PROCUREMENT NOTICE . GLOBALMINISTRY PROCUREMENT COM MITTEE,

MINISTRY OF HEALTH, NUTRITION & INDIGENOUS MEDICINE

The Chairman, Ministry Procurement Committee of The Ministry of Health, Nutrition & Indigenous Medicinewill receive sealed bids for supply of following items to the Depaftment of Health Seruices.

Bid Number Item Description

AruWl3/19 Rapid Dengue Test-immunochromatography tgG &IgM antibody Strips andDengue -NS- I antigen -ICT strips

03.09.2018 60,000/- +taxes

Bids should be prepared as per particulars given in the Bidding Documents available to prospective bidderson working days between 0930 hours to 1500 hours from above dates at the Head Office, No,75, SirBaron Jayatillake Mawatha, Colombo 1. These could be purchased on cash payment of a non-refundableBidding document Fee per set as mentioned above. Offers received without enclosing originalpayment receipt are liable to be rejected.

Whcrever necessary potential bidder/bidders should get registered in terms of the Public Contract Act No,3of l9B7 before collecting the Bid Documents and also should get the contract registered after the tenderis awarded.

All Bids should be accompanied by a Bid Bond as specified in the Bidding Documents.

Sealed Bids may be sent by post under registered cover or may be personally deposited in the boxavailable for this purpose at Internal Audit Depaftment in Mezzanine floor of the State PharmaceuticalsCorporation at No, 75, $ir Baron Jayatillake Mawatha, Colombo 1, Sri Lanka.

Bids will be closed at the Head office of the State Pharmaceuticals Corporation on the datesand time mentioned above and will be opened immediately thereafter.

Bidders or their authorised representatives will be permitted to be present at the time of opening of Bids.

Bidding Documents are being sent to Sri Lanka missions abroad and foreign missions in Sri Lanka,

CHAIRMAN - MINISTRY PROCUREMENT COMMITTEEMINISTRY OF HEALTH, NUTRITION & INDIGENOUS MEDICINEC/O STATE PHARMACEUTICALS CORPORATION OF SRI LANKA

75, SIR BARON JAYATILLAKE MAWATHACOLOMBO 1

SRI I.ANKA.

TEL/FAXE.MAIL

: 00 94-11- 2335008: impmanager@spc.lk

ClosingDate &Time

16.10.2018At 11.00 am

.L

D;te ofissuing of

BidDocuments

Non-refundableBid Fee perset- LKR

Chairman- Procurement Entity0n behalf ofCHAIRMAN - MINISTRY PROCUREMENT COMMITTEE

MINISIRY OF HEALTH, NUTRITiON & INDIGENOUS MEDICINE

CIO STATE PHARMACEUTiCALS CORPORATION OF SRI LANKA

75, SIR BARON JAYANLLAKE MAWATHA

COLOMBO 1

SRI LANKA.

ANNEX - 1ABID No. : DHS/M/LlwwlslLgDATEOFISSUE : O3RDSEPTEMBER 2018cLosrNG DATE & TrME : 16rH OCTOBER 2018 AT 11.00 A.tg. SRr LANKA TrME

ORDER LIST NUMBERT 2019/SPC/ [t_/RlDloo148

ITEMNO

SR NO ITEM

1 42800103 ItemrRapid Dengue test - immuIgG & lgM antibody strips

Specification:Rapid Dengue test - immuIgG & IgM antibody strips

2 42800503 Item:Dengue - NS-1 antigen - ICT

Specification:Dengue - NS-1 antigen - ICT

QUANTITYstrips

DELIVERY

:ography

106,000 35,000-01/0u2a1935,000-01/0512a]936,000-01/1012019

260,000 65,000-01/0L1201965,000-01/041701965,000-01/081201965,000-01i 121aafi

immunochromatography

munochromatog

strips

stripsPacking: l strip

The amount of Bid Bond : LKR 4948,000.00 or USD 301837.00

Bid Bond should be submitted with valid up to 14.05.2019 together with the tender

Non refundable Bid document fee LKR 60,000.00 per set

Special Conditlo$t for Tendering

1. Rapid Dengue Test-Immunochromatography IgG & IgM antibody stripsI. Should detect the antibody from all four dengue virus serotypesI1. Should detect either prirnary or dengue infection for the second time (secondary dengue

infection)2, Dengue *NS-l antigen ICT strips

I. Should detect the antigens from all four dengue virus serotypes.II. Should detect acute infection either primary or dengue infection for the second time (Secondary

dengue infection)3. Frir Rapid Dengue test and Dengue -NS-l antigen ICT strips.

L Should mention the type of sample (whole blood/serum/plasma), timing and container ofcollection.

il. Result should be collected within 15-20 minutes after specimen transfer to device.III. The interference substances for the test should be clearly stated, (e.9. hemolyzed

specimen/drugs)N. Sensivity should be >9590 (compared standard assay details should be submitted along with

the bid)V. Specificity should be >980/o (compared standard assay details should be submitted along with

the bid)VI. Should be tested for cross reactivity with the zika, Hepatitis C virus, Chickengunya & Japanese

Encephalitis)VIL Lower limit of detection should be stated clearly.VIII. Any limitations of the test should be clearly stated.il. Shelf life of the kit should be minimum L year at the time of delivery.Reagents and materials should provided.

I. Individually sealed aluminium foil pouches contalning one cassette device with one desiccant

iI. Instruction sheet for use, including test procedure in English

III. Assay bidder in dropper bottleIV. Specimen transfer device is preferable

V. Dengue positive antibody control kit should be provided with each batch of Rapid Dengue Test.

Should contain positive and negative controls

Dengue positive NSl control kit should be provided with each batch of Dengue NS1

Ag. Should contain positive and negative controls'

Storage of the Kit

I. Preferably the storage temperature should have a wide range 2-300 C.

AssaY Procedure

i. Volume of sample for test should vary from 25-100u1

For Technical Evaluation

I. 25-40 Nos. of sample strips for each item should provided with control kit for Technical

Evaluation,

Note: Bidder should comply with the above conditions, if not the bid witl not be considered for

evaluation.

