Supply of Ortho Trauma Surgery Implants and Services

OPTION CLAUSE: The Purchaser reserves the right to increase or decrease the quantity to be ordered up to 25 percent of bid quantity at the time of placement of contract. The purchaser also reserves the right to increase the ordered quantity up to 25% of the contracted quantity during the currency of the contract at the contracted rates. The delivery period of quantity shall commence from the last date of original delivery order and in cases where option clause is exercised during the extended delivery period the additional time shall commence from the last date of extended delivery period. The additional delivery time shall be (Increased quantity ÷ Original quantity) × Original delivery period (in days), subject to minimum of 30 days. If the original delivery period is less than 30 days, the additional time equals the original delivery period. The Purchaser may extend this calculated delivery duration up to the original delivery period while exercising the option clause. Bidders must comply with these terms.

Bidder financial standing: The bidder should not be under liquidation, court receivership or similar proceedings, should not be bankrupt. Bidder to upload undertaking to this effect with bid.

Buyer Organization specific Integrity Pact shall have to be complied by all bidders. Bidders shall have to upload scanned copy of signed integrity pact as per Buyer organizations policy along with bid. Click here to view the file

Data Sheet of the product(s) offered in the bid, are to be uploaded along with the bid documents. Buyers can match and verify the Data Sheet with the product specifications offered. In case of any unexplained mismatch of technical parameters, the bid is liable for rejection.

Experience Criteria: The Bidder or its OEM {themselves or through reseller(s)} should have regularly, manufactured and supplied same or similar Category Products to any Central / State Govt Organization / PSU for 3 years before the bid opening date. Copies of relevant contracts to be submitted along with bid in support of having supplied some quantity during each of the year. In case of bunch bids, the primary product having highest value should meet this criterion.

Manufacturer Authorization:Wherever Authorised Distributors/service providers are submitting the bid, Authorisation Form /Certificate with OEM/Original Service Provider details such as name, designation, address, e-mail Id and Phone No. required to be furnished along with the bid

Scope of supply (Bid price to include all cost components) : Only supply of Goods

• 8.Turnover Bidder Turn Over Criteria: The minimum average annual financial turnover of the bidder during the last three years, ending on 31st March of the previous financial year, should be as indicated in the bid document. Documentary evidence in the form of certified Audited Balance Sheets of relevant periods or a certificate from the Chartered Accountant / Cost Accountant indicating the turnover details for the relevant period shall be uploaded with the bid. In case the date of constitution / incorporation of the bidder is less than 3 year old, the average turnover in respect of the completed financial years after the date of constitution shall be taken into account for this criteria.
• 9.Turnover OEM Turn Over Criteria: The minimum average annual financial turnover of the OEM of the offered product during the last three years, ending on 31st March of the previous financial year, should be as indicated in the bid document. Documentary evidence in the form of certified Audited Balance Sheets of relevant periods or a certificate from the Chartered Accountant / Cost Accountant indicating the turnover details for the relevant period shall be uploaded with the bid. In case the date of constitution / incorporation of the OEM is less than 3 year old, the average turnover in respect of the completed financial years after the date of constitution shall be taken into account for this criteria. In case of bunch bids, the OEM of CATEGORY RELATED TO primary product having highest bid value should meet this criterion.
• 10.Purchase Preference (Centre) Purchase preference to Micro and Small Enterprises (MSEs): Purchase preference will be given to MSEs as defined in Public Procurement Policy for Micro and Small Enterprises (MSEs) Order, 2012 dated 23.03.2012 issued by Ministry of Micro, Small and Medium Enterprises and its subsequent Orders/Notifications issued by concerned Ministry. If the bidder wants to avail the Purchase preference, the bidder must be the manufacturer of the offered product in case of bid for supply of goods. Traders are excluded from the purview of Public Procurement Policy for Micro and Small Enterprises. In respect of bid for Services, the bidder must be the Service provider of the offered Service. Relevant documentary evidence in this regard shall be uploaded along with the bid in respect of the offered product or service. If L-1 is not an MSE and MSE Seller (s) has/have quoted price within L-1+ 15% of margin of purchase preference /price band defined in relevant policy, such Seller shall be given opportunity to match L-1 price and contract will be awarded for percentage of 25% of total value.

