroplasty)
Signature:
Name:
Designation:
Seal
39
Annexure TO Turnover Criteria as per clause 17 of the tender
Description of Turnover
F.Y. 2014-15 F.Y. 2015-16 F.Y. 2016-17
Total Turnover
Less Sale from ESI/ Govt Departments
Less
Sale from 3rd Party Sale
Net Eligible (Balance Turnover ) from Open Market in (Rs.)
Net Eligible (Balance Turnover) from Open Market in percentage (%)
Signature :
Name :
Designation :
Seal
40
**CHECK LIST OF THE DOCUMENTS ONLINE:
1. Earnest Money Deposit in the form of Demand Draft. MSE firms are exempted from
submitting EMD subject to submission of valid MSE Certificate from appropriate authority
(as per S. No. 26 of Check List).
2. Forwarding letter of the bidder/ firm.
3. List of items quoted as per Annexure ‘A’ (without rates) to be filled.
4. Three years’ Manufacturing & Marketing Experience certificate duly signed by the State
Drug Controller for items covered under Drugs in prescribed format i.e. Annexure-B-1
(should not have been issued more than six months from the opening of tender) AND for
items not covered under Drugs in prescribed format i.e. Annexure-B-2
5. Certificate of acceptance of Terms and Conditions in Annexure ‘C’.
6. Production certificate for the last three preceding years in respect of Items quoted as per
Annexure ‘D’. For Imported items- i) Form 10 , ii) form 41.
7. Information as per prescribed proforma (Annexure ‘E’).
8. Undertaking as per Annexure-‘G’.
9. Undertaking as per Annexure-‘H’.
10. Audited financial statement (Balance Sheet and Profit & Loss Account Statement) in respect
of annual turnover. (Only relevant documents are to be uploaded).
Fifty Percent or more of the annual turnover shall be from the trading of the items in open
market i.e exclusive of supply to ESI/ Government Departments/Third Party. A certificate
from the Chartered Accountant with reference to sale in the open market should be
uploaded.
11.
a. Attested photocopy of DGQA Registration Certificate.(If applicable)
b. Attested photocopy of valid WHO-GMP Certificate.(If applicable)
12. Attested photocopy of Drug/Item Manufacturing License with the list of products approved as
applicable.
13. Certificate of approval of Drug Controller General of India for new item(s) (if applicable).
14. Certificate of sole manufacturer/ Proprietary of product from State Drugs Controller(if
applicable).
15. Valid import license – Form 10 & Form 41 (if applicable )
16. An affidavit duly notarized on stamp paper worth of Rs. 100/- in clear and unambiguous
language regarding Terms and condition 14A (i) of Tender Enquiry.
17. An affidavit duly notarized on stamp paper worth of Rs. 100/- in clear and unambiguous
language regarding Terms and condition 14A (ii) of Tender Enquiry.
18. Non-Conviction Certificate for last three continuous years. Non-Conviction Certificate must
have been issued on or after 30.09.2017 from the Drug Controller of the concerned State.
19. Copy of the recent GST Certificate along with affidavit The bidder will submit an
undertaking of GST ACT compliance on a non-judicial stamp paper of Rs. 50/-. ESIC
will not hold any responsibility including impact on price due to non-compliance of GST
Act.
41
20. Attested photocopy of valid ISI/European CE/US FDA license /Certificate (in case of items
where “ISI/European CE/US FDA Mark” is asked for ).
21.
i. Affidavit as per clause 14(L) of Terms & Conditions.
ii. Affidavit on Stamp Paper as per clause 14(S) of Terms & Conditions.
iii. Affidavit – as per annexure T.
22. Scanned copy of self attested Original Label of all the products quoted.
23. Scanned copy of self attested Literature/Brochures/Catalogue of all quoted items
24. Company/Authorized Signatory to submit Employer Code No. & copy of last three
contributions towards ESI in case factory is covered under ESI Act.