Strecial Fonditions for tendering :

1. offers shoula Ue a.cornpanieO *ittr the vatid registration certificate issued by the National Medicines

Regulatory AuthoritY in Sri Lanka

Z. Oflered item should bear both our SR number and the Item number. However at the bid opening only the

item numbers will be read out. Therefore price quoted should be shown against each item number.

3. If the shipment is being effected on FCL basis both FOB and Freight charges should be quoted

separately against each item in addition to quoted C & F price.

4. The volume of the totalquantity of each item should be given in cubic meters (m3)

S. Foreign offers should be on C & F (CPT/CFR) Cotombo basis. FOB offers are not acceptable. Ifoffers are received on Import & Supply basis from local suppliers, those offers should be inLKR. All local suppliers/manufacturers shoutd quote in LKR for the total delivery price to MSD

stores,

6. Fax/E-mail offers directly sent to State Pharmaceuticals Corporation are not acceptable.

Tenderers are requested to draw their attention to the ctause "submlssion of Bids" of the bid' document in this regard.

Z, If awarded supplier is unable to adhere the delivery schedule due to nci fault of the SPC/Ministry would

result in the supplier being surcharge 0,5olo of total bid amount per day from the due delivery date'

B. The original payment receipt has to be annexed to the offer. Offers without same will be reiected'

9. We reserue the right to reject offers which do not comply above.

10. The offer should be valid for a period of 180 days from the date of closing bid.

(Annexure *IV )

{jENh,R.A.t, CONDITIONS Ol"'SU-I'}']LY irOB$PC ORDE-I.1"! -AppLeg}ie lbr Laboratorv l191ns

{ iure r;rl {Product & ( 'iulsiplllttt:ttts;

\.!

1. The consignments supplied in respect of an orcler concerned, shall exactly match with the reference

sample submitted and the produot inf<xmation (item descriptiorrs, shelf life/warranty where applicable,

mangfacturer's name, country of manufacture, country of origin, etc.) provided in the bid document by

the supplier, which has been accepted by the procurement committee, and included in the Indent /Pux;hase Order (PO), issued by SI'C.

2. AII items shall be supplied, sourcing fiom the manufactnrer and country of manuf'acturer, stated in the

Purchase Order (P0)/Inclent of SPC and wherever applicable shall have a valid product registration

from NMRA.

3. Maintaining the validity of the product registration during the period ofi supply(delivery schedule),

obtaining imporl license / manufacture licensing at NMRA, is it pre-requisite for the supply ofrelevant laboratory items. Hence all suppliers shall produce relevant valid registration

certificates/licenses, whetr requested by MSD/SPC'

When the validity of the product/manufacturing licenses and registrations of NMRA (eg;

manufacturing license, product registration and GMP certificates), of local manufacturers I local

suppliers, lapses during the year or during the period of supply (delivery schedule), it shall be

exiended / renewed by the supplier. A certified copies of afore mentioned valid certificates shall be

submitted to MSD by the supplier when deliveries are made.

4. 'l'he number of batches per consignment slrall be minimal. Batch quantity shall be an equal multiple ofthe qgantity of the consignmelrt and the propoflionate size of the batch quantity shall be not less than

157o o1'the quantity in the consignmont.

5. If MSD decides to accept a consignment, with deviations fi'om cefiain teniier conditions (eg: with

regard to labeling/packaging or any other rectifiable defec,t at the time ol recre.ipt in Sri I.anka) drre to

o,,-urgr,,"y, tfiat sliall be clone subject to, either rcctifying thc dcfcct i,vithin 05 i,vorking days by the

supplier, 6r recovering the total cost [al of rectifying the defect by MSD {vra a duly contracted third

party providing such services), from the supplier with a 25% strrcharge on the.labeling cost. (total

charge,= [a]+[a1x0.25) or 2o/o af the invoiced value, whichever is the highest ".

All possible tender deviations such as Packing, labeling, delivery schedule, storage status, payment

mocie & conditions, etc., shall be communicated and agreed upon before accepting the tender award

by the supplier. Noncompliance of same shall be considered as tender violations, to apply penalty(as

clause No. 37).

6. The specifications of the product offered in the bid, by the supplier shall match with the tender

specifications for the item and any fonn of alternate olfers wiit not be entertainedT unless otherwise

mentioned in this bidding document.

Shelf life & Warrantees

8. Freshly manufacturecl stocks of the procluct shall be supplied; thereby the residual Shelf Life (shelf life

rernaining at the time of delivery oi goods in Sri Lanka/MSD stores in case of local supplies) of the

product, ihatl b" 85% of'the shelf life requested(specified in orderllndentlP0)'

in ."upr"t of the items with requested shelf life equal or more than 24 months, any deficit between the

residual shelf life ancl requested shelf, shall not be more than 04 months.

?

In the violation of the above tender condition, SPC/MSD reserves the right to accept a reduceclquantity, that is usable (as per the consumption rate) up to three months before the expiry of same andwill subject to application of a penalty'(as clause No. 37 ).When the shelf life is not spccified in the indent/lio/item spec; the requrested shelf litb shall beconsidered as 24 months ibr laboratory items.

Standarels & Qualitv

9. Any product deficient of its sub componentsl accessories, not at the specified quality standards or allits components not unitized appropriately in packaging (as a set), shall be reiecte{4.

I0. Withdrawal from use of items due to quality failure found as manufacturer's /supplier's fault:(a). In case of batch withdrawal. value of entire batch quantity supplied shall be recovereds flom

the supplier.(b).ln case of product withdrawal, value of entire product quantity suppliecl shali be recovereds

Irom the supplier.(c). ln the event of either a) or b) abo',.,e, supplier shall be surchargeds the total cost involved for

MSD, of the quality failed supplies witb25o/o administrative surehargc of-the same.

ll.The storage conditions and the packing requirements of the product shall conform to the informationgiven by the manufacturer and accepted by NMRA lbr the product registration

The bidder must provide with the bid" a declaration to certify the NMRA accepted product details suchas; storage conditions, pack detaiis/contents/sizes and standard batch quantity/size ofthe product.

