Notifications

Dear User,

Dear Buyers,
Sellers Suspended due to non-compliance with GFR Rule 144(xi):
Sellers and Brands listed in the "Sellers Suspended due to non-compliance with GFR Rule 144(xi) " either been determined as non-compliant or have failed to prove their compliance for clause 26 of GTC. till 31.01.2024.
These sellers, the brands owned by them and all the catalogs uploaded by them have been removed from GeM marketplace. These are not eligible for any bid participation on GeM (even through Custom bid and or BOQ bid modes).
Buyers are advised to ensure that they reject such offers received in any bid process form such sellers or other sellers offering products of these brands because of suspension due to noncompliance of GTC clause 26.
GeM reserves the right to cancel such contracts even if placed by the buyer. Buyers are advised to check updated list on regular basis on GeM.
I have gone through the list of Sellers Suspended due to non-compliance with GFR Rule 144(xi). I confirm that I have rejected all such bids which are form such sellers or other sellers offering products of these brands. I understand that this is not an exhaustive listing and I have also done due diligence in respect of remaining sellers for the compliance of GTC clause 26.
Note:
No EMD to be taken from exempt category of sellers even by way of specific clauses mentioned in ATC / STC. Such clauses which are against the GeM GTC, will be treated as null and void.
However, State Government / State Autonomous / State Local Bodies / State PSU / Cooperatives may choose to seek EMD from MSE bidders by specifying the same in ATC / STC of the Bid. In case no such clause is included in ATC / STC, EMD exemption as per para (m) above shall prevail.
Dear Sir/Ma'am,
A technical issue reported in product bids published/drafted since 14th July 2023 9:00 a.m. . The brand name and related information was mentioned in title of the item for the bid created instead of category name of item. Therefore, buyers are advised to cancel such bids and publish fresh bid by 18th July 2023. These bids shall never be treated as PAC bid and they will be brand neutral unless otherwise created as PAC Bid.
Revised IM Policy effective from 1st July'23 - Click here.
Dear Buyer,
Issue of notification regarding OEM / Compatible Cartridge / Consumable (View More)
Some cases have been reported where bidders have claimed non receipt of prior intimation of RA start. In order to ensure that no prospective eligible bidder is left out due to non intimation on time, it has been decide that RA will henceforth start 24 hours after the buyer proceeds for the RA creation and initiated RA. RA Start date and End Date will be notified to both buyer and sellers.
GeM system maintenance activity is planned from 17/06/2023 9:00 PM until 18/06/2023 02:00 PM. While we will work towards avoiding any outages, the system may be unstable intermittently. As a preventive measure, you are requested to either prepone or postpone Bid related activities such as Bid creation, Evaluation, Seek Clarification, Reply Representation and Negotiations etc, to other dates as per your convenience. Also, you may like to avoid keeping Bid end date and Bid Opening dates on or near these dates if feasible.
Please find enclosed OM dated 28.04.2023 on revised format for Registration of bidders from countries sharing land border with India under Rule 144 (xi) for your kind information and necessary action.
Notification regarding Cyber Security Control matrix
Please note that insecure products, solutions, and services lead to exposure to threats and cyber security breaches which affects procuring entities. Assuring cyber security as a feature of products and services require ensuring cyber security compliances as a part of procurement This will also help in building a cyber-security culture. Building awareness in government agencies to adopt cyber security controls as part of the procurement of ICT products and services, as well as engaging industry to put cyber security control requirements into practise, is crucial for meeting the objective of ensuring cyber security.

It is noted that many times due to lack of awareness various clauses, provisions, and guidelines regarding cyber security requirements mandated by MeitY are not being incorporated while making procurements by buyer organisations. In order to give inputs to the procuring authorities regarding these aspects, Indian Computer Emergency Response Team (CERT-In) drafted a discussion paper regarding cyber security control matrix for the procurement of services and solutions by government organisations. The control matrix includes governance and policy, confidentiality, availability, regulatory complexity, audits and situational awareness, data security, application security, and network security. Discussion paper indicates the specification and requirements of different controls as well as indicative methods for verification for each control matrix. A copy of the discussion paper is enclosed herewith.

All the organisations making procurement through GeM are hereby requested to take note of the discussion paper drafted by CERT-In on "Cyber Security Controls Matrix for Procurement of Services and Solutions by Government Organisations ". which is enclosed as Annexure.

It may be noted that procuring entities may select and include appropriate and applicable controls from the control matrix indicated in the discussion paper as a part of their procurement of ICT services and solutions. Procuring entities may also consider adding additional specific controls as per their risk profile and scope of services.

It may also be noted that the adoption of cyber security controls by procuring entities in the procurement process may be kept voluntary (as best practises). However, after a year, based on the outcomes, learning control may be mandated as a part of all ICT-related procurement by government entities.

