bid document for rate contract for supply of generic drugs for …€¦ · start date and time for...
TRANSCRIPT
Government Medical Store Depot Directorate General of Health Services
Medical Store Organization
Bid Document For
Rate Contract for Supply of Generic Drugs for a Period of Two Years
Government Medical Store Depot Chennai – 600 003 Medical Store Organization
Directorate of General of Health Services Ministry of Health and Family welfare
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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 ............................................................................................................ 10
General Instructions To Bidders .......................................................................... 10
Definitions and Abbreviations .............................................................................. 10
Definitions ............................................................................................................ 10
Abbreviations ....................................................................................................... 11
Introduction .......................................................................................................... 11
Registration of Manufacturing Units ..................................................................... 12
Bid securing declaration / Earnest Money Deposit .............................................. 12
Validity of the Bid ................................................................................................. 12
Performance Security Deposit ............................................................................. 12
Eligibility Criteria .................................................................................................. 13
Preparation and Online Submission of Bids ........................................................ 14
Technical Bid ....................................................................................................... 14
Price Bid (BoQ) .................................................................................................... 15
Prices ................................................................................................................... 15
Opening of Technical and Price Bid..................................................................... 15
Minor Infirmity/Irregularity/Non-Conformity .......................................................... 16
Award of Contract ................................................................................................ 16
Other Award Criteria ............................................................................................ 16
Section-III ........................................................................................................... 18
Special Instructions To Bidders ........................................................................... 18
Bid Data Sheet (BDS) .......................................................................................... 18
Chapter-II Conditions of Contract .................................................................... 19
Section –I ............................................................................................................ 20
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General Conditions Of Contract(GCC) ............................................................. 20
Delivery Period .................................................................................................... 20
Rate Contract ...................................................................................................... 20
Packing and Marking Required ............................................................................ 20
Shelf Life .............................................................................................................. 21
Warranty .............................................................................................................. 22
Recalls ................................................................................................................. 22
Annual Estimated Drawls ..................................................................................... 22
Bar coding ........................................................................................................... 23
General Terms ..................................................................................................... 26
Firm Delivery Period Clause ................................................................................ 27
Delays in the Supplies Performance of the Contract ........................................... 27
Penalty Clause .................................................................................................... 27
Termination for Default ........................................................................................ 28
Force Majeure ..................................................................................................... 28
Fall Clause ........................................................................................................... 28
Inspection and Tests ............................................................................................ 29
Transit Insurance ................................................................................................. 29
Termination for Solvency ..................................................................................... 30
Laws Governing the Contract .............................................................................. 30
Resolution of Disputes ......................................................................................... 30
Section –II ........................................................................................................... 31
Special Conditions Of Contract (SCC)............................................................................ 31
Chapter-III Schedule of Requirement ............................................................... 32
Chapter-IV Specifications and allied Technical Details .................................. 36
Chapter-V Price Schedule ................................................................................. 38
Chapter-VI Standard Forms .............................................................................. 40
Form-I Rate Contract Form .................................................................................. 41
Form-II Bid-Securing Declaration ........................................................................ 42
Form-III Bank Guarantee Form for Performance Security ................................... 43
Chapter-VII Other Bid Forms (Annexure) ......................................................... 44
Annexure-A Check list of List of Scanned Documents to be uploaded in pdf format in Volume I ................................................................................................ 45
Check list of List of Scanned Documents to be uploaded in pdf format in Volume II........................................................................................................................... 45
Annexure-B Letter Of Bid .................................................................................... 46
Annexure-C Bidder information form ................................................................... 47
Annexure-D Questionnaire .................................................................................. 48
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Annexure-E Certificate Regarding De-Registration/ Debarred / Blacklisted / Banning / Suspended For Business Etc .............................................................. 49
Annexure-F Details Of Items Quoted In The Tender Without Rate..................... 50
Annexure-G Manufacturing & Marketing Certificate ........................................... 51
Annexure-H Details Of All Manufacturing Units Of The Bidder ........................... 52
Chapter-VIII Appendix ....................................................................................... 53
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 ........... 54
Appendix-II Public Procurement (Preference to Make in India), Order 2017 ...... 59
Appendix-III Purchase preference as per Public Procurement Policy for Micro & Small Enterprises ................................................................................................. 63
Appendix-IV Procedure for Registration of Manufacturing Unit…………………..64
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Notice Inviting Tender (NIT)
Tender Number: GMSDCHN /Group-A/50 INJ/ 2018-19/02
Govt. Medical Store Depot, Chennai ,Medical Store Organization, DGHS, (hereinafter referred as Tenders Inviting Authority unless the context otherwise requires) invites Online Bids for Generic Drugs as enclosed in Chapter-III –(Schedule of Requirements ) included in the Vocabulary of Medical Store(VMS Book) through e-procurement portal https://eprocure.gov.in/eprocure/app (Two bids System i.e. Technical Bid and Price Bid) for Supply of Generic Drugs for a period of two years from the date of conclusion of Rate contract.
Bidders are advised to participate online and complete set of bidding documents can be downloaded from Medical Stores Organisation” website “https://mso.gov.in or Directorate General of Health Services website “dghs.gov.in” or from central procurement portal “eprocure.gov.in” bearing Tender ID No. No. 2018_DGHS_386136_1
Bidding Schedule
Date of Issue/Publishing of Tender 20.09.2018 at 10.00 Hrs
Start Date and time for downloading tender documents
20.09.2018 at 11.00 Hrs
Date and Venue of Pre-bid Meeting and awareness/ orientation session
04.10.2018 at 11.00 Hrs
Government Medical Store Depot 37, Naval Hospital Road, Periamet,
Chennai – 600 003
Start date and time for submission of online Bids 06.10.2018 at 10.00 Hrs
Last date and time for submission of online Bids 27.10.2018 at 15.00 Hrs
Date and time of opening Technical Bids online 29.10.2018 at 11.00 Hrs
Tender opening venue Government Medical Store Depot
37, Naval Hospital Road, Periamet, Chennai – 600 003.
Date and time of opening of Price Bids online Will be informed later on
Address for Communication and Website
Government Medical Store Depot 37, Naval Hospital Road, Periamet,
Chennai – 600 003. Tel No. 044-25610621 / 25610822
Fax No. 044-25611459 E-mail: [email protected]
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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 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 Medical Stores Organisation” website
“https://mso.gov.in or from the website “dghs.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.
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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.
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 Chennai, No.37, Naval Hospital road, Periamet, Chennai -600 003_as specified in the bidding schedule and interested bidders can participate there.
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(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 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 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).
(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.
(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 firm will be debarred/de-registered for bidding a period of three years.
(5.4) Deleted.
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 direct demanding officer /Purchaser and the bank guarantee should be in favour of direct demanding officer
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/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 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.
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 from Medical Stores Organisation” website
“https://mso.gov.in or from the website “dghs.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
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(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 20% of total tendered value.
(iii) A sub –target of Min. 20% (i.e. 4% out of 20%) 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
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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.
(ii) Blister /Aluminum strip pack of not more than 140 tabs /caps should be packed in thick cardboard box so that container should provide adequate protection to the drugs. However, manufacturers of items having market packs more than 140 tablets per carton may submit their specifications and proper justification in support of their bigger packing for consideration before supply is made to the consignee Depots.
(b) 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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( 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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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 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.
28
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
29
(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.