Escalation Matrix For Service Support : Bidder/OEM must provide Escalation Matrix of Telephone Numbers for Service Support.

Availability of Service Centres: Bidder/OEM must have a Functional Service Centre in the State of each Consignee's Location in case of carry-in warranty. (Not applicable in case of goods having on-site warranty). If service center is not already there at the time of bidding, successful bidder / OEM shall have to establish one within 30 days of award of contract. Payment shall be released only after submission of documentary evidence of having Functional Service Centre.

Dedicated /toll Free Telephone No. for Service Support : BIDDER/OEM must have Dedicated/toll Free Telephone No. for Service Support.

The bidder is required to upload, along with the bid, all relevant certificates such as BIS licence, type test certificate, approval certificates and other certificates as prescribed in the Product Specification given in the bid document.

Bidders can also submit the EMD with Account Payee Demand Draft in favour of ESI Fund Account No. 01 payable at Indore . Bidder has to upload scanned copy / proof of the DD along with bid and has to ensure delivery of hardcopy to the Buyer within 5 days of Bid End date / Bid Opening date.

Bidders can also submit the EMD with Banker’s Cheque in favour of ESI Fund Account No. 01 payable at Indore . Bidder has to upload scanned copy / proof of the BC along with bid and has to ensure delivery of hardcopy to the Buyer within 5 days of Bid End date / Bid Opening date.

Successful Bidder can submit the Performance Security in the form of Account Payee Demand Draft also (besides PBG which is allowed as per GeM GTC). DD should be made in favour of ESI Fund Account No. 01 payable at Indore . After award of contract, Successful Bidder can upload scanned copy of the DD in place of PBG and has to ensure delivery of hard copy to the original DD to the Buyer within 15 days of award of contract.

Buyer Added text based ATC clauses TERMS & CONDITIONS FOR Supply of Orthopaedic Implants with Instrument Sets & Surgery Su pport Services ESIC Medical College & Hospital, Nanda Nagar, Indore (M.P.)

