Government Medical Store Depot New Delhi Directorate General of Health Services

Medical Store Organization

Bid Document For

Rate Contract for Supply of Anti Malarial Medicines/Kits

Government Medical Store Depot New Delhi Medical Store Organization

Directorate of General of Health Services Ministry of Health and Family welfare

C-4, Qutab Institutional Area , New Delhi-110 016 Ph: 011-46064184, 41024368

Fax: 011-41024369 E mail: gmsddelhi-mohfw@nic.in ,

gmsdnewdelhi@yahoo.co.in

mailto:gmsdnewdelhi@yahoo.co.in

CONTENTS

Contents Notice Inviting Tender (NIT) ........................................................................................................ 5

Bidding Schedule ................................................................................................ 5 Chapter-I Instructions To Bidders ........................................................................................... 6

Section-I ............................................................................................................... 7 Instructions for Online Bid Submission .................................................................. 7 Registration ........................................................................................................... 7 Instruction For Searching For Tender Documents On CPP Portal ........................ 7 Preparation Of Bids ............................................................................................... 7 Submission Of Bids ............................................................................................... 8 Assistance To Bidders ........................................................................................... 8 Section-II .............................................................................................................. 9 General Instructions To Bidders ............................................................................ 9 Definitions and Abbreviations ................................................................................ 9 Definitions .............................................................................................................. 9 Abbreviations ....................................................................................................... 10 Introduction .......................................................................................................... 10 Registration of Manufacturing Units ..................................................................... 11 Bid securing declaration / Earnest Money Deposit .............................................. 11 Validity of the Bid ................................................................................................. 11 Performance Security Deposit ............................................................................. 11 Eligibility Criteria .................................................................................................. 12 Preparation and Online Submission of Bids ........................................................ 13 Technical Bid ....................................................................................................... 13 Price Bid (BoQ) .................................................................................................... 14 Prices ................................................................................................................... 14 Opening of Technical and Price Bid..................................................................... 14 Minor Infirmity/Irregularity/Non-Conformity .......................................................... 15 Award of Contract ................................................................................................ 15 Other Award Criteria ............................................................................................ 15 Section-III ........................................................................................................... 17 Special Instructions To Bidders ........................................................................... 17 Bid Data Sheet (BDS) .......................................................................................... 17

Chapter-II Conditions of Contract .......................................................................................... 18 Section –I ............................................................................................................ 19

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General Conditions Of Contract(GCC) ............................................................. 19 Delivery Period .................................................................................................... 19 Rate Contract ...................................................................................................... 19 Packing and Marking Required ............................................................................ 19 Shelf Life .............................................................................................................. 20 Warranty .............................................................................................................. 21 Recalls ................................................................................................................. 21 Annual Estimated Drawls ..................................................................................... 21 Bar coding ........................................................................................................... 22 General Terms ..................................................................................................... 25 Firm Delivery Period Clause ................................................................................ 26 Delays in the Supplies Performance of the Contract ........................................... 26 Penalty Clause .................................................................................................... 26 Termination for Default ........................................................................................ 27 Force Majeure ..................................................................................................... 27 Fall Clause ........................................................................................................... 27 Inspection and Tests ............................................................................................ 28 Transit Insurance ................................................................................................. 28 Termination for Solvency ..................................................................................... 29 Laws Governing the Contract .............................................................................. 29 Resolution of Disputes ......................................................................................... 29 Section –II ........................................................................................................... 30 Special Conditions Of Contract (SCC)............................................................................ 30

Chapter-III Schedule of Requirement .................................................................................... 31 Chapter-IV Specifications and allied Technical Details ....................................................... 33 Chapter-V Price Schedule ...................................................................................................... 35 Chapter-VI Standard Forms.................................................................................................... 37

Form-I Rate Contract Form .................................................................................. 38 Form-II Bid-Securing Declaration ........................................................................ 39 Form-III Bank Guarantee Form for Performance Security ................................... 40

Chapter-VII Other Bid Forms (Annexure) .............................................................................. 41 Annexure-A Check list of List of Scanned Documents to be uploaded in pdf format in Volume I ................................................................................................ 42 Check list of List of Scanned Documents to be uploaded in pdf format in Volume II........................................................................................................................... 42 Annexure-B Letter Of Bid .................................................................................... 43 Annexure-C Bidder information form ................................................................... 44 Annexure-D Questionnaire .................................................................................. 45

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Annexure-E Certificate Regarding De-Registration/ Debarred / Blacklisted / Banning / Suspended For Business Etc .............................................................. 46 Annexure-F Details Of Items Quoted In The Tender Without Rate..................... 47 Annexure-G Manufacturing & Marketing Certificate ........................................... 48 Annexure-H Details Of All Manufacturing Units Of The Bidder ........................... 49

Chapter-VIII Appendix ............................................................................................................. 50 Appendix-I Guidelines for action to be taken against the Manufacturing unit and the contract holding firms in the event of failure of drug in laboratory test ........... 51 Appendix-II Public Procurement (Preference to Make in India), Order 2017 ...... 56 Appendix-III Purchase preference as per Public Procurement Policy for Micro & Small Enterprises ................................................................................................. 60 Appendix-IV Procedure For Registration of Manufacturing Unit .......................... 61

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Notice Inviting Tender (NIT)

Tender Number: PS/2/Anti-malarials/2019-20/05

Govt. Medical Store Depot New Delhi ,Medical Store Organization, DGHS, (hereinafter referred as Tenders Inviting Authority unless the context otherwise requires) invites Online Bids for Anti malarial Medicines/Kits as enclosed in Chapter-III –(Schedule of Requirements ) through e-procurement portal https://eprocure.gov.in/eprocure/app (Two bids System i.e. Technical Bid and Price Bid) for Supply of Anti malarial Medicines/Kits .

Bidders are advised to participate online and complete set of bidding documents can be downloaded from website “https://uatdvdmsmsodelhi.dcservices.in/IMCS/hissso/loginLogin.imcs” or “dghs.gov.in” or from central procurement portal “eprocure.gov.in” bearing Tender ID No. 2019_DGHS_526117_1

Bidding Schedule

Date of Issue/Publishing of Tender 10-12-2019 at 17.00 Hours

Start Date and time for downloading tender documents 10-12-2019 at 17.30 Hours Date and Venue of Pre-bid Meeting Date 19-12-2019 at 11.00 Hours

Venue- Govt Medical Store Depot C-4 Qutub Institutional Area New Delhi-110016

Start date and time for submission of online Bids 22-12-2019 16.00 Hours Last date and time for submission of online Bids 13-01-2020 14.00 Hours

Date and time of opening Technical Bids online 14-01-2020 14.00 Hours

Tender opening venue Govt Medical Store Depot C-4 Qutub Institutional Area New Delhi-110016

Date and time of opening of Price Bids online Will be informed later on

Address for Communication In-charge GMSD New Delhi Govt Medical Store Depot C-4 Qutub Institutional Area New Delhi -110016 Tele:011-46064184,Fax:011-46024369 email:gmsddelhi-mohfw@gov.in

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https://eprocure.gov.in/eprocure/app

Chapter-I Instructions To Bidders

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Section-I

Instructions for Online Bid Submission As per the directives of Department of Expenditure, this tender document has been published on the Central Public Procurement Portal (URL: https://eprocure.gov.in). The bidders are required to submit soft copies of their bids electronically on the CPP Portal, using valid Digital Signature Certificates. The instructions given below are meant to assist the bidders in registering on the CPP Portal, prepare their bids in accordance with the requirements and submitting their bids online on the CPP Portal. More information useful for submitting online bids on the CPP Portal may be obtained at: https://eprocure.gov.in/eprocure/app

Registration 1) Bidders are required to enrol on the e-Procurement module of the Central Public Procurement Portal (URL:

https://eprocure.gov.in/eprocure/app ) by clicking on the link “Click here to Enrol”. Enrolment on the CPP Portal is free of charge.

2) As part of the enrolment process, the bidders will be required to choose a unique username and assign a password for their accounts.

3) Bidders are advised to register their valid email address and mobile numbers as part of the registration process. These would be used for any communication from the CPP Portal.

4) Upon enrolment, the bidders will be required to register their valid Digital Signature Certificate (Class II or Class III Certificates with signing key usage) issued by any Certifying Authority recognized by CCA India (e.g. Sify / TCS / nCode / eMudhra etc.), with their profile.