All buyer organization as well as seller/service providers are requested to note the above.
Push Button Procurement (PBP) functionality enhanced - No need for buyer to certify reasonableness of rates:
GeM has enhanced the Push button Procurement functionality enabled as per DoE OM number F.6/7/2022-PPD dated 11th January 2023. The new guidelines for PBP are as follow:
1. (a) The total procurement value of the specific case may be up to Rs. Five lakhs inclusive of all taxes (No splitting of requirement to be done to bring procurement under this method).
2. (b) This method will be enabled by GeM only for select categories where at least ten sources are listed, and marketplace is sanitized.
3. (c) Once PBP bid is invited on GEM, contract will be placed directly by Gem System without any human intervention i.e., no evaluation or rejection of bids by buyer and without any need for buyer to certify reasonableness of price. Provided conditions as per DoE OM are satisfied, which would be checked by Gem system, - Not by buyer.
4. (d) GeM system would itself check that at least five bids are received (with minimum two Different brands).
5. (e) Individual bidders may quote more than reference price of PBP. GeM system would ensure that order is placed only if lowest price received after PBP is below the GeM marketplace price for identical requirements.
Please refer push button procurement Manual for detailed guidelines. The details of Categories enabled for PBP are available here.
Buyers are advised to comply the latest OM No.F.7/10/2021-PPD (1) dated 23.02.2023 issued by DoE for the restrictions under Rule 144(xi) of the General Financial Rules (GFRs), 2017 while procuring on GeM.
With reference to the clause 4, Section xiii, Sub-section 'm' of GeM GTC, it is to bring to your kind attention that the following categories of Sellers are exempted from furnishing Bid Security:
1. 1. Micro and Small Enterprises who are manufacturer of the Primary Product Category or Service Provider of the Primary Service Category and give specific confirmation to this effect at the time of bid submission and whose credentials are validated online through Udyam Registration / Udyog Aadhaar (as validated by Government from time to time) and through uploaded supporting documents.
2. 2. Start-ups as recognized by Department of Industrial Policy and Promotion (DIPP).
3. 3. KVIC, ACASH, WDO, Coir Board, TRIFED and Kendriya Bhandar.
4. 4. Sellers who have got their credentials verified through the process of Vendor Assessment by Vendor Assessment Agencies for the Primary Product / Primary Service for which Bid / RA has been invited.
5. 5. Sellers/ Service Provider having annual turnover of INR 500 Crore or more, at least in one of the past three completed financial year(s)
6. 6. Micro and Small Enterprises registered with NSIC for the Primary Product Category whose credentials are validated through NSIC database and through uploaded supporting documents.
7. 7. Micro and Small Enterprises registered with DIC for the Primary Product Category whose credentials are validated through DIC database and through uploaded supporting documents.
8. 8. Sellers / Service Providers holding BIS License for the Primary Product Category whose credentials are validated through BIS database and through uploaded supporting documents.
9. 9. Central / State PSUs.
10. 10. Seller / Service Provider registered with designated Agency / Authority as specified in the bid document by the Buyer – such bidder shall have to upload scanned copy of relevant registration document in place of Bid Security document while ] bidding.
Note: No EMD to be taken from exempt category of sellers even by way of specific clauses mentioned in ATC / STC by the Buyers. Such clauses which are against the GeM GTC, will be treated as null and void.
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Financing period of maximum 180 days.
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With reference to the OM No.F.6/1/2023-PPD dated 06.01.2023, from Dept. of Expenditure, the minimum service charges for the commission based Manpower Outsourcing services has been revised to 3.85%. Procuring entities can also fix the service charges above 3.85% with proper justification on file, wherever required. However, such service charges should not exceed 7% in any case. It is also recommended to use the Least Cost Selection (LCS) especially in High Value Bids, the template for which can be assessed on this link.
DPIIT has issued OM P-45014/33/2021-BE-II (E-64737) dated December 20th, 2022 related to common examples of "Restrictive and discriminatory conditions against the local suppliers" and "Other conditions which make the bid non compliant to PPP-Mll Order''. Buyers are advised to comply with the same and ensure that their tenders are compliant with PPP-MII Order and don't include restrictive and discriminatory conditions against the local suppliers.
Single packet bid has been enabled on GeM and buyers can procure using it. In single packet bidding both technical and financial offerings are being opened simultaneously and buyers evaluate both financial and technical offers simultaneously and publish the evaluation results. Please refer to the user manual for details.
Additional disclaimer and recommendation for buyers for procurement of Drugs/Medicine through Custom/BOQ bids:
All Provisions of Drugs and Cosmetics Act, 1940 and Rules made there under as amended till date will always be applicable. This will include all notifications issued by Central Drugs Standard Control Organisation (CDSCO), Ministry of Health & Family Welfare (MoHFW) and Department of Pharmaceuticals (DOP), Ministry of Chemicals & Fertilizers from time to time in this regard.

The sellers are registered on GeM based on self-declaration of valid Drug License, product certification, test reports etc. However, buyers mandatorily check and validate the details at their end for all applicable licenses and certifications e.g., validity and authenticity/genuineness of drug license, product certification, manufacturer certification/licenses, test reports etc.