12. Immediately a{ter delivery at MSD, the consignments shall be subjected to testing appropriatelydrawn, one random batclr sample_(Post-delivery sample) o1'the consignment at a govolnment/semi-govemmentlaccredited laboratory t', If th* sample is found to be substandard, random batch sampleswill bc tested fiom all the batches/lots in the consignnrent, aud entire expenses on such tests, Iike valueof samples, transport, sanrpling & testing charges. etc, will be recovered trom the supplier.

I3. Consignments supplied to MSD vir:lating the storage oonditions indicated on product iabels and/orproduct infbrmation leaflet (as accepted lor product registration at NMRA), shall be considered as

quality a{fected consignments and quality assurance of such oonsignments shall be carried out by post-delivery testing at government / serni govenunent laboratory in Sri Lanka or at an accreditedlaboratory (fbreignilocal). All the expenses on such an event, including slorage cost shall be borne bythe supplier. lf found to be quality affected the consignment will be treated as qualityfaileds(as clauseNo.ll).

l'ack size. Labeline & Packasing

14. O1'fers for pack sizes at a lower level(snialler quantity per pack) than the pack size specified in the itemdescription/specification and MSD order [,ist, are also acceptable, but higher level (larger quantity perpack) pack sizes will not be entertained unless otherwise otlbred with the original bid and acceptecl bythe procurement committee, with the concurrence of MSD.

6

15. Each; innermost pack. shall bear the item Description, SR No, Batch No/Lot no., Reference/Catalogue

no.(not for phaimaceuticals), Date of Manufacture, Date of Expiry and o'S'l'ATE LOGO" ofGovernment of Sri [,anka.It is essential to inolude and exactly match the dates of Expiry & date of Manufacture (in any form as,.Year & Month,,or,,No Exp."), in the innermost pack and supplier's invoice.

16. Description of the Item, SR No, Date of Manufacture, Date of Expiry, Llatch No, Name and address ofmanufacturer and "STATE LOGO" of Sri Lanka Government shall be clearly marked on the outer

covering of the indivi<1ual/innermost pack containing the minimum unit of n'ieasure, including blister

& strip iards and on the outer cover ot- the carton/box, . The format of the Date ofManuiacture/Date of Expiry should be declared in the offer and it shall consist at least the YEAR and

MONTH.

t?. All outer most caftons (shipping packages) shall bear the MSD Purchase Order No, SPC Indent No.,

SR No, Batch No, apd Daie of Expiry in size I.5cm letters / figures in prominently visible manner.

This may be printed, stencilecl or label properly affixed.

lg. Batch Number of the product shall be separately Barcoded (in Code 128 or 2D formats) and Barcode

shall be printed on the labels atall levels of packing as described below, conforming to the industry

standards in Barllude printing and pasting.

Format shall be according to Code 128 or 2D standards'

Maximum barcode size shall be 5'0cm (length) x 2.5cnr (width).

19. In case of receiving gootls uncler inappropr:iate packaging conditions(not irr good order), was to be

softe6 out by MSDIo selecr the itenis in good order by 100% checking/handling of the consignment,

all expenses incurred to MSD in suoh an event (including demurrage charges, cold stores charges'

labor charges etc. or any other eharges incurred until goods are ready for acceptance), have to be paid

to MSD by the local supplier, belore attending to checking the consignment 100%, by MSD.

In respeci of SPC imported supplies, if the local agent does not follow suit as above, such extra

**p.r.,r.u incumed to MSp shall be recovered lrom the supplier t by SnC and refund to MSD.

Storage Conditions & Temperature.

20. If the storage temperature & conditions are not specified in the item specification, NMRA accepted

nroduct storage conditions, shall conftrillr to Sri Lalkan ambient storage conditions in thc ranges ofio0c +l- 20c i*emperature and 7s%+l-5% relative humidity.'lhe product storage conclitions shall be

clearly indicated at all levels of labelslpackages/boxes.

21. In respect of the products requiring controlled temperature storage (Eg.< 250c,2-25oc, 15-200c/300c,

2-g0c etc,i, supplier shall provide MSD with latest product stability study reports with the invoice ofthe consignmelt,(report shall include studies; at 300c +l- 20c & 75% +l'5% RH for AC stored items

and at Z56c+.1-Zcc it 60a/o il- 5% RIl fr:r Coltl storeel items. It shall be a true copy of the latest repoft

submitted to NMRA or a report issueci within last 05 years). (r'efer clause N<1.12)

Deliverv Requlrements

25. Ail items shall be supplied as per.the latest/final delivery schedule, communicated to the supplier, as

an amended Indent/po deliveiy schedule (if not amended, original schedule in the lndentlPo will

apply) mutually agreed between MSD& SPC, at the time of establisiring the paymefi terms (1,/C, DP,

f1f1, Lic). Any ieviation fiorn this agreecl delivery sclredule shall be feated as a defaulted delivery.

1

contmvening the ahove directions, if the delivery schedute is violatecl by the supplier for no fault ofMSD/SPC/MOH ad in the event MSD decid.*,o.u".*firry rr.r, consignmerr in full or parr thereoi;that is deliverecl after the due delivery clate, condition ruo. zy'on delayed ieliveries, shall be applied.26. All c,nsignments shall be delivered at Medicar supplies Division or alternate receiving point asdirected. IJowever sencling cor.rsignments t

sh a I I be av o i ited, -un

r;:: :lilJr'rf lff lii,27' Defaulted consignments with respect to delivery scheduie shall only be considered for acceptance,sub'iect to a penalty imposecl lbr ihe delay duc t,, *uppri.m

-faurf, allowing a graceperiod up ro twoweeks' Consignments deiivered afler. that grace p.rio.iln*l be *rnsidered?or acoeptance sub.ject to apcnalty I to the supplier as clescribecl below-;

(a)' A penalty af as% per day of the consignment value, calculated cornnrencing from the l5th ciayup to 60th day delay lrom the due delivery iatc, u* p*, the indent/po or its, lates-t amended cleiiveryschedules.