OR
Company/Authorized Signatory to submit an Affidavit giving address of Manufacturing unit
with a declaration that this factory / manufacturing unit is outside the implemented area /
notified area by ESI Corporation.
OR
Company / Authorized Signatory to submit a certificate from the Regional Director that the
factory is not coverable under ESI Act, in case the factory is within the covered / notified
area.
25. Certificate of Registration of the company as Micro and Small enterprises under the Ministry
of Micro Small and Medium enterprises from appropriate authority. (if applicable )
26. Letter of authorization to sign and submit the tender along with specimen signature of the
authorized signatory.
27. Annexure “L” are to be uploaded.
28. Annexure ‘P’ & Detail of licenses are to be filled. Annexure EMD & TO are to be uploaded.
29. Undertaking as per clause 14(E) of Terms & Conditions.
30. Copy of any other document as required.
Note:
*In case any of the required document as listed above is not applicable for a firm, then
firm/bidders has to submit the reasonability for the same on letter head of the firm and
upload this document in that particular point of check list.
It is the sole responsibility of the bidder to submit the Bid online & manually (Only EMD).
All documents as listed above should be clear & legible, duly attested / notarized, properly
indexed & serially page numbered. All documents should be duly signed digitally for online
submission by the authorized signatory. Copies to be uploaded and submitted online should
be in proper resolution.
The above said instructions should be followed strictly, failing which the tender will be
summarily rejected.
The bidder who submits false, forged or fabricated documents or conceals facts with intent
to win over the tender, EMD of such bidder will be forfeited and bidder/ firm will be liable
for blacklisting in addition to legal action as deemed fit.
42
Special Instruction regarding Price Bid/Quoting of Rate of an Item in the Tender
Notes(1):-one rate should be quoted for each seriol no. /column
Note(2):-Rate to be quoted for each subdivision (a,b,c,d etc or iL-1,iL-2,iL-3 etc. ) of an
item no. individually as well as the total consolidated rate(a+b+c+d+e+etc. OR iL-1+iL-2
etc=Total rate).This total rate will be considered for L-1 ,L-2,L-3 preferences.Only bidder
who is able to quote ALL the sub -divisions of an item;example a,b,c,d, or iL-1,iL-2 etc.
of an item no. will be considered for evaluation of that item.If any sub-division of that
item no. is not quoted,the Bidder will be disqualified for that particular item No.
Note(3):-Instrument sets to be provided to ESI Units free of cost in respect of Implants
Purchased for Orthopedic surgery one day prior to surgery against a challan.The Bidder
shall be responsible to supply and collect back the Instrument sets against receipt after
the completion of surgery without any cost.No claim in respect of any damage to
instrument during use or due to normal wear & tear shall be admissible.The surgical
technique of the implant used should be provided along with the instrument set (Both
Hard & soft copy).Failure to provide instruments as and when required will be considered
as non performance.
Note(4):-supply order may be placed for an individual item (as a whole including all sub-
division )as well as any of the sub-division of a particular item .
Note(5):- Manufacturer name and Batch No. should be mentioned on every Implant where
ever feasible.
Note(6):-Test Report of appropriate material used (SS316L & Medical grade Titanium
Alloy )for every batch should be submitted at the time of supply of Implant.This test
report should be from a Govt. certified agency.
Note(7):-The Suppliers have to give an undertaking that the Implant supplied has been
constructed from the material whose test report has been submitted at the time of supply.