In case of custom/BOQ bid, it is recommended to take Notarized Undertaking from private drug manufacturers for necessary compliances. (attached format of "Notarized Undertaking")

Only manufacturers for particular drugs/medicine may be eligible to participate in the bid or quote for the drugs/medicine.
The service category “Healthcare Human Resource Outsourcing Service” has been merged with the other existing manpower outsourcing services which are Manpower Outsourcing Services - Minimum Wage and Manpower Outsourcing Services - Fixed Remuneration . Hence, it has been disabled from the market for all new bids. Buyers can hire the healthcare resources from these 2 manpower outsourcing service categories. There will be no impact on already published bids.
GeM has launched the Push button procurement functionality on experimental basis enabling buyer to buy upto 5 lakhs simplifying the procurement process and require minimal intervention from buyer. This is system driven procurement enabled for the limited 50 categories . This has been enabled vide DoE OM number F.6/7/2022-PPD dated 11th January 2023. The buyer may refer the push button procurement manual for further details. The details of categories enabled for PBP is available here. The key guidelines for PBP are as follow
1. (a) PBP will be made only on GeM through bidding (PBP through Direct Purchase, L-1, Custom-bid etc. are not permitted).
2. (b) The total procurement value of the specific case is not to exceed Rupees Five lakhs, inclusive of all taxes.
3. (c) This will be additional method of procurement and procuring entities are free to use or not to use this additional method of procurement.
4. (d) This method can be used only in case of at least five bids are received. In case of less than five bids are received, the procurement is to restart using usual procurement methods.
5. (e) No splitting of requirement is to be done so as to bring procurement under this method.
6. (f) Once bid is invited on GeM, contract will be placed directly by GeM without any human intervention. (Provided condition 3 (d) above is complied.)
7. (g) This method will be permitted by GeM only for such categories, where at least ten sources are listed.
Load Based Bidding
Bids are currently being evaluated on GeM based on the price quoted by the bidder at the time of bid participation. However, there are some use cases when the buyer publishes a bid and expects certain technical and commercial parameters to be used to evaluate the price, resulting in the evaluated price being different from the bidder's offered price.

To capture detailed technical and commercial parameters, GeM has added another feature whereby a buyer can declare the Technical and Commercial Loading Criteria for Bid Evaluation during Bid Creation itself, which will be printed for the bidders' reference in the Bid document.

The selection of the Techno Commercial for Bid Evaluation will be optional for the buyer and the same can be saved as "No," if buyer doesn’t wish to go with the same.

This will be used by the buyer for the limited categories available in the GeM marketplace.