5) Only one valid DSC should be registered by a bidder. Please note that the bidders are responsible to ensure that they do not lend their DSCs to others which may lead to misuse.

6) Bidder then logs in to the site through the secured log-in by entering their user ID / password and the password of the DSC / e-Token.

Instruction For Searching For Tender Documents On CPP Portal 1) There are various search options built in the CPP Portal, to facilitate bidders to search active tenders by

several parameters. These parameters could include Tender ID, organization name, location, date, value, etc. There is also an option of advanced search for tenders, wherein the bidders may combine a number of search parameters such as organization name, form of contract, location, date, other keywords etc. to search for a tender published on the CPP Portal.

2) Once the bidders have selected the tenders they are interested in, they may download the required documents / tender schedules. These tenders can be moved to the respective ‘My Tenders’ folder. This would enable the CPP Portal to intimate the bidders through SMS / e-mail in case there is any corrigendum issued to the tender document.

3) The bidder should make a note of the unique Tender ID assigned to each tender, in case they want to obtain any clarification / help from the Helpdesk.

4) The bidders can also download the Tender document from the MSO website “mso.gov.in”.

Preparation Of Bids 1) Bidder should take into account any corrigendum published on the tender document before submitting their

bids.

2) Please go through the tender advertisement and the tender document carefully to understand the documents required to be submitted as part of the bid. Please note the number of volumes in which the bid documents have to be submitted, the number of documents – including the names and content of each of the document that need to be submitted. Any deviations from these may lead to rejection of the bid.

3) Bidder, in advance, should get ready the bid documents to be submitted as indicated in the tender document / schedule and generally, they can be in PDF / XLS / RAR / DWF formats. Bid documents may be scanned with 100 dpi with black and white option.

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4) To avoid the time and effort required uploading the same set of standard documents which are required to be submitted as a part of every bid, a provision of uploading such standard documents( e.g. PAN card copy, annual report, auditor certificates etc.) has been provided to the bidders. Bidders can use “ My Space” area available to them to upload such documents. These documents may be directly submitted from the “My Space” area while submitting a bid, and need not be uploaded again and again. This will lead to a reduction in the time required for bid submission process.

Submission Of Bids 1) Bidder should log into the site well in advance for bid submission so that he/she upload the bid in time i.e. on

or before the bid submission time. Bidder will be responsible for any delay due to other issues.

2) The bidder has to digitally sign and upload the required bid documents one by one as indicated in the tender document.

3) Bidder has to select the payment option as “offline” to pay the EMD (if applicable) and enter details of the instrument.

4) Bidder should sign a Bid securing declaration accepting that if they withdraw or modify their bids during the period of validity, or if they are awarded the contract and if they fail to sign the contract, or to submit a performance security before the deadline defined in the request for bid document, they will be suspended for the period of three (3) years from the date of disqualification.

5) A standard BoQ format has been provided with the tender document to be filled by all the bidders. Bidders are requested to note that they should necessarily submit their financial bids in the format provided and no other format is acceptable. Bidders are required to download the BoQ file, open it and complete the white coloured (unprotected) cells with their respective financial quotes and other details (such as name of the bidder). No other cells should be changed. Once the details have been completed, the bidder should save it and submit it online, without changing the filename. If the BoQ file is found to be modified by the bidder, the bid will be rejected.

6) The serve time (which is displayed on the bidders’ dashboard) will be considered as the standard time for

referencing the deadlines for submission of the bids by the bidders, opening of bids etc. The bidders should follow this time during bid submission.

7) All the documents being submitted by the bidders would be encrypted using PKI encryption techniques to ensure the secrecy of the data. The data entered cannot be viewed by unauthorized persons until the time of bid opening. The confidentiality of the bids is maintained using the secured Socket Layer 128 bit encryption technology. Data storage encryption of sensitive fields is done.

8) The uploaded tender documents become readable only after the tender opening by the authorized bid openers.

9) Upon the successful and timely submission of bids, the portal will give a successful bid submission message & a bid summary will be displayed with the bid no. and the date & time of submission of the bid with all other relevant details.

10) The bid summary has to be printed and kept as an acknowledgement of the submission of the bid. This acknowledgement may be used as an entry pass for any bid opening meetings.

Assistance To Bidders (i) Any queries relating to the tender document and the terms and conditions contained therein should be

addressed to the Tender Inviting Authority for a tender or the relevant contact person indicated in the tender.

(ii) A Bidders awareness/orientation program may also to be conducted in the office of Govt Medical Store Depot New Delhi as specified in the bidding schedule and interested bidders can participate there.

(iii) Any queries relating to the process of online bid submission or queries relating to CPP Portal in general may be directed to the 24x7 CPP Portal Helpdesk.

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Section-II

General Instructions To Bidders

1 Definitions and Abbreviations The following definitions and abbreviations, which have been used in these documents, shall have the meanings as indicated below: 1.1 Definitions

(i) “Purchaser” means the organization purchasing goods and services as incorporated in the Tender Enquiry document.

(ii) “Tender” means Bids / Quotation / Tender received from a Firm / Tenderer /Bidder. (iii) “Tenderer” means Bidder/ the Individual or Firm submitting Bids / Quotation / Tender (iv) “Supplier” means the individual or the firm supplying the goods and services as incorporated in the

contract. (v) “Goods” means the drugs etc. which the supplier is required to supply to the purchaser under the

contract. (vi) “Services” means services allied and incidental to the supply of goods, such as transportation,

installation, commissioning, provision of technical assistance, training, after sales service, maintenance service and other such obligations of the supplier covered under the contract.

(vii) “Earnest Money Deposit” (EMD) means Bid Security/ monetary or financial guarantee to be furnished by a tenderer along with its tender.

(viii) “Contract” means the written agreement entered into between the purchaser and/or consignee and the supplier, together with all the documents mentioned therein and including all attachments, annexure etc. therein.

(ix) “Performance Security” means monetary or financial guarantee to be furnished by the successful tenderer for due performance of the contract placed on it. Performance Security is also known as Security Deposit.

(x) “Consignee” means the GMSD in-charge/State Cold Chain Officer Hospital/Institute/Medical College/Depot person to whom the goods are required to be delivered as specified in the Contract. If the goods are required to be delivered to a person as an interim consignee for the purpose of dispatch to another person as provided in the Contract then that “another” person is the consignee, also known as ultimate consignee.

(xi) “Specification” means the document/standard that prescribes the requirement with which goods or service has to conform.

(xii) “Inspection” means activities such as measuring, examining, testing, gauging one or more characteristics of the product or service and comparing the same with the specified requirement to determine conformity.

(xiii) “Day” means calendar day. (xiv) “Drugs and Cosmetics Act” means Drugs and Cosmetics Act 1940 of India, tobe read along with its

amendments till date. (xv) “Local supplier” means a supplier or service provider whose product or service offered for

procurement meets the minimum local content as prescribed under this Order or by the competent Ministries/ Departments in pursuance of this order.

(xvi) “Local content” means the amount of value added in India which shall, unless otherwise prescribed by the Nodal Ministry, be the total value of the item procured excluding net domestic indirect taxes) minus the value of imported content in the item (including all customs duties) as a proportion of the total value in percent.

(xvii) “L1” means the lowest tender or lowest bid or the lowest quotation received in a tender, bidding process or other procurement solicitation as adjudged in the evaluation process as per the tender or other procurement solicitation.

(xviii) “Margin of purchase preference” means the maximum extent to which the price quoted by a local supplier may be above the L1 for the purpose of purchase preference.

(xix) “Nodal Ministry” means the Ministry or Department identified pursuant to this order in respect of a particular item of goods or services.

