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Government Medical Store Depot New Delhi Directorate General of
Health Services
Medical Store Organization
Bid Document For
Rate Contract for Supply of Anti Malarial Medicines/Kits
Government Medical Store Depot New Delhi Medical Store
Organization
Directorate of General of Health Services Ministry of Health and
Family welfare
C-4, Qutab Institutional Area , New Delhi-110 016 Ph:
011-46064184, 41024368
Fax: 011-41024369 E mail: [email protected] ,
[email protected]
mailto:[email protected]
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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
..............................................................................................................
9 General Instructions To Bidders
............................................................................
9 Definitions and Abbreviations
................................................................................
9 Definitions
..............................................................................................................
9 Abbreviations
.......................................................................................................
10 Introduction
..........................................................................................................
10 Registration of Manufacturing Units
.....................................................................
11 Bid securing declaration / Earnest Money Deposit
.............................................. 11 Validity of the
Bid
.................................................................................................
11 Performance Security Deposit
.............................................................................
11 Eligibility Criteria
..................................................................................................
12 Preparation and Online Submission of Bids
........................................................ 13
Technical Bid
.......................................................................................................
13 Price Bid (BoQ)
....................................................................................................
14 Prices
...................................................................................................................
14 Opening of Technical and Price
Bid.....................................................................
14 Minor Infirmity/Irregularity/Non-Conformity
.......................................................... 15 Award
of Contract
................................................................................................
15 Other Award Criteria
............................................................................................
15 Section-III
...........................................................................................................
17 Special Instructions To Bidders
...........................................................................
17 Bid Data Sheet (BDS)
..........................................................................................
17
Chapter-II Conditions of Contract
..........................................................................................
18 Section –I
............................................................................................................
19
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General Conditions Of Contract(GCC)
............................................................. 19
Delivery Period
....................................................................................................
19 Rate Contract
......................................................................................................
19 Packing and Marking Required
............................................................................
19 Shelf Life
..............................................................................................................
20 Warranty
..............................................................................................................
21 Recalls
.................................................................................................................
21 Annual Estimated Drawls
.....................................................................................
21 Bar coding
...........................................................................................................
22 General Terms
.....................................................................................................
25 Firm Delivery Period Clause
................................................................................
26 Delays in the Supplies Performance of the Contract
........................................... 26 Penalty Clause
....................................................................................................
26 Termination for Default
........................................................................................
27 Force Majeure
.....................................................................................................
27 Fall Clause
...........................................................................................................
27 Inspection and Tests
............................................................................................
28 Transit Insurance
.................................................................................................
28 Termination for Solvency
.....................................................................................
29 Laws Governing the Contract
..............................................................................
29 Resolution of Disputes
.........................................................................................
29 Section –II
...........................................................................................................
30 Special Conditions Of Contract
(SCC)............................................................................
30
Chapter-III Schedule of Requirement
....................................................................................
31 Chapter-IV Specifications and allied Technical Details
....................................................... 33
Chapter-V Price Schedule
......................................................................................................
35 Chapter-VI Standard
Forms....................................................................................................
37
Form-I Rate Contract Form
..................................................................................
38 Form-II Bid-Securing Declaration
........................................................................
39 Form-III Bank Guarantee Form for Performance Security
................................... 40
Chapter-VII Other Bid Forms (Annexure)
..............................................................................
41 Annexure-A Check list of List of Scanned Documents to be
uploaded in pdf format in Volume I
................................................................................................
42 Check list of List of Scanned Documents to be uploaded in pdf
format in Volume
II...........................................................................................................................
42 Annexure-B Letter Of Bid
....................................................................................
43 Annexure-C Bidder information form
...................................................................
44 Annexure-D Questionnaire
..................................................................................
45
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Annexure-E Certificate Regarding De-Registration/ Debarred /
Blacklisted / Banning / Suspended For Business Etc
.............................................................. 46
Annexure-F Details Of Items Quoted In The Tender Without
Rate..................... 47 Annexure-G Manufacturing &
Marketing Certificate ...........................................
48 Annexure-H Details Of All Manufacturing Units Of The Bidder
........................... 49
Chapter-VIII Appendix
.............................................................................................................
50 Appendix-I Guidelines for action to be taken against the
Manufacturing unit and the contract holding firms in the event of
failure of drug in laboratory test ........... 51 Appendix-II
Public Procurement (Preference to Make in India), Order 2017 ......
56 Appendix-III Purchase preference as per Public Procurement
Policy for Micro & Small Enterprises
.................................................................................................
60 Appendix-IV Procedure For Registration of Manufacturing Unit
.......................... 61
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Notice Inviting Tender (NIT)
Tender Number: PS/2/Anti-malarials/2019-20/05
Govt. Medical Store Depot New Delhi ,Medical Store Organization,
DGHS, (hereinafter referred as Tenders Inviting Authority unless
the context otherwise requires) invites Online Bids for Anti
malarial Medicines/Kits as enclosed in Chapter-III –(Schedule of
Requirements ) through e-procurement portal
https://eprocure.gov.in/eprocure/app (Two bids System i.e.
Technical Bid and Price Bid) for Supply of Anti malarial
Medicines/Kits .
Bidders are advised to participate online and complete set of
bidding documents can be downloaded from website
“https://uatdvdmsmsodelhi.dcservices.in/IMCS/hissso/loginLogin.imcs”
or “dghs.gov.in” or from central procurement portal
“eprocure.gov.in” bearing Tender ID No. 2019_DGHS_526117_1
Bidding Schedule
Date of Issue/Publishing of Tender 10-12-2019 at 17.00 Hours
Start Date and time for downloading tender documents 10-12-2019
at 17.30 Hours Date and Venue of Pre-bid Meeting Date 19-12-2019 at
11.00 Hours
Venue- Govt Medical Store Depot C-4 Qutub Institutional Area New
Delhi-110016
Start date and time for submission of online Bids 22-12-2019
16.00 Hours Last date and time for submission of online Bids
13-01-2020 14.00 Hours
Date and time of opening Technical Bids online 14-01-2020 14.00
Hours
Tender opening venue Govt Medical Store Depot C-4 Qutub
Institutional Area New Delhi-110016
Date and time of opening of Price Bids online Will be informed
later on
Address for Communication In-charge GMSD New Delhi Govt Medical
Store Depot C-4 Qutub Institutional Area New Delhi -110016
Tele:011-46064184,Fax:011-46024369 email:[email protected]
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https://eprocure.gov.in/eprocure/app
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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 II or Class III
Certificates with signing key usage) issued by any Certifying
Authority recognized by CCA India (e.g. Sify / TCS / nCode /
eMudhra etc.), with their profile.
5) Only one valid DSC should be registered by a bidder. Please
note that the bidders are responsible to ensure that they do not
lend their DSCs to others which may lead to misuse.
6) Bidder then logs in to the site through the secured log-in by
entering their user ID / password and the password of the DSC /
e-Token.
Instruction For Searching For Tender Documents On CPP Portal 1)
There are various search options built in the CPP Portal, to
facilitate bidders to search active tenders by
several parameters. These parameters could include Tender ID,
organization name, location, date, value, etc. There is also an
option of advanced search for tenders, wherein the bidders may
combine a number of search parameters such as organization name,
form of contract, location, date, other keywords etc. to search for
a tender published on the CPP Portal.