• 1.Scope of work and services: - Subject: Proposal for Procurement of Trauma Surgery Support Services through Ge M for a Period of 01 Year (Extendable up to 25% as per GeM Rules) It is proposed to float a Custom Bid on GeM for providing Trauma Surgery Suppor t Services for the Orthopaedic Department of the Hospital. The details of the propos ed arrangement are as follows:
• 1.Duration of Contract · The service contract will remain valid for 01 year. · The contract may be extended up to 25% of the original contract period/value, as permitted under GeM rules.
• 2.Scope of Services The selected bidder will be required to provide the following services on a case-to-c ase basis, as and when trauma surgeries are scheduled:
• a)Supply of Orthopaedic Implants · The bidder must supply all required orthopaedic implants (SS/ Titanium, pl ates, nails, screws, external fixators, prosthetic components, etc.). · All implants must be sterile and certified (BIS/CE/US-FDA/ISO/CDSCO).
• b)Supply of Supporting Instruments · The bidder must bring all supporting instruments, instrument sets, pow er tools, and accessories required for the specific trauma surgery. · Instruments must be in sterile/ready-to-use condition.
• c)On-site Surgical Assistance · The supplier must provide technical support personnel for the duration of t he surgery. · The personnel must ensure correct implant-instrument matching and support the surgical team as required.
• 3.Demand and Supply Mechanism · The hospital will not place a bulk order for all implants at the start of the c ontract. · Instead, implants and instruments will be requisitioned procedure-wise. · Prior to each surgery, the Orthopaedic Department will inform the supplier about: o Type of fracture/condition o Planned procedure o Required implant set(s) and instruments The supplier must ensure timely availability of all required items before the start of surgery.
• 4.Post-Surgery Accounting & Billing · After completion of the surgery, the supplier must: o Submit a detailed list of implants actually used (with batch/lot numb ers). o Retrieve all unused implants and instruments. o Submit a usage report countersigned by the Orthopaedic HOD/Operatin g Surgeon. · Bills will be processed only after the certification from the Orthopaedic HOD confirming: o The implants used o Adequacy of services provided o Successful completion of procedure
• 5.The number of trauma surgery cases indicated in the attached document is purel y an estimate and has been provided only for the purpose of price fixation an d bid evaluation. The actual number of surgeries will depend on:
• 1.Patient inflow
• 2.Type and severity of fractures
• 3.Clinical requirements as assessed by the Orthopaedic Department The hospital does not guarantee that the estimated number of cases will be fully c onsumed during the contract period. The actual case load may increase or decreas e based on real-time patient requirements. Accordingly: · The estimated quantity shall not be treated as a confirmed order. · The hospital shall not be liable to assure or commit any minimum number of cases to the service provider. · Payment shall be made only for the actual number of surgeries perform ed and the implants actually used, as certified by the Orthopaedic HOD afte r each surgery. · No claim shall be entertained by the supplier for variation in the number of surgeries from the estimated figures. This condition is in accordance with GeM rules for service bids where demand is dyna mic and procedure-based.
• 2.GENERAL CONDITIONS
• 1.All items supplied must match the specifications mentioned in the bid and should comply with relev ant Indian/International standards.
• 2.All implants must be sterile and must carry valid certifications such as BIS / CE / US-FDA / ISO / CDSCO.
• 3.All components in a set (implants + instruments) must be from the same manufacturer/OEM to e nsure full compatibility.
• 4.The final implant size will be decided by the surgeon during the surgery.
• 5.Product Data Sheet for all offered items must be uploaded on GeM. 6. “Make in India” (MII) preference will be given only if the bidder uploads a valid OEM Local Content C ertificate.
• 7.MSME preference is applicable only if the bidder is the actual manufacturer.
• 8.A valid GST Registration Certificate must be submitted.
• 9.All pages of the bid document and annexures must be signed by the authorized signatory.
• 2.TECHNICAL & QUALITY REQUIREMENTS
• 1.ESIC may conduct random testing of implants (including metallurgy or quality checks). The bidder must cooperate and allow inspection of manufacturing/import premises if required.
• 2.All implants, plates, screws, nails, and instruments must be fully compatible with each other.
• 3.Only certified implants (BIS/CE/US-FDA) will be accepted.
• 4.Bidder/OEM must submit an Escalation Matrix with names, designations, and contact numbers of responsible persons.
• 5.Bidder must provide a 24×7 toll-free or dedicated support line for assistance.
• 6.Bidder must have a functional office in Indore district for at least one year. If not, an undertaking must be submitted to open the office within 1 month of award of contract.
• 7.Complete support services, along with compatible instrument sets, must be provided during surg eries.
• 3.DEMONSTRATION & TECHNICAL EVALUATION ESIC may request a physical demonstration of the implant system and instrument sets in the tec hnical evaluation stage and regarding the date and time to be informed by the email. A trained and qualified technical representative from the bidder must be present during evaluation.
• 4.DELIVERY OF SUPPLIES
• 1.Supplies must be delivered on the same day after receiving email/telephone intimation from ESIC.
• 2.No delay, refusal, or partial supply is allowed. If the supplier fails, ESIC will purchase items from the open market at the supplier’s cost.
• 3.All deliveries shall be made to ESIC Medical College & Hospital, Nanda Nagar, Indore (M.P.).
• 4.Each supply must be accompanied by a detailed challan showing item name, batch number, manuf acturing date, expiry date, and quantity.
• 5.Elective Surgeries: Complete implant + instrument set must be supplied within 24 hours of intimation. Preferably, the implant and instruments should be provided one day before the planned sur gery.
• 6.Emergency Surgeries: Delivery must be made within 4 hours of intimation.
• 7.For urgent/emergency needs, the maximum allowed delivery time is 4 hours.
• 8.All instruments must be in good working condition, properly cleaned, calibrated, and ready for use.
• 9.Delays in supplying implants or instruments will attract penalties as per GeM rules.
• 5.RISK PURCHASE If the supplier fails to provide items on time, ESIC can buy the items from other sources. Any additional cost will be recovered from the defaulting bidder.
• 6.MARKING & LABELLING REQUIREMENTS
• 1.Every implant must clearly display: Manufacturer Name/Logo Batch Number Barcode/QR Code
• 2.Packaging must clearly show: Item name Manufacturing & Expiry dates Compliance with the Drugs & Cosmetics Act, 1940
• 3.All supplied products must meet the requirements of the Drugs & Cosmetics Act, 1940 and its rules.
• 7.PAYMENT TERMS & CONDITIONS