30
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, after thirty (30) days from the commencement of such informal negotiations, the purchaser and the supplier have been unable, to resolve amicably a contract dispute, either party may require, that the dispute be referred for resolution, to the formal mechanism specified in clause 24.3.below.
24.3 The dispute resolution mechanism to be applied pursuant to clause 24.2 shall be as follows:
a) In event of any dispute or difference between the parties hereto, such disputes or differences shall be resolved amicably by mutual consultation. If such resolution is not possible, then the unresolved dispute or difference shall be referred to arbitration of the sole arbitrator to be appointed by Ministry of Health on the recommendation of the Secretary, Department of Legal Affairs (“Law Secretary”), Government of India. The provisions of Arbitration and Conciliation Act, 1996 (No. 26 of 1996) shall be applicable to the arbitration under this clause. The venue of such arbitration shall be at Delhi or any other place, as may be decided by the arbitrator. The language of arbitration proceedings shall be English. The arbitrator shall make a reasoned award (the “Award”), which shall be final and binding on the parties”. The expenses of the arbitration proceedings shall be shared equally by the parties to the agreement. However, Expenses incurred by each party in connection with the preparation, presentation shall be borne by the party itself.
b) Pending the submission of and / or decision on a dispute, difference or claim or until the arbitral
award is published; the Parties shall continue to perform all of their obligations under this Agreement without prejudice to a final adjustment in accordance with such award.
24.4 The venue of arbitration shall-be New Delhi or the stations of respective depots placing orders.
31
Section –II
Special Conditions Of Contract (SCC)
The following Special Conditions of Contract (SCC) will apply for this purchase. These Special Conditions of Contracts will modify/supplement the corresponding General Conditions of Contract (GCC). The corresponding GIT clause numbers have also been indicated in the text below:
In case of any conflict between the provision between the provision in the GCC and that in the SCC, the provision contained in the SCC shall prevail.
S/No. GCC Clause No.
Topic SCC Provision
1. Chapter-II , Section I , Clause No 3. Packing and Marking Required, Para 3.1 Packing For Tablets And Capsules, Sub Para 3.1(a) initial packing
Packing of Tablets and Capsules
Modified as:- 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.
32
Chapter-III
Schedule of Requirement
33
Schedule of Requirements List of drugs for which bids are invited, along with specification.
Sl.NO
Item Description ( Nomenclature + Strength + Dosage Form + Specification) VMS No PACK SIZE
ITEM
GROUP
Remarks (if any)
1
METHYLPREDNISOLONE ACETATE
INJECTION I.P 40 MG/ ML G18003 Box of 10 Vials of 1 mL A
2
TESTOSTERONE PROPIONATE INJECTION
I.P 25MG/ML G18007 Box of 10 Amp of 1 mL A
3
HORMONE RELEASING IUD
(LEVONORGESTREL RELEASING IUD ) G18010
Box of 25 INTRA
UTERINE DEVICE A
4 INSULIN (SOLUBLE) INJECTION 40IU /ML G18018 Box of 10 vials of 10 mL A
5 GLUCAGON INJECTION 1 MG / ML G18021
Mono Carton of VIAL
of 1 mL A
6
AQUEOUS IODINE ORAL SOLUTION
SOLUTION 8 MG / 5 ML G18031
Mono Carton of
BOTTLE of 100 mL A
7 ESTRADIOL GEL SINGLE USE PATCH 0.10% G18049 Box of 10 SACHETS A
8
GNRH ANALOGUE LEUPROLIDE ACETATE
INJECTION 3.75MG G18050 VIAL of 3.75 mg A
9 FSH INJECTION 200 IU/ML G18053 VIAL A
10 DMPA INJECTION 50MG/ML G18054 AMP of 3 mL A
11 DMPA INJECTION 150MG/ML G18055 AMP of 3 mL A
12 ESTRIOL CREAM 0.1%W/W G18059 Box of 10 Tubes of 15 g A
13
HYDROXYPROGESTERONE INJECTION I.P
250MG/ML G18067 Box of 10 Amp of 1 mL A
14
CHORIONIC GONADOTROPHIN INJECTION
I.P 5000IU/ML G18074 AMP of 1 mL A
15
BASIC ISOPHENE INSULIN(25%
SOLUBLE+75% ISOPHENE) R DNA ORIGIN
INJECTION 100IU/ML G18096 FLEXPEN of 3 mL A
16
BASIC ISOPHENE INSULIN(25%
SOLUBLE+75% ISOPHENE) R DNA ORIGIN
INJECTION 40IU/ML G18097
Box of 5 Cartrideges of
3 mL A
17
BASIC ISOPHENE INSULIN(25%
SOLUBLE+75% ISOPHENE) R DNA ORIGIN
INJECTION 40IU/ML G18098 VIAL of 10 mL A
18
BASIC ISOPHENE INSULIN(50%
SOLUBLE+50% ISOPHENE) R DNA ORIGIN
INJECTION 100IU/ML G18099
Box of 5 Cartridges of 3
mL A
19
BASIC ISOPHENE INSULIN(50%
SOLUBLE+50% ISOPHENE) R DNA ORIGIN
INJECTION 100IU/ML G18100 VIAL of 10 mL A
20
BASIC ISOPHENE INSULIN(50%
SOLUBLE+50% ISOPHENE) R DNA ORIGIN
INJECTION 100IU/ML G18101 FLEXPEN of 3 mL A
21
BASIC ISOPHENE INSULIN(50%
SOLUBLE+50% ISOPHENE) R DNA ORIGIN
INJECTION 40IU/ML G18102
Box of 5 Cartriges of 3
mL A
22
BASIC ISOPHENE INSULIN(50%
SOLUBLE+50% ISOPHENE) R DNA ORIGIN
INJECTION 40IU/ML G18103 FLEXPEN of 3 mL A
23
BASIC ISOPHENE INSULIN(50%
SOLUBLE+50% ISOPHENE) R DNA ORIGIN
INJECTION 40IU/ML G18104 VIAL of 10 mL A
24
BASIC ISOPHENE INSULIN(30%
SOLUBLE+70% ISOPHENE) R DNA ORIGIN
INJECTION 40IU/ML G18105
Box of 5 Cartriges of 3
mL A
34
25
BASIC ISOPHENE INSULIN(30%
SOLUBLE+70% ISOPHENE) R DNA ORIGIN
INJECTION 100IU/ML G18106
Box of 5 Cartriges of 3
mL A
26 BETAMETHASONE INJECTION 4MG/ML G18109 Box of 50 Amp of 1 mL A
27 EXENATIDE INJECTION 5MCG G18119 INJECTION of 1.2 mL A
28 INSULIN GLARGINE INJECTION 100IU/ML G18136 VIAL of 10 mL A
29 INSULIN GLARGINE INJECTION 100IU/ML G18137
Box of 5 Cartriges of 3
mL A
30 INSULIN GLARGINE INJECTION 100IU/ML G18138 FLEXPEN of 3 mL A
31 INSULIN (SOLUBLE) INJECTION 100IU /ML G18139
Box of 5 Cartriges of 3
mL A
32 INSULIN (SOLUBLE) INJECTION 100IU /ML G18140 FLEXPEN of 3 mL A
33
ISOPHANE INSULIN, RDNA,
MONOCOMPONENT HUMAN INSULIN,
BISYNTHETIC INJECTION 40IU /ML G18141 VIAL of 10 mL A
34
ISOPHANE INSULIN, RDNA,
MONOCOMPONENT HUMAN INSULIN,
BISYNTHETIC INJECTION 100IU /ML G18142
Box of 5 Cartriges of 3
mL A
35
ISOPHANE INSULIN, RDNA,
MONOCOMPONENT HUMAN INSULIN,
BISYNTHETIC INJECTION 100IU /ML G18143 FLEXPEN of 3 mL A
36 NPH HUMAN INSULIN INJECTION 100IU/ML G18144 VIAL of 10 mL A
37 METHOXSALEN LOTION 1% G18173
Box of 10 Bottles of 25
mL A
38 METHOXSALEN LOTION 0.75% G18174
Box of 10 Bottles of 30
mL A
39
NANDROLONE DECONATE INJECTION
25MG /ML G18179 Box of 10 Vials A
40
NANDROLONE DECONATE INJECTION
50MG /ML G18180 Box of 10 Vials A
41
NANDROLONE DECONATE INJECTION
100MG /ML G18181 Box of 10 Vials A
42
PYRIDOSTIGMINE BROMIDE INJECTION 5
MG / ML G20006 Box of 10 Amp of 2 mL A