(b)' when the delay exceeds 60clays prirchase orclcr will be considered as automatically cancelleti, ondefaulted performance. In such o titrutinn" MSn reserve the right ,o ,*"or*, Iiquidated damages or torevoke the cancellation (eg' if payments have been releasecl pior to such a cancellation), and acoeptthe consignment subjectta aZSi/o'admin surch,,rj". ---'

28' (i)' Il'any local purchases were to be rnacle by Msll/spc to ensure continuity of supply (<iue tononcompliance of Indent/l'}o/its' atttcntleil: tleliverv scheclule); in the ,n*1iing period inciusive of thegrace period fbr delivery fror, eltte delivt'v tlnlc. utra expenditure incurre<J o, such local purchases,over the landed cost of relevant sPC tttain unler. slmll be recr:vered from the supplier:.(ii)' If a deiivery dcfaulted (violati[g delivery scheclule in the inderrypo) spc supplier/his localagent,who participate in an urgent Iocal prirchase tender of sPC or MSD for the same item, quoting the sameproduct or any siffriiar ptoduct, is bound to supply the krcal purchase orcler at the landed cost of thedefaulted sPC rnain orcler. kl violations of thc ,u*, ilr*

".rst cliflerence will be set ofl'{.rom thepayments to the supprierof the corresponding spc main'order.

29' In respect of local manufacturers/ losal srppliers, all deliveries shall be made only on week claysexcluding public holiclays, also allowing *d"quut* tir'," to enabie rhe completion of the receivingprocess at MSD store's before 3'30 p.nr. In the evenl of failure to rneet this deadline clue to supplier,slault (eg' In delivery; time, product, docume,l, etc.) gonj, shail be acceptecl on tr,e fbllowing worki,gday' such date shall be counted fbr. working oui'penalties as per 'N". iz (regarding defaultedconsignment) of the conclitions o{.supply.

As an alternative, supplier can request MSD to take over the consignment on the same day. stibject tcrsettling all adl. experses (i.e. srafro't, forklifi charge,.i..l nrnasD, by the supprier.

30'"I'he extension of'L/c's overstepping delivery scheclules in the Indent/po/its, amenclments, shall not inany way aflbct the rccovery oi'tutJ delivery .h..g;r,-;; per condition No. 2T (rega*JiHg defaulted

f::ifl:ffi'yr?)[T'Y other direct or indirect additlonat costs/riquiclateo aamages, relating/consequent

3l' when adequate storage space is nor available at MSD. to accept a delivery defaulteci consignment(deviating from the delivery scheclule in the IndentlPo/its' amencrnrents) u,der the condition No. 27,any additional expenses caused to MsD or sPC in arranging temporary external storage and otherexpenses (eg' demurr:age, detenti'tt, container storage. re-hanclling cur"r transport, etc.) shall be borneby the supplier.

o

Documents & Information

32. MSD Order No, Item Description, SI{ No, Batch No., Date of Manufacture, Date of Expiry and

product Storage Condition, shall be indicated in all Supply Invoices and detailed Packing Lists.

33. One of the tender samples of the selected bid shall be forwarded to MSD, for using as a reference

sample (can rnake it; a part of the last consignment or a returnable to supplier) for checking the

.onfor*ity of the consignments received under the indent/Por0.(applicable for laboratory items )'The images of the; specimen labels, minimum pack and outer most boxlshipper carton, that satisfies

thc above mentioned labeling conditions, shall also be provided within 14 days of releasing the indent

by SPC. Reference sample will be sent by Procurement Errtity to MSD.

34. The supplier shall submit all shipping documents to (lncluding Bills of l-ading I Draft Air Way Bills

etc.) SPC imports department and MSD by e-mail(r"ltow instnrctions in webslte www,msd.sov.lk ), at least 03 days

before the Expected Time of Arrival (ETA) of sea fieighted consignments & 02 days before the ETA

of Air freighted consignments.

35. After releasilg the lndent/Po or establishing LlC, the latest logistical position of manufacturing &supply on the Indent/Po, shall be updated biweekty through e-rnails to SPC with a copy to MSD" by

the supplier.( lollow instructions in the website www.msd.gov.lk)

If it i; not complied or the information so provided are found to be incomplete/false, the grace period

(for suppiy delays) mentioned ip the clause2T will not be applicable.

Common conditions:0. fn aAaition to tt e general conditiorm of supply given herein, any other relevant conditions as per the

tender document issued by SPC, are also applicable. The order/item specific;

Abbreviatians :NMRA ; National Medicines Regulatory Authority/Sri Lanka, SPC ; State Pharmaceuticals

corporation, MSD; Medical Supplies Division/Ministry af Health-sri Lanka.

ggfflqlq1t!- SUantitf-Sl5grule5-ehould be lo-lwardeil fe!-.erA!CA!9U

N.B. If Local Agent Commission to be paid the percentage should be clearly indicate in annex 1 B

SM/ns

Please refer Clobal Bid DocumentF: -glsbal Tender - Bid Doc

ir

PROCUREMENT NOTICE . GLOBALMINISTRY PROCUREMENT COM MITTEE,

MINISTRY OF HEALTH, NUTRITION & INDIGENOUS MEDICINE

The Chairman, Ministry Procurement Committee of The Ministry of Health, Nutrition & Indigenous Medicine

will receive sealed bids for supply of following items to the Department of Health Services.

Bids should be prepared as per pafticulars given in the Bidding Documents available to prospective bidders

on working days between 0930 hours to 1500 hours from above daLes at the Head Office, No'75, Sir

naron layitillake Mawatha, Colombo 1. These could be purchased on cash payment of a non-refundableEidding document Fee per set as mentioned above, offers received without enclosing original

payment receipt are liable to be rejected.

Wherever necessary potential bidder/bidders should get registered in terms of the Pubtic Contract Act No.3

of 1987 before collecting the Bid Documents and also should get the contract registered after the tender

is awarded.