(xx) “Rate contract” ( or the term ‘framework agreement’ in certain contexts) means an agreement between a Central Purchase Organisation or Procuring Entity with one or more bidders, valid for a

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specified period of time, which sets out terms and conditions under which specific procurements can be made during the term of the agreement and may include an agreement on prices which may be either predetermined or be determined at the stage of actual procurement through competition or a predefined process allowing their revision without further competition

1.2 Abbreviations (i) “T E Document” means Tender Enquiry Document (ii) “NIT” means Notice Inviting Tenders. (iii) “GIT” means General Instructions to Tenderers (iv) “SIT” means Special Instructions to Tenderers (v) “GCC” means General Conditions of Contract (vi) “SCC” means Special Conditions of Contract (vii) “DGS&D” means Directorate General of Supplies and Disposals (viii) “NSIC” means National Small Industries Corporation (ix) “PSU” means Public Sector Undertaking (x) “CPSU” means Central Public Sector Undertaking (xi) “MSME” means Micro, Small &Medium Enterprises (xii) “MSE” means Micro &Small Enterprises (xiii) “LC” means Letter of Credit (xiv) “DP” means Delivery Period (xv) “BG” means Bank Guarantee (xvi) “ED” means Excise Duty (xvii) “CD” means Custom Duty (xviii) “GST” means Goods and Service Tax (xix) “DOD” means Date of Delivery. (xx) ” MOH&FW” means Ministry of Health & Family Welfare, Government of India (xxi) “Dte. GHS” means Directorate General and Health Services, MOH&FW. (xxii) “MSO” means Medical Stores Organization. (xxiii) “GMSD” Government Medical Stores Depot. (xxiv) “VMS” Vocabulary of Medical Stores containing list of the drugs procured by MSO. (xxv) “Agent” means Agent of Foreign Manufacturer for the offered stores/drug(s) as perDrugs and

Cosmetics Act and Rules.

2 Introduction (2.1) The tenders will be received online through portal https://eprocure.gov.in/eprocure/app. In the Technical Bids,

the bidders are required to upload various documents. The bidder must upload scanned copy of all documents which are legible and in .pdf format.

(2.2) Possession of a Valid Class II/III Digital Signature Certificate (DSC) in the form of smart card/e-token in the company's name is a prerequisite for registration and participating in the bid submission activities through https://eprocure.gov.in/eprocure/app . Digital Signature Certificates can be obtained from the authorized certifying agencies, details of which are available in the web site https://eprocure.gov.in/eprocure/app under the link “Information about DSC”.

(2.3) Tenderer / Contractor are advised to follow the instructions provided in the ‘Instructions to the Contractors / Tenderer for the e-submission of the bids online through the Central Public Procurement Portal for e Procurement at https://eprocure.gov.in/eprocure/app .

(2.4) The parties to the contract, which shall be deemed to be “Rate Contract “ and which is intended for the supply of stores of the description set forth in the schedule to the Tender during the period specified shall be contractor of the first part and purchaser(s) name in the schedule of the Tender of second part.

(2.5) No guarantee can be given as to the number or quantity of the stores which will be ordered during the period of Rate Contract which is in the nature of standing offer only from the contractor, but the purchaser(s) undertake(s) to order from the contractor all stores as detailed in the schedule of stores and prices which he / they require(s) to purchase except that he / they reserve(s) the right. 2.5.1 Of submitting to competition any supply of articles included in the contract, the total value of which

exceeds such amount as Secretary (whose decision shall be final) may determine upon consideration of Tenders.

2.5.2 Of placing this Rate Contract simultaneously or at any time during its period with one or more contracts as /they thinks fit, and

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2.5.3 Of obtaining from sources any stores referred to in the contract to meet emergency, if the Secretary (whose decision shall be final) is satisfied that the contractor is not in a position to supply specific quantities or number of days within the period in which supply is required.

(2.6) The Rate Contract in respect of quality procurement shall be governed by the provisions contained in the Drugs and Cosmetics Act, 1940 as amended up to date and the Drugs and Cosmetics Rules, 1945 as amended up to date.

3. Registration of Manufacturing Units ( 3.1 ) In case the bidder is a Domestic manufacturer, the MSO/GMSDs accept the drugs only from the manufacturing units duly inspected and registered with Medical Store Organisation /GMSDs.

Manufacturers of unregistered units may also submit their bids if they have already paid the registration fee and applied for registration with concerned GMSDs/MSO, if they produce evidence thereof. However, the Rate Contract will be subject to registration of the manufacturing unit of the drug. [Note-The detailed procedure for registration of manufacturing units can be seen at Appendix-IV]

(3.2) If the validity of registration of the manufacturing unit of the drug to be quoted by the bidder has expired, the bidders will be treated as unregistered unless he has applied for renewal of registration within the validity of the registration period.

(3.3) If a Bidder has two or more separate manufacturing units at different sites/premises and bidder intends to quote for the drugs manufactured at any of its unregistered manufacturing units, then the bidder will be treated as unregistered manufacturer for supply of that drug rendering him ineligible to participate in the bid unless he has applied for registration, before the last date of submission of Bid and produce evidence thereof.

4 Bid securing declaration / Earnest Money Deposit (4.1) Bidder should sign a Bid securing declaration accepting that if they withdraw or modify their bids during the

period of validity, or if they are awarded the contract and if they fail to sign the contract, or to submit a performance security before the deadline defined in the request for bid document, they will be suspended for the period of three (3) years from the date of disqualification. In the absence of Bid securing declaration in the prescribed proforma (Form II) given in Chapter VI -Standard Forms, the tenders will be rejected and will not be opened.

(4.2) The Micro and Small enterprises (MSEs) and the firms registered with National Small Industries Corporation (NSIC) etc. are exempted from submitting the Bid Security/ Earnest Money Deposit as per prevailing rules. However, they have to submit the valid documentary evidence in support of MSE/Registration with NSIC (indicating the items for which they are registered.) along with the technical bid.

5 Validity of the Bid

(5.1) The bid shall be valid for a period of 120 days extendable for a period of another 120 days from the last date of submission of the bids (fixed initially in the publication of the tender). Validity of the Earnest money deposit should be 45 days, beyond the final bid validity period in any case. However, the Tender Inviting Authority may request the bidders to extend the bid validity beyond.

(5.2) If the bidder refuses the extension of bid validity then they will lose all rights in respect of all of their bids submitted together and all the bids will be summarily rejected without forfeiting the Earnest Money Deposit.

(5.3) In case the bidder withdraws his bid within its validity period or fails to deposit performance security within specified time after award of contract, the Earnest Money will be forfeited or the firm will be debarred/de-registered for bidding a period of three years.

(5.4) The bid security of the unsuccessful bidders will be returned to them after expiry of the final bid validity and latest within one month after the award of the contract /Supply Order.

6 Performance Security Deposit (6.1) Successful Bidder/Contractor will have to furnish a Performance Security Deposit with the purchaser

equivalent of 5% of the order received from the demanding officer/Purchaser in the form of bank guarantee or in the form of demand draft. The Demand draft should be drawn in favour of “The Accounts Officer of

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direct demanding officer /Purchaser and the bank guarantee should be in favour of direct demanding officer /Purchaser valid for a period of 60 days beyond the date of completion of all contractual obligations of the supplier, including warranty obligations

(6.2) Demand Draft finally accepted as Performance Security Deposit would be credited to Govt. Account under proper Head of Account.

(6.3) Govt. will not pay any interest on Earnest Money Deposit / Performance Security Deposit, which would stand, credited to Govt. Accounts.

(6.4) Performance Security Deposit will be returned to the Bidder after a period of 60 days beyond the date of completion of all contractual obligations of the supplier, including warranty obligations by the depots or Medical Stores Organisation.

(6.5) If the contractor fails or neglects to observe or perform any of his obligations under the contract, it shall be lawful for the purchaser to forfeit the Performance Security Deposit furnished by the contractor.

7 Eligibility Criteria 7.1 The following bidders are eligible to participate in the tender:-

(i) Domestic Manufacturers having valid own manufacturing license or loan license are eligible to quote the drugs manufactured at their manufacturing units (premises) duly inspected and registered with MSO / GMSDs for supply of drugs. Manufacturers of unregistered units may also submit their bids if they have already paid the registration fee and applied for registration with MSO, if they produce evidence thereof as clarified under Clause 3. However, the Rate Contract will be subject to registration of the manufacturing unit of the drug.

(ii) Direct importer holding valid import license. A letter from original manufacturer should also be

submitted that the original firm is not marketing the product directly in India.

No third party manufacturers are allowed to quote for any generic drug. 7.2 Annual Turnover Requirement of the Bidder

(i) Pharmaceutical firm having minimum annual turnover of Rs. 100 Crore in each of the last two years will be eligible to quote bid for drugs included in Group ‘A’ (The Group A drugs-includes essential drugs like drugs acting on Central Nervous System, Cardio Vascular System, Endocrine System, Anti-cancer & Higher Antibiotics).

(ii) Pharmaceutical firm having minimum annual turnover of Rs. 50/- Crore in each of the last two years will be eligible to quote bid for drugs included in Group ‘B’(The Group B drugs-includes rest of the drugs not covered under Group A).