43
Item Schedule
Item
No. Name of Items
Bone Cement
320 Bone Cement with low viscosity , 20g
321 Bone Cement with medium viscosity, 20g
322 Bone Cement with high viscosity , 20g
323 Bone Cement with low viscosity , 40g
324 Bone Cement with medium viscosity ,40g
325 Bone Cement with high viscosity, 40g
326 Bone Cement with Gentamycin, low viscosity , 20g
327 Bone Cement with Gentamycin, medium viscosity, 20g
328 Bone Cement with Gentamycin, high viscosity, 20g
329 Bone Cement with Gentamycin, low viscosity, 40g
330 Bone Cement with Gentamycin,medium viscosity, 40g
331 Bone Cement with Gentamycin,high viscosity, 40g
332 Bone Cement with Gentamycin + Clindamycin, 40g
333 Bone Cement with Gentamycin + Vancomycin,40g
334 Bone Cement with Tobramycin, 40g
335 Bone Cement with colistin + Erythromycin, 20g
336 Bone Cement with colistin + Erythromycin, 40g
337 Bone Cement mixing bowl with spatula,SS
338 Disposable Cement Gun
339 Re-usable Cement Gun set, (Autoclavable)
339a Re-usable Cement Gun
339b Accessories for cement gun
340 Re-usable vacuum mixing Cement Gun set, (Autoclavable)
340a Re-usable cement gun
340b Accessories for vacuum mixing cement gun
340c Vacuum Pump
Gentamycin Beads
(the beads should be attached in a surgical wire to form a chain)
341 Gentamycin Cement Beads 3to5mm Dia. (10 beads)
342 Gentamycin Cement Beads 3to5mm Dia.(30 beads)
343 Gentamycin Cement Beads 7to9mm Dia. (10 beads)
344 Gentamycin Cement Beads 7to9mm Dia. (30 beads)
Hip Joints
Hemiarthroplasty
345 A M Prosthesis 37mm to 57 mm with 2 mm increment
Bipolar prosthesis (Pre-sterile)
346 Fixed Bipolar head with fenestrated femoral stem Small/Medium/Large,SS
347 Bipolar hip prothesis (Talwarkar Type) 37mm to 57mm with 2mm increment
Cemented Modular Bipolar (US FDA approved)
348 Cemented Bipolar Hip Prosthesis set
44
348a Bipolar Hip Prosthesis (Modular Type)Cobalt chrome Cup & Head various Sizes with various
neck length
348b Bipolar Hip Prosthesis (Modular Type) femoral Stem various Sizes,cemented
348c Cement Restrictor
348d Stem Centralizer
Non Cemented Bipolar (US FDA approved)
349 Non cemented Bipolar Hip Prosthesis set
349a Non cemented Bipolar Hip Prosthesis (Modular Type)Cup & Head various Sizes with various
neck length
349b Non cemented Bipolar Hip Prosthesis (Modular Type) HA coated femoral Stem
various Sizes
350 Non cemented Bipolar Hip Prosthesis Set
350a Non cemented Bipolar Hip Prosthesis (Modular Type)Cup & Head various Sizes
with various size neck length
350b Non cemented Bipolar Hip Prosthesis (Modular Type) Porous coated femoral Stem various Sizes
Total hip arthroplasty (US FDA approved)
Cemented basic THR (US FDA approved)
351 Basic Cemented Total Hip System
351a Total Hip Acetabular cups various sizes
351b Total hip Metal Head various sizes with various Neck Length
351c Femoral stem various sizes
351d Stem Centralizer
351e Cement Restrictor
352 Basic Cemented Total Hip System with ultra high molecular weight polyethylene (US FDA
approved)
352a Modular Stem (Stainless Steel) ,Double tappered,Highly
Polished,Collar Less,Self Centering, Variable Offsets.
352b Modular Internal Head,various sizes,Stainless Steel with various neck length.
352c Modular THR 10° Acetabular cup with highly cross linked polyethylene
352d Stem Centralizer
352e Cement Restrictor
353 Hybrid Total Hip Replacement Set (US FDA Approved)
353a Cemented Modular Stem: (Stainless Steel) Small,Medium,Large,Double tappered,Highly
Polished,Collar Less,Self Centering,Variable Offsets.
353b Modular Internal Head: various sizes, with various neck length.