All Bids should be accompanied by a Bid Bond as specified in the Bidding Documents.

Sealed Bids may be sent by post under registered cover or may be personally deposited in the box

available for this purpose at'internal Audit Department in Mezzanine floor of the State Pharmaceuticals

Corporation at No. 75, Sir Baron Jayatillake Mawatha, Colombo 1, Sri Lanka.

Bids will be closed at the Head office of the State Pharmaceuticals Corporation on the dates

and time mentioned above and will be opened immediately thereafter.

Bidders or their authorised representatives will be permitted to be present at the time of opening of Bids.

Bidding Documents are being sent to Sri Lanka missions abroad and foreign missions in Sri Lanka.

CHAIRMAN - MINISTRY PROCUREMENT COMMITTEE

MINISTRY OF HEALTH, NUTRITION & INDiGENOUS MEDICINE

CIO STATE PHARMACEUTICALS CORPORATION OF SRI LANKA

75, SIR BARON ]AYATILLAKE MAWATHA

COLOMBO 1

SRI LANKA.

TEL/FAXE-MAIL

Bid Number

16.10,2018At 11.00 am

Intravenous Administration SetVolume Controlled 10O-150m1

: 00 94-11- 2335008: impmanager@spc.lk

l')

ClosingDate &Time

Item Description Date ofissuing of

BidDocuments

Non-refundableBid Fee per

set- LKR

03.09.2018 :s,oool- +

Chairman- Procurement EntityOn behalf ofCIIA]RHAN _ MINISTRY PROCUREMENT COMMITTEE

TPISTIIOF HEALTH, NUTRTrION & INDIGENOUS MEDICINECIO STATE PI.IARMACTUTICAI.S CORPORATION OF SRi LANM75, SIR BARON.]AYANLLAKE MAWAIHACOLOMBO 1

SRI LANKA.

T

ANNEX - TA

BID NO,DATE OF ISSUE

: DHSlMlslww 17ltg: O3RD SEPTEMBER 2018

TH

Qrder List No. 2019/S-PCI NJ R/S/00045

ITEM QUANTITYNos.

Volume Controlled Intravenous Administratton 1,400,000

Set for gravity infusion, Conforming to ISO

standards, comprising; Piercing spike,

Calibrated fluid chamber 100m1 to 150m1, 150

to 180cm long tubing with flow controldeviceand a floating diaphram, "Y" injection site,

Bacteria proof air inlet with snap vent, Luer

lock fitting and complete with piercing spike'

Sterile non-toxic and pyrogen free.

Packing: 1 Nos.

Bid Bond value Rs. 2,370,000.00 or USD L4.7720A

valid up to 14.05.2019 has to be submitted with the bid.

Sufficient quantity of samples should be forwarded for evaluation'

N.B.If Local Agent commission to be paid thc percentage slrould be clearly indicate in annex 1B'

Non - refundable Bid fee - Rs. 35,000,00 + taxes

SpeciAl Co.nditigns for tendering :

l. Offers should be accompanied with the valid registration certificate issued by the National Medicines

;-rrr.t"v Authority in Sii tanka Formerly Cosmetic Devices and Drugs Authority'

2. offered item should bear both our sR number and the Item number.

3, Foreign offers should be on c & F (Cpr/cFR) Colombo basis. FoB offers are not acceptable. rfoffers are received on Import & iuppiy basis from local suppliers, those offers should be in

LKR. All local suppliers/manufactureis stroutU quote in LKR for the total delivery price to MSD

stores,

4, FaxlE-mail offers direcuy sent to state Pharmaceuticals corporation are not acceptable'

Tenderers "ru

r"qu""t"a t'o ar"* their attention to the clause "submission of Bids" of the bid

document in this regard.

S. If the shipment is being effected on FCL basis both FOB and Freight charges slrould be quoted

separately against uu.[ it** in addition to quoted C & F price. The volume of the total quantity of each

item should be given in cubic meters (m3)

6. The original payment receipt for purchasing the bidding document has to be annexed to the offer' Offers

without same will be rejected'

ITEMNO

150,000-Jan l2A$150,000-Feb/2019

150,000-Marl20L9150,000-Apr/2019

150,000-MaVl2019

150,000-Jun 120t9150,000-Jul/2019

150,000-Aug l2AL9150,000-Sep/2019

50,000-Oct/2019

14100501

It1

SR NO

7. we reserue the right to reject offers which do not compry above.

L The offer should be valid up to 13.04.2019

cON prTrONS or suP-Pl.y-

Procluct & Consignments

I' The consignments supplied in respect oi'an order concerned, shall exactly match with the reference'santple sttlrnritted and the plotluut irtlirnnalion (itcrn desoiptions" shelt'lif'ciwan"nly where applical:le,manutlclurer's firitlrc, country of rnanul'ircturc. countr,v of tirigin. ctc.; prtx,ided in tile bicl docirruenf hytht: supplier. *hT!] lras br-xn acceplerl by the pro"ui*,n*,,1 cornrrritt*e. an4 inclp4erl irr thc lnrJe,t /Ilurchase Order (l)()). issucd by Sl)(..

2' All items shall be supplied, sourcing from the manufacturer and country of manufactureq stated in thePurchase order (Po)/Indent of SPc and wherever applicable shall have a valid product registrationfrom NMRA.

3' Maintaining the validity of the product registration during the perioil of supply(delivery schedule),obtaining import lioense / nranul'aclure licensing at NMRA. is a pre-requisite for the supply ofsurgical items' lcnce all suppliers shall produce r:elevant valid registration cl*ificates/licenses, whenrequested by MSD/SpC.

when the validity of' the productlrnanufhcturing licenses ancl registrations of NMI{A (eg;ntanufacturing license, product registration and GMP certifioates), ofiocal manufacturer.s I localsuppliers, lapses tlrrring the year or duritg thc period of supply (aerivery schedule), it shall treextended / rcttcw-sd b)' rhe supplirsr. A eerriiietl copies of afore *entlc,n"d valid ce(ificates shall besubmitted to Msl) by the srrpplicr when tleliveries are made.