2) Once the bidders have selected the tenders they are
interested in, they may download the required documents / tender
schedules. These tenders can be moved to the respective ‘My
Tenders’ folder. This would enable the CPP Portal to intimate the
bidders through SMS / e-mail in case there is any corrigendum
issued to the tender document.
3) The bidder should make a note of the unique Tender ID
assigned to each tender, in case they want to obtain any
clarification / help from the Helpdesk.
4) The bidders can also download the Tender document from the
MSO website “mso.gov.in”.
Preparation Of Bids 1) Bidder should take into account any
corrigendum published on the tender document before submitting
their
bids.
2) Please go through the tender advertisement and the tender
document carefully to understand the documents required to be
submitted as part of the bid. Please note the number of volumes in
which the bid documents have to be submitted, the number of
documents – including the names and content of each of the document
that need to be submitted. Any deviations from these may lead to
rejection of the bid.
3) Bidder, in advance, should get ready the bid documents to be
submitted as indicated in the tender document / schedule and
generally, they can be in PDF / XLS / RAR / DWF formats. Bid
documents may be scanned with 100 dpi with black and white
option.
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4) To avoid the time and effort required uploading the same set
of standard documents which are required to be submitted as a part
of every bid, a provision of uploading such standard documents(
e.g. PAN card copy, annual report, auditor certificates etc.) has
been provided to the bidders. Bidders can use “ My Space” area
available to them to upload such documents. These documents may be
directly submitted from the “My Space” area while submitting a bid,
and need not be uploaded again and again. This will lead to a
reduction in the time required for bid submission process.
Submission Of Bids 1) Bidder should log into the site well in
advance for bid submission so that he/she upload the bid in time
i.e. on
or before the bid submission time. Bidder will be responsible
for any delay due to other issues.
2) The bidder has to digitally sign and upload the required bid
documents one by one as indicated in the tender document.
3) Bidder has to select the payment option as “offline” to pay
the EMD (if applicable) and enter details of the instrument.
4) Bidder should sign a Bid securing declaration accepting that
if they withdraw or modify their bids during the period of
validity, or if they are awarded the contract and if they fail to
sign the contract, or to submit a performance security before the
deadline defined in the request for bid document, they will be
suspended for the period of three (3) years from the date of
disqualification.
5) A standard BoQ format has been provided with the tender
document to be filled by all the bidders. Bidders are requested to
note that they should necessarily submit their financial bids in
the format provided and no other format is acceptable. Bidders are
required to download the BoQ file, open it and complete the white
coloured (unprotected) cells with their respective financial quotes
and other details (such as name of the bidder). No other cells
should be changed. Once the details have been completed, the bidder
should save it and submit it online, without changing the filename.
If the BoQ file is found to be modified by the bidder, the bid will
be rejected.
6) The serve time (which is displayed on the bidders’ dashboard)
will be considered as the standard time for
referencing the deadlines for submission of the bids by the
bidders, opening of bids etc. The bidders should follow this time
during bid submission.
7) All the documents being submitted by the bidders would be
encrypted using PKI encryption techniques to ensure the secrecy of
the data. The data entered cannot be viewed by unauthorized persons
until the time of bid opening. The confidentiality of the bids is
maintained using the secured Socket Layer 128 bit encryption
technology. Data storage encryption of sensitive fields is
done.
8) The uploaded tender documents become readable only after the
tender opening by the authorized bid openers.
9) Upon the successful and timely submission of bids, the portal
will give a successful bid submission message & a bid summary
will be displayed with the bid no. and the date & time of
submission of the bid with all other relevant details.
10) The bid summary has to be printed and kept as an
acknowledgement of the submission of the bid. This acknowledgement
may be used as an entry pass for any bid opening meetings.
Assistance To Bidders (i) Any queries relating to the tender
document and the terms and conditions contained therein should
be
addressed to the Tender Inviting Authority for a tender or the
relevant contact person indicated in the tender.
(ii) A Bidders awareness/orientation program may also to be
conducted in the office of Govt Medical Store Depot New Delhi as
specified in the bidding schedule and interested bidders can
participate there.
(iii) Any queries relating to the process of online bid
submission or queries relating to CPP Portal in general may be
directed to the 24x7 CPP Portal Helpdesk.
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Section-II
General Instructions To Bidders
1 Definitions and Abbreviations The following definitions and
abbreviations, which have been used in these documents, shall have
the meanings as indicated below: 1.1 Definitions
(i) “Purchaser” means the organization purchasing goods and
services as incorporated in the Tender Enquiry document.
(ii) “Tender” means Bids / Quotation / Tender received from a
Firm / Tenderer /Bidder. (iii) “Tenderer” means Bidder/ the
Individual or Firm submitting Bids / Quotation / Tender (iv)
“Supplier” means the individual or the firm supplying the goods and
services as incorporated in the
contract. (v) “Goods” means the drugs etc. which the supplier is
required to supply to the purchaser under the
contract. (vi) “Services” means services allied and incidental
to the supply of goods, such as transportation,
installation, commissioning, provision of technical assistance,
training, after sales service, maintenance service and other such
obligations of the supplier covered under the contract.
(vii) “Earnest Money Deposit” (EMD) means Bid Security/ monetary
or financial guarantee to be furnished by a tenderer along with its
tender.
(viii) “Contract” means the written agreement entered into
between the purchaser and/or consignee and the supplier, together
with all the documents mentioned therein and including all
attachments, annexure etc. therein.
(ix) “Performance Security” means monetary or financial
guarantee to be furnished by the successful tenderer for due
performance of the contract placed on it. Performance Security is
also known as Security Deposit.
(x) “Consignee” means the GMSD in-charge/State Cold Chain
Officer Hospital/Institute/Medical College/Depot person to whom the
goods are required to be delivered as specified in the Contract. If
the goods are required to be delivered to a person as an interim
consignee for the purpose of dispatch to another person as provided
in the Contract then that “another” person is the consignee, also
known as ultimate consignee.
(xi) “Specification” means the document/standard that prescribes
the requirement with which goods or service has to conform.
(xii) “Inspection” means activities such as measuring,
examining, testing, gauging one or more characteristics of the
product or service and comparing the same with the specified
requirement to determine conformity.
(xiii) “Day” means calendar day. (xiv) “Drugs and Cosmetics Act”
means Drugs and Cosmetics Act 1940 of India, tobe read along with
its
amendments till date. (xv) “Local supplier” means a supplier or
service provider whose product or service offered for
procurement meets the minimum local content as prescribed under
this Order or by the competent Ministries/ Departments in pursuance
of this order.
(xvi) “Local content” means the amount of value added in India
which shall, unless otherwise prescribed by the Nodal Ministry, be
the total value of the item procured excluding net domestic
indirect taxes) minus the value of imported content in the item
(including all customs duties) as a proportion of the total value
in percent.
(xvii) “L1” means the lowest tender or lowest bid or the lowest
quotation received in a tender, bidding process or other
procurement solicitation as adjudged in the evaluation process as
per the tender or other procurement solicitation.
(xviii) “Margin of purchase preference” means the maximum extent
to which the price quoted by a local supplier may be above the L1
for the purpose of purchase preference.