353c Cementless Acetabular cup: HA Coated with option of screws
353d Acetabular highly crosslink Poly cup liner: different sizes
353e Stem centralizer
353f Cement restrictor
353g Cancellous Screws for Acetabular Cup
BASIC CEMENTLESS HIP SYSTEM(US FDA approved)
354 BASIC Cementless Hip System
354a Cementless Hip System HA Coated Titanium alloy femoral stem with various
Sizes
354b Cementless Hip System metal head 28 mm with variable neck length
354c Cementless Hip System Acetabular cup Cementless HA Coated with option of
screws
45
354d Cementless Hip System Acetabular highly crosslink Poly cup liner
different sizes
354e Bone screw to fix the cup
355 BASIC Cementless Hip System(Porous Coated)
355a Cementless Hip System Porous Coated Titanium alloy femoral stem with various
Sizes
355b Cementless Hip System metal head 28 mm with variable Neck Length
355c Cementless Hip System Acetabular cup Cementless poro Coated with option of
screws
355d Cementless Hip System Acetabular highly crosslink Poly cup liner with 10°
LPW different sizes
355e Bone screw to fix the cup
356 BASIC Cementless Hip System
356a Cementless Hip System HA Coated Titanium alloy femoral stem(Double tappered with UHMP)
various sizes
356b Cementless Hip System metal head 28mm,32mm,36mm with variable neck length
356c Cementless Hip System Acetabular cup Cementless HA Coated with option of
screws
356d Cementless Hip System Acetabular highly crosslink Poly cup liner different sizes
356e Bone screw to fix the cup
Advanced THR ( US FDA approved)
357 Advanced Cementless Hip System(Ceramic on poly)
357a Cementless Hip System HA Coated femoral stem,different sizes
357b Cementless Hip System ceramic head28mm, 32mm,36 mm with variable neck
length
357c Cementless Hip System acetabular cup - HA coated with option of screws,
Should accomodate 28mm,32mm,36 mm head with same cup
357d Cementless Hip System acetabular highly crosslink poly cup liner different sizes,should
accommodate 28mm,32mm,36mm head
357e Bone screw to fix the cup
358 Advanced Cementless Hip System(ceramic on ceramic)
358a Cementless Hip System HA Coated femoral stem,different sizes
358b Cementless Hip System ceramic head(Bilox-Delta)-28mm, 32mm,36 mm with variable neck
length
358c Cementless Hip System acetabular cup - HA coated with option of screws,
Should accomodate 28mm,32mm,36 mm head with same cup
358d Cementless Hip System acetabular ceramic liner(Bilox-Delta),should accommodate28mm,
32mm,36mm head
358e Bone screw to fix the cup
High performance THR(US FDA approved)
359 High performance Cementless Hip System
359a
PRIMARY FEMORAL STEM: Non cemented primary femoral tapered
short,rounded tipped short stem made of Titanium alloy porocoated with layer of HA allowing
preservation of femoral neck
359b
NON CEMENTED ACETABULAR CUP:NonCemented hemispherical
acetabular cup made of Titanium alloy with peripheral anti rotation fins with inbuilt ceramic liner
made of zirconia & alumina, with different diameters
359c CERAMIC FEMORAL HEAD FOR CUP:Ceramic femoral head with various sizes
359d FEMORAL ADAPTOR SLEEVE: Femoral adaptor sleeve made of Titanium alloy with clean
taper fit and compatible with the inner ceramic taper of the femoral head with different sizes
46
360 Advance Cementless Hip System ( US FDA approved)(ceramic on poly)
360a Acetabular cup of various sizes with dual mobility and additional fixation of screws in acetabular
cup
360b Head Ceramic : various sizes
360c Femoral Stem HA Coated:Various Sizes
360d Screws for Cup Fixation
361 High performance Cementless Hip System
361a
Uncemented Femoral Stem: Uncemented primary femoral tapered blade style stem made of
Titanium alloy with poro coating with high friction Titanium coating, with anterior & posterior
longitudinal flute, Should be proximal femoral bone preserving
361b Bilox-Delta ceramic head: 32mm,36mm with variable neck length
361c Uncemented hip system acetabular cup HA/PORO coated with option of screws, Should
accomodate 32mm,36mm head with same cup
361d Uncemented hip system acetabular highly crosslink poly cup liner with 10° LPW ,various sizes,
should Accommodate 32mm,36mm head
361e Bone screw to fix the cup
362 High performance Cementless Hip System - Trabacular Metal
362a Uncemented hip system HA coated femoral stem,various sizes.