4''r'he number of batches per consignment shall be minimal. Batch quantity shall be an equal multiple ofthe quantity o1'the consignment and the proportionate size of thetatch quririity shall be not less thanI5% of the quantity in the consignment. r-'----'-'

5' If MSD decides to accept a consignment" with devinlinns i'rnm t:crtnirl trrndcg conrlititl,s (eg: lvitlrregard to labeling/packaging or any other rectifiable clq{eet at rlrc tinre o{,reccipr irr Sri lank*) tlue t,an urgency, that shall be done subject to, either rectityirrg the dt:{bct withirr 05 wgrkipg tlavs hy rhcsupplier, or recovering the total cost [a] of rectilyirrg tt,*'il"rir*, i:y MSD 1r,iri ,r .luly cr]nlrdcts4 thirdparty providing such services), fmm the supplici *iit, u 2591o.surchag. n;r it,e'tai,.,ti,rg cost. ({otalcharge : [al+[a]x0.25) or 2o/o af the invoicerl value, whichcv*r ir tfr*''f.,illfir*i.AII possible tender deviations such as Packing, labeling, delivery schedule, storage status, paymentmode & conditions, etc., shall be communicaied and a[ieeel ,rpon b"f'or* u.""fting the ten4er awar<lby the supplier. Noncompliance of same shall be consiiered as-tender violations, to apply pelalty.

6' The.specifications of the product offered in the bid, by the supplier shall match with the tenderspecifications for

]he item and any fonn of alternate tffers wiil not be entertained, unless otherwisementioned in this bidding documents.

.Shelf Iife & Warrnntces

7' lireshly tnnntrthcttrroct sygtll of'the pnxlucr shdll hs supplicdt thereby the residual shelf Life (shelf lifet'ctuainittll at lltc tiltte of tlulivuy ol'guorls irr sri l,alrkdii4sll stores in "ure

of local supplies) of therrrtxJrut. sh$ll bc'85orr or'rhr' sheil'rire rcqucsrcrr(spce ifir;ir irr grder4ndelt/po).ln rer;pccl of'thc itenls with requcstetl shell'lilk ctlual or more than 24 rnonths, any deficit between therc.sidtritl shell'lifir attd requesled shelf lil-g. shall oui lr" nrorc than 04 r.norrths,

,!

In the violation of the above tender condition, SPC/MSD reserves the right t<i accept a reduced

quantity, that is usable (as per the consumption rate) up to three months before the expiry of same and

will subject to application of a penalty.When the shell life is riot specified in the indent/l'}Olitem spec; the requested shelf life shall be

considered as, 36 months fbr surgical items.

Standards & Oualitv

8. Standards: in addition to Pharmacopoeial Standards that are indicated in the item specifications, other

Pharmacopoeial Standards that are registered at National Medicines Regulatory Authority in Sri Lanka

are also acceptable when no bidders have quoted for the standard specified in the item specification,

9, Any product deficient of its sub components/ acoessories, not at the specified quality standards or all

its components not unitized appropriately in packaging (as a set), shall be r:ejected.

I0. Withdrawalfrom use of items due to quality failure found as manufacturer's/Supplier's fault:(a). tn case of batch withdrawal, value of entire batch quantity supplied shall be recovered from the

supplier.(b).In case of product withdrawal, valuc of entire product quantity supplied shall be recovered from

the supplier.(c). In the event of either a) or b) above, supplier shall be surcharged the total cost involved for

MSD, of the quality failed supplies with25Yo administrative surcharge of the same.

ll. The storage conclitions and the packing requirements of the product shall conform to the informationgiven by the manufhcturer and accepted by NMRA for the product registration.

The bidder must provide rvith the bid, a declaration to certify the NMRA accepted product details such

as; storage conditions, pack details/contents/sizes and standard batch quantitylsize of the product.

12. Imrnediately after delivery at MSD, the consignments shall be subier:ted to testing appropriately

clralvn, one random batch sample (Post-delivery sample) of the consignment at a government/semi-

governnrent/accredited laboratory. If the sample is filund to be substandard, random batch samples willbe tested from all the batches/lots in the consignment, and entire expenses on such tests, like value ofsamples, transport, sampling & testing charges. etc. will be recovered fiom the supplier.

13. Consignments supplied to MSD violating the storage conditions indicated on product labels andlor

product information leaflet (as accepted fbr product registration at NMRA), shall be considered as

quality affected consignments and quality assurance of such consignments shall be carried out by post-

delivery testing at government / semi government laboratory in Sri Lankaot at an accredited

laboratory (foreign/local). All the expenses on such an event, including storage cost shall be borne by

the supplier. If found to be quality affected the consignment will bc treated as quality failed (as clause

No.l0).

Pack size, Labeline & Packaeins

r*. Offers for pack sizes at a lower level(smaller quantity per pack) than the pack size specified in the item

description/specification and MSD order List, are also acceptable, but higher level (larger quantity per

pack) pack sizes will not be entertained unless otherwise offered with the original bid and accepted by

the procurement committee, with the concurrence of MSD.

rs. Each; innermost pack, shall bear the item Description, SR No, Batch No/Lot no., Reference/Catalogue

ng.(not for pharmaceuticals), Date of Manufacture, Date of Expiry and "STATE LOGO" of(iovernment of Sri I-anka.

It

It is essential to include and exactly match the dates of Expiry & date of Manufacture (in any lorm as"Year & Month" or o'No Exp."). in the inrrermost pack and sr"rpplier's invoice.

lo. Description of the ltem, SR No, Date of'Manulacture, i)ate of Expiry, Batch No, Name and address ol'manufacturer and "STA'IE LOG()" of Sri l.anka Government shall be clearly marked on the outercovering of the individual/innermost pack containing the minimum unit of measure, including blister& strip cards and on the outer oover of the carton/box.The fbrrr,at of the Date of Manufacturc/Datc of'Fixpiry should he declared in the o{'fer arrci ir shallcorrsist at least the YI.IAR & MON'l't{.