7.3 In case of imported product Bidder should have valid WHO GMP Certificate or CoPP (Certificate of Pharmaceutical Product) from the concerned licensing Authority.

7.4 Bidder should have valid Manufacturing License issued by competent authority under Drugs & Cosmetic Act and should adhere to the norms of Schedule M of the D & C Act & Rules/GMP Certificate on the date of bid opening for the category of products manufactured in India.

7.5 A Non-Conviction certificate for two years from the Licensing authority / Drug Controller of the concerned State. The Certificate must have been issued within six months from the date of opening of the Tender.

7.6 As on last date of submission of the bids, Bidder (Manufacturer / importer/Loan licensee) should have Manufacturing &Marketing experience for at least 2 years (24 months) for the drug quoted.

This would not apply to drugs, which were introduced in India less than 2 years ago. A certificate from the Drug Controller General (India) shall be required for all new drug formulations to this effect.

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8 Preparation and Online Submission of Bids

8.1 Technical Bid

8.1.1 The Item(s) as per Tender enquiry should be clearly marked and highlighted in Drug Manufacturing or Import License / manufacturing and marketing certificate documents submitted.

8.1.2 The bidders are required to upload various documents in Technical bids in two volumes , as listed in Clause 8.1.3 (Volume –I)and 8.1.4. (Volume –II) The bidders are advised to arrange all the documents to be uploaded in Volume I and Volume II in the same chronological order of the checklist (Annexure-A). All these pages of Volume I and Volume II should be serially numbered and signed with the rubber stamp of the firm on each page before uploading.The Tender shall be liable to be rejected if the same are not uploaded with the Technical BID online

8.1.3 List of Scanned Documents to be uploaded in pdf format in Volume I (Documents as per check list - Annexure A)

(i) Copy of duly filled , signed & stamped Check list of documents uploaded (Annexure A) (ii) Copy of the Bid Securing Declaration as per Clause 4 (Form II ). (iii) Copy of the valid registration certificates or application of registration and proof of

registration fee paid in respect of all domestic manufacturing units of the drugs quoted. (iv) Copy of notarized power of attorney. The bidder shall sign the bid or a person duly

authorized to bind the bidder to the contract. The authorized signatory should have power of attorney from the Proprietor / Partners of the firm/ MD / Chairman / President duly attested and signed by Notary Public

(v) The Bidder Information form (Annexure-C) (vi) Questionnaire (Annexure- D) (vii) Latest Income Tax Return and GST Return (viii) Copy of valid NSIC Registration/MSME Certificate if any (ix) Certificate regarding de-registration/ debarred / blacklisted / banning / suspended for

business etc. (Annexure-E) (x) The annual turnover statements for formulations for the last two years duly certified by the

Auditor / chartered accountant.. (xi) Non-conviction certificate for two continuous years from the Drug Controller of the State (xii) Details of item quoted in the tender without Rate(Annexure-F) (xiii) Certificate from the Manufacturers or Chartered Accountant regarding two years (24

months) manufacturing and marketing experience of the particular item of any strength. The Certificate must have been issued within past six month from the date of opening of Tender. In the case of direct importer, evidence for importing the quoted item for last two years will be produced in the prescribed proforma (Annexure- G).

(xiv) Details of manufacturing units of the Drugs quoted by the Bidder, and Data to establish the manufacturing during last two years, duly certified by the concerned Domestic Manufacturer. - (Annexure-H)

(xv) Copies of CoPP (Certificate of Pharmaceutical Product) in respect of the imported formulations/drugs quoted in the Tender.

(xvi) The local supplier shall be required to provide self-certification / Certificate of Cost Auditor / Chartered Accountant that the item offered meets the minimum local content as per provisions of the order placed at Appendix-II.

8.1.4 List of Scanned Documents to be uploaded in pdf format in Volume II

(Documents as per check list - Annexure A) (i) Valid Drug Manufacturing /Import License with its validity. If revalidation of drug license has

been applied for the copy of application to State Drug / Licensing authority may be attached with a certificate that application for renewal was made within time frame as per Drug and Cosmetic Act as amended up to date and that has not been deleted by licensing authority and Certificate of approval of Drug Controller General of India for new drugs if any.

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(ii) Letter of Bid (Annexure-B) along with the Tender Document duly ink signed and stamped on each page.

(iii) Copy of Certificate of original manufacturer of product from the State Drug Controller) if any.

(iv) Copy of Certificate of sole manufacturer of product from State Drugs Controller if any (v) .

8.2 Price Bid (BoQ)

8.2.1 The price bid will also be known as financial document and every bidder will be required to submit its price in excel (BoQ) format attached to the respective tender document.

8.2.2 Please note that PRICE BID is to be submitted online only and no copy is to be submitted physically.

9 Prices

9.1. The Tenderer shall indicate on the Price Schedule (BoQ) the specified components of prices shown therein. All the columns shown in the price schedule should be filled up as required. If any column does not apply to a tenderer, same should be clarified as “NA” by the tenderer

9.2 Rates should be quoted on Free Delivery on Door Delivery Basis to all Govt. Medical Store Depots located at Kolkata, Chennai, Guwahati, Hyderabad, Karnal, Mumbai and New Delhi and all the transit loss whatsoever will be borne by the supplier firm (any monetary limit is not acceptable). Uniform rates for all the depots must be quoted. Quotations at different rates for different depots will not be considered.

9.3 Deleted. 9.4 No conditional offer / discounts for early delivery / payment etc will be accepted. Any conditional price /rate

quote shall render the financial BID disqualified on ground of conditionality. 9.5 The prices quoted by the Bidders should be on firm and fixed basis during the currency of the rate approval,

except in respect of such drugs where prices are governed by Essential Commodities Act 1955 and Drugs Price Control Order 2013, in which cases the prices quoted should not exceed the ceiling price of DPCO/NPPA. While claiming payment, Bidders shall be required to submit a certificate to this effect from Internal Auditor / Chattered Accountant / Managing Director.

9.6 The price quoted by the Bidder should be less than the price obtained by them from the trade.

10 The purchaser’s reserves the right to accept in part or in full any Tender or reject any Tender without assigning any reason or to cancel the E-Tendering process and reject all Tenders at any time prior to award of contract, without incurring any liability whatsoever to the affected Tendered or Bidders.

11 The purchaser may demand to see the original document or submission of attested /certified copy of any document which has been submitted online or other document(s) requiring clarification

12 All the information called for in all the BID documents should be answered, failing which, the bid shall not be considered and is liable to be rejected without any further reference.

13 The price of drug is not to be revealed in technical Bid and each page of the quotation must be uploaded in the prescribed format otherwise it will be liable to rejected.

14 Opening of Technical and Price Bid

(i) The Technical Bids of the respective tender will be opened as per the bidding schedule of the tender. The Technical bids will be scrutinized by the respective Technical Evaluation Committee.

(ii) The Price Bids of only those Bidders whose Technical bids are found responsive on satisfying the criteria for technical evaluation will be opened and only they shall be eligible to be present at the date and time for opening of Price Bid.

(iii) The Date and time of opening of the Price Bid will be announced on the e-procurement portal https://eprocure.gov.in /e-procure/app and MSO website “http://mso.gov.in after the completion of evaluation of Technical Bids by the Technical Evaluation Committee.

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15. Minor Infirmity/Irregularity/Non-Conformity If during the preliminary examination, the purchaser find any minor informality and / or irregularity and/or non-conformity in a tender, the purchaser may waive the same provided it does not constitute any material deviation and financial impact and, also, does not prejudice or affect the ranking order of the tenderers. Wherever necessary, the purchaser will convey its observation on such “minor” issues to the tenderer by registered/speed post etc. asking the tenderer to respond by a specified date. If the tenderer does not reply by the specified date or gives evasive reply without clarifying the point at issue in clear terms, that tender will be liable to be ignored.

16 The firms may submit their bids if the terms and conditions as prescribed are acceptable to the bidders and

they fulfil all the eligibility criteria. Therefore bidders are advised to read Terms and conditions and Instructions of Bid Documents carefully before submitting their quotations.

17 Award of Contract 17.1 The purchaser also reserve the rights (1) to enter into parallel Rate Contract(s) simultaneously or at any time

during the period of the Rate Contract with one or more Bidder(s) as purchaser think fit and (2) to place ad-hoc contract or contracts simultaneously or at any time during the period of this contract with one or more supplier(s) / Tenders(s) for such quantity of such item or items as the purchaser (whose decision shall be final) may determine

17.2 The purchaser reserves the option to give a purchase preference to the offers from public sector units etc., over those offers from other large scale units in accordance with the policies of the Govt. of India from time to time.