Categories where Load based will be applicable - BIOMASS and types of pumps like HSD, Screw , Fuel, Petrol pump.
Bunching of predefined categories has been enabled now for bidding. Buyer can create bunch bid of items from same category. Buyer can also create bunch bid of items from different categories if such categories are enabled for bunching by GeM. If the item categories that you are trying to bunch are not enabled to be bunched together and you feel that these are items are having same Supplier / OEM base and are required to be bought together and bunching will not lead to restriction in competition, then you may please send an email request to GeM at request-bunch@gem.gov.in for enabling bunching of such categories. Please mention exact name of GeM categories that you are requesting for enabling bunching. Your request would be examined by GeM team and if it is found that such bunching would not lead to restrictive bidding, GeM would enable bunching of those categories. This is a one time exercise and once enabled, all buyers can bunch those categories in all their future bids. Custom and BoQ items are by default enabled to be bunched with other regular categories.
The option of acceptance/ rejection of Direct Purchase/ L1 orders will be discontinued on GeM from 29th July 22 onwards. All the orders placed on GeM shall be auto accepted unless the buyer is red flagged or the order is for a freight intensive item. Only in these cases, the sellers will get an option to Accept/ Reject the order. Even in these cases, the order shall be auto accepted in 5 days if no action is taken by the seller.
The functionality for the collection of interest amount on the delayed payments as per DoE OM No.F.6/18/2019-PPD dated 3rd July 2020 is being made live from 01st August 2022, which would be applicable on all CRAC issued/generated on or after 01st August 2022. If the payment is delayed beyond prescribed timelines, the buyer will be liable to deposit interest as per DoE OM. Interests due showing in the Buyer dashboards for older contracts are being reset to zero and all future interests would have to be paid using online functionality deployed on the GeM using the SBI payment gateway.
Please read DO from CEO GeM regarding misuse of Custom / BoQ based bids.
DP and L-1 purchase for multiple consignee is not allowed. Buyer can add multiple consignees during bid creation.
Bunching of the items has been disabled for Direct Purchase and L1 purchase. For ordering multiple items put the items in separate carts and proceed to checkout in each cart.
GeM is in process to phase out the use of OTP based on authentication process at various stages of procurement like bid floating, bid submissions, invoicing, CRAC generation, Bill process, payment etc. For seamless and hassle-free transition it is advised to get yourself registered for esign or DSC based authentication services and complete all associated formalities. The exact date of disablement of the OTP based authentication will be communicated in near future.
GeM is in a process of development of functionality to deal the statutory variations of contract like GST, VAT etc online. In meantime till such functionality is deployed buyers and sellers are advised to deal variation of taxes OFFLINE at their end with due verification and scrutiny as per enforced tax rates, contract clause and applicable guidelines of organization.
Direct RA is being disabled. Please use BID to RA in place of Direct RA.
Escalation of Tickets – Please raise a ticket while flagging any issue to GeM, it helps better tracking, monitoring, and faster resolution. Further it helps in escalating it to higher level if issue is not resolved within defined timeline. Now tickets can be escalated https://gem.gov.in/gemtickets/create to higher level.
Training for registration and bidding for buyers and sellers - GeM offers self-help trainings for buyers and sellers to register and procure services from the GeM portal without any external help. The link to access these training programs is https://gem.gov.in/training/training_module.
Input Tax Credit - Input Tax Credit and Reverse Charge Mechanism feature in BID has been implemented. Input Tax Credit is required by Buyers who are eligible for Input Tax Credit on GST and GST cess (wherever applicable) in their purchase. Since they get credit of GST therefore, they require financial evaluation of BID considering input tax credit (ITC) so that L1 evaluation is on Net landed Cost to the Buyer. There are three types of sellers in this case. One is regular GST registered seller, unregistered seller and seller registered under composition scheme. This functionality is for all goods and services except services on commission base.
Custom bid and BOQ Bid- GeM strongly recommend use of category based bids - Use of Custom Bid / BoQ bid is not allowed for items for which regular category is available on GeM. Buyer can use the features of Additional parameters also to suit its requirement. Any bid created under Custom / BoQ category shall be cancelled by GeM without any notice, if it is found that regular category is available on GeM for similar items.
Creation of secondary user under different primary user with same mail id: The secondary user registration using an existing email address should be allowed for all the roles - Buyer, Consignee and PAO/DDO.
GeM has revised its Transaction Charge policy. This can be accessed at here
Vaccines and Generic Drugs/Medicine categories - Categories of Vaccines required under the Universal Immunization Program (UIP) of MoHFW have been made live in consultation with them. The categories of TB medicines required under National TB program of MoHFW and other generic drugs/medicines have been made live.
Unlimited RA Auto Extensions - Now there is NO limit on number auto-extensions allowed in reverse auctions, GeM recommends use of unlimited auto extension for best price discovery.
Bid opening from 3 days instead of 10 days only for central Gov & Central CPSE buyers and not applicable on BOQ and custom bids.
BID Life cycle from system has been removed from the system for all types of bids/RA.
Technical evaluator: Evaluation can be based on Single/Multiple evaluator(s) or self, selection for Tender Committee (TC) option shall also be available
Re-blocking of funds - Buyers will now be able to block funds which they had not done at the time of order placement due to reasons like change of financial years etc.
- New Functionalities on Services
L1 negotiation: Buyer now gets an option to negotiate with L1 discovered from the financial evaluation. In case service provider has uploaded the price breakup then service provider gets the option to upload revised price breakup after conducting their negotiations with the buyer.
MSE preference: If buyer has selected MSE preference in bid then buyer will get option to send price match request to MSE if Non MSE bidder is selected as L1 and MSE price quoted is within L1+X% (X as defined in bid) range. In case buyer has not opted for MSE preference then buyer needs to provide competent authority approval with detail of approving authority.
Minimum floor price: A new feature has made live to solve the above problem, minimum floor price feature is available for buyers to define the minimum floor price below which no service provider would be able to quote in bid. This feature will help buyers to get reasonable price offers in bids. This feature is available for all PSUs/CPSEs/State Buyers and MoD.
Online invoicing for services - In order to introduce end to end procurement on GeM Invoicing has been made live on GeM for service providers and buyers to streamline the complete process.
Invoice rejection by consignee - Once the invoice raised by service provider, consignee now has the feature to reject the invoice against some rejection reasons which will be visible to service provider. Based on the comments, service provider will be able to update the invoice and then submit again.
Provision to upload additional SLA and SOW and ATC - Buyer has provision to write or upload document files for all of above features which will further become part of bid document and contract document and service provider has to abide by that. The terms and condition, scope of work or SLA mentioned by buyer will supersede by default conditions mentioned in SLA of the service.
Price breakup - GeM has introduced the functionality where Buyer can request for Price Breakup, Format to be uploaded by buyer for the breakup of components on cost/price offered by Service Provider in the Bid. Format uploaded by buyer may be used by service provider as reference for providing financial breakup. L1 will be evaluated by system basis on lowest price offered. GeM restricts this document to be available only during financial evaluation step, buyer will be able to open this document after financial will be open.
Custom filter for buyer - GeM has introduced feature to choose “Others” option from the list of values of technical parameters in case desired parameter is not available. Buyer has to select “Intent of Buying” as “Bid” to enter the Customized Requirement.
GeM system maintenance activity is planned from 25/06/2022 9:00 PM until 26/06/2022 12:00 Noon. While we will work towards avoiding any outages, the system may be unstable intermittently. As a preventive measure, you are requested to either prepone or postpone Bid related activities such as Bid creation, Evaluation, Seek Clarification, Reply Representation and Negotiations etc, to other dates as per your convenience. Also, you may like to avoid keeping Bid end date and Bid Opening dates on or near these dates if feasible. Please note, during this period Buyers can access all previous and ongoing Bid/RA status and details from their panel.
Forward Auction is a new feature addition into GeM platform enabling integrated B2B (Business to Business) and B2C (Business to Customer) auction featuring pan India auctioneers and bidders. As a GeM registered buyer, user can create “Auction” to sell off goods/materials/immovable assets within GeM portal using Forward Auction application and can reach out pan India bidders at a larger scale. To know more, click here
Advanced Search- https://bidplus.gem.gov.in/advance-search
Please click here to view the service approval process flow.
"Buyer Selected Non-Golden Parameters are now mandatory Bid requirement” - Buyers can now choose both Golden and Non-Golden Parameters for defining the Bid Requirements. This will enable Buyers to impose a non-golden parameter as a mandatory specification for their Bids.