43 CHLORPROMAZINE SYRUP 25 MG / 5 ML G24004
Box of 10 Bottles of 100
mL A
44
CHLORPROMAZINE INJECTION I.P 25 MG /
ML G24005 Box of 25 Amp of 2 mL A
45 HALOPERIDOL INJECTION I.P 5 MG / ML G24009 Box of 10 Vials of 1 mL A
46
FLUPHENAZINE DECONATE INJECTION I.P
25MG/ML G24037 Box of 10 Amp of 1 mL A
47 RESPERIDONE LIQUID 1MG. G24041
Box of 10 Bottles of 50
mL A
48 LORAZEPAM INJECTION 2MG/ML G24044 Box of 10 Amp of 2 mL A
49 OLANZAPINE INJECTION 10MG G24045 Box of 10 Amp of 2 mL A
50 TRICLOFOS ORAL SOLUTION 500MG/5ML G24059
Box of 10 Bottles of 5
mL A
35
36
Chapter-IV
Specifications and allied Technical Details
37
Specifications and allied Technical Details
As indicated in the Schedule of requirement against each drug
38
Chapter-V
Price Schedule
39
PRICE SCHEDULE
Enclosed as BOQ at . xls format to be submitted online only
Tender Enquiry Authority : Govt. Medical Store Depot ______ ,Medical Store Organization, DGHS
Name of the Work: Supply of Generic Drugs for a period of two years from the date of conclusion of Rate contract Contract No: Name of the Bidder/ Bidding Firm / Company :
Sl.
No.
Item
Description
VMS Quantity For
Which Rate
is to be
Quoted(Rate
Unit) R/U
Packing
/Pack
Size
Item
Group
Basic
Price
Quoted
Per
Rate
Unit
(R/U)in
Rs.
GST
in (%)
Price offered
(inclusive of
all Taxes)
per Rate
Unit(R/U)
(Rs.)
Price
Offered
Per Rate
Unit
(R/U)
In Words
40
Chapter-VI
Standard Forms
41
Form-I
Rate Contract Form
_________________________
_________________________
(Address of the purchaser’s Office issuing the contract)
Contract No___________ dated______________
Subject: The Rate Contract for Supply of Drugs to MSO / GMSDs valid for a period of ___
Years from Date _____________ to Date __________
1. Name & address of the Supplier: ______________________________
2. Purchaser’s Tender document No________ dated___________and subsequent Amendment
/Corrigendum No____________, dated_________ (if any), issued by the purchaser
3. Supplier’s Tender No_________ dated_________and subsequent communication(s) No____________
dated _________ (if any), exchanged between the supplier and the purchaser in connection with this
tender.
4. In addition to this Contract Form, all documents etc., which are included in the documents mentioned
under paragraphs 2 and 3 above and Purchaser’s Notification of Award, shall also be deemed to form
and be read and construed as integral part of this contract
5.Brief particulars of the goods and services which shall be supplied/ provided by the supplier are as
under:
Sl
No.
Brief description
of goods/services
Packing Shelf
Life
Accounting
unit
Rate
Unit
Unit
Price
Remarks
____________________________
(Signature, name and address
of the purchaser’s authorised official)
For and on behalf of__________________ Received and accepted this contract
________________________________________________
(Signature, name and address of the supplier’s executive
duly authorised to sign on behalf of the supplier)
For and on behalf of _________________________
(Name and address of the supplier)
____________________
(Seal of the supplier)
Date: _________________________
Place: _________________________
42
Form-II
Bid-Securing Declaration
Date: [insert date (as day, month and year)]
Tender No.: [insert number of tendering process]
Alternative No.: [insert identification No if this is a Bid for an alternative]
To: [insert complete name of the Tender Inviting Authority]
I/We*, the undersigned, declare that:
I/We* understand that, according to your conditions, bids must be supported by a Bid-Securing
Declaration.
I/We* accept that I/we* may be disqualified/ suspended from bidding for any contract with the MSO/
GMSDs/ Tender inviting Authority for the period of 3 years, if I am/we* are* in breach of any obligation
under the bid conditions, because I/we*:
(a) have withdrawn or modified my/our* Bid during the period of bid validity specified in the
Form of Bid; or
(b) having been notified of the acceptance of our Bid by the [MSO/ GMSDs/ Tender
inviting Authority] during the period of bid validity, (i) fail or refuse to execute the
Contract, if required, or (ii) fail or refuse to furnish the Performance Security, in
accordance with the Instruction to Bidders.
I/We* understand this Bid Securing Declaration shall cease to be valid if I am/we are* not the successful
Bidder, upon the earlier of (i) the receipt of your notification of the name of the successful Bidder; or (ii)
thirty days after the expiration of the validity of my/our* Bid.
Signed: [insert signature of person whose name and capacity are shown]
In the capacity of [insert legal capacity of person signing the Bid Securing Declaration]
Name: [insert complete name of person signing the Bid Securing Declaration]
Duly authorized to sign the bid for and on behalf of: [insert complete name of Bidder]
Dated on ____________ day of __________________, _______ [insert date of signing]
Corporate Seal (where appropriate)
[Note: In case of a Joint Venture, the Bid Securing Declaration must be in the name of all partners to the
Joint Venture that submits the bid.]
43
Form-III
Bank Guarantee Form for Performance Security
To
WHEREAS _____________________________ (Name and address of the supplier) (Hereinafter
called “the supplier”) has undertaken, in pursuance of contract no___________________ dated
_____________ to supply (description of goods and services) (herein after called “the contract”).
AND WHEREAS it has been stipulated by you in the said contract that the supplier shall furnish you
with a bank guarantee by a scheduled commercial bank recognized by you for the sum specified therein
as security for compliance with its obligations in accordance with the contract;
AND WHEREAS we have agreed to give the supplier such a bank guarantee;
NOW THEREFORE we hereby affirm that we are guarantors and responsible to you, on behalf of the
supplier, up to a total of. ________________________ (Amount of the guarantee in words and figures),
and we undertake to pay you, upon your first written demand declaring the supplier to be in default under
the contract and without cavil or argument, any sum or sums within the limits of (amount of guarantee)
as aforesaid, without your needing to prove or to show grounds or reasons for your demand or the sum
specified therein.
We hereby waive the necessity of your demanding the said debt from the supplier before presenting us
with the demand.