I7.All outer most cartons (shipping packages) shall bear the MSD Purchase Or'der No, SPC lndent No..SR No, Batch No, and Date of L,xpiry in size l.5cm letters / figures in prominently visitrle manner.Tlris may be printed, stenciled or label properly affixed.

18. tlatch Number of the product shall be separately Barcoded (in Code 128 or 2D fiormats) and Barcodeshall be printed on the labels at all levels of packing as clescribed below, conforming to the inclustrystandards in Barcocle printing and pasting.Iiormat shall be according to Code 128 or 2D standarcls.Maximunr harcode size shall be 5.0crn (length) x 2.5cm (width).

19. In case of receiving goods under irrappropriate packaging conditions(nr:t in good order), was to besorted out by MSD to select the items iri good order hy I00% checking/handling of the consignment,all expenses incured to MSD in such an event (including demurrage charges, colcl stores charges,labor charges etc. or any other charges inqurred until goods are ready {br acceptance), lrave to be pair{to MSD by the local supplier, belbre attending to r:hecking the consignment 100%, by MSD.

In respect of SPC imported supplies, if the local agent does not lbliow suit as above, such extmexpenses incured to MSD shall be recovered from the supplier by SPC and refur:cl to MSD.

Storage Conditions & I'emnerature

20. If the storage temperature & conditions ale not specitied in the itern specification, NMRA acceptedproduct storage oonditions, shall conform to Sri Lankan ambienl storage conditions in the ranges of-iO"c +/- 2"c temperature and 75t/a +l-5a/o relativs hurnidity. I'he product storage conclitions shall beclearly indicated at all levels of iabels/packages/boxes.

21. Maintenanoe of Cold Chain;a.ln case of cold storage items, cold chain monitors (ternperature recording devices) shatl be

included for each carton and the cold chain shall be maintained according to the manufacturer'sinstruitions during storage, tratlsport and delivery.

b. Supplier shall use suitable prominently visible identi{ication marks ol'international standard,with appropriate colours and sizes lbr casy identification of colcl cargo. Supplier shall usestandardized USB Devices fbr temperature data logging inside the packages and shall provide fteeof charge, data Iogger rcaders &/ software (rcading ,tpps compatihle with Windows-07/latest)to wharf department of SI'C in advance, to enable examining the rnaintenance of cold chain i1transit, and before taking over the consignnient by MSD.

c.ll'the cold chain break is observed at the time of taking over the consignments by MSD, suclrconsignments shall be rejected, indicating the reason on the relevant WDN or copy of thedelivery documents. It-t such an event, the SPC shall arrange necessary cold storage for thecot1signntent urtil 'observed cold chain break' is investigated leading to acceptance / totalre.iection of'consignment and the expenses borne by MSD i SPC in aranging the cold storageslrall be recovered from the supplier.

d. 'l'he vehicles transporting colct cargo to MSD shall be equipped with temperature monitoringdevices and the vehicle shall have NMRA approval fbr transport of pharmaceuticals.

t

e.The suppliers shall dispatch consignments of the iterns, which require coldchain tnaintenanoe, to

arrive in Sri l.,anka during Monday to 't'hursday to avoid additiorial demurrage & storage charges

during weekends, during which MSD stores is closed. In case of non-compliance of this condition,

any additional expenses incurred to MSD and SPC, to Custom clearlstore/re<;eive such

consignments shall be recovered from the supplier.

22.lnrespect of the products requiring controllecl temperature storage (Eg.< 25ac,2'250c, 15-200c/300c,

2-80c etc.), supplier shall provide MSD with latestproduct stability study reports with the invoice ofthe consignment.(report shall include studies; at 300c +l- Zac &.75% +l- 5o/o RI{ for AC stored items

and at 250c +l- 20c & 60yo +l- 5% RH fior: Cold stored items. It shall be a true copy of the latest report

submitted to NMRA or a report issued within last 05 years). (ref'er clause No.l 1)

Delivery Requirements

23. All items shall be supplied as per the latest/final delivery schedule, communicated to the supplier, as

an amendecl Indent/Po delivery schedule (if not amended, original schedule in the lndent/P0 willapply) mutually agreed between MSD& SPC, at the time of establishing the payment terms (L/C, DP,'IT, etc). Any deviation fronr this agreed delivery schedule shall be treated as a defaulted delivery.

Contravening the above directions, if the delivery schedule is violated by the supplier for no fault ofMSD/SPC/MOH ancl in the event MSD decides to accept any such consignment in full or part thereof,

that is delivered after the due delivery date, Condition No, 25 on delayed deliveries, shall bs applied.

24,l\lt consignments shall be delivered at Mcclical Supplies llivision or an alternate receiving point as

directed. ilo*eoer sending consignments tn rgrclr iri l,nnltit l'rom l5rl' llctomber to l(}th JaTunryshall be avoided, unless otherwise prior apprclval has been granted by MSD for such deliveries.

25. Defaulted consignments with respect to delivery schedule shall only be considered tbr acceptance,

subjcct to a pcnulty irnpr::;etl fur thc clelay due to suppliers fault, allorving a gracc pcriod ttp to tr'vo

weeks. Consignments delivered after that grace period shali be considered for acceptance subject to apenalty to the supplier as clescribed below ;

(a). Apenalty of 0.5%perdayof tl,econsignmentvalue,calculatedcommencingfromthe l5thdayup to 60th day delay fi'om the due delivery date, as pcr the indentiP0 or its' Iatest amended delivery

schcdulcs.

(b). When the delay exceeds 60days purchase order will be considered as automatically cancelled, on

clefaulted performance. In such a situation, MSD reserve the right to recover liquidated damages or to

revoke the cancellation (eg. if payments have been released prior to such a cancellation), and accept

the consignment subjectta a25Yo admin surcharge'

?,6. (i). If any leical purchases were to be made by MSD/SPC to ensure continuity of supply (due to

noncompliance of lndent/Polits' amended; delivery schedule); in the ensuing period incltrsive of the

grace period for delivcry fiom due delivery date, extra expenditure incurred on such local purchases,

over the landed cost of relevant SPC main order, shall be recovered llom the supplier.