(xix) “Nodal Ministry” means the Ministry or Department
identified pursuant to this order in respect of a particular item
of goods or services.
(xx) “Rate contract” ( or the term ‘framework agreement’ in
certain contexts) means an agreement between a Central Purchase
Organisation or Procuring Entity with one or more bidders, valid
for a
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specified period of time, which sets out terms and conditions
under which specific procurements can be made during the term of
the agreement and may include an agreement on prices which may be
either predetermined or be determined at the stage of actual
procurement through competition or a predefined process allowing
their revision without further competition
1.2 Abbreviations (i) “T E Document” means Tender Enquiry
Document (ii) “NIT” means Notice Inviting Tenders. (iii) “GIT”
means General Instructions to Tenderers (iv) “SIT” means Special
Instructions to Tenderers (v) “GCC” means General Conditions of
Contract (vi) “SCC” means Special Conditions of Contract (vii)
“DGS&D” means Directorate General of Supplies and Disposals
(viii) “NSIC” means National Small Industries Corporation (ix)
“PSU” means Public Sector Undertaking (x) “CPSU” means Central
Public Sector Undertaking (xi) “MSME” means Micro, Small
&Medium Enterprises (xii) “MSE” means Micro &Small
Enterprises (xiii) “LC” means Letter of Credit (xiv) “DP” means
Delivery Period (xv) “BG” means Bank Guarantee (xvi) “ED” means
Excise Duty (xvii) “CD” means Custom Duty (xviii) “GST” means Goods
and Service Tax (xix) “DOD” means Date of Delivery. (xx) ”
MOH&FW” means Ministry of Health & Family Welfare,
Government of India (xxi) “Dte. GHS” means Directorate General and
Health Services, MOH&FW. (xxii) “MSO” means Medical Stores
Organization. (xxiii) “GMSD” Government Medical Stores Depot.
(xxiv) “VMS” Vocabulary of Medical Stores containing list of the
drugs procured by MSO. (xxv) “Agent” means Agent of Foreign
Manufacturer for the offered stores/drug(s) as perDrugs and
Cosmetics Act and Rules.
2 Introduction (2.1) The tenders will be received online through
portal https://eprocure.gov.in/eprocure/app. In the Technical
Bids,
the bidders are required to upload various documents. The bidder
must upload scanned copy of all documents which are legible and in
.pdf format.
(2.2) Possession of a Valid Class II/III Digital Signature
Certificate (DSC) in the form of smart card/e-token in the
company's name is a prerequisite for registration and participating
in the bid submission activities through
https://eprocure.gov.in/eprocure/app . Digital Signature
Certificates can be obtained from the authorized certifying
agencies, details of which are available in the web site
https://eprocure.gov.in/eprocure/app under the link “Information
about DSC”.
(2.3) Tenderer / Contractor are advised to follow the
instructions provided in the ‘Instructions to the Contractors /
Tenderer for the e-submission of the bids online through the
Central Public Procurement Portal for e Procurement at
https://eprocure.gov.in/eprocure/app .
(2.4) The parties to the contract, which shall be deemed to be
“Rate Contract “ and which is intended for the supply of stores of
the description set forth in the schedule to the Tender during the
period specified shall be contractor of the first part and
purchaser(s) name in the schedule of the Tender of second part.
(2.5) No guarantee can be given as to the number or quantity of
the stores which will be ordered during the period of Rate Contract
which is in the nature of standing offer only from the contractor,
but the purchaser(s) undertake(s) to order from the contractor all
stores as detailed in the schedule of stores and prices which he /
they require(s) to purchase except that he / they reserve(s) the
right. 2.5.1 Of submitting to competition any supply of articles
included in the contract, the total value of which
exceeds such amount as Secretary (whose decision shall be final)
may determine upon consideration of Tenders.
2.5.2 Of placing this Rate Contract simultaneously or at any
time during its period with one or more contracts as /they thinks
fit, and
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2.5.3 Of obtaining from sources any stores referred to in the
contract to meet emergency, if the Secretary (whose decision shall
be final) is satisfied that the contractor is not in a position to
supply specific quantities or number of days within the period in
which supply is required.
(2.6) The Rate Contract in respect of quality procurement shall
be governed by the provisions contained in the Drugs and Cosmetics
Act, 1940 as amended up to date and the Drugs and Cosmetics Rules,
1945 as amended up to date.
3. Registration of Manufacturing Units ( 3.1 ) In case the
bidder is a Domestic manufacturer, the MSO/GMSDs accept the drugs
only from the manufacturing units duly inspected and registered
with Medical Store Organisation /GMSDs.
Manufacturers of unregistered units may also submit their bids
if they have already paid the registration fee and applied for
registration with concerned GMSDs/MSO, if they produce evidence
thereof. However, the Rate Contract will be subject to registration
of the manufacturing unit of the drug. [Note-The detailed procedure
for registration of manufacturing units can be seen at
Appendix-IV]
(3.2) If the validity of registration of the manufacturing unit
of the drug to be quoted by the bidder has expired, the bidders
will be treated as unregistered unless he has applied for renewal
of registration within the validity of the registration period.
(3.3) If a Bidder has two or more separate manufacturing units
at different sites/premises and bidder intends to quote for the
drugs manufactured at any of its unregistered manufacturing units,
then the bidder will be treated as unregistered manufacturer for
supply of that drug rendering him ineligible to participate in the
bid unless he has applied for registration, before the last date of
submission of Bid and produce evidence thereof.
4 Bid securing declaration / Earnest Money Deposit (4.1) Bidder
should sign a Bid securing declaration accepting that if they
withdraw or modify their bids during the
period of validity, or if they are awarded the contract and if
they fail to sign the contract, or to submit a performance security
before the deadline defined in the request for bid document, they
will be suspended for the period of three (3) years from the date
of disqualification. In the absence of Bid securing declaration in
the prescribed proforma (Form II) given in Chapter VI -Standard
Forms, the tenders will be rejected and will not be opened.
(4.2) The Micro and Small enterprises (MSEs) and the firms
registered with National Small Industries Corporation (NSIC) etc.
are exempted from submitting the Bid Security/ Earnest Money
Deposit as per prevailing rules. However, they have to submit the
valid documentary evidence in support of MSE/Registration with NSIC
(indicating the items for which they are registered.) along with
the technical bid.
5 Validity of the Bid
(5.1) The bid shall be valid for a period of 120 days extendable
for a period of another 120 days from the last date of submission
of the bids (fixed initially in the publication of the tender).
Validity of the Earnest money deposit should be 45 days, beyond the
final bid validity period in any case. However, the Tender Inviting
Authority may request the bidders to extend the bid validity
beyond.
(5.2) If the bidder refuses the extension of bid validity then
they will lose all rights in respect of all of their bids submitted
together and all the bids will be summarily rejected without
forfeiting the Earnest Money Deposit.
(5.3) In case the bidder withdraws his bid within its validity
period or fails to deposit performance security within specified
time after award of contract, the Earnest Money will be forfeited
or the firm will be debarred/de-registered for bidding a period of
three years.
(5.4) The bid security of the unsuccessful bidders will be
returned to them after expiry of the final bid validity and latest
within one month after the award of the contract /Supply Order.