Payment will be made per surgery/case, based on actual implants used in that month. Payment will be released only after: Successful completion of surgery Approval and certification of usage by the HOD (Orthopaedics)

• 8.LIQUIDATED DAMAGES (LD) LD will be charged @ 0.5% per week, up to a maximum of 10% of the value of undelivered items. Frequent implant breakage, repeated poor-quality supply, or non-performance may lead to blacklisting.
• 9.BLACKLISTING / CONTRACT VIOLATION If the bidder violates any terms & conditions, ESIC may take the following actions: Termination of contract Forfeiture of Performance Security Blacklisting on GeM Legal action as per rules
• 10.In the event that any bidder/participant is found to have submitted false documents or made false claims, the Earnest Money Deposit (EMD) shall be liable to be forfeited.
• 11.RIGHTS OF THE INSTITUTION: ESIC reserves the full right to accept or reject any bid, in whole or in pa rt, without assigning any reason. No claim or compensation will be entertained from bidders on this decision.
• 12.Experience Criteria: As per the experience criteria applied, the Bidder or its OEM (themselves or through reseller(s)) must have regularly manufactured and supplied the same or similar category products to any Central/State Governm ent Organisation/PSU during the financial years 2023–24, 2024–25 and 2025-26 before the bid opening date. Copies of relevant contracts must be submitted along with the bid as proof of having supplied some quantity during each of the financial years. In the case of bunch bids, the primary product category having the highest value must meet this criterion.
• 13.Authorization Letter: An authorization letter issued by the Original Manufacturer, valid at the time of bid submission, must be su bmitted.
• 14.Verification of OEM Authorization: OEM authorization may be verified at any stage during the bid evaluation. If any misconduct, falsification, or forged certificate is found in the submitted documents, the bid will be liable for rejection, and appropriat e legal action shall be initiated.
• 15.Variation at the Time of Contract Placement: At the time of contract placement, the Buyer may increase or decrease the quantity by up to 25% of the i nitially tendered quantity.
• 16.Performance Statement (on Bidder Letterhead): A Performance Statement of supplies made during at least one of the last three financial years (2023–24, 2024–25 and 2025-26) before the bid opening date must be submitted. Tender Document No. Tend No./ xxxx; Tender Title: GOODS Bidder's Name [Address and Contact Details] Bidder's Reference No. Date.......... The Bidder or its OEM {themselves or through re-seller(s)} should have supplied same or similar Category (Trauma Surgery Ortho Implants) Products for 30% of bid quantity, in at least one of the last three Fi nancial years before the bid opening date to any Central / State Govt Organization / PSU. Copies of relevan t contracts (proving supply of cumulative order quantity in any one of financial year) to be submitted along with bid in support of quantity supplied in the relevant (2023–24, 2024–25 and 2025-26) Financial year. In case of bunch bids, the category related to primary product having highest bid value should meet this cr iterion. Provide the details in following format.
• S.No. Order issued by Contract Ord er No. & Date Quantity orde red Quantity supp lied Completed/ n ot Completed (Signature with date) (Name and designation) (Duly authorized to sign bid for and on behalf of Name & address of Bidder and seal of company]
• 17.Tender Checklist: For technical evaluation, the following documents (as per the checklist) must be submitted at the time of b id submission.