17.3 The MSO / GMSDs will initially award Rate Contract(s) with L1 only. However in case L1 is debarred or not able to supply the drug then MSO may conclude the rate contract with L2 for the remaining period of the Rate Contract ,provided he agrees to supply at L1 rate. Also if both L1 & L2 are debarred or not able to supply the drug then the MSO may conclude the rate contract with L3 for the remaining period of the Rate Contract, provided he agrees to supply at L1 rate.

18 Other Award Criteria

The DIPP has notified a Public Procurement order-2017 (Preference to Make in India) order 2017 vide Order no P-45021/2/2017-B.E-II dated 15th June 2017 (Appendix-II). The procurement policy for Micro & Small Enterprises 2012 has been notified under MSMED Act, 2006 (Appendix-III). The orders mandates that purchase preference shall be given to local suppliers and MSEs in all procurement undertaken by procuring entities. General principles as per above orders and criteria fixed by MoHFW shall be followed for various scenarios for award of contract. Accordingly, the criteria of award of contract will be as under: (I) Public Procurement (Preference to Make in India)

Requirement of Purchase Preference: Subject to the provision of the Order P-45021/2/2017-B.E-II dated 15th June 2017 (Appendix-II)and to any specific instructions issued by the Nodal Ministry or in pursuance of this Order, purchase preference shall be given to local suppliers in all procurements undertaken by procuring entities in the manner specified hereunder:

a. In procurement of goods in respect of which the Nodal Ministry has communicated that there is

sufficient local capacity and local competition, and where the estimated value of procurement is Rs. 50 lakhs or less, only local suppliers shall be eligible. If the estimated value of procurement of such goods is more than Rs. 50 lakhs the provision of sub-paragraph b or c as the case may be, shall apply

b. In the procurement of goods which are not covered by paragraph “a” and which are divisible in

nature, the following procedure shall be followed: (i) Among all qualified bids, the lowest bid will be termed as L1 if L1 is from a local supplier,

the contract for full quantity will be awarded to L1 15

(ii) If L1 bid is not from a local supplier 50% of the order quantity shall be awarded to L1 price for the remaining 50% quantity subject to the local suppliers quoted price falling within the margin of purchase preference and contract for that quantity shall be awarded to such local supplier subject to matching the L1 price. In case such lowest eligible local supplier fails to match the L1 price of accepts less than the offered quantity, the next higher local supplier within the margin of purchase preference shall be invited to match the L1 price for remaining quantity and so on, and contract shall be awarded accordingly. In case some quantity is still left uncovered on local suppliers then such balance quantity may also be ordered on the L1 bidder.

c. In procurements of goods not covered by sub-paragraph “a” and which are not divisible and in

procurement of services where the bid is evaluated on price alone the following procedure shall be followed: (i) Among all qualified bids, the lowest bid will be termed as L1 if L1 is from a local supplier,

the contract will be awarded to L1. (ii) If L1 is not from a local supplier, the lowest bidder among the local suppliers, will

be invited to match L1 price subject to local supplier’s quoted price falling within the margin of purchase preference and the contract shall be awarded to such local supplier subject to matching the L1 price.

(iii) In case such lowest eligible local supplier fails to match the L1 price, the local supplier with the next higher bid within the margin of purchase preference shall be invited to match the L1 price and so on and contract shall be awarded accordingly. In case none of the local suppliers within the margin of purchase preference matches the L1 price then the contract may be awarded to the L1 bidder.

Purchase preference as per Public Procurement Policy for Micro &Small Enterprises (i) Purchase preference to micro and small enterprises registered with district industry centers

or khadi and village industries commission or khadi and village industries board or coir board or national small industries corporation or directorate of handicrafts and handloom or any other body specified by ministry of MSME.

(ii) In case participating MSEs quote price within price band of L1+15%, such MSE shall 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 MSE and such MSE shall be allowed to supply up to 25% of total tendered value.

(iii) A sub –target of Min. 25% (i.e. 4% out of 25%) has been earmarked for procurement from MSEs owned by the SC or ST entrepreneurs. Provided that, in event of failure of such MSEs to participate in tender process or meet tender requirement and L-1 price, 4% sub-target for procurement earmarked for MSEs owned by SC or ST entrepreneurs shall be met from other MSEs

(iv) Out of the total annual procurement from Micro and Small Enterprises, 3 per cent from within the 25 per cent target shall be earmarked for procurement from Micro and Small Enterprises owned by women

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Section-III

Special Instructions To Bidders

Bid Data Sheet (BDS)

The following specific data for the Goods to be procured shall complement, supplement, or amend the provisions in the Instructions to Bidders (ITB).Whenever there is a conflict; the provisions herein shall prevail over those in ITB.

S/No. ITB

Clause Reference

Bid Data that shall prevail over those in ITB

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Chapter-II Conditions of Contract

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Section –I

General Conditions Of Contract(GCC) 1. Delivery Period

The time for and the date of delivery of stores stipulated in the supply order shall be deemed to be the essence of the contract and delivery must be completed within stipulated Date of Delivery which is normally 60 days unless specified otherwise.

2. Rate Contract

(i) The Rate Contract shall be operative for a period of two years from the date of its finalization i.e. from the date of issue of Rate Contract with a condition that in case if there is a fall in final cost due to reduction in cost of raw material, custom duty exemption etc. the manufacturer will have to reduce the price proportionately to extend the benefit of such reduction to Government.

(ii) The Contract Holding Firm shall note that supply orders may be placed up to the last day of the currency of the Rate Contract.

(iii) Whenever any Purchase Order is placed during the validity of the contract it shall be binding on the firm to supply it as per Schedule given by the purchaser.

(iv) The rate Contract will be concluded with the Domestic Manufacturers registered with MSO or the Importers Only.

3. Packing and Marking Required 3.1. Packing For Tablets And Capsules.

(a) Initial Packing (i) Unless otherwise specified in Supply Order. Tablets/ Capsules are required to be packed in

standard Aluminum /Aluminum Blister. The aluminum strip should be of thickness not less than 0.03mm. The packing material should have compatibility with the tablet, capsules. The manufacturer will submit a self-certificate with each consignment specifying thickness of Aluminum Foil.

(b) Blister /Aluminum strip pack of not more than 150 tabs /caps should be packed in thick cardboard box so that container should provide adequate protection to the drugs.

(c) Final Packing. Final packing shall be done in corrugated fiber Board boxes confirming to IS: 2771 (part-I):1990 suitably cushioned/ lined and strong enough to bear Rail/Road transit hazards. The supplier should furnish a self-certificate with each consignment to the effect that packing material is confirming to IS: 2771 (part-I):1990.

3.2. Packing For Bottles. Bottles should confirm the container/content compatibility test. (a) Initial Packing

Initial packing shall be done in single well corrugated fibre board boxes weighing not more than 10 KG confirming to lS2771 (Part-I) 1990 suitably nested and strong enough to bear the Rail/Road Transit Hazards.

(b) Final Packing Final packing shall be done in 7-ply corrugated fiber Board Boxes weighing not more than 15 Kgs conforming to lS/277l/Part-I: 1990 suitable Cushioned lined and strong enough to bear the Rail/Road Transit Hazards. The supplier should furnish a self-certificate with each consignment to the effect that packing material is confirming to IS: 2771 (part-I):1990

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3.3 Packing For Injection

Vial/Ampoules should confirm the container/content compatibility test. (a) Initial Packing

In neutral plain glass ampoule/ vial confirming to IS:1984 (Part-I) 1971 for relevant capacity provided with rubber stopper and pilfer proof metallic seal(in case of vials) and enclosed in strong card board carton and 25/50 vials/ampoules enclosed in well cushioned nested card board carton.

(b) Final Packing Final packing shall be done in corrugated fiber board boxes confirming to IS: 2771(Part4):1990 suitable Cushing and liner and strong enough to bear the Rail/Road transit hazards. The supplier should furnish a self-certificate with each consignment to the effect that packing material is confirming to IS: 2771 (part-I):1990.

3.4. PACKING INSTRUCTION FOR IV FLUIDS

(a) Initial Packing PVC bottles should confirm the container/content compatibility test for the contents of the container and should be manufactured by Form Fill Seal (FFS) Technology of relevant capacity as indicated in the Schedule of Requirements.