6 Performance Security Deposit (6.1) Successful
Bidder/Contractor will have to furnish a Performance Security
Deposit with the purchaser
equivalent of 5% of the order received from the demanding
officer/Purchaser in the form of bank guarantee or in the form of
demand draft. The Demand draft should be drawn in favour of “The
Accounts Officer of
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direct demanding officer /Purchaser and the bank guarantee
should be in favour of direct demanding officer /Purchaser valid
for a period of 60 days beyond the date of completion of all
contractual obligations of the supplier, including warranty
obligations
(6.2) Demand Draft finally accepted as Performance Security
Deposit would be credited to Govt. Account under proper Head of
Account.
(6.3) Govt. will not pay any interest on Earnest Money Deposit /
Performance Security Deposit, which would stand, credited to Govt.
Accounts.
(6.4) Performance Security Deposit will be returned to the
Bidder after a period of 60 days beyond the date of completion of
all contractual obligations of the supplier, including warranty
obligations by the depots or Medical Stores Organisation.
(6.5) If the contractor fails or neglects to observe or perform
any of his obligations under the contract, it shall be lawful for
the purchaser to forfeit the Performance Security Deposit furnished
by the contractor.
7 Eligibility Criteria 7.1 The following bidders are eligible to
participate in the tender:-
(i) Domestic Manufacturers having valid own manufacturing
license or loan license are eligible to quote the drugs
manufactured at their manufacturing units (premises) duly inspected
and registered with MSO / GMSDs for supply of drugs. Manufacturers
of unregistered units may also submit their bids if they have
already paid the registration fee and applied for registration with
MSO, if they produce evidence thereof as clarified under Clause 3.
However, the Rate Contract will be subject to registration of the
manufacturing unit of the drug.
(ii) Direct importer holding valid import license. A letter from
original manufacturer should also be
submitted that the original firm is not marketing the product
directly in India.
No third party manufacturers are allowed to quote for any
generic drug. 7.2 Annual Turnover Requirement of the Bidder
(i) Pharmaceutical firm having minimum annual turnover of Rs.
100 Crore in each of the last two years will be eligible to quote
bid for drugs included in Group ‘A’ (The Group A drugs-includes
essential drugs like drugs acting on Central Nervous System, Cardio
Vascular System, Endocrine System, Anti-cancer & Higher
Antibiotics).
(ii) Pharmaceutical firm having minimum annual turnover of Rs.
50/- Crore in each of the last two years will be eligible to quote
bid for drugs included in Group ‘B’(The Group B drugs-includes rest
of the drugs not covered under Group A).
7.3 In case of imported product Bidder should have valid WHO GMP
Certificate or CoPP (Certificate of Pharmaceutical Product) from
the concerned licensing Authority.
7.4 Bidder should have valid Manufacturing License issued by
competent authority under Drugs & Cosmetic Act and should
adhere to the norms of Schedule M of the D & C Act &
Rules/GMP Certificate on the date of bid opening for the category
of products manufactured in India.
7.5 A Non-Conviction certificate for two years from the
Licensing authority / Drug Controller of the concerned State. The
Certificate must have been issued within six months from the date
of opening of the Tender.
7.6 As on last date of submission of the bids, Bidder
(Manufacturer / importer/Loan licensee) should have Manufacturing
&Marketing experience for at least 2 years (24 months) for the
drug quoted.
This would not apply to drugs, which were introduced in India
less than 2 years ago. A certificate from the Drug Controller
General (India) shall be required for all new drug formulations to
this effect.
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8 Preparation and Online Submission of Bids
8.1 Technical Bid
8.1.1 The Item(s) as per Tender enquiry should be clearly marked
and highlighted in Drug Manufacturing or Import License /
manufacturing and marketing certificate documents submitted.
8.1.2 The bidders are required to upload various documents in
Technical bids in two volumes , as listed in Clause 8.1.3 (Volume
–I)and 8.1.4. (Volume –II) The bidders are advised to arrange all
the documents to be uploaded in Volume I and Volume II in the same
chronological order of the checklist (Annexure-A). All these pages
of Volume I and Volume II should be serially numbered and signed
with the rubber stamp of the firm on each page before uploading.The
Tender shall be liable to be rejected if the same are not uploaded
with the Technical BID online
8.1.3 List of Scanned Documents to be uploaded in pdf format in
Volume I (Documents as per check list - Annexure A)
(i) Copy of duly filled , signed & stamped Check list of
documents uploaded (Annexure A) (ii) Copy of the Bid Securing
Declaration as per Clause 4 (Form II ). (iii) Copy of the valid
registration certificates or application of registration and proof
of
registration fee paid in respect of all domestic manufacturing
units of the drugs quoted. (iv) Copy of notarized power of
attorney. The bidder shall sign the bid or a person duly
authorized to bind the bidder to the contract. The authorized
signatory should have power of attorney from the Proprietor /
Partners of the firm/ MD / Chairman / President duly attested and
signed by Notary Public
(v) The Bidder Information form (Annexure-C) (vi) Questionnaire
(Annexure- D) (vii) Latest Income Tax Return and GST Return (viii)
Copy of valid NSIC Registration/MSME Certificate if any (ix)
Certificate regarding de-registration/ debarred / blacklisted /
banning / suspended for
business etc. (Annexure-E) (x) The annual turnover statements
for formulations for the last two years duly certified by the
Auditor / chartered accountant.. (xi) Non-conviction certificate
for two continuous years from the Drug Controller of the State
(xii) Details of item quoted in the tender without Rate(Annexure-F)
(xiii) Certificate from the Manufacturers or Chartered Accountant
regarding two years (24
months) manufacturing and marketing experience of the particular
item of any strength. The Certificate must have been issued within
past six month from the date of opening of Tender. In the case of
direct importer, evidence for importing the quoted item for last
two years will be produced in the prescribed proforma (Annexure-
G).
(xiv) Details of manufacturing units of the Drugs quoted by the
Bidder, and Data to establish the manufacturing during last two
years, duly certified by the concerned Domestic Manufacturer. -
(Annexure-H)
(xv) Copies of CoPP (Certificate of Pharmaceutical Product) in
respect of the imported formulations/drugs quoted in the
Tender.
(xvi) The local supplier shall be required to provide
self-certification / Certificate of Cost Auditor / Chartered
Accountant that the item offered meets the minimum local content as
per provisions of the order placed at Appendix-II.
8.1.4 List of Scanned Documents to be uploaded in pdf format in
Volume II
(Documents as per check list - Annexure A) (i) Valid Drug
Manufacturing /Import License with its validity. If revalidation of
drug license has
been applied for the copy of application to State Drug /
Licensing authority may be attached with a certificate that
application for renewal was made within time frame as per Drug and
Cosmetic Act as amended up to date and that has not been deleted by
licensing authority and Certificate of approval of Drug Controller
General of India for new drugs if any.
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(ii) Letter of Bid (Annexure-B) along with the Tender Document
duly ink signed and stamped on each page.
(iii) Copy of Certificate of original manufacturer of product
from the State Drug Controller) if any.
(iv) Copy of Certificate of sole manufacturer of product from
State Drugs Controller if any (v) .
8.2 Price Bid (BoQ)
8.2.1 The price bid will also be known as financial document and
every bidder will be required to submit its price in excel (BoQ)
format attached to the respective tender document.