362b Bilox-Delta ceramic head: 32mm,36 mm with variable neck length.
362c Uncemented trabecular metal cup different sizes accommodate large head with screw option.
362d Uncemented hip system Acetabular highly crosslink Polycup liner with 10° LPW ,various
sizes,should Accommodate 32mm,36mm head.
362e Bone screw to fix the cup.
363 High performance Cementless Hip System - Modular THR
363a
Uncemented Femoral Stem,Proximal Sleeve,Femoral Head- Femoral
Head: 36mm ceremic head of alumina & zerconia with different neck length
Stem:Non-cemented proximal loading option Titanium Alloy, Tapered with coronal slot & Distal
flutes ,Variable Neck Length diameter & offset
Sleeve:Poro-coated proximal femoral sleeve with locking mechanism with femoral stem ,various
sizes
363b Non-cemented Titanium acetabular cup with gription poro coating with locking
mechanism for liner,various sizes with screw locking option
363c Highly crosslink Poly cup liner with 10° LPW different sizes,should
Accommodate 32mm,36mm head
363d Bone screw to fix the cup
Revision Cemented THR (US FDA approved)
364 Revision Cemented Hip System
364a Cemented long Stem ,various sizes & offsets
364b Acetabular cup with Multihole
364c Large diameter Head 32mm,36mm
364d Stem centralizer
364e Cement restrictor
364f Highly cross linked polyethylene
Revision uncemented THR( US FDA approved)
365 Revision Cementless Hip System(Distally interlocked stem)
365a
Revision Uncemented Acetabular Cup : Multi hole Titanium alloy actebular shells with a full
180° hemisphere poro coated with option of multiple screw holes for fixation with options to fit
all liners (Metal,ceramic & poly) of various sizes
365b Revision Acetabular Screw:5.5mm Titanium Alloy Acetabular revision screws for
peripheral area of cup in various sizes
47
365c Titanium Cancellous screw 6.5 mm Self Tapping for use in central area of the cup
365d Uncemented Hip System Acetabular highly crosslink Poly Cup Liner with 10° LPW ,various
sizes,should Accommodate 32,36 head.
365e Ceramic femoral head for cup:- Ceramic femoral head made of alumina & zirconia with various
sizes.
365f
Distally Interlocked Femoral Reconstruction Revision Hip System- HA Coated Distal locking
option with various diameter & length with the provision of reconstruction of trochanter &
cerclage cable hole.
365g Distal Interlocked Screw--Titanium Distal locking Self Tapping various sizes.
366 Cementless Acetabular Reconstruction system
366a
Acetabular Reconstruction system-Acetabular reconstruction Titanium ring with HA coated
acetabular shell with option of multiple central & peripheral screws with corresponding screws(8
screws)
366b Posteriorly lipped highly crosslinked poly liner-various sizes
366c Bilox-Delta ceramic femoral head for cup, various sizes
366d Femoral Revision System-Distally fixed revision femoral stem, porous coated with calcar
replacement options,different diameter
367 Revision Cementless Hip System (US FDA Approved)
367a Cementless fluted Distal Femoral fixation stem,All sizes and diameters (Titanium)
367b HA Coated Cone Body ,Proximal part, All sizes and with independent version between cone body
and stem
367c Metal Head with 32mm,36mm with various Neck Length
367d Ceramic Head with 32mm,36mm with various Neck Length
367e Highly crosslink Polycup liner multihole, different sizes to accommodate 28-36mm
head
367f Acetabular cup with HA Coated with option of screws to accommodate 32-36mm head with same
cup
367g Acetabular Screws
368 Acetabular Mesh,SS (US FDA approved)
369 Acetabular Mesh,Titanium(US FDA approved)
370 Femoral mesh,Titanium(US FDA approved)
371 Acetabular Cage, various sizes,Titanium(US FDA approved)
AcetabularAugments (US FDA approved)
372 Trabecular Acetabular Augments,Various Sizes
373 Trabecular Acetabular Restrictor,Various Sizes
374 Trabecular Acetabular Screws,Various Sizes
Knee Arthroplasty(US FDA approved)
375 Uni-condylar mobile knee system consisting of femoral components, tibial inserts & tibial tray
of various sizes.