We further agree that no change or addition to or other modification of the terms of the contract to be
performed there under or of any of the contract documents which may be made between you and the
supplier shall in any way release us from any liability under this guarantee and we hereby waive notice of
any such change, addition or modification.
This guarantee shall be valid up to and including the ______ day of ___________, 20___
(Signature with date of the authorised officer of the Bank)
………………………………………………………….
Name and designation of the officer
………………………………………………………….
………………………………………………………….
Seal, name & address of the Bank and address of the Branch
44
Chapter-VII
Other Bid Forms (Annexure)
45
Annexure-A
Check list of List of Scanned Documents to be uploaded in pdf format in Volume I
SlNo Documents to be uploaded At Page No
1 Copy of duly filled , signed & stamped of Check list of documents uploaded in Technical Bid ( Annexure A)
2 Copy of the Bid Securing Declaration as per Clause 4.(Form II)
3 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.
4 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
5 The Bidder Information form ( Annexure-C)
6 Questionnaire (Annexure- D )
7 Copy of Latest Income Tax Return and GST Return
8 Copy of valid NSIC Registration/MSME Certificate if any
9 Certificate regarding de-registration/ debarred / blacklisted / banning / suspended for business etc. (Annexure-E)
10 The annual turnover statements for formulations for the last two years duly certified by the Auditor / chartered accountant.
11 Non-conviction certificate for two continuous years from the Drug Controller of the State
12 Details of item quoted in the tender without Rate (Annexure-F)
13 Certificate from the Manufacturers or Chartered Accountant regarding two years 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).
14 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)
15 Copies of CoPP (Certificate of Pharmaceutical Product) in respect of the imported formulations/drugs quoted in the Tender.
16 Copy of self-certification / Certificate of Cost Auditor / Chartered Accountant that the item offered meets the minimum local content ( in case of local supplier ) as per provisions of the order placed at Appendix-II
Check list of List of Scanned Documents to be uploaded in pdf format in Volume II
1 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.
2 Letter of Bid ( Annexure-B) along with the Tender Document duly ink signed and stamped on each page
3 Copy of Certificate of original manufacturer of product from the State Drug Controller) if any
4 Copy of Certificate of sole manufacturer of product from State Drugs Controller if any.
Note*-The certificates issued should not be more than one year old on the date of opening of the Tender.
(Signature of the Bidder)
Name in block letters _________________________________
Capacity in which the Tender has been signed with stamp/seal _____________________
46
Annexure-B
Letter Of Bid
(To be given on Company Letter Head) To
The Deputy Asst. Director General (Stores) Dte. General of Health Services (Medical Stores Organization) No.37, Naval Hospital Road, Periamet, Chennai - 600 003
Sub: Letter of Undertaking and Acceptance of Terms & Conditions of Tender.
Tender Reference No:
Madam/Sir,
(1) I/We hereby offer to supply the stores detailed in the Tender Document, or such portion thereof as you may specify in the order, at the price given in the Price Bid (BOQ) and agree to hold this offer open till 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) from the date of the Tender opened or extended date of opening.
(2) I/We have read and understood the Tender Document and instruction to Bidders mentioned in therein which form part of the contract /agreement and I / we shall abide hereby by the terms / conditions / clauses contained therein and examine the specifications quoted in the Tender hereto and am/are fully aware of the nature of the stores required and my/our offer is to supply stores strictly in accordance with the requirement.
(3) I/We further convey our unconditional acceptance to all your standard terms and conditions specified in the Tender Document (s)/ Corrigendum(s) and the instructions to Bidders, in toto.
(4) I/We also herby certify that we have submitted all the documents as mentioned in the check list and if any of the information submitted by us, is found false/incorrect, Tender Inviting Authority has full right to reject our tender and debar to participate in any procurement process for a period of 3 years from the date of debarment.
(5) In case any provisions of this tender are found violated , then your department/ organization shall without prejudice to any other right or remedy be at liberty to reject this tender/bid absolutely.
(6) All the Tender documents are duly filled in and signed by me/us with stamp / seal without any alteration in the prescribed proformas.
Yours faithfully,
(Signature of Bidder)
Name in Block Letters__________________________________________
Capacity in which Tender has been signed With rubber seal ___________________________________________
Address in Full_______________________________________________
Date Place
Authorized signatory should attach in original letter of authority on the letter head of the firm duly signed by a Proprietor / partners / companies through memorandum of association / board meeting
47
Annexure-C
Bidder information form
(Proforma to be Filled in by the Bidder)
(I) General Information
(a) Name of the firm. (b) Address (c) Email & Telephone No. (d) Whether the firm is Indian / Multi-national. (e) Whether small / medium / large-scale company. (f) Person responsible for conduct of business. (g) Particulars of Licenses held under Drugs & Cosmetics Act & the details. (If the license is under renewal.
Certificate from the Drug Controller that the License is under renewal and deemed to be in force should be enclosed.
(h) Details of all manufacturing units of the dugs quoted by the Bidder, which are registered / applied for registration with MSO viz-Name, Address, MSO Registration Number, Categories of Pharmaceutical
dosage forms for supply of which registered, Validity period of registration. (Annexure H) (i) The other Procurement agency with which registered and the agencies to whom drugs quoted supplied
during last one year. (j) (i) Has the firm even been convicted, if yes give details.
(ii) Any case pending in Court with details. (k) Have the firm ever been black listed / debarred by any procurement agency. If yes, details thereof. (l) Has the firm ever been debarred / black listed for supply of drug / drugs by M.S.O. If yes, give details.
(II) Financial
(a) Annual turnover for formulations during the last two years. (Year wise).
(b) Name and address of the bankers to the firm and the facilities available for the bank. (c) PAN Number (d) GST Registration Details
DECLARATION
I______________________________ proprietor / partner / director of M/s _____________________________________ hereby declare that the information given in this form is true and correct to the best of my knowledge and belief.
(Signature of the Bidder)
Name in block letters _________________________________
Capacity in which the
Tender has been signed with stamp/seal _____________________
Address in full _________________________________
E-mail Address _________________________________
Fax No. __________________________________
Telephone No. _________________________________
Date ___________________________
48
Annexure -D
Questionnaire
Directorate General Of Health Services
(Medical Stores Organisation)
Additional Questionnaire for Rate Contract Enquiries
Sl.NO Questions Reply 1 What is your Assessed/Installed capacity?
Have you enclosed documentary evidence in support thereof
2 (i) Are you MSME or registered as small Scale unit with the NSIC. If so, indicate your current Registration number and date and period up to which the registration is valid.
(ii) In case you are MSME or registered with NSIC for the item quoted, confirm whether you have attached a photocopy of the registration certificate Indicating the items for which you are registered.
3 Have you furnished attested copy of your latest and valid Drug Manufacturing License issued by State Drug Controller indicating each of the item for which Tender is submitted.
4 Have you furnished the copies of Registration certificates/application for registration of all manufacturing units of the drugs in respect of the Domestically Manufactured formulations/ drugs quoted in the Tender submitted?
5 Have you furnished copy of valid WHO GMP or COPP (Certificate of Pharmaceutical Product) in respect of the imported formulations/ drugs quoted in the Tender?
6 Have you furnished attested copy of latest Income Tax Return and GST Return?
7 Have you furnished attested copy of last two years statement of accounts duly audited and certified by CA / Auditor in support of your annual turnover of Rs 50 Crores and above
8 Have you furnished a notarized copy of the power of attorney in favor of the persona(s) signing the BID to bind the manufacturer / Bidder to the contract?