8.2.2 Please note that PRICE BID is to be submitted online only
and no copy is to be submitted physically.
9 Prices
9.1. The Tenderer shall indicate on the Price Schedule (BoQ) the
specified components of prices shown therein. All the columns shown
in the price schedule should be filled up as required. If any
column does not apply to a tenderer, same should be clarified as
“NA” by the tenderer
9.2 Rates should be quoted on Free Delivery on Door Delivery
Basis to all Govt. Medical Store Depots located at Kolkata,
Chennai, Guwahati, Hyderabad, Karnal, Mumbai and New Delhi and all
the transit loss whatsoever will be borne by the supplier firm (any
monetary limit is not acceptable). Uniform rates for all the depots
must be quoted. Quotations at different rates for different depots
will not be considered.
9.3 Deleted. 9.4 No conditional offer / discounts for early
delivery / payment etc will be accepted. Any conditional price
/rate
quote shall render the financial BID disqualified on ground of
conditionality. 9.5 The prices quoted by the Bidders should be on
firm and fixed basis during the currency of the rate approval,
except in respect of such drugs where prices are governed by
Essential Commodities Act 1955 and Drugs Price Control Order 2013,
in which cases the prices quoted should not exceed the ceiling
price of DPCO/NPPA. While claiming payment, Bidders shall be
required to submit a certificate to this effect from Internal
Auditor / Chattered Accountant / Managing Director.
9.6 The price quoted by the Bidder should be less than the price
obtained by them from the trade.
10 The purchaser’s reserves the right to accept in part or in
full any Tender or reject any Tender without assigning any reason
or to cancel the E-Tendering process and reject all Tenders at any
time prior to award of contract, without incurring any liability
whatsoever to the affected Tendered or Bidders.
11 The purchaser may demand to see the original document or
submission of attested /certified copy of any document which has
been submitted online or other document(s) requiring
clarification
12 All the information called for in all the BID documents
should be answered, failing which, the bid shall not be considered
and is liable to be rejected without any further reference.
13 The price of drug is not to be revealed in technical Bid and
each page of the quotation must be uploaded in the prescribed
format otherwise it will be liable to rejected.
14 Opening of Technical and Price Bid
(i) The Technical Bids of the respective tender will be opened
as per the bidding schedule of the tender. The Technical bids will
be scrutinized by the respective Technical Evaluation
Committee.
(ii) The Price Bids of only those Bidders whose Technical bids
are found responsive on satisfying the criteria for technical
evaluation will be opened and only they shall be eligible to be
present at the date and time for opening of Price Bid.
(iii) The Date and time of opening of the Price Bid will be
announced on the e-procurement portal https://eprocure.gov.in
/e-procure/app and MSO website “http://mso.gov.in after the
completion of evaluation of Technical Bids by the Technical
Evaluation Committee.
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15. Minor Infirmity/Irregularity/Non-Conformity If during the
preliminary examination, the purchaser find any minor informality
and / or irregularity and/or non-conformity in a tender, the
purchaser may waive the same provided it does not constitute any
material deviation and financial impact and, also, does not
prejudice or affect the ranking order of the tenderers. Wherever
necessary, the purchaser will convey its observation on such
“minor” issues to the tenderer by registered/speed post etc. asking
the tenderer to respond by a specified date. If the tenderer does
not reply by the specified date or gives evasive reply without
clarifying the point at issue in clear terms, that tender will be
liable to be ignored.
16 The firms may submit their bids if the terms and conditions
as prescribed are acceptable to the bidders and
they fulfil all the eligibility criteria. Therefore bidders are
advised to read Terms and conditions and Instructions of Bid
Documents carefully before submitting their quotations.
17 Award of Contract 17.1 The purchaser also reserve the rights
(1) to enter into parallel Rate Contract(s) simultaneously or at
any time
during the period of the Rate Contract with one or more
Bidder(s) as purchaser think fit and (2) to place ad-hoc contract
or contracts simultaneously or at any time during the period of
this contract with one or more supplier(s) / Tenders(s) for such
quantity of such item or items as the purchaser (whose decision
shall be final) may determine
17.2 The purchaser reserves the option to give a purchase
preference to the offers from public sector units etc., over those
offers from other large scale units in accordance with the policies
of the Govt. of India from time to time.
17.3 The MSO / GMSDs will initially award Rate Contract(s) with
L1 only. However in case L1 is debarred or not able to supply the
drug then MSO may conclude the rate contract with L2 for the
remaining period of the Rate Contract ,provided he agrees to supply
at L1 rate. Also if both L1 & L2 are debarred or not able to
supply the drug then the MSO may conclude the rate contract with L3
for the remaining period of the Rate Contract, provided he agrees
to supply at L1 rate.
18 Other Award Criteria
The DIPP has notified a Public Procurement order-2017
(Preference to Make in India) order 2017 vide Order no
P-45021/2/2017-B.E-II dated 15th June 2017 (Appendix-II). The
procurement policy for Micro & Small Enterprises 2012 has been
notified under MSMED Act, 2006 (Appendix-III). The orders mandates
that purchase preference shall be given to local suppliers and MSEs
in all procurement undertaken by procuring entities. General
principles as per above orders and criteria fixed by MoHFW shall be
followed for various scenarios for award of contract. Accordingly,
the criteria of award of contract will be as under: (I) Public
Procurement (Preference to Make in India)
Requirement of Purchase Preference: Subject to the provision of
the Order P-45021/2/2017-B.E-II dated 15th June 2017
(Appendix-II)and to any specific instructions issued by the Nodal
Ministry or in pursuance of this Order, purchase preference shall
be given to local suppliers in all procurements undertaken by
procuring entities in the manner specified hereunder:
a. In procurement of goods in respect of which the Nodal
Ministry has communicated that there is
sufficient local capacity and local competition, and where the
estimated value of procurement is Rs. 50 lakhs or less, only local
suppliers shall be eligible. If the estimated value of procurement
of such goods is more than Rs. 50 lakhs the provision of
sub-paragraph b or c as the case may be, shall apply
b. In the procurement of goods which are not covered by
paragraph “a” and which are divisible in
nature, the following procedure shall be followed: (i) Among all
qualified bids, the lowest bid will be termed as L1 if L1 is from a
local supplier,
the contract for full quantity will be awarded to L1 15
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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 25% of total tendered value.
(iii) A sub –target of Min. 25% (i.e. 4% out of 25%) has been
earmarked for procurement from MSEs owned by the SC or ST
entrepreneurs. Provided that, in event of failure of such MSEs to
participate in tender process or meet tender requirement and L-1
price, 4% sub-target for procurement earmarked for MSEs owned by SC
or ST entrepreneurs shall be met from other MSEs
(iv) Out of the total annual procurement from Micro and Small
Enterprises, 3 per cent from within the 25 per cent target shall be
earmarked for procurement from Micro and Small Enterprises owned by
women
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Section-III
Special Instructions To Bidders
Bid Data Sheet (BDS)
The following specific data for the Goods to be procured shall
complement, supplement, or amend the provisions in the Instructions
to Bidders (ITB).Whenever there is a conflict; the provisions
herein shall prevail over those in ITB.