All Golden parameters of the category and only those non-Golden parameters which Buyer has selected while creating bid (with values as selected by the Buyer or better than that), will now form part of the overall item specifications in Bid and will be published in the Bid document. Please note that the Non-Golden Parameters which are not specifically selected by the Buyer will now be discarded from bid and will not be published in bid and Sellers can offer a product with any of the allowed values for such non-golden parameters. If buyer want to make any non-golden parameter a part of bid, he must select that parameter and select its allowed values while creating bid, else GeM system would presume that buyer has no specific choice for that parameter and will accept any value for that parameter. No bid can then be rejected for such non selected parameter.
It is also to be noted that the values of the reference product are no longer part of the bid and only allowed values will be part of bid. For Golden parameters, by default GeM would incorporate all values that are better than the reference product's values in the bid. Buyer can select and allow any more values that he feels appropriate so that the bid is as generic as possible to attract maximum competition. Similarly for Buyer chosen non-golden parameters also, reference product's value and better values would be allowed by default and Buyer can add more values of his choice.
Sellers would now need to mandatorily comply with complete Bid specifications to proceed with Bid participation. Since bidders will now be pre-filtered and allowed to offer only those products which are matching with allowed values of Golden as well as non-Golden parameters (Buyer selected), there would now be no need for Buyer's to check or reject any bid on the ground of specification mis-match as far as GeM catalogues are concerned.

Please be informed that all the buyers registered on the GeM portal have to update the GSTIN details mandatorily. You may log into your buyer account and get the option to update GSTIN under the "My Account" section. Also please note that if you do not have a GSTIN number, you will have to give acceptance to the declaration that you are not liable to fall under the ambit of GST on your buyer dashboard.

Request you to please do the needful at the earliest.

Incident management policy has been revised, please click here to view the new policy.
Please click here to see the important updates about the Payments OM
As per the OM issued by the Department of Expenditure, Ministry of Finance (No.F.6/18/2019.PPD), the following provisions have been enabled on GeM -

Proof of Delivery Submission

The system would not allow the seller to generate an invoice, if the delivery period of an order has passed. The sellers must also submit the proof of their delivery to the consignee's location before the delivery date of the orders has passed, for their shipments to be eligible for Auto PRC and Auto CRAC
Auto PRC and Auto CRAC

Auto PRC

In case if the seller has submitted the proof of delivery before the order's delivery date has passed, their shipments would be eligible for auto PRC. This means that if the consignee does not generate the PRC within 4 days from the date of delivery as per the proof of delivery submitted by the seller, then the system would generate an auto PRC, marking all the shipped quantities as PRC accepted. At this point, the consignee would have 2 more days to make any modifications. In case, if still no action has been taken by the consignee within these 2 days, then this system generated auto PRC would be considered as the final PRC which could no longer be modified.
Auto CRAC

In case if the seller has submitted the proof of delivery before the order's delivery date has passed and the final PRC is also completed (through the system or by the consignee), then their shipments would be eligible for auto CRAC. This means that if the consignee has not generated the CRAC within 10 days from the date of delivery as per the proof of delivery submitted by the seller, then the system would generate an auto CRAC, marking all the PRC quantities as CRAC accepted. At this point, the consignee would have 3 more days to make any modifications. In case, if still no action has been taken by the consignee within these 3 days, then this system generated auto CRAC would be considered as the final CRAC which could no longer be modified.
Supplementary Invoice

For product orders where the consignee has made some rejections at the PRC or CRAC stage, the sellers would now have an option to issue a supplementary invoice against these rejected quantities. This option would be available to the seller before the delivery date of the order has passed.