9 Does the product fall under the previews of Essential Commodities Act 1955 and Drugs Price Control Order 2013 and the price quoted do not exceed notified price.
10 Have you furnished self-certification / Certificate of Cost Auditor / Chartered Accountant that the item offered meets the minimum local content ( in case of local supplier ) as per provisions of the order placed at Appendix-II
(Signature of the Bidder)
Name in Block Letters………………….. Seal Date
49
Annexure-E
Certificate Regarding De-Registration/ Debarred / Blacklisted / Banning / Suspended For Business Etc
(To be submitted by the Bidder in Company’s letterhead)
To, (Name of purchaser) Sub: Certificate regarding de-registration/ debarred / blacklisted / banning / suspended for business etc. Ref Tender Reference No_______________ due on………………………… We certify that we have not been de-registered or debarred or blacklisted or banned / suspended for business for any product or constituent of the product we have quoted, by Medical Stores Organisation (MSO) / GMSD, Director General of Health Services, Ministry of Health & Family Welfare, GOI, New Delhi / Drugs Controller, till the due date of submission of BID as specified in the subject BID. If we, at a later date, are found guilty of suppressing facts in this regard, such act on our part shall be considered a fraudulent practice in accordance with the Instructions to Bidders and the Purchaser shall be entitled to reject our BID and forfeit the BID Security for the product quoted, submitted by us against this Tender. We have also noted that after submission of BID and before award contract, if we are deregistered or debarred or blacklisted by Medical Stores Organisation (MSO) of Directorate General of Health Services, Ministry of Health & Family Welfare, GOI / Drug Controller, our BID will be considered as Non-responsive. Date ________ Signature ____________ Place ________ Print Name ____________ Designation ____________ Common Seal ____________
50
Annexure-F
Details Of Items Quoted In The Tender Without Rate
1. Tender Inviting Authority: ____________________________
2. Tender No: ______________________________________
3. Bidder Name and Address: _______________________
Sl.No of the drug in tender enquiry
VMS No.
Product Description ( Nomenclature + Strength + Dosage Form + Specification + Pack Size ,if relevant )
Packing offered
Shelf Life of item offered (in Months)
Type of Drug Licence ( Self Mfg. OR loan Licence OR Import Licence)
Name and address of Manufacturing unit
Registration No of manufacturing unit (with MSO)
Page No at which Manufacturing License uploaded
Page No at which Annexure-G uploaded
Page No at which Annexure-H uploaded
1 2 3 4 5 6 7 8 9 10 11
Note: The packing of Capsule and Tablet offered should not be more than mono carton / box of 10 x15 strip pack
Note-1. Specification of the drugs should be IP/ NFI if the product is officially in IP / NFI. Where Item is not in included in the IP/ NFI ,
The Specification Should be as per Drug Manufacturing Licence / permitted by the Drug Control Authorities
2. 2. The product offered by the bidder should be of the same dosages form, strength, packing and specifications as demanded. The bidder should use a separate sheet if there is any deviation in the Technical specification of the product offered.
Abbreviations for indicating Specification
IP Indian Pharmacopeia
NFI National Formulary of India
BP British Pharmacopeia
USP United States Pharmacopeia
CPT Confirming to Performance Test / Specification of the Drug as per Drug Manufacturing Licence / permitted by the Drug Control Authorities
Signature along with address & seal of Manufacturer or Chartered Accountant
51
Annexure-G
Manufacturing & Marketing Certificate
This is to certify that M/s__________________________________________________________________________are holding valid manufacturing Licence No. ._________________________________________ Date ___________of the State and they are manufacturing and marketing the following products since the last two years [As on last date of submission of bids]. It is further certified that the following products are also being marketed for the last two years (24 months).
S. No.
Sl. No. of the drug as in tender enquiry
Name of the product& Strength
Pharmacopoeia Specification
Packing
1. 2. 3. 4. 5. 6. 7. 8. 9. 10.
Signature and seal of Manufacturer or Chartered Accountant
Dated: Note: -
1. Firm should have two completed years‟ experience of marketing and manufacturing as on date of opening of the Tender. Bidders holding loan licenses are also acceptable.
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Annexure-H
Details Of All Manufacturing Units Of The Bidder
(Use separate sheet for the drugs manufactured at different manufacturing units) 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.*
1. Name and Address of the Mfg. Unit registered with MSO------------------------------------------------------------------------ 2. Registration No. of the mfg. Unit ------------------------------------------------------------------------------------------------------- 3. Validity period of registration of the mfg. Unit---------------------------------------------------------------------------------------- 4. Categories of Pharmaceutical dosage forms for supply of which registered ------------------------------------------------
5. Manufacturing License No. and “Form No.” of Drugs &Cosmetic Act, on which issued----------------------------------
Sl. No. of the drug as in the Tender enquiry
Name &specification of the drug
Mfg. License No.
Serial No. of the drug in the mfg. license
Date of issue of Mfg. Licence for the drug
Date of marketing the 1st batch (commercial batch)
Total No. of Batches manufactured during last two years (24 months)*
Total Quantity of drug manufactured during last two years (24 months)*
1. 2. 3. 4. 5. 6. 7. 8.
*Note- In case of imported drugs, the total No. of Batches & Quantities imported during last two years (24 months) are to be given by the bidder.
Signature, Name & Designation of authorised signatory along with address & seal of Manufacturer
Note: Firm will have to produce documentary evidence in respect of production as and when asked for.
53
Chapter-VIII
Appendix
54
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
In the event of drugs supplied found substandard in laboratory test, the following deregistration / debarment action will be taken against the manufacturing unit and contract holding firms (both)
(i) For Category 'B' defects, the manufacturer and contractor will be debarred for supply to
MSO of that particular product declared not of standard quality for a period of 3 years.
(ii) In regard to category 'A' defects, the supplier will be debarred for the supply of that product for 3 years from the date of failure and for repeated failure of category „A‟ defect within one year from previous date of failure; the supplier shall be debarred from supply of all products for a period of 5 years.
List of Category 'A' defects and Category 'B' Defects are as follows
Category 'B' Defects Tablets
i) Presence of spot/discoloration ii) Lump formations in few containers due to moisture. iii) Failing in uniformity of weight. iv) Picking. v) Chipping. vi) Capping. vii) Rough surfaces. viii) Brittle Tablets. ix) Non uniformity in diameter. x) Uneven coating. xi) Non declaration of colour used on the label. xii) Failing in limit test (e.g. free salicylic acid). xiii) Assay 70% and above of the label claim for thermo labile products and 5% within
permitted limits for thermo stable products. xiv) Failing in particle size (Griseofulvin tablets). xv) Net content.
Capsules
i) Presence of spots/discoloration. ii) Lump formation in container due to moisture. iii) Failing in uniformity of weight. iv) Cake/lump formation of content of capsule. v) Failing in limit tests (e.g. Analgin and Nifedipine capsules). vi) Assay-70% and above of the label claim for thermo labile products and 5% within
permitted limits for thermo stable products. vii) Net content.
Liquid Orals (syrups /elixirs /solutions/suspensions/ emulsions / mixtures etc.) i) Presence of foreign matter. ii) Change of colour. iii) Presence of suspended matter. iv) Cracking of emulsion. v) Sedimentation. vi) Dispersible cake/lump formation. vii) Net content. viii) Non declaration of colour on label.