S/No. ITB
Clause Reference
Bid Data that shall prevail over those in ITB
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Chapter-II Conditions of Contract
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Section –I
General Conditions Of Contract(GCC) 1. Delivery Period
The time for and the date of delivery of stores stipulated in
the supply order shall be deemed to be the essence of the contract
and delivery must be completed within stipulated Date of Delivery
which is normally 60 days unless specified otherwise.
2. Rate Contract
(i) The Rate Contract shall be operative for a period of two
years from the date of its finalization i.e. from the date of issue
of Rate Contract with a condition that in case if there is a fall
in final cost due to reduction in cost of raw material, custom duty
exemption etc. the manufacturer will have to reduce the price
proportionately to extend the benefit of such reduction to
Government.
(ii) The Contract Holding Firm shall note that supply orders may
be placed up to the last day of the currency of the Rate
Contract.
(iii) Whenever any Purchase Order is placed during the validity
of the contract it shall be binding on the firm to supply it as per
Schedule given by the purchaser.
(iv) The rate Contract will be concluded with the Domestic
Manufacturers registered with MSO or the Importers Only.
3. Packing and Marking Required 3.1. Packing For Tablets And
Capsules.
(a) Initial Packing (i) Unless otherwise specified in Supply
Order. Tablets/ Capsules are required to be packed in
standard Aluminum /Aluminum Blister. The aluminum strip should
be of thickness not less than 0.03mm. The packing material should
have compatibility with the tablet, capsules. The manufacturer will
submit a self-certificate with each consignment specifying
thickness of Aluminum Foil.
(b) Blister /Aluminum strip pack of not more than 150 tabs /caps
should be packed in thick cardboard box so that container should
provide adequate protection to the drugs.
(c) Final Packing. Final packing shall be done in corrugated
fiber Board boxes confirming to IS: 2771 (part-I):1990 suitably
cushioned/ lined and strong enough to bear Rail/Road transit
hazards. The supplier should furnish a self-certificate with each
consignment to the effect that packing material is confirming to
IS: 2771 (part-I):1990.
3.2. Packing For Bottles. Bottles should confirm the
container/content compatibility test. (a) Initial Packing
Initial packing shall be done in single well corrugated fibre
board boxes weighing not more than 10 KG confirming to lS2771
(Part-I) 1990 suitably nested and strong enough to bear the
Rail/Road Transit Hazards.
(b) Final Packing Final packing shall be done in 7-ply
corrugated fiber Board Boxes weighing not more than 15 Kgs
conforming to lS/277l/Part-I: 1990 suitable Cushioned lined and
strong enough to bear the Rail/Road Transit Hazards. The supplier
should furnish a self-certificate with each consignment to the
effect that packing material is confirming to IS: 2771
(part-I):1990
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3.3 Packing For Injection
Vial/Ampoules should confirm the container/content compatibility
test. (a) Initial Packing
In neutral plain glass ampoule/ vial confirming to IS:1984
(Part-I) 1971 for relevant capacity provided with rubber stopper
and pilfer proof metallic seal(in case of vials) and enclosed in
strong card board carton and 25/50 vials/ampoules enclosed in well
cushioned nested card board carton.
(b) Final Packing Final packing shall be done in corrugated
fiber board boxes confirming to IS: 2771(Part4):1990 suitable
Cushing and liner and strong enough to bear the Rail/Road transit
hazards. The supplier should furnish a self-certificate with each
consignment to the effect that packing material is confirming to
IS: 2771 (part-I):1990.
3.4. PACKING INSTRUCTION FOR IV FLUIDS
(a) Initial Packing PVC bottles should confirm the
container/content compatibility test for the contents of the
container and should be manufactured by Form Fill Seal (FFS)
Technology of relevant capacity as indicated in the Schedule of
Requirements.
(b) Final Packing Final packing shall be done in corrugated
fiber cardboard carton (7ply only) confirming to lS: 2771
(Part-I):1990 duly nested containing not more than 24 bottles. The
supplier should furnish a self-certificate with each consignment to
the effect that packing material is confirming to IS: 2771
(part-I):1990
3.5. Packing of each drug item should be strictly according to
the requirements specified in the list of each
category of drugs and or as indicated in the Tender enquiry in
detail. 3.6. The package will indicate the name of the
manufacturer, the date of manufacture, date of expiry and the
batch no. The labels both on Innermost packing and outer
Containers should be marked with the words "CG SUPPLY NOT FOR SALE"
in bold red letters
3.7 Labelling and packing shall be as per the provisions
contained in the Drugs and Cosmetics Rules 1945 as
amended up-to-date, other particulars of labelling, if any,
prescribed by the Direct Demanding Officer in his supply order
should be complied with.
3.8. The supplier shall provide such packing of the goods as is
required to prevent their damage or deterioration
during transit to their final destination as indicated in the
contract. The packing shall be sufficient to withstand, without
limitation, rough handling during transit and exposure to extreme
temperatures, sunlight and humidity during transit and storage.
Packing case size and weights shall take into consideration, where
applicable, the remoteness of the Goods' final destination. All
primary packaging containers, which come in contact with the
pharmaceuticals or drug content, shall strictly conform to the
specifications in the relevant pharmacopoeia to protect the quality
and integrity of the goods.
3.9. Offers with packing not in terms of the requirement of
Tender enquiry shall be summarily ignored.
4. Shelf Life
4.1 Minimum shelf life of the drugs offered should be mentioned
in months against each item in the Annexure –F to be uploaded in
Technical Bid.
4.2 The Bidder should note that at the time when the stores are
offered for inspection, the life of the drugs shall
not have passed more than one sixth (1/6th) of the
effective/useful life of the drug counted from the date of
manufacture. Loss or premature deterioration due to biological and
other activities during the life potency of the drugs shall have to
be made good by the contractor free of cost or shall have to refund
the cost of substandard drugs lying with depot or at the indentors
end.
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5. Warranty 5.1. Supplies must fully comply in all respect with
the Technical specifications and conditions laid down in the
contract and in accordance with the Pharmacopoeia standards.
5.2. Each supply should be accompanied with a "Warranty
Certificate" duly signed by the Bidder as under:
"The Contractor/Seller hereby declares that the stores as
detailed below sold to the purchaser under this contract shall be
of the best quality and workmanship and shall be strictly in
accordance with the specifications and particulars mentioned in the
description clause here of and the contractor/seller hereby
guarantees that the stores would continue to conform to the
description of and quality aforesaid for a period of useful life of
minimum of five sixth (5/6th) of the specified shelf life from the
date of delivery of the said stores to the purchaser ,, have
overages within the ranges set forth in the technical specification
and are not subject to recall by the applicable Regulatory
Authority due to unacceptable quality or adverse Pharmaceuticals
reaction. Notwithstanding the above, the fact that the said stores
fail to conform to the description and quality aforesaid or have
deteriorated and the decision of the purchaser in that behalf is
final and conclusive, the purchaser will be entitled to reject the
said stores or such part thereof as may be discovered not to
conform to the said description and quality. Losses due to
premature deterioration due to biological and other activities
during life potency will be made good and supplied by the firm at
its own cost at consignee’s site. On such rejection, the stores
will be at the seller's risk and all provisions herein contained
relating to the rejection of stores shall apply. The
Contractor/Seller shall if so called upon to do so by the purchaser
in writing, replace the stores free of cost at the ultimate
destination within a period of forty five days or such further
period as may be extended from time to time by the purchaser at his
discretion, on application made there under by the
contractor/Seller after the stores or such portion of the stores
thereof as is rejected by the purchaser and in such an event the
above mentioned warranty period shall apply to the stores replaced
from the date of the replacement thereof otherwise the
contractor/seller shall pay to the purchaser such damage as may
arise by reason of the breach of the conditions. Nothing herein
contained shall prejudice any other rights of the purchaser in that
behalf under this contract or otherwise".
i S
Signature name & designation and date with rubber stamp.