(b) Final Packing Final packing shall be done in corrugated fiber cardboard carton (7ply only) confirming to lS: 2771 (Part-I):1990 duly nested containing not more than 24 bottles. The supplier should furnish a self-certificate with each consignment to the effect that packing material is confirming to IS: 2771 (part-I):1990

3.5. Packing of each drug item should be strictly according to the requirements specified in the list of each

category of drugs and or as indicated in the Tender enquiry in detail. 3.6. The package will indicate the name of the manufacturer, the date of manufacture, date of expiry and the

batch no. The labels both on Innermost packing and outer Containers should be marked with the words "CG SUPPLY NOT FOR SALE" in bold red letters

3.7 Labelling and packing shall be as per the provisions contained in the Drugs and Cosmetics Rules 1945 as

amended up-to-date, other particulars of labelling, if any, prescribed by the Direct Demanding Officer in his supply order should be complied with.

3.8. The supplier shall provide such packing of the goods as is required to prevent their damage or deterioration

during transit to their final destination as indicated in the contract. The packing shall be sufficient to withstand, without limitation, rough handling during transit and exposure to extreme temperatures, sunlight and humidity during transit and storage. Packing case size and weights shall take into consideration, where applicable, the remoteness of the Goods' final destination. All primary packaging containers, which come in contact with the pharmaceuticals or drug content, shall strictly conform to the specifications in the relevant pharmacopoeia to protect the quality and integrity of the goods.

3.9. Offers with packing not in terms of the requirement of Tender enquiry shall be summarily ignored.

4. Shelf Life

4.1 Minimum shelf life of the drugs offered should be mentioned in months against each item in the Annexure –F to be uploaded in Technical Bid.

4.2 The Bidder should note that at the time when the stores are offered for inspection, the life of the drugs shall

not have passed more than one sixth (1/6th) of the effective/useful life of the drug counted from the date of manufacture. Loss or premature deterioration due to biological and other activities during the life potency of the drugs shall have to be made good by the contractor free of cost or shall have to refund the cost of substandard drugs lying with depot or at the indentors end.

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5. Warranty 5.1. Supplies must fully comply in all respect with the Technical specifications and conditions laid down in the

contract and in accordance with the Pharmacopoeia standards. 5.2. Each supply should be accompanied with a "Warranty Certificate" duly signed by the Bidder as under:

"The Contractor/Seller hereby declares that the stores as detailed below sold to the purchaser under this contract shall be of the best quality and workmanship and shall be strictly in accordance with the specifications and particulars mentioned in the description clause here of and the contractor/seller hereby guarantees that the stores would continue to conform to the description of and quality aforesaid for a period of useful life of minimum of five sixth (5/6th) of the specified shelf life from the date of delivery of the said stores to the purchaser ,, have overages within the ranges set forth in the technical specification and are not subject to recall by the applicable Regulatory Authority due to unacceptable quality or adverse Pharmaceuticals reaction. Notwithstanding the above, the fact that the said stores fail to conform to the description and quality aforesaid or have deteriorated and the decision of the purchaser in that behalf is final and conclusive, the purchaser will be entitled to reject the said stores or such part thereof as may be discovered not to conform to the said description and quality. Losses due to premature deterioration due to biological and other activities during life potency will be made good and supplied by the firm at its own cost at consignee’s site. On such rejection, the stores will be at the seller's risk and all provisions herein contained relating to the rejection of stores shall apply. The Contractor/Seller shall if so called upon to do so by the purchaser in writing, replace the stores free of cost at the ultimate destination within a period of forty five days or such further period as may be extended from time to time by the purchaser at his discretion, on application made there under by the contractor/Seller after the stores or such portion of the stores thereof as is rejected by the purchaser and in such an event the above mentioned warranty period shall apply to the stores replaced from the date of the replacement thereof otherwise the contractor/seller shall pay to the purchaser such damage as may arise by reason of the breach of the conditions. Nothing herein contained shall prejudice any other rights of the purchaser in that behalf under this contract or otherwise".

i S

Signature name & designation and date with rubber stamp. 5.3. If the supplier, having been notified, fails to replace within the period specified above, the purchaser may

proceed to take such remedial action as may be necessary at the suppliers' risk and expense and without prejudice to other rights which the purchaser may have against the supplier under the contract.

6. Recalls If products must be recalled because of problems with product quality or adverse reaction to the pharmaceutical, the supplier will be obliged to notify the purchaser, providing full details about the reason leading to the recall, and shall take steps to replace the product in question at suppliers own cost at the ultimate destination with a fresh batch of acceptable pharmaceuticals or withdraw and give a full refund if the product has been taken off the market due to safety problems.

7. Annual Estimated Drawls The annual value of drugs to be ordered by the Department will be dependent on individual requirements of the various drugs including the items in the subject inquiry A) Purchaser : The President of India B) Inspection Authority : DGHS New Delhi C) Inspecting Officer : Head of the Depots or their authorised

Representative(s) for the respective requirement. D) Place of Inspection : At Consignee Premises / firms premises. E) Paying Authority : Pay & Accounts Officer, Ministry of Health

And Family Welfare, of concerned Depots F) Rate Contract : Dte. General of Health Services (Medical Store operating

officers Organisation), New Delhi and its GMSDs Located at Kolkata, Chennai, Guwahati,Hyderabad, Karnal, Mumbai& New Delhi.

SO No. & Date

Nomenclature & Specification

Name &Address of Manufacturing Unit

Batch No.

DOM & DOE

Qty. of each batch

Remarks

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Successful Bidders will have to deposit 5% of the total value of the order as Performance Security Deposit in the form of demand draft drawn in favour of PAO of the respective depots or bank guarantee in the prescribed form in favour of The President of India, which can be obtained, from the depot. 100% Payment will be made on finalization of bills duly supported by original inspection note, original supply order, Invoice &delivery challan etc. Demand for advance payment will not be admissible.

If firm is deregistered / debarred for the supply of item after issue of Tender enquiry for any particular item offers for such item will not be considered. If firm is deregistered / debarred for the supply of the item /blacklisted banned during the currency of agreement all orders already placed by demanding officer up to the date of order coming in to force shall be executed by the firm during delivery period specified in such contract. No extension of delivery period in such contract shall be considered.

8. Bar coding All medicines supplied should be bar-coded as under:

All medicines supplied should incorporate GS1 barcodes at various packaging levels (primary, secondary and tertiary level packaging) and should encode the information within the barcodes as mentioned below

The GS1 barcode requirements for medicines/drugs at various packaging levels can also be downloaded from the website of Ministry of Health & Family Welfare, Govt. of India at below link:

http://mohfw.nic.in/gs1_barcode_&_User_Manuals.htm

GS1 barcode requirements

On Medicines/Drugs procured by MSO

These requirements cover medicines/drugs procured by Medical Stores Organization (MSO) for both branded & generic pharmaceuticals/drugs. For medical devices & other medical supplies separate GS1 barcode requirements apply which are available at http://mohfw.nic.in/gs1_barcode_&_User_Manuals.htm

Barcode requirements using GS1 identification standards are provided below at various levels of product packaging which include at primary, secondary and shipper/carton levels and need to be complied with while supplying medicines/drugs to MSO.

Section A) Primary Level Packaging Primary Level Packaging: Is defined as the first level of packaging in direct contact with the product and marked with an AIDC (Automatic Identification and Data Capture) data carrier either on the packaging or on a label affixed to the packaging. It may consist of a single item or group of items for a single therapy such as a Kit. For packaging configurations that include a retail consumer trade item, primary packaging is a packaging level below the retail consumer trade item.

Barcodes using GS1 standards are required to be marked ontothe primary level of packaging encoding GS1 product identification code (called GTIN–Global Trade Item Number). Where product is packed in a mono carton (e.g. ointments, eye/ear drops etc), barcode encoding GTIN should be marked on the mono carton itself.

GTINs (Global Trade Item Numbers): It is the GS1 identification key used to uniquely identify each product type/variant. It is created using a GS1 or U.P.C. Company Prefix number. GTIN can be of 14 digits (i.e. GTIN -14) or 13 digits (i.e. GTIN -13) or 12 digits (i.e. GTIN -12) or 8 digits (i.e. GTIN -8) depending on barcode symbology used.

Note: Barcodes using GS1 standards are required to be marked on product packaging in addition to existing statutory labeling & marking requirements.