375a Femoral Component CoCr pegged - five sizes
375b Tibial Component CoCr ,Anatomically shaped -Six Sizes
375c Tibial Insert-Five Sizes,3-8mm
Total Knee System
376 Basic TKR (US FDA approved) Titanium tibial tray
376a Femoral Component ,Co-Cr,various sizes
376b Tibial Component, Titanium,various sizes
376c Tibial insert, various sizes
376d Patellar Button, various sizes
48
377 Basic TKR Pcl sacrificing(US FDA approved)Co-Cr Tibial tray
377a Femoral Component ,Co-Cr,various sizes
377b Tibial Component, Co-Cr, various sizes
377c Tibial insert, various sizes
377d Patellar Button, various sizes
378 TKR Fixed Bearing both PS and Cr with intraoperative change from one design to another
378a Femoral Component Co-Cr All sizes
378b Tibial component Titanium All sizes
378c Tibial Insert All sizes - HCP
378d Patellar Button All sizes
High Flex Knee System PS-CR (US FDA approved)
379 Cruciate retaining high flexion knee system
379a Femoral Component Co-Cr All sizes
379b Tibial Tray CoCr All sizes
379c Highly cross linked poly insert All sizes
379d Patellar Button All sizes
Advanced Knee System (US FDA approved)
380 Advanced Knee System
380a Posterior stabilized fixed bearing femoral components with ability to attach extender stems
380b Highly crosslinked poly insert with locking mechanism ,with option of both cruciate Substituting
and retaining various sizes
380c Co-Cr tibial tray with ability to attach extention stem ,various sizes and augments
380d Patella along with three pegs
381
Patient specific Total knee Prosthesis (US FDA approved):-consists of -Femoral Component
-TIBIAL component -TIBIAL INSERT
The TKR design should be Patient 's own CT or MRI based ,the mechanical based alignment to
be matched with patient's own mechanical axis,the cutting Block must provide patient's own
Should have faster turn around time(less than 6 weeks).
Revision knee system(US FDA approved)
382 Revision knee system(US FDA approved)
382a Semi constraint total knee prosthesis:- Femoral component with the ability to accept Any kind of
metal augments & offset extension stem
382b Femoral metal augment for distal & posterior femur,various sizes
382c Femoral extension stem,various offset & sizes
382d Tibial component with ability to accept varoius sizes tibial augmentation blocks , wedges &
extension stem .
382e Semi constraint tibial knee inserts -all sizes
382f Metal tibial wages-step,hemi & full of various sizes and thickness
382e Tibial extension stem-various offset & sizes
383 Semi constraint total knee prosthesis System (US FDA approved)
383a Semi constraint total knee prosthesis:- Femoral component with the ability to accept any kind of
poro-coated metaphyseal sleeves & offset extension stem
383b Metaphyseal porocoated femoral sleeves,various sizes
383c Femoral extension stem,various offset & sizes
383d Semi constraint mobile bearing tibial knee inserts,all sizes
383e Tibial component -mobile bearing tray with ability to accept varoius sizes poro- coated
metaphyseal sleeves & extension stem
383f Metaphyseal porocoated tibial sleeves,various sizes.