5.3. If the supplier, having been notified, fails to replace within
the period specified above, the purchaser may
proceed to take such remedial action as may be necessary at the
suppliers' risk and expense and without prejudice to other rights
which the purchaser may have against the supplier under the
contract.
6. Recalls If products must be recalled because of problems with
product quality or adverse reaction to the pharmaceutical, the
supplier will be obliged to notify the purchaser, providing full
details about the reason leading to the recall, and shall take
steps to replace the product in question at suppliers own cost at
the ultimate destination with a fresh batch of acceptable
pharmaceuticals or withdraw and give a full refund if the product
has been taken off the market due to safety problems.
7. Annual Estimated Drawls The annual value of drugs to be
ordered by the Department will be dependent on individual
requirements of the various drugs including the items in the
subject inquiry A) Purchaser : The President of India B) Inspection
Authority : DGHS New Delhi C) Inspecting Officer : Head of the
Depots or their authorised
Representative(s) for the respective requirement. D) Place of
Inspection : At Consignee Premises / firms premises. E) Paying
Authority : Pay & Accounts Officer, Ministry of Health
And Family Welfare, of concerned Depots F) Rate Contract : Dte.
General of Health Services (Medical Store operating
officers Organisation), New Delhi and its GMSDs Located at
Kolkata, Chennai, Guwahati,Hyderabad, Karnal, Mumbai& New
Delhi.
SO No. & Date
Nomenclature & Specification
Name &Address of Manufacturing Unit
Batch No.
DOM & DOE
Qty. of each batch
Remarks
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Successful Bidders will have to deposit 5% of the total value of
the order as Performance Security Deposit in the form of demand
draft drawn in favour of PAO of the respective depots or bank
guarantee in the prescribed form in favour of The President of
India, which can be obtained, from the depot. 100% Payment will be
made on finalization of bills duly supported by original inspection
note, original supply order, Invoice &delivery challan etc.
Demand for advance payment will not be admissible.
If firm is deregistered / debarred for the supply of item after
issue of Tender enquiry for any particular item offers for such
item will not be considered. If firm is deregistered / debarred for
the supply of the item /blacklisted banned during the currency of
agreement all orders already placed by demanding officer up to the
date of order coming in to force shall be executed by the firm
during delivery period specified in such contract. No extension of
delivery period in such contract shall be considered.
8. Bar coding All medicines supplied should be bar-coded as
under:
All medicines supplied should incorporate GS1 barcodes at
various packaging levels (primary, secondary and tertiary level
packaging) and should encode the information within the barcodes as
mentioned below
The GS1 barcode requirements for medicines/drugs at various
packaging levels can also be downloaded from the website of
Ministry of Health & Family Welfare, Govt. of India at below
link:
http://mohfw.nic.in/gs1_barcode_&_User_Manuals.htm
GS1 barcode requirements
On Medicines/Drugs procured by MSO
These requirements cover medicines/drugs procured by Medical
Stores Organization (MSO) for both branded & generic
pharmaceuticals/drugs. For medical devices & other medical
supplies separate GS1 barcode requirements apply which are
available at
http://mohfw.nic.in/gs1_barcode_&_User_Manuals.htm
Barcode requirements using GS1 identification standards are
provided below at various levels of product packaging which include
at primary, secondary and shipper/carton levels and need to be
complied with while supplying medicines/drugs to MSO.
Section A) Primary Level Packaging Primary Level Packaging: Is
defined as the first level of packaging in direct contact with the
product and marked with an AIDC (Automatic Identification and Data
Capture) data carrier either on the packaging or on a label affixed
to the packaging. It may consist of a single item or group of items
for a single therapy such as a Kit. For packaging configurations
that include a retail consumer trade item, primary packaging is a
packaging level below the retail consumer trade item.
Barcodes using GS1 standards are required to be marked ontothe
primary level of packaging encoding GS1 product identification code
(called GTIN–Global Trade Item Number). Where product is packed in
a mono carton (e.g. ointments, eye/ear drops etc), barcode encoding
GTIN should be marked on the mono carton itself.
GTINs (Global Trade Item Numbers): It is the GS1 identification
key used to uniquely identify each product type/variant. It is
created using a GS1 or U.P.C. Company Prefix number. GTIN can be of
14 digits (i.e. GTIN -14) or 13 digits (i.e. GTIN -13) or 12 digits
(i.e. GTIN -12) or 8 digits (i.e. GTIN -8) depending on barcode
symbology used.
Note: Barcodes using GS1 standards are required to be marked on
product packaging in addition to existing statutory labeling &
marking requirements.
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http://mohfw.nic.in/gs1_barcode_&_User_Manuals.htmhttp://mohfw.nic.in/gs1_barcode_&_User_Manuals.htm
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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 Earnest Money Deposit /Performance Security
Deposit and / or (b) Imposition of penalty and/or (c) Termination
of the contract for default.
11.2 If at any time during the performance of the contract, the
supplier should encounter conditions impending
timely delivery of the goods, the supplier shall promptly notify
the purchaser in writing of the facts of the delay its likely
duration and its clause(s). As soon as practicable after receipt of
the suppliers notice, the purchaser shall evaluate the, situation
and may at Its discretion extend the suppliers time for performance
in which case the extension shall be ratified by the parties by
amendment of the contract. The extension of the delivery period
will be subject to the following conditions.
a. The Purchaser shall deduct from the contractor under the
provision of Clause 12 penalty / liquidated damages on
the stores, which the contractor has failed to deliver within
the delivery period fixed for delivery.
12. Penalty Clause
If the supplier fails to deliver any or all of the goods within
the time period(s) specified in the contract the purchaser shall
without prejudice to its other remedies under the contract, deduct
from the contract price, as liquidated damages a sum equivalent to
1% of the delivered price of the delayed goods for each week of
delay or part thereof, until actual delivery up to a maximum
deduction of 10 percent of the delayed goods contract price. Once
the maximum is reached, the purchaser may consider termination of
the contract.
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13. Termination for Default 13.1 The purchaser may without
prejudice to any other remedy for breach of contract, by written
notice of default sent to
the supplier, terminate the contract in whole or in part a. If
the supplier fails to deliver any or all of the goods within the
time periods specified in the contract or any
extension thereof granted by the purchaser pursuant to Penalty
clause 12. Or
b If the supplier fails to promptly replace any goods rejected
submitted for testing or subject to recall ordered by the
applicable Regulatory Authority in the country of manufacture due
to unacceptable quality or reports of adverse drugs reaction after
giving prompt notice of the recall.
c. If the supplier fails to perform any other obligation(s)
under the contract. 13.2. In the event, the purchaser terminate the
contract in whole or in part, pursuant to above clause 13.1 and
without
prejudice to the purchaser’s other remedies, the purchasers may
procure upon such terms and in such manner as it deems appropriate,
goods or services, similar to those undelivered or unformed, the
supplier shall be liable to the purchasers for any excess cost for
such similar goods. However, the supplier shall continue
performance of the contract to the extent not terminated.
