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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

dmc-rc@esic.nic.in 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.

Email

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

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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)