49
383g Tibial extension stem-various offset & sizes Cable wiring system for periprosthetic fractures
384 Highly Advance Modular TKR (US FDA approved) with option of rotating plateform/fixed
bearing with high flexion knee
384a Femoral Component CoCr for more than 10 sizes compatible with PS & PR
384b Tibial insert with 1mm increment for common sizes and 2mm increment for uncommon sizes
with anti-oxidant properties
384c Tibial Component CoCr 10 Sizes
384d Patellar Button with anti-oxidant properties all sizes
385 Cable wiring system,SS (US FDA approved)
385a Cable wire with sleeves,SS
385b Sleeve for cable wire,SS
386 Cable wiring system,Co-Cr (US FDA approved)
386a Cable wire with sleeves,Co-Cr
386b Sleeve for cable wire,Co-Cr
Shoulder Arthroplasty
Hemi -shoulder Arthroplasty
387 Neer Prosthesis - Fixed Shoulder various Sizes.
Modular hemi shoulder Arthroplasty (US FDA approved)
388 Modular hemi shoulder Set Cemented (US FDA approved)
388a Hemi-shoulder stem Cemented,Co-Cr
388b Hemi-shoulder Humeral Head All sizes
389 Modular hemi shoulder Set Uncemented (US FDA approved)
389a Hemi-shoulder stem Uncemented, Co-Cr
389b Hemi-shoulder Humeral Head All sizes
Total Shoulder replacement prosthesis (US FDA approved)
390 Total Shoulder replacement prosthesis system Cemented (US FDA approved)
390a Total shoulder humeral stem with holes in fins for muscle and soft tissue Reconstruction-
cemented
390b Humeral Head All sizes
390c Glenoid prosthesis crosslinked poly.
391 Total Shoulder replacement prosthesis system Uncemented (US FDA approved)
391a Total shoulder humeral stem with holes in fins for muscle and soft tissue Reconstruction-
uncemented
391b Humeral Head All sizes
391c Glenoid prosthesis crosslinked poly.
Reverse shoulder arthroplasty (US FDA approved)
392 Reverse shoulder prosthesis system
392a Cemented Humeral Stem with 0°-10° Retroversion,Co-Cr
392b Non Cemented Humeral Stem with 0°-10° Retroversion,Co-Cr
392c High mobility humeral polythelene cup
392d Glenoid implant with fixation screws
392e Locking/Non Locking fixation screws
Elbow Arthroplasty (US FDA approved)
393 Cemented Total Elbow Implant with accessories
393a Humeral Component,various Sizes
393b Ulna Component,various sizes
394 Uncemented Total Elbow Implant with accessories
50
394a Humeral Component-various Sizes
394b Ulna Component-various sizes
395 Radial Head Replacement Prosthesis Set , All Sizes
395a Radial Head Prosthesis
395b Stem All sizes
396 Pulse Lavage wound debridement system: (Disposable battery operated with Concurrent suction
and fan spray tip)
TUMOR PROSTHESIS (All attachments of entire range of modular tumor prosthesis
should be press fit for terminally ill patients)
397 Proximal Femur Resection Modular Hip Prosthesis set
397a Proximal Femoral STEM:with fixed length of 120 mm with dia. 10 mm ,11 mm and 12 mm
397b Proximal Body: dia. 24 mm with length sizes 50-100 mm with increment of 10 mm
397c Connecting Piece: 40-54 mm Dia.(increment of 2 mm)
397d FEMORAL HEAD:Taper of 12/14 mm with fixed length of 100 mm
397e Uncemented HA/PORO Coated Cup:- 24 mm and 28 mm dia. with neck length of -3 mm,0
mm,+4 mm and +8mm
397f Bone screw to fix the cup
398
Distal Femur resection modular knee prosthesis Set
(The tapered stick of stem is inserted in the tapered groove of spacer which is fitted with the
tibial-femoral hinge)
398a Tibial-Femoral Hinge:-should consists of femoral condyle and Tibial plateform with stem joined
with a pin,size constant,Length of femoral condyle 80 mm
398b Distal Femoral Prosthesis:10 mm,11 mm,12 mm dia., L 120 mm
398c Femoral Stem:24 mm dia.,L 50-100 mm(increment of 10mm)
398d Tibial Tray
398e Stem Extender
398f Poly Insert
398g Limiting Bolt
399 Proximal Tibial Resection Modular knee Prosthesis Set
399a Proximal Tibial Prosthesis
399b Connecting Pin
399c Tibial Stem
399d Distal Femoral Component
399e Stem Extractor
399f Poly Insert
399g Limiting Bolt
400
Indigenous Modular/Proximal Humerous Resection Shoulder Prosthesis Set
(Half head to fitted on the top of 12/14 mm tapered head ,the bottom portion of the tapered head
is inserted into spacer which is fitted in the top of tapered stick of stem to make a complete
prosthesis)
400a Stem: 7mm,8mm and 9mm dia.,L 75mm
400b Spacer:L 25mm,40mm,60mm,80mm,100mm
400c Taper Head:with a Head of 12/14mm taper, standard length of 60mm
400d Half Head:33mm,35mm,37mm,39mm,41mm and 43mm Dia.