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Barcode Symbology: GS1 Data Matrix (two dimensional) symbology is the preferred option.

GS1 Data Matrix symbology can encode product data in much smaller space than what is possible with one dimensional barcode symbology. This is an important consideration in healthcare sector due to very limited availability of printing space on product packaging, after complying with other statutory labeling& marking requirements. GS1 Data Matrix is thus the preferred option for marking in the healthcare sector.

Schematic example of GS1 Data Matrix symbology encoding GTIN-14 using Application Identifier (01) at Primary level packaging is as below:

(01)08901107000011

For specs related to GS1 Data Matrix barcode, refer to GS1 general specifications available on http://www.gs1india.org.in/gs1barcodes/pc_index.htm.

Other barcode symbologies (EAN/UPC, GS1–128 and GS1 Databar) on primary level packaging shall also be acceptable. Details on other GS1 barcode symbologies (EAN/UPC, GS1 – 128, ITF-14, GS1 Databar), are available at http://www.gs1india.org.in/gs1barcodes/pc_index.htm

Section B) Secondary Level Packaging

Secondary Level Packaging: Is defined as a level of packaging that may contain one or more primary packages or a group of primary packages containing a single item.

NOTE: There may be additional intermediate packaging levels above the secondary level packaging, but below the Shipper / Carton level packaging. These intermediate packaging levels are not required to be barcoded at this time. Examples of these exclusions include:

Inner packs (bundles) Intermediate packs (inner case)

At Secondary level packaging, the barcode should encode the following information:

1) Product identification code (Unique GTIN-14 of secondary pack)* using application identifier (01) 2) Expiry Date in YYMMDD format using application identifier (17) 3) Batch/Lot Number using application identifier (10) or Serial No using application identifier (21).

*Note: GTIN-14 of secondary level packaging should be different from GTIN-14 of primary and shipper pack. For details on generation of same, refer to GS1 General Specifications.

The above barcoding requirements shall be in addition to existing statutory labeling & marking requirements.

Barcode Symbology: Any of the following GS1 barcode symbologies can be used to encode above stated data in barcodes at Secondary level packaging:-

GS1-128, GS1 Data Matrix, GS1 Data Bar.

Examples

a) GS1-128 symbology, encoding GTIN + Expiry Date + Batch/Lot No is represented schematically as below:-

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http://www.gs1india.org.in/gs1barcodes/pc_index.htmhttp://www.gs1india.org.in/gs1barcodes/pc_index.htm

(01)08901107000028(17)090400(10)ab12345 b) GS1-128 symbology, encoding GTIN + Expiry Date + Serial No is represented schematically as below:-

Details on other GS1 barcode symbologies at secondary packaging level (GS1 Datamatrix and GS1 Databar) are available at http://www.gs1india.org.in/gs1barcodes/pc_index.htm Section C) Shipper/Carton Level Packaging Shipper/Carton Level Packaging: Is defined as a level of packaging that may contain one or more primary/secondary levels of packaging.

Shippers/cartons can be considered orderable trade items (requires homogeneous pack) AND may also be considered logistics units (heterogeneous packs). The following rules apply to each variation:

i) The requirements for the orderable trade item (homogeneous pack):

The first barcode:

1) Product Identification (Unique GTIN-14 of Shipper pack) using application identifier (01) 2) Expiry Date in YYMMDD format using application identifier (17) 3) Batch/Lot Number using application identifier (10)

The second barcode:

a. SSCC (Serial Shipping Container Code) to identify individual carton uniquely using application identifier (00)

(Single Label for each carton)

*Note: GTIN-14 of shipper level packaging should be different from GTIN-14 of primary and secondary pack. For details on generation of same, refer to GS1 General Specifications.

(01)08901107000028(17)090400(21)122347842306

Product name : ABCDXYZ Expiry date : 04/09 (April/09) Batch no. : ab12345

(01)08901107000035(17)090400(10)ab12345

(00)189011070000000018

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http://www.gs1india.org.in/gs1barcodes/pc_index.htm

Barcode Symbology: GS1-128 and GS1 DataMatrix symbologies can be used to generate the first barcode. The second barcode (SSCC) requires GS1-128.

Human readable information on the label will be as per existing statutory labelling& marking requirements. ii) The requirements for logistics unit (heterogeneous pack):

If multiple items are packed in a carton / shipper (heterogeneous pack), and / or the shipper / carton level packaging is not an orderable unit, only second barcode should be present (i.e. SSCC).

Human readable information on the label will be as per existing statutory labelling& marking requirements.

Schematic example of GS1-128 symbology for the logistics unit (heterogeneous pack) encoding above stated data at Shipper/ Carton Level Packaging is as below:

SSCC (Serial Shipping Container Code) to identify individual carton uniquely using application identifier (00)

(Single Label for each carton)

General Notes:

1. While barcoding has been chosen as the automatic identification data capture (AIDC) technology currently, future requirements may demand use of any other data capture technology.

2. Data requirements as stipulated above, take into account minimum level of AIDC marking. MSO

however reserves the right to modify the same and direct implementation of higher level of AIDC marking (additional data requirements) in future, in the event of higher perceived risks in line with GS1 General Specifications.

3. Complete details on GS1 standards along with technical guidelines can be downloaded from

www.gs1india.org or www.gs1.org

4. For any assistance, you can contact support section of GS1. The Contact details of GS1 are available on their website www.gs1india.org

9. General Terms (i) Bidder should note the period for which the offers should remain open for acceptance. The offers from those

firms, who have not kept the validity open till the period stipulated in the Tender enquiry, will be treated as non-responsive and will be ignored without making any back reference. Where any firm keeps the offer valid till the required date as stipulated in the Tender enquiry but at the same time gives a discount clause for shorter validity such discount will be summarily ignored and such offers will be considered only in respect of the price quoted by them for full validity. Bidders may further note that in the absence of any indication of the date up to which the offer has, been kept valid it will be assumed that their offer will remain open for acceptance for the period Specified in the schedule to Tender enquiry. It may further be noted that if the date up to which the offer is to remain open being or is declared a closed holiday for the Government offices, the offer shall remain open for acceptance till the next working day.

(00)189011070000000018

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(ii) Quotations qualified by vague and indefinite expression such as "Immediate Acceptance” "subject to prior sale" etc. will not be considered. Request for advance payment whatsoever will not be considered. Telegraphic / Letter Head/Fax Quotations without complete Tender Documents shall be summarily ignored.

(iii) Withdrawal of any rates after opening of the Tenders will render the, entire offer invalid and also may involve administrative action against the Bidders.

(iv) No deviation in specifications and/or nomenclature of stores will be considered. Packing specifications mentioned in the Tender Document must be strictly adhered to.

10. Firm Delivery Period Clause

10.1 The Bidders should indicate the guaranteed delivery period for completion of supply from date of placement of individual supply orders, against the Rate Contract with monthly rate of supply against individual items quoted by the Bidder with lead time, if any required by them for commencement of supplies. The contract shall be maintained / at the station / stations indicated by them in the Tender.

10.2 Upon receipt of an order from any officer authorized to place orders, the successful Bidder shall, within

seven days intimate, to such officer the quantity which can be supplied within the period stipulated therein and the time required to supply the balance. If the successful Bidders shall fail to give such intimation within the time aforesaid he shall be deemed to have agreed to supply the stores within the delivery date stipulated in the supply order. If the successful Bidders is unable to supply stores or any part thereof within the time specified in the supply order and intimates the time within which the supply order will be made by him the officer placing the supply order will notify his acceptance of the delivery time offered by the contractor or negotiate until an agreement is reached, in all cases, the delivery time as deemed to be accepted by the successful Bidder or agreed upon as aforesaid between him and the officer placing the supply order shall be deemed to be of the essence of the contract and delivery must be completed not later than such date. If in any case no agreement with respect to the delivery time is reached between the contractor and the officer who has issued the supply order, It shall be lawful for such officer to withdraw the supply order, and the contractor shall have no claim in respect of such withdrawals.

11. Delays in the Supplies Performance of the Contract

11.1 Delivery of the stores shall be made by the supplier in accordance with the time scheduled, as per clause 10 above. Any deviation performance of its delivery obligations shall render the supplier liable to any or all of the following action. (a) Forfeiture of its Earnest Money Deposit /Performance Security Deposit and / or (b) Imposition of penalty and/or (c) Termination of the contract for default.