For more information on the OM, please click here.

All transactions on Gem 2.0 can be accessed here.

Home

Drugs and Pharmaceutical Products

Immunomodulating Drugs

Vaccines and antigens and toxoids

Measles- Rubella (MR) Vaccine under Universal Immunization Programme of MoHFW (Q1 Category)

Unbranded--ZYDUS LIFESCIENCES LIMITED Measles- Rubella (MR) Vaccine under Universal Immunization Programme of MoHFW

Unbranded

Manufactured by: ZYDUS LIFESCIENCES LIMITED

(ZYVAC MR)

Product Details

Our Price: Price Not Available

MRP/Unit: NA

Availability: No quantity available for selected consignee location

Product id: 5116877-61008843876

Country Of Origin: India

Local Content (MII): 95%

Seller Details

Price Not Available

Specifications

Category Specific Documents

Applicable Specification Document

Special Terms & Conditions

Special Terms and Conditions for Vaccines under Universal Immunization Programme (UIP)

All Provisions of Drugs and Cosmetics Act, 1940 as amended till date and rules made there under will always be applicable.
The purchase shall be made through bidding/RA only irrespective of the value.
The foreign manufacturer is permitted to bid through its Agent in India (as per Drugs and Cosmetics Act and Rules).Supplies should be made directly by the bidder and not through any other Agency/Dealer/Distributor.
Vaccines must fully comply in all respect with the uploaded Technical specifications and in accordance with the Pharmacopoeia standards wherever applicable.
Domestic as well as foreign primary manufacturers (or the Agent thereof in terms of Drugs and Cosmetics Act 1940) are eligible to participate in the BID. (Primary manufacturer is a manufacturer that performs all the manufacturing and processing operations needed to produce goods in their appropriate dosages form, including processing, blending, formulating, filling, packing, labelling and quality testing).
The production capacity of the manufacturer of the offered vaccine should be at least 20% of the required quantity of the item.
In case the bidder is a Domestic manufacturer: The bidder must possess manufacturing license and Good Manufacturing Practices (GMP) certificate complying to the revised Schedule ‘M’ of Drugs and Cosmetics Act 1940, for the manufacturing facility which should be valid on the date of bid opening and shall remain valid till the date of completion of supply.

In case the bidder is a foreign Manufacturer (or it’s Agent in terms of Drugs and Cosmetics Act 1940):

In case the bidder itself is a foreign vaccine manufacturer, it must possess WHO PQS certification for the manufacturing facility of the offered vaccine which should be valid on the date of bid opening and shall remain valid till the date of completion of supply.

In case the authorized agent of the (WHO PQS certified) foreign vaccine manufacturer is the bidder, then he shall be responsible for supply of the offered vaccine in India. He must fulfil all the regulatory requirements as per the Drugs & Cosmetics Act 1940 and submit all the supporting documents along with the bid.

In case the bidder is a Domestic manufacturer:

Bidder should not have been convicted. A certificate from the State Drug Authorities should support this.

In case the bidder is a foreign Manufacturer (or it’s Agent in terms of Drugs and Cosmetics Act 1940):

The bid must be accompanied with non-conviction certificate of the foreign manufacturer issued by the regulatory authority for manufacturing of the Drugs in the country of origin of the offered vaccine.

For all regulated products the bidder should have at least two years of manufacturing and marketing experience of the particular items as a manufacturer for each regulated product quoted in the bid. However, this would not apply to regulated products which have been licensed by DCGI less than two years ago. A certificate from DCG (I) shall be required for all new regulated products to this effect.
The bidder shall submit the Market Standing Certificate issued by the Licensing Authority to the buyer.
The bidder shall submit the Production Capacity certificate issued by the licensing authority to the buyer.
The bidder shall submit the valid Non –conviction certificate issued by the Licensing Authority to the buyer.
The bidder should have Long Term (Real Time) Stability Data of the quoted product in specified packing for at least for 3 batches, to support shelf life.
Bid should not be submitted by the firm/company for the product(s) for which the firm / company has been blacklisted/debarred/deregistered/banned by any State Government / Central Government / its Drug procurement agencies or if the Firm/Company is debarred as a whole by any of these agencies.
During the period of contract if the firm / Company is blacklisted/debarred/deregistered/banned by any State Government / Central Government / its Drug procurement agencies / convicted by any Court of law in India, it shall be intimated to buyer along with relevant authentic document by supplier within one month.
In case of offered imported drugs/stores, the successful bidder shall be entirely responsible for import of offered drugs/stores, custom clearance, payment of customs duty and delivery of the same at the consignee’s place. Please note that in case of imported drugs/stores, the successful bidder after import in India shall arrange necessary storage (at his own cost) for the same. The successful bidder shall also arrange necessary facilities for inspection of imported drugs/stores. Only after satisfactory inspection and independent quality control laboratory batch analysis (as per clause 17 and the sampling plan specified in this document), the successful bidder shall be permitted to dispatch such imported drugs/stores to the consignee’s place.