• S.No. Checklist Item Yes/No 01 Experience Criteria: As per the experience filter applied, the Bidder or its OEM (themselves or through reseller(s)) must have regularly manufactured and suppl ied the same or similar category products to any Central/State Government Org anization/PSU during the financial years 2023–24, 2024–25 and 2025-26 befo re the bid opening date. Copies of relevant contracts must be submitted along with the bid as proof of having supplied some quantity in each of the financial ye ars. In the case of bunch bids, the primary product category with the highest val ue must meet this criterion. 02 Past Performance: The Bidder or its OEM (themselves or through reseller(s)) must have supplied the same or similar category products equivalent to 30% of the bid quantity in at least one of the last three financial years (2023–24, 202 4–25 and 2025-26) to any Central/State Government Organization/PSU before the bid opening date. Copies of relevant contracts showing cumulative supply q uantity in any one financial year must be submitted. In the case of bunch bids, t he primary product category with the highest bid value must meet this criterion. 03 OEM Turnover Certificate: As per the tender document, turnover details for t he last three financial years (2023–24, 2024–25 and 2025-26) must be submi tted. Documentary evidence in the form of audited balance sheets or a certificat e from a Chartered Accountant/Cost Accountant must be uploaded. 04 Bidder Turnover Certificate: As per the tender document, turnover details for the last three financial years (2023–24, 2024–25 and 2025-26) must be subm itted. Documentary evidence in the form of audited balance sheets or a certifica te from a Chartered Accountant/Cost Accountant must be uploaded. 05 OEM Authorization: In cases where authorized distributors submit the bid, a M anufacturer’s Authorization Form (MAF)/Certificate containing OEM details such as name, designation, address, email ID, and phone number must be uploaded along with the bid. 06 MII Preference: If the bidder intends to avail Purchase Preference under the M ake in India (MII) policy, the bidder must upload a valid OEM Local Content Certificate and must be the manufacturer of the offered product. 07 MSME Preference: If the bidder intends to avail MSME Purchase Preference, th e bidder must be the manufacturer of the offered goods. 08 EMD & PBG: Earnest Money Deposit must be submitted as per the tender docu ment. 09 Escalation Matrix: The bidder must provide an escalation matrix containing th e names, designations, and contact numbers of responsible persons. 10 Undertaking for Compliance with Medical Devices Rules (MDR), 2017 11 Local Office Address: The bidder must have a functional office in Indore distri ct for at least one year. If not, an undertaking must be submitted stating that an office will be established within one month of award of the contract. 12 Undertaking: An undertaking must be submitted stating that the bidder accep ts all the terms and conditions of the bid (On stamp of Rs 100/- which should be notarized). 13 Product Data Sheets: Product data sheets for all offered items must be uploa ded. 14 Bidder Financial Standing Certificate: Valid financial standing certificates m ust be submitted as per the bid requirements. 15 GST Registration Certificate: A valid GST Registration Certificate must be up loaded. 16 Signed Bid Document: All pages of the bid document and annexures must be duly signed by the authorized signatory. 17 Bidder Must Comply the following point while participate ion in the bid. - If the bi dder/contractor/supplier/seller or any employee of the bidder/contractor/supplie r/seller or any person acting on behalf of the bidder/contractor/supplier/seller, ei ther directly or indirectly, is a relative of any of the officers/officials (regular/con tractual) of Employees' State Insurance Corporation n (ESIC), or alternatively, if any relative of an officer/official of ESIC has financial interest/stake in the bidder 's/contractor's/supplier's/seller's firm, the same shall be disclosed by the bidder/ contractor/supplier/seller at the time of filing of the tender/participation in the pr ocurement process . Failure to disclose this information shall result in cancellati on of the bidder’s participation. .

Buyer uploaded ATC document Click here to view the file.