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ix) Assay-70% and above of the label claim for thermo labile products and 5% within permitted limits for thermo stable products.
x) Minor variation in pH.
External Preperations (ointment/solutions/cream/liniment/lotions/emulsions/like preparations). i) Separation of phases. ii) Foreign matter. iii) Consistency/ homogeneity. iv) Extradition of content from tube (outside the nozzle/cap). v) Limit test (e.g. kinetic viscosity). vi) Weight/ml. vii) Assay-70% and above of the label claim for thermo labile products and 5% within
permitted limits for thermo stable products. Opthalmic Preparations (eye ointment/drops/solutions etc.) i) Presence of particulate matter. ii) Odour. iii) Clarity. iv) Extradition of content from tube/container v) Consistency. vi) Particles. vii) Assay-70% and above of the label claim for thermo labile products and 5% within
permitted limits for thermo stable products. viii) Minor variation in pH. Powders (oral use) i) Assay-70% & above of the label claim for thermo labile products and 5% within permitted
limits for thermo stable products. ii) Formation of mass/lump/cake) due to moisture. Injectables, Including Transfusion Fluids. i) Presence of particulate matter/glass pieces/precipitation. ii) Change of colour/description. iii) Extractable volume. iv) Uniformity of weight (for dry powders). v) Particle size. vi) Assay-70% and above of the label claim for thermo labile products and 5% within
permitted limits for thermo stable products. vii) Isolated case of fungus growth.
Cosmetics
i) Net content. ii) Not conforming to any other standard as mentioned in IS except for heavy metal test. Bulk Drugs i) Description. ii) Solubility. i) Any other test specified in monograph not mentioned in Category A. Aerosols / Inhalations. i) Assay-70% and above of the label claim for thermo labile products and 5% within
permitted limits for thermo stable products. ii) Number of deliveries per container /water content/deposition of omitted dose (limit). iii) Particulate matter. iv) Pressure testing. v) Delivery rate. vi) Tests such as total acids.
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Mechanical Contraceptives (Condoms). i) Description. ii) Air inflation test. iii) Dimensions iv) Colour fastness. Intrauterial Contraceptives Devices. i) Description. ii) Full test. iii) Flexibility Category „A‟ Defects.
Tablets. i) Assay- below 70% for thermo labile products and below 5% of the permitted limits for
thermo stable products. ii) Disintegration (except for marginal variation to be viewed on case to case basis). iii) Dissolution (except for marginal variation to be viewed on case to case basis). iv) Contamination with foreign matters. v) Most of the tablets observed in powder form inside the strip pouches. vi) Content uniformity. vii) Addition of permitted colour when not recommended in Pharmacopoeia.
Capsules. i) Assay- below 70% for thermo labile products and below 5% of the permitted limits for
thermo stable products. ii) Disintegration (except for marginal variation to be viewed on case to case basis). iii) Dissolution (except for marginal variation to be viewed on case to case basis). iv) Content uniformity.
Liquid Orals i) Assay- below 70% for thermo labile products and below 5% of the permitted limits for
thermo stable products. ii) Presence of foreign matter such as fly/insect. iii) Fungus growth. iv) Non dispersible cake/lump formation. v) Addition of non-permissible colors.
External Preparations. i) Assay- below 70% for thermo labile products and below 5% of the permitted limits for
thermo stable products. ii) Phenol coefficient (RWC) less than label claim
Grade I : less than 16 Grade II : less than 8 Grade III: less than 4
ii) For other soluble disinfectants below 80% of the required limit. iv) Fungal growth.
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Opthalmic Preparation i) Assay- below 70% for thermo labile products and below 5% of the permitted limits for
thermo stable products ii) Foreign matter. iii) Metal particles. iv) Fungal growth. v) Fails in sterility. Powders (Oral use). i) Assay- below 70% for thermo labile products and below 5% of the permitted limits for
thermo stable products. ii) Fungal growth. Powders (External use)
i) Assay-below 70% for thermo labile products and below 5% of the permitted limits for
thermo stable products. ii) Fungal growth.
Injections Including Transfusion Fluids.
i) Sterility. ii) Pyrogen test. iii) Toxicity. iv) Assay- below 70% for thermo labile products and below 5% of the permitted limits for
thermo stable products. v) Fails in any other biological test. vi) Fungal growth in different samples from different sources of same batches.
Sterile Disposable Perfusion Sets.
i) Sterility. ii) Pyrogen test. iii) Toxicity.
Sterile Disposable Hypodermic Syringes.
i) Sterility. ii) Pyrogen test. iii) Toxicity.
Sterile Disposable Hypodermic Needles. i) Sterility. ii) Pyrogen test. iii) Toxicity.
Bulk Drugs
i) Assay-less than permitted limits. ii) Heavy metal test/arsenic test. iii) Sterility. iv) Toxicity. v) Microbial limit test.
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Aerosols/Inhalations i) Assay-below 70% for thermo labile products and below 5% of the permitted limits for
thermo stable products. ii) Leak test. Sera/Vaccine i) Toxicity. ii) Sterility. iii) Potency. Sutures/Catguts i) Sterility. ii) Tensile strength. Mechanical Contraceptives i) Water leakage test. ii) Tensile properties Intrauterine Contraceptive Devices i) Memory test. ii) Ash content. iii) Sterility. iv) Implantation test. Cosmetics i) Use of non-permitted colours/dyes ii) Presence of heavy metal.
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Appendix-II No. P-45021/2/2017-B.E.-II
Government of India Ministry of Commerce and Industry Department of Industrial Policy and Promotion
Dated 15th June, 2017
Udyog Bhawan, New Delhi
To
All Central Ministries / Departments /CPSUs /All concerned
OR DE R
Subject:- Public Procurement (Preference to Make in India), Order 2017
Whereas it is the policy of the Government of India to encourage „Make in India‟ and promote manufacturing and production of goods and services in India with a view to enhancing income and employment, and Whereas procurement by the Government is substantial in amount and can contribute towards this policy objective, and Whereas local content can be increased through partnerships, cooperation with local companies, establishing production units in India or Joint Ventures (JV) with Indian suppliers, increasing the participation of local employees in services and training them. Now therefore the following Order is issued:
1. This Order is issued pursuant to Rule 153 (iii) of the General Financial Rules 2017
2. Definitions: For the purposes of this Order: 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.
„Local supplier’ means 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.
‘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.
„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.
‘Nodal Ministry’ means the Ministry or Department identified pursuant to this order in respect of a particular item of
goods or services.
Procuring entity means a Ministry or department or attached or subordinate office of, or autonomous body controlled
by the Government of India and includes Government companies as defined in the Companies Act.
3. Requirement of Purchase Preference: Subject to the provision of the Order P-45021/2/2017-B.E-II dated 15th
June 2017 (Annexure -M)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.
60
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 3a 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
(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 3a 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.
4. Exemption of small purchases: Notwithstanding anything contained in paragraph3 procurements where the estimated
value to be procured is less than Rs. 5 Lakhs shall be exempt from this Order. However, it shall be ensured by procuring
entities that procurement is not split for the purpose of avoiding the provisions of this Order.
5. Minimum local content: The minimum local content shall ordinarily be 50%. The Nodal Ministry may prescribe a higher
or lower percentage in respect of any particular item and may also prescribe the manner of calculation of local content.