In case of offered indigenous drugs/stores, the successful bidder shall be entirely responsible to offer the same for inspection at the manufacturer’s facility. The successful bidder shall also arrange necessary facilities for inspection of offered drugs/stores. Only after satisfactory inspection and independent quality control laboratory batch analysis (as per clause 17 and the sampling plan specified in this document), the successful bidder shall be permitted to dispatch the offered drugs/stores to the consignee’s place.

Inspection, Testing and Quality Control

The buyer and/or its nominated representative(s) will, without any extra cost to the buyer, inspect and/or test the ordered goods and the related services to confirm their conformity to the contract specifications and other quality control details incorporated in the contract. The buyer shall inform the supplier in advance, in writing, the buyer’s programme for such inspection and, also the identity of the officials to be deputed for this purpose.
The Technical Specification and Quality Control and Sampling Requirements incorporated in the contract shall specify what inspections and tests are to be carried out and, also, where and how they are to be conducted. If such inspections and tests are conducted in the premises of the supplier or its subcontractor(s), all reasonable facilities and assistance to the buyer’s inspector at no charge to the buyer.
If during such inspections and tests the contracted goods fail to conform to the required specifications and standards, the buyer’s inspector may reject them and the supplier shall either replace the rejected goods or make all alterations necessary to meet the specifications and standards, as required, free of cost to the buyer and resubmit the same to the buyer’s inspector for conducting the inspections and tests again.
In case the contract stipulates pre-despatch inspection of the ordered goods at supplier’s premises, the supplier shall put up the goods for such inspection to the buyer’s inspector well ahead of the contractual delivery period, so that the buyer’s inspector is able to complete the inspection within the contractual delivery period.
If the supplier tenders the goods to the buyer’s inspector for inspection at the last moment without providing reasonable time to the inspector for completing the inspection within the contractual delivery period, the inspector may carry out the inspection and complete the formality beyond the contractual delivery period at the risk and expense of the supplier. The fact that the goods have been inspected after the contractual delivery period will not have the effect of keeping the contract alive and this will be without any prejudice to the legal rights and remedies available to the buyer under the terms & conditions of the contract.
The buyer’s/consignee’s contractual right to inspect, test and, if necessary, reject the goods after the goods’ arrival at the final destination shall have no bearing of the fact that the goods have previously been inspected and cleared by buyer’s inspector during pre-dispatch inspection mentioned above.
Goods accepted by the buyer/consignee and/or its inspector at initial inspection and in final inspection in terms of the contract shall in no way dilute buyer’s/consignee’s right to reject the same later, if found deficient in terms of the warranty clause of the contract, as incorporated under Clause 18.
INSPECTION (Vaccines) :

Every batch proposed to be supplied against the bid would be tested at an approved laboratory i.e CDL Kasauli and cleared by the Inspecting Officer after inspection.
Life at the time of supply: At the time of supply to the consignee, the shelf life of vaccine should not have crossed more than 6 months from the date of manufacturing.

Inspection authority: Drug Controller General of India
Inspecting Officer: To be specified in NoA. However, the Assistant Director General, Medical Store Depot of the area concerned or the District Health/Family Welfare Officer of the district, the District Immunization Officer are generally authorized to carry out the inspection.
Pre inspection by the suppliers

Manufacturers/contractors should satisfy themselves that the stores are in accordance with the terms of the contract and fully conform to the required specifications before tendering them for inspecting to the officer nominated under the terms of contract. If this inspector finds that the pre-inspection has not been carried out or on examination of any sample from any portion of the consignment if the materials are not found to fully conform to the particulars governing the supply, the entire consignment shall be rejected.

A declaration by the contractor that necessary pre-inspection has been carried out of the stores tendered for inspection will be submitted along with the challan. Test protocols for tests carried out will be submitted along with the offer for inspection.

WARRANTY

The supplier warrants comprehensively that the goods supplied under the contract is new, unused and incorporate all recent improvements in design and materials unless prescribed otherwise by the buyer in the contract. The supplier further warrants that the goods supplied under the contract shall have no defect arising from design, materials (except when the design adopted and / or the material used are as per the buyer’s specifications) or workmanship or from any act or omission of the supplier, that may develop under normal use of the supplied goods under the conditions prevailing in India.

This warranty shall remain valid for 24 months after the goods or any portion thereof as the case may be, have been delivered to the final destination and accepted by the buyer in terms of the contract, unless specified otherwise.

In case of any claim arising out of this warranty, the buyer/consignee shall promptly notify the same in writing to the supplier.

Upon receipt of such notice, the supplier shall, with all reasonable speed (or within the period, if specified) repair or replace the defective goods or parts thereof, free of cost, at the ultimate destination. The supplier shall take over the replaced parts/goods after providing their replacements and no claim, whatsoever shall lie on the buyer for such replaced parts/goods thereafter.