14. Force Majeure 14.1 Notwithstanding provisions of clause 11,
12 and 13 the supplier shall not be liable for forfeiture of its
performance
security, penalty or termination for default if and to the
extent that, it’s delay in performance or other failure to perform
its obligations under the contracts is the result of an event of
force majeure
14.2 For the purpose of this clause, force majeure means an
event beyond the control of the supplier and not involving the
suppliers fault or negligence and not foreseeable and
unanticipated by and not brought about at the instance of the
supplier and which has caused the non-performance or delay in
performance. Such events may include, but are not restricted to,
acts of the purchaser either in its Sovereign or contractual
capacity, wars or revolutions, fires, floods, epidemics, quarantine
restriction and freight embargoes.
14.3 If a force majeure situation arises, the supplier shall
promptly notify the purchaser in writing of such conditions and the
cause thereof. Unless otherwise directed by the purchaser in
writing the supplier shall continue to perform its obligations
under the contract as far as reasonably practical and seek all
reasonable alternative means for performance not prevented by the
force majeure event.
15. Fall Clause 15.1. The Bidder should confirm acceptance to
the fall clause given herein under 15.2 The price charged for the
store supplied under the contract by the contractor shall in no
event exceed the lowest price
at which the contractor sells the stores or offers to sell
stores of identical description to any persons / organisations
including the purchaser or any Department of the Central Government
or any Department of a State Government or any statutory
Undertaking of the Central or State Government, as the case may be
during the period till performance of all supply orders placed
during the currency of the Rate Contract is completed. In any
subsequent date after submission of the quotation or placing of a
supply order, the manufacturer (the term manufacturer will also
include his authorised distributor/agent) reduces the sale price of
such stores “ In case there is a fall in the institutional price
due to reduction in price of raw material, customs duty exemption
etc. the manufacturer will have to reduce the price proportionately
” or sells or offers to sell such stores to any other party at a
price lowest than the price charged/chargeable against the supply
order placed by the Medical Stores Depot, the manufacturer
(including his authorised distributor/agent as aforesaid in case
the quotation is submitted by them and the supply is also effected
by them) Will forth-with notify such reduction in sale price to the
officer-in-charge of the Govt. Medical Store Depot and the price
payable for the stores to be supplied against the supply order
after the date of such reduction in sale price coming into force,
shall stand correspondingly reduced. The above stipulation will,
however, not apply to: (a) Export / Deemed Exports by the
Contractor
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(b) Sale of drugs which have short leftover expiry dates, and
(c) Tender submitted in response to fixed quantity contract
enquiries issued by MSO.
15.3. Contractor shall submit a certificate to the concerned Pay
and Accounts Officer at the time of claiming payment for
supplies made against Rate Contract that stores of description
identical to the stores supplied to GMSD(s) under the Rate Contract
have not been offered / sold by them to any persons / organizations
up to the date of bill / completion of supply against all supply
orders placed at a price lower than the price charged to the
purchaser(s) under the Rate Contract. It is further certified that
there is no fall in the institutional price due to reduction in
price of raw material, customs duty exemption etc. and in such
case, the manufacturer will have to reduce the price
proportionately.
16. Samples against this Tender inquiry if called for shall be
furnished by the date stipulated. Failure to do so will entail
the quotation being ignored.
17 Inspection and Tests
17.1 The purchaser or its representative shall have the rights
to inspect and/or to test the goods to confirm their conformity to
the contract technical specifications. The inspection and tests
shall be conducted at the manufacturer works and/or at the goods
final destination and inspection note will be released on receipt
of satisfactory test report.
17.2 Unless otherwise provided for in the contract if the
special tests or independent test proves satisfactory and the
stores or any instalment thereof is accepted, the quantity expended
in test will be deemed to have been taken delivery of/by the
purchaser and, be paid for as such.
17.3 (A) Should any inspected or tested goods fail to conform to
the specifications, the purchaser may reject them and the supplier
will remove the rejected stores at their cost.
(B) In case any item is found substandard either at the
inspection stage or during the shelf life of the
item, the report of the Government approved laboratory shall be
accepted by the firms. If the same is disputed by the firms giving
the reasons, the sample will be sent to Central Drug Laboratory,
Kolkata and the report of CDL will only be accepted as final and
conclusive report. The de-registration / debarment action will be
taken against the manufacturing unit and contract holding firms
(both) according to the category-A and category-B defects as per
guidelines issued by the Ministry of Health & Family Welfare.
(Appendix-I)
(C) In the event of failure of their products, in addition to
the debarment /de-registration action, the 5%
performance security of the suppliers will be forfeited and the
testing charges involved will be recovered by MSO/GMSDs from the
supplying firms.
17.4 The purchasers right to inspect, test and, where necessary
reject the goods after the goods arrival at the final
destination shall in no way be limited or waived by reason of
the goods having previously been inspected, tested and passed by
purchaser or its representatives prior to the goods dispatch from
the place of manufacture.
17.5 Nothing in clause 17.3 shall in any way release the
supplier from any warranty or other Obligations under the
contract.
17.6 The supplier will be responsible to take back the rejected
stores from the depots/consignee place and replace with fresh stock
duly inspected within forty five days or as stipulated in the
notice issued to the supplier, at their own cost up to the
consignees or depots.
17.7 In case of Pre Despatch Inspection, stores will be
delivered at consignee’s side within the validity of the
inspection note. 18. Non-supply and/or rejection on
inspection/test repeatedly will be considered as bad Performance,
which would render
the Bidders liable to be debarred from participation of the
Bidders In future.
19. Transit Insurance
19.1 The depot shall not be responsible for any
breakage/leakage/shortage during transit etc.
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19.2 The purchaser will not pay separately for transit insurance
and the supplier will be responsible till the entire stores
contracted for arrive in good condition at destination.
20. No material assistance whatsoever will be provided by the
purchaser. 21. All Tender documents attached with the invitation to
tender are Sacrosanct for considering any offer as a complete
offer.
22. Termination for Solvency The purchaser may at any time
terminate the contract by giving written notice to the supplier
without compensation to
supplier if the supplier becomes a bankrupt or otherwise
insolvent provided that such termination will not prejudice to
affect any right of action or remedy which has accrued or will
accrue thereafter to the purchaser.
23. Laws Governing the Contract
23.1 This contract shall be governed by the laws of India for
the time being in force
23.2 Irrespective of the place of delivery, the place of
performance or place of payment under the contract, the contract
shall be deemed to have been made at the place from which the
contract has been issued.
23.3 The court of the station of the depot placing the orders
shall alone have the jurisdiction to decide any dispute
arising out of or in respect of the contract.
24. Resolution of Disputes
24.1 The purchaser and the supplier, shall make every effort to
resolve amicably by direct informal negotiation any disagreement or
dispute arising between them under or In connection with the
contract
24.2 If, afte