6. Margin of Purchase Preference: The margin of purchase preference shall be 20%
7. Requirement for specification in advance: The minimum local content the margin of purchase preference and the
procedure for preference to Make in India shall be specified in the notice inviting tenders or other form of procurement
solicitation and shall not be varied during a particular procurement transaction.
8. Government E-marketplace: In respect of procurement through the Government E- marketplace(GeM) shall as far as
possible, specifically mark the items which meet the minimum local content while registering the item for display, and
shall, wherever feasible, make provision for automated comparison with purchase preference and without purchase
preference and for obtaining consent of the local supplier in those cases where purchase preference is to be exercise
9. Verification of local content
a. The local supplier at the time of tender bidding or solicitation shall be required to provide self-certification that the item offered meets the minimum local content and shall give details of the location(s) at which the local value addition is made.
b. In cases of procurement for a value in excess of Rs. 10 crores, the local supplier shall require to provide a
certificate from the statutory auditor or cost auditor of the company (in the case of companies) or from a practicing
cost accountant or practicing chartered accountant (in respect of suppliers other than companies) giving the
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percentage of local content.
c. Decisions on complaints relating to implementation of this Order shall be taken by the competent authority which is
empowered to look into procurement-related complaints relating the procuring entity.
d. Nodal Ministries may constitute committees with internal and external experts for independent verification of self-
declarations and auditors /accountants certificates on random basis and in the case of complaints.
e. Nodal Ministries and procuring entities may prescribe fees for such complaints.
f. False declarations will be breach of the Code of Integrity under Rule 175(1)(i)(h) of the General Financial Rules for
which a bidder or its successors can be debarred for up to two years as per Rule 151(iii) of the General Financial
Rules along with such other actions as may be permissible under law.
g. A supplier who has been debarred by any procuring entity for violation of this Order shall not be eligible for
preference under this Order for procurement by any other procuring entity for the duration of the debarment. The
debarment for such other procuring entities shall take effect prospectively from the date on which it comes to the
notice of other procurement entities in the manner prescribed under paragraph 9th below.
h. The Department of Expenditure shall issue suitable instructions for the effective and smooth operation of this
process, so that
I. The fact and duration of debarment for violation of this Order by any procuring entity are promptly brought to the
notice of the Member-Convenor
II. On a periodical basis such cases are consolidated and a centralized list or de- centralized lists of such suppliers
with the period of debarment is maintained and displayed on website(s).
III. In respect of procuring entities other than the one which has carried out the debarment the debarment takes effect
prospectively from the date of uploading on the website(s) in such a manner that ongoing procurement are not
disrupted.
10 Specified in Tenders and other procurement solicitations
(a) Every procuring entity shall ensure that the eligibility conditions in respect of previous experience fixed in
any tender or solicitation do not require proof of supply in other countries or proof of exports.
(b) Procuring entities shall endeavour to see that eligibility conditions, including on matters like turnover,
production capability and financial strength do not result in unreasonable exclusion of locals suppliers who
would otherwise be eligible beyond what is essential for ensuring quality or credit worthiness of the supplier.
(c) Procuring entities shall within 2 months of the issue of this Order review all existing eligibility norms and
conditions with reference to sub-paragraphs ”a” and “b” above.
(d) If a Nodal Ministry is satisfied that Indian suppliers of an item are not allowed to participate and/or compete
in procurement by any foreign government, it may, if it deems appropriate restrict or exclude bidders from
that country frame eligibility for procurement of that item and/ or other items relating to that Nodal Ministry. A
copy of every instruction or decision taken in this regard shall be sent to the Chairman of the Standing
Committee.
(e) For the purpose of sub-paragraph 10d above, a supplier or bidder shall be considered to be from a country
if (i) the entity is incorporated in that country, or ii)a majority of its shareholding or effective control of the
entity is exercised from that country; or (iii) more that 50%of the value of the item being supplied has been
added in that country. Indian suppliers shall mean those entities which meet any of these tests with respect
to India.
11. Assessment of supply base by Nodal Ministries: The Nodal Ministry shall keep in view the domestic
manufacturing /supply base and assess the available capacity and the extent of local competition while identifying
items and prescribing minimum local content or the manner of its calculation, with a view to avoiding cost increase
from the operation of this Order.
12. Increase in minimum local content: The Nodal Ministry may annually review the local content requirements with a
view to increasing them, subject to availability of sufficient local competition with adequate quality.
13. Manufacture under license /technology collaboration agreements with phased indigenization . While notifying
the minimum local content. Nodal Ministries may make special provisions for exempting suppliers from meeting the
stipulated local content if the product is being manufactured in India under a license from a foreign manufacturer who
62
holds intellectual property rights and where there is a technology collaboration agreement /transfer of technology
agreement for indigenous manufacture of a product developed abroad with clear phasing of increase in local content
14. Powers to grant exemption and to reduce minimum local content : Ministries /Departments of Government of
India and the Boards of Directors of Government companies or autonomous bodies may by written order,
i. Reduce the minimum local content below the prescribed level; educe the margin of purchase preference below 20%;
ii. Exempt any particular item or procuring or supplying entities or class or classes of items or procuring or supplying entities from the operation of this Order or any part of the Order
A copy of every such order shall be marked to the Member-Convenor of the Standing Committee constituted under
this Order.
15. Directions to Government companies: In respect of Government companies and other procuring entities not
governed by the General Financial Rules, the administrative Ministry or Department shall issue policy directions
requiring compliance with this Order.
16. Standing Committee: A standing committee is hereby constituted with the following membership:
Secretary, Department of Industrial Policy and Promotion−Chairman Secretary, Commerce Member Secretary, Ministry of Electronics and information Technology-Member Joint Secretary (Public Procurement),Department of Expenditure –Member Joint Secretary (DIPP)─Member Convenor
The Secretary of the Department concerned with a particular item shall be a member in respect of issues relating to
such item. The Chairman of the Committee may co-opt technical experts as relevant to any issue or class of issues
under its consideration.
17. Functions of the Standing Committee: The Standing Committee shall meet as often as necessary as but not less
than once in six months. The Committee
i. Shall oversee the implementation of this order and issues arising there from, and make recommendations to
Nodal Ministries and procuring entities.
ii. Shall annually assess and periodically monitor compliance with this Order.
iii. Shall identify Nodal Ministries and the allocation of items among them or issue of notifications on minimum local
content.
May require furnishing of details or returns regarding compliance with this Order and related matters.
a. May, during the annual review or otherwise, assess issues, if any, where it is felt that the manner of
implementation of the order results in any restrictive practices, cartelization or increase in public expenditure and
suggest remedial measures.
b. May examine cases covered by paragraph13 above relating to manufacture under license / technology transfer
agreements with a view to satisfying itself that adequate mechanisms exist for enforcement of such agreements
and for attaining the underlying objective of progressive indigenization.
c. May consider any other issue relating to this Order which may arise. 18. Removal of difficulties: Ministries / Departments and the Boards of Director of Government companies may issue
such clarifications and instructions as may be necessary for the removal of any difficulties arising in the
implementation of this Order.
19. Ministries having existing policies: Where any Ministry or Department has its own policy for preference to local
content approved by the Cabinet after 1st January, 2015, such policies will prevail over the provisions of this Order.
All other existing orders on preference to local content shall be reviewed by the Nodal Ministries and revised as
needed to conform to this Order, within two months of the issue of this Order.