In the event of any rectification of a defect or replacement of any defective goods during the warranty period, the warranty for the rectified/replaced goods shall be extended to a further period of twenty four (24) months from the date such rectified / replaced goods starts functioning to the satisfaction of the buyer.

If at any time during the shelf life of the stores the samples drawn from the batches in stock are declared not conforming to the specifications, the buyer shall stop the use of the quantity in stock and the supplier shall replace or cause to replace within a period of one month of quantity remain unused, which shall be free replacement.

The above warranty will also apply to replacement batches.

Replacement has to be made for any defects observed by the buyer within one month or the time specified by the buyer considering the manufacturing process for a particular vaccine.

If the supplier, having been notified, fails to rectify/replace the defect(s) within a reasonable period (or within the period, if specified), the buyer may proceed to take such remedial action(s) as deemed fit by the buyer, at the risk and expense of the supplier and without prejudice to other contractual rights and remedies, which the buyer may have against the supplier.

QUALITY CONTROL AND SAMPLING PLAN REQUIREMENTS

When the products are ready for the shipment, supplier shall inform Ministry of Health & Family Welfare (MOHFW) through an offer slip, which contains at least the following details, along with the certificate of Analysis (COAs) of each batch that are being ready for inspection.

Description of the product
Batch Number/ Lot Numbers

Batch Quantity/ Lot Quantity
After reviewing the offer slip and COAs, MOHFW shall depute their personnel to draw random samples from the offered batches.
Personnel carrying out the inspection and sampling are having the right to verify the batch records or any other document which may bear impact on the product quality of offered batches/ to conduct and audit before commencing the inspection and sampling.
Three sets of sample of required quantity as per the sampling plan will be drawn at random from each batch by the personnel deputed by the MOHFW at the manufacture’s premises.
One set of sealed sample shall be sent to an independent laboratory that is identified by the MOHFW to confirm whether the goods conform to the prescribed specification. One set of sealed sample shall be retained with the manufacturer as counter sample. The Govt control set shall be retained with the manufacturer in case of vaccine. The three sets of samples will be packed, sealed and duly signed by the inspecting personnel with the time and date of sampling.
Only after receiving the satisfactory reports from the testing laboratories, manufacturer shall be allowed to dispatch the goods that are confirming the product requirement as per the standards mentioned in the bid document.
Manufacturer shall arrange the extra products from each batch to replenish the batch quantity after taking the random sampling. The cost of the samples will be borne by the supplier.

Packing

The vaccines shall be supplied strictly in the packaging specified in the uploaded Technical specifications.
The packing for the goods to be provided by the supplier should be strong and durable enough to withstand, without limitation, the entire journey during transit including transhipment (if any), rough handling, open storage etc. without any damage, deterioration etc. As and if necessary, the size, weights and volumes of the packing cases shall also take into consideration, the remoteness of the final destination of the goods and availability or otherwise of transport and handling facilities at all points during transit up to final destination as per the contract.
The quality of packing, the manner of marking within & outside the packages and provision of accompanying documentation shall strictly comply with the requirements as provided in Technical Specifications and Quality Control Requirements. In case the packing requirements are amended due to issue of any amendment to the contract, the same shall also be taken care of by the supplier accordingly.
Packing instructions: Unless otherwise mentioned in the Technical Specification and Quality Control Requirements, the supplier shall make separate packages for each consignee (in case there is more than one consignee mentioned in the contract) and mark each package on three sides with the following with indelible paint of proper quality:

Contract number and date
Brief description of goods including quantity
Packing list reference number
Country of origin of goods
Consignee’s name and full address
Supplier’s name and address 21. The bidders shall be responsible to arrange safe delivery, at the consignee’s addresses mentioned in supply order maintaining the cold chain.

Features

PRODUCT INFORMATION

Vaccine type	Measles- Rubella (MR) Vaccine
Conformity to technical specifications including Quality assurance , labeling, marking, packing etc	As per detailed Technical Specifications uploaded in GeM Portal
Uploaded technical specification has been seen, read and understood	Yes
Compliance to uploaded Technical Specifications	Yes
Compliance to uploaded Special Terms and Conditions	Yes
The label on each vial should include Vaccine Vial Monitor (VVM) designed to meet the heat stability curve of the vaccine supplied as specified in uploaded technical specifications	Yes
Conformity to technical specifications of Vaccine Vial Monitor (VVM)	As per Annex I of uploaded Technical Specifications in GeM Portal
Scope of supply covers all components complete as per uploaded technical specifications	Yes
Dose package	Vials of 5 doses

CERTIFICATIONS & REPORTS

Product approved from the statutory authority in its country of origin	Yes
Availability of valid drug license for the product issued from the competent regulatory authority defined under Drugs & Cosmetics Act, 1940 & Rules there under as amended till date	Yes
Drug license number	G/28D/VAC/03
Submission of all necessary certifications, licenses and test reports to the buyer	Yes