(ii). If a delivery defaulted (violating delivery schedule in the indent/I'O) SPC supplier/his local agent,

who parlicipate in an urgent local purchase tender of SPC or MSD for the same item, quoting the same

protluct or any similar product, is bound to supply the local purchase order at the landed cost of the

defaulted SPC main order. In violations of the same, the cost differerrce will be set off from the

payments to the supplier of the oorresponding SPC main order.

27.1n respect of local manuf'acturers/ local suppliers, all deliveries shall be made only on week days

excluding public holidays, also allowing adequate time to enable the completion of the receiving

process at MSD stores belbre 3.30 p.m. In the event of lailure to meet this deadline due to supplier's

{8

fault (eg. In delivery; time, product. dooument, etc.) goods shall be accepted on the following workingday" such date sltall be counted for working out penalties as per No. 25 (r-egarding defaultedconsignmenl) of the conditions of supply.As an alternative, supplier oan request MSD to take over the consignment on the sarne day, subject tosettling all adl. expenses (i.e, staff OT, fbrklift charge, etc.) of MSD, by the suppiier.

28. I'he extension of I-lC's oversteppillg delivery schedules in the IndentlP0/its' amendments, shall not inany way affect the recovery of late delivery chargcs, as pcr Condition No, 25 (regarding defaulteclconsiguments) and any other direct or indirect additional costs/liquidated damages, relating/ionsequenrto extension of L/C.

29. When adequate storage space is not availabie at MSD, to accept a delivery ciefaultecl consignment(deviating frorn the delivery schedule in tlie Indent/P0iits' amendments) under the condition No. 25any additional expenses catmed to MSD or SPC in arranging temporary exterrral storage and otherexpenses (eg. demurrage, detention, container storage, rc-handling cum transport, etc.) shall he borneby the supplier.

Documents & Information

30. MSD Order No, Item l)escription, SR No, Batch No., Date of Manul'acture, Date of Expiry andprnduct Storage Condition, shall be indicated in all Supply Invoices and detailed Packing Lists.

31. One of the tender samples of the selected bid shall be forwardecl to MSI), for using as a refcrencesarnple (can make it; a part of thc last consignment or a returnable to supplier) fcrr checking theconformity of the consignmenls reoeived urrder the indent/P0 (Applicable for all surgical items)'l'he images of the; specimen labels, minimum pack and outer most hoxlshipper carton, that satisfiesthe above mentioned laheling conditions. shall also be provided within I4 days of releasing the inclentby SPC. Reference sample to be sent by Procurcment Entity to MSD.

32. 'l'he supplier shall submit all shipping documents to (lncluding tlills of Lacling / Draft Air Way Billsctc.) SPC Imports departuretit afld MSD by o-mail(rrtow instruerions in websitr: rvww.msd.sov.[k ), at least 03 daysbelore tlre Expected Time of Alrival (EI"A) ol sea fi'eighted consignmenrs & 02 days befbre rhe El'Aof Air freighted consignments.

33. After releasing the Indent/PO or establishing LlC, the latest logistical position of- manufacturing &supply on the lndent/P0, shall be updated biweekly througlr e-mails to SPC with a copy ro IrASO bythe supplier.( follow instructions in the website www.msd.gov.lk)If it is not complied or the information so provided are found to be incomplete/fblse, the grace period(fbrjsupply delays) mentioned in rhe clause 25 will not be applicabre.

ry34. In addition to the generai conditions of supply given herein, and any other relevant conditions as per

the tencier document issued by SPC, are also-appiicable. "I'he orcler/item specitic.

r NoteLast sentence of the I't paragraph of page No. 25 in Global Tcnder MPC hidding document to beamended fo read as "fn the evcnt of goods being rejected due to un-acceptable quality, the totalvaluc and adtlitional21a/o of the total value at landed costwill be reimbursed',

Abbreviatilsns |NMRA ; National Medicine.s Regulatory Authority/Sri Lankd, SIIC ; St:ate Phcrmcrceuticalscorytration, MSD; Medical supplies Divisksn/lu{ini,stry ol'Heolth-sri Lanka.

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1.

Snecial Conditions for Tendering

Art works and diagrams with dirnensions for relevant products with catalog numbers should be

provided.

Usage instruction pamphlet/user manuals in print/pdf/video format should be provided. (Such

instructions should carry details on maintenance, compatibility and storage)

Srtttlsrcn! quant|ty, of samples should be lorwarded fqr evaluation,

Soeqial Conditions

Suppliers should submit all shipping documents including the Bill of lading or Air Way Bill to SPC at

least 2-3 days prior to arrival of the consignments to prevent any delay in clearance.

In the event of an award made to you on this tender, SPC reserve the right to cancellsuspend the

procuring of said order in any stage, if you would be placed the defaulted supplier's list due toquality failure found in your previous supplies made to SPC or non compliance of contractual

agreement.

Where a purchase for a particular item is being made for the first time from a supplier, or where there

are previous quality failures on goods supplied by a Particular supplier payments will only be made

upon testing the quality and standards of the goods and comparing the bulk supply with the samples

provided along with the offer.

In the event of delivery of consignments deviating from given delivery schedule by MSD due to default

of supplier and same is rejected due lack of storage space avallable at MSD warehouses, any resulting

demurrage charges incurred shall be borne by the suppliers concerned.

All Shipment should be made exclusively on vessels belonging to the_ Ceylon Shipping

Corporation or those chaftered by CSC. Shipments on other vessels will be permitted in

instances where vessels of the Ceylon Shipping Corporation do not call at the Port ofShipment or if they are not available for timely shipment of cargo. In which event thesupplier should attich a waiver certificate issued by Ceylon Shipping Corporation on theirAuthorized Agent in the supplier's country'

AM/ns

Please refer Clobal Bid Documeut

F: Global Tender - Bid Document for Surgical ltems MPC

2.

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