20. Transitional provision: This Order shall not apply to any tender or procurement for which notice inviting tender or
other form of procurement solicitation has been issued before the issue of this Order.
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Appendix-III
Purchase preference as per Public Procurement Policy for Micro & Small Enterprises
(i) In exercising of the powers conferred in Section11 of the Micro, Small and Medium Enterprises Development
(MSMED) Act 2006, the Government has notified a new Public Procurement Policy for Micro & Small Enterprises
effective from 1st
April 2012. The policy mandates that 20% of procurement of annual requirement of goods and
services by all Central Ministries / Public Sector Undertakings will be from the micro and small enterprises.
Government has also earmarked a sub target of 4% procurement of goods & services out of 20% from MSEs owned
by SC/ST entrepreneurs.
(ii) In accordance to the above notification the participating Micro and Small Enterprises(MSEs) in a tender, quoting price within the band of L 1+15% would be allowed to supply a portion of the requirement by bringing down their price to the L1price,in a situation where L1 price is from someone other than an MSE. Such MSEs would be allowed to supply up to 20% of the total tendered value. In case there are more than one such eligible MSE, the 20% supply will be shared equally. Out of 20% of the quantity earmarked for supply from MSEs, 4% quantity is earmarked for procurement from MSEs owned by SC/ST entrepreneurs. However, in the event of failure of such MSEs to participate in the tender process or meet the tender requirements and the L1 price, the 4% quantity earmarked for MSEs owned by SC/ST entrepreneurs will be met from other participating SMEs.
(iii) The MSEs participating in the tender shall enclose with their tender a copy of their valid registration certificate with District Industries Centres or Khadi and Village Industries Commission or Khadi and Village Industries Board or Coir Board or National Small Industries Corporation or any other body specified by Ministry of Micro and Small enterprises in support of their being an MSE, failing which their tender will be liable to be ignored.
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Appendix-IV
Procedure For Registration of Manufacturing Unit
The GMSDs /MSO accept the drugs only from the manufacturing units registered with
Medical Store Organisation. In case manufacturer fails to get their manufacturing unit registered with Medical Store Organisation, no supply will be accepted from them even if they are successful bidders in the Tenders floated by GMSDs/MSO. Objective of registration: - The objective of the Registration of Manufacturing Unit with MSO is to ascertain the facility and technical capability to manufacture the particular type of drugs.
Application for Registration of Manufacturing Unit :- Any manufacturer desirous of having registration of their manufactured unit with MSO for supply of medical stores shall apply on the prescribed forms MSD-1104 & MSD-1105.The Proforma of these forms are given below and can be downloaded for this purpose. The duly filled application form along with all documents and a non refundable registration fees of Rupees 20000/- (Rupees Twenty Thousand only) in the form of a bank draft drawn in favour PAO, dealing with concerned GMSD may be submitted to the nearest GMSD. The seven GMSDs are located at Mumbai, Kolkata, Guwahati, Hyderabad, Chennai, Karnal and New Delhi .They are catering to the whole population of the country and their jurisdiction are given below . When application completed in all respect is received by the concerned Medical Store Depot from a firm for Registration of its manufacturing unit, the concerned GMSD will deal with the application for registration of manufacturing units as per procedure. The decision with regard to the registration of manufacturing unit of the applicant will be communicated to the firm in form MSD-1107 by concerned GMSD/ MSO. Validity period of Registration of Manufacturing Unit:-The registration of the manufacturing unit will be valid for a period of five years from the date of its registration. Application for Renewal of Registration of Manufacturing Unit:-The manufacturer shall apply for renewal of registration before expiry of its registration at least 90 days before expiry of initial registration if so desired. Renewal of registration will be done on the basis of verification of papers regarding annual turnover, manufacturing & marketing and performance regarding business with G M S D / MSO during the period of registration. No renewal registration fee will be charged. However if request for renewal is received after the expiry of validity of registration, it will be considered as a fresh registration case and a registration fee of Rupees 20,000/- will be charged. In case of alteration of name or address of manufacturing unit or manufacturing site the application shall be treated as also fresh registration.
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Jurisdiction For Registration Of Manufacturing Units
Sl. No. Location of GMSD
Jurisdiction For Registration Of Manufacturing Units
1. Kolkata West Bengal, Orissa, Bihar, Jharkhand, Andaman &Nicobar Island,
2. Chennai Tamil Nadu, Karnataka, Kerla, Pudduchery , Lakshadeep and Andaman &Nicobar Island,
3. Mumbai Maharastra, Madhya Pradesh, Gujarat, Goa, Daman & Diu, Chhatisgarh, Dadar & Nagar Haveli
4. Karnal
Haryana, Punjab, Himachal Pradesh, J&K,and Chandigarh
5. Hyderabad
Andhra Pradesh, Telenagana
6. Guwahati Sikkim, Assam, Arunachal Pradesh, Manipur, Meghalya ,Mizoram, Nagaland and Tripura
7. New Delhi
Uttar Pradesh, Delhi, Uttrakhand, and Rajasthan
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MSD-1104 APPLICATION FORM FOR REGISTRATION OF MANUFACTURING UNIT OF THE FIRM
1. Name of the firm
2. Full address of the firm. (in block letters)
Post Office Pin Code
Telephone Fax Mobile E-mail ID
3 Full address of the manufacturing unit (in block letters)
Post Office Pin Code
Telephone Fax Mobile E-mail ID
4 Name under which licensed and the period for which the same are in force
5 Who is the owner, Please give full name and address
Post Office Pin Code
Telephone Fax Mobile E-mail ID
6(i) Are you a manufacturer?
(ii) If so, please give details quoting your manufacturing licence No.
7 Are you a manufacturer‟s agent? If so, please give details.
(i) Name of each manufacturer.
(ii) Address of each manufacturer.
Post Office Pin Code
Telephone Fax Mobile E-mail ID
(iii) Stores manufactured /Dosage form manufacturing sections.
(iv) Letter of authority appointing you as agents in original which must indicate whether the manufacturer will also deal with Govt. direct or only through your Agency.
8 Are you a stockist only? If so, please give details.
9 Name of your Bankers.
The name of the party in which the account stands
Address of your Bankers
Post Office Pin Code
Telephone Fax Mobile E-mail ID
10 Are you on the list of approved Contractors of DGS & D, other Central Govt. Dept., State Govt.? If so, please furnish copies of letters issued by the Dept. Concerned for registration of your name as approved contractors.
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11 Did you apply for registration with this depot before under existing or other name? If so, with what result.
12. Are you already doing business with MSO under some other name, if so please give details.
13. Have you ever been convicted for contravening the provision of Drugs & Cosmetics Act and Rules there under in the past? If so, furnish details.
14. Was your manufacturing licence suspended or cancelled in the past? If so, furnish particulars.
15. Please State whether in the event of rejection etc. you would take back the rejected stores from the depot at your cost.
16. Please indicate if you will be in a position to quote F.O.R. Depot i.e. effect door delivery at depot.
17. Declaration to be made by the applicant. (Vide question 4 above).
18 Whether all the documents listed in MSD-1105 is enclosed?
NAME OF PARTNERSHIP / PROPRIETORSHIPOR COMPANY
I/We do hereby declare that the entries made in this application form are true to the best of my/our knowledge and also that we shall be bound by the acts of our constituted attorney.
PARTNER/ PROPRIETOR/AUTHORISED REPRESENTATIVES