401 Elbow Prosthesis Set
401a Stem:7mm,8mm and 9mm Dia.,L 75mm
401b Spacer:L 20-100mm(increment of 20mm)
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401c Elbow Hinge with Ulna Stem:standard Size
HIGH PERFORMANCE TUMOR PROSTHESIS (US FDA APPROVED)
402
Humeral Tumor Prosthesis( US FDA APPROVED):-Humeral Head with porous coating with
different diameter,extension piece should have male/female tapering for different anatomy with
different lengths & Humeral stem should have different length and diameter.
403
Proximal Tibia Tumor Prosthesis( US FDA APPROVED) set consisting of femoral
component,tibial component,articulating mechanism,articular surface,extension piece and
intramedullary stem .(Proximal tibial component should have male/female tapering to address
different patient profile,whole assembly must work as rotating hinge for better patient
outcome,femoral component should have option of femoral stem, distal wedge ,femoral
component should have different sizes with address different
anatomy(male/female),Intramedillary stem should have straight/bowed option for different
anatomy & should also have option of with and without body option,Tibial insert should have
different thickness option (10-24 mm))
404
Distal Femur Tumor Prosthesis( US FDA APPROVED):-Distal femoral
component should have male/female tapering with left/right option, whole assembly must work as
rotating hinge to address different patient need,should have extension piece option(30-200 mm) to
manage resection of distal femur,Intramedillary stem should have straight/ bowed option for
different anatomy,Intramedillary stem should have option of with and without body option,should
have different tibia sizes to address different anatomy,should have bumper option to avoid
anterior sublaxtion,should have option of tibial stem with different diameter and insert with
different thickness
405
Proximal femur Tumor Prosthesis( US FDA APPROVED):-Should have
proximal femoral component with and without trochanteric option with porous body for osteo
integration,different extension piece(30-200 mm) to address resection length,Intramedillary stem
should have straight/ bowed option for different anatomy, Intramedillary stem should have option
of with and without body option
406 Pre-sterile Disposable Ortho suction canula with Bone filter , Single use,
407 Pre-sterile Disposable Ortho suction canula with Bone filter -Single use for Spine surgery
Spacers for hip and knee
408 Antibiotic Spacers mould for infected hip joint(THR) ,All sizes, Disposable
409 Antibiotic Spacers mould for infected Knee joint(TKR) ,All sizes, Disposable
410 Antibiotic Spacers for hip joint(High resistance bone cement body loaded with Anti biotic),All
sizes
411 Antibiotic Spacers for knee joint ,All sizes
466 Rotating Hinge Knee Replacement Components (US FDA Approved)
466a Femoral Component: Various Sizes
466b Femoral Stem Extender
466c Distal and Posterior Femoral Augments
466d Tibial Component:Various Sizes
466e Tibial Stem Extender
466f Tibial Augments
466g Tibial Poly insert
466h Hinge Kit
466i Sleeves (Optional)
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