11.2 If at any time during the performance of the contract, the supplier should encounter conditions impending

timely delivery of the goods, the supplier shall promptly notify the purchaser in writing of the facts of the delay its likely duration and its clause(s). As soon as practicable after receipt of the suppliers notice, the purchaser shall evaluate the, situation and may at Its discretion extend the suppliers time for performance in which case the extension shall be ratified by the parties by amendment of the contract. The extension of the delivery period will be subject to the following conditions.

a. The Purchaser shall deduct from the contractor under the provision of Clause 12 penalty / liquidated damages on

the stores, which the contractor has failed to deliver within the delivery period fixed for delivery.

12. Penalty Clause

If the supplier fails to deliver any or all of the goods within the time period(s) specified in the contract the purchaser shall without prejudice to its other remedies under the contract, deduct from the contract price, as liquidated damages a sum equivalent to 1% of the delivered price of the delayed goods for each week of delay or part thereof, until actual delivery up to a maximum deduction of 10 percent of the delayed goods contract price. Once the maximum is reached, the purchaser may consider termination of the contract.

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13. Termination for Default 13.1 The purchaser may without prejudice to any other remedy for breach of contract, by written notice of default sent to

the supplier, terminate the contract in whole or in part a. If the supplier fails to deliver any or all of the goods within the time periods specified in the contract or any

extension thereof granted by the purchaser pursuant to Penalty clause 12. Or

b If the supplier fails to promptly replace any goods rejected submitted for testing or subject to recall ordered by the applicable Regulatory Authority in the country of manufacture due to unacceptable quality or reports of adverse drugs reaction after giving prompt notice of the recall.

c. If the supplier fails to perform any other obligation(s) under the contract. 13.2. In the event, the purchaser terminate the contract in whole or in part, pursuant to above clause 13.1 and without

prejudice to the purchaser’s other remedies, the purchasers may procure upon such terms and in such manner as it deems appropriate, goods or services, similar to those undelivered or unformed, the supplier shall be liable to the purchasers for any excess cost for such similar goods. However, the supplier shall continue performance of the contract to the extent not terminated.

14. Force Majeure 14.1 Notwithstanding provisions of clause 11, 12 and 13 the supplier shall not be liable for forfeiture of its performance

security, penalty or termination for default if and to the extent that, it’s delay in performance or other failure to perform its obligations under the contracts is the result of an event of force majeure

14.2 For the purpose of this clause, force majeure means an event beyond the control of the supplier and not involving the

suppliers fault or negligence and not foreseeable and unanticipated by and not brought about at the instance of the supplier and which has caused the non-performance or delay in performance. Such events may include, but are not restricted to, acts of the purchaser either in its Sovereign or contractual capacity, wars or revolutions, fires, floods, epidemics, quarantine restriction and freight embargoes.

14.3 If a force majeure situation arises, the supplier shall promptly notify the purchaser in writing of such conditions 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 reasonably practical and seek all reasonable alternative means for performance not prevented by the force majeure event.

15. Fall Clause 15.1. The Bidder should confirm acceptance to the fall clause given herein under 15.2 The price charged for the store supplied under the contract by the contractor shall in no event exceed the lowest price

at which the contractor sells the stores or offers to sell stores of identical description to any persons / organisations including the purchaser or any Department of the Central Government or any Department of a State Government or any statutory Undertaking of the Central or State Government, as the case may be during the period till performance of all supply orders placed during the currency of the Rate Contract is completed. In any subsequent date after submission of the quotation or placing of a supply order, the manufacturer (the term manufacturer will also include his authorised distributor/agent) reduces the sale price of such stores “ In case there is a fall in the institutional price due to reduction in price of raw material, customs duty exemption etc. the manufacturer will have to reduce the price proportionately ” or sells or offers to sell such stores to any other party at a price lowest than the price charged/chargeable against the supply order placed by the Medical Stores Depot, the manufacturer (including his authorised distributor/agent as aforesaid in case the quotation is submitted by them and the supply is also effected by them) Will forth-with notify such reduction in sale price to the officer-in-charge of the Govt. Medical Store Depot and the price payable for the stores to be supplied against the supply order after the date of such reduction in sale price coming into force, shall stand correspondingly reduced. The above stipulation will, however, not apply to: (a) Export / Deemed Exports by the Contractor

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(b) Sale of drugs which have short leftover expiry dates, and (c) Tender submitted in response to fixed quantity contract enquiries issued by MSO.

15.3. Contractor shall submit a certificate to the concerned Pay and Accounts Officer at the time of claiming payment for

supplies made against Rate Contract that stores of description identical to the stores supplied to GMSD(s) under the Rate Contract have not been offered / sold by them to any persons / organizations up to the date of bill / completion of supply against all supply orders placed at a price lower than the price charged to the purchaser(s) under the Rate Contract. It is further certified that there is no fall in the institutional price due to reduction in price of raw material, customs duty exemption etc. and in such case, the manufacturer will have to reduce the price proportionately.

16. Samples against this Tender inquiry if called for shall be furnished by the date stipulated. Failure to do so will entail

the quotation being ignored.

17 Inspection and Tests

17.1 The purchaser or its representative shall have the rights to inspect and/or to test the goods to confirm their conformity to the contract technical specifications. The inspection and tests shall be conducted at the manufacturer works and/or at the goods final destination and inspection note will be released on receipt of satisfactory test report.

17.2 Unless otherwise provided for in the contract if the special tests or independent test proves satisfactory and the stores or any instalment thereof is accepted, the quantity expended in test will be deemed to have been taken delivery of/by the purchaser and, be paid for as such.

17.3 (A) Should any inspected or tested goods fail to conform to the specifications, the purchaser may reject them and the supplier will remove the rejected stores at their cost.

(B) In case any item is found substandard either at the inspection stage or during the shelf life of the

item, the report of the Government approved laboratory shall be accepted by the firms. If the same is disputed by the firms giving the reasons, the sample will be sent to Central Drug Laboratory, Kolkata and the report of CDL will only be accepted as final and conclusive report. The de-registration / debarment action will be taken against the manufacturing unit and contract holding firms (both) according to the category-A and category-B defects as per guidelines issued by the Ministry of Health & Family Welfare. (Appendix-I)

(C) In the event of failure of their products, in addition to the debarment /de-registration action, the 5%

performance security of the suppliers will be forfeited and the testing charges involved will be recovered by MSO/GMSDs from the supplying firms.

17.4 The purchasers right to inspect, test and, where necessary reject the goods after the goods arrival at the final

destination shall in no way be limited or waived by reason of the goods having previously been inspected, tested and passed by purchaser or its representatives prior to the goods dispatch from the place of manufacture.

17.5 Nothing in clause 17.3 shall in any way release the supplier from any warranty or other Obligations under the contract.

17.6 The supplier will be responsible to take back the rejected stores from the depots/consignee place and replace with fresh stock duly inspected within forty five days or as stipulated in the notice issued to the supplier, at their own cost up to the consignees or depots.

17.7 In case of Pre Despatch Inspection, stores will be delivered at consignee’s side within the validity of the

inspection note. 18. Non-supply and/or rejection on inspection/test repeatedly will be considered as bad Performance, which would render

the Bidders liable to be debarred from participation of the Bidders In future.

19. Transit Insurance

19.1 The depot shall not be responsible for any breakage/leakage/shortage during transit etc.

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19.2 The purchaser will not pay separately for transit insurance and the supplier will be responsible till the entire stores contracted for arrive in good condition at destination.

20. No material assistance whatsoever will be provided by the purchaser. 21. All Tender documents attached with the invitation to tender are Sacrosanct for considering any offer as a complete

offer.

22. Termination for Solvency The purchaser may at any time terminate the contract by giving written notice to the supplier without compensation to

supplier if the supplier becomes a bankrupt or otherwise insolvent provided that such termination will not prejudice to affect any right of action or remedy which has accrued or will accrue thereafter to the purchaser.

23. Laws Governing the Contract

23.1 This contract shall be governed by the laws of India for the time being in force

23.2 Irrespective of the place of delivery, the place of performance or place of payment under the contract, the contract shall be deemed to have been made at the place from which the contract has been issued.

23.3 The court of the station of the depot placing the orders shall alone have the jurisdiction to decide any dispute

arising out of or in respect of the contract.

24. Resolution of Disputes

24.1 The purchaser and the supplier, shall make every effort to resolve amicably by direct informal negotiation any disagreement or dispute arising between them under or In connection with the contract

24.2 If, afte