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STATEPHARMACRT]TICA
(ESTABUSHED(JNDERT}IE STATE
)SRI7LANKA
4 '
ACL NO 49OF 1957)
IMPORTING ON BEHALF OFTHE DIRECTORGENERALOF I{EALTH SERVICES
GLOBAL TENDER
(CAPC/MPC)
TENDER DOCUMENTS FOR
PROCUREMENTOF PHARMACEUTICALS
FOR THE DEPARTMENTOF HEALTH SERVICESOF
THE GOVERNMENTOF SRI LANKA
All ShippingDocuments
andCorrespondence
STATEPHARMACEUTICALSCORPORATIONOF SRI LANKA
P O. Box l?57.
75, Sir Baron JayatillakeMawatha.
COLOMBOOI.
SRI LANKA.
Fax:
94-ll-24462M
Tphone: (00) 94- l l -2391538ot 2326227o( 2120356.9
E- mail : [email protected]
CORPORATION
STATEPHARMACEUTICALS
OF SRILANKA
TERMS
A N DC O N D I T I O N
OSFT E N D E R
01. INTRODUCTION
s Corporalron(SPC) of Sn Lanka is a fully Sn Lanka
01.1 The Slate Pharmaceutica
Surgical
Governmenlowned organizationengaged in lhe procurementof Pharmaceuttcals,
in the Privale
ltems,Laboratory
Chemicalsetc, for tts ow4 slocksand distflbution
Consumable
Hosprtals
of
the
Departmenl
of
Health
Servtces
for
use
in
all
Government
Sector.and
, and
throughN4edrcal
SuppliesDivison (MSD)
hospitals
underlhe provncralsCouncrls
01 2 Procuremenlis marnlydone by World Wde Tendersstrctly accordrngto terms
herewrth
and specifications
as statedIn the documents
conditions
productsin]portedrntoSrt Lankasholrldbe those registered
01 3
All Pharmaceutical
wrlhthe CosmetrcsDevices& DrlrgsAuthorilyof Sri Lanka Therefore.all crospecliveBrdders
to attend lo such Regtstralon However we may
shoud advrsetheir Local Representatrves
underspecialcrrcumslances
mporldrugswhicirare unregrstered
Letterof Credrtwith 75%
01 4 Paymentfor all rmportswill be C&F bass by rffevocable
of the valueof the.documentary
creditbeingavailabieto the supplrerat the time of shipment
and lhe balance25% after60 daysffom the date of paymentof the frrstBlll,providedall terms
in the Documentary
Credithavebeenskrctlycompliedwrth
andconditions
the lollowingterms&
tenderersare advrsedlo readand understand
01 5 All prospective
plea
insufficient
infofmaton will
no
of
lack
of
informatron
or
covefingthis Tenderas
condrlions
be entertained
afterclosingof Tender.
TO TENDER
02. INVITATION
02.1The Chaiman,MinislryProcurement
Committee,Ministryot Healthwill receivesealedTengivenin the Annex - 1A and receivingwillbe
procurement
pharmaceuticals
the
dersforthe
ol
closedat 10.00a.m. on the date given therein.
for
or theirAccredited
Agents/ Represenlatives
02.2 Foreignand LocalManufacturerysuppliers
in the capacityol
Sri LankanMarketare eligibleto bid in this Tender lf tendereris participating
agent,tenderershouldprovidevaliddocumentaryproof(s) to establishhis authorityto act on
behalfol lhe orincioalto be usedin Sri Lankaas per
02.3 The itenvilemsofferedshouldbe carrieda validregistration
oara01.3above.
02.4 The Tenderofferslrom local manutacture;/ suppliersshouldbe inctusiveot Supply&
DeliverywilhinColomboMunicipalLimitsand the loreigncomponentof the pricewill be paid
direct to the principlemanulacturer
in loreigncurrencyby openingof a letterol creditagainst
him, Local componentof the price ancludingLocalAgenl's Commissionwill be paid to the
Representetive
in SriLankanCunency.
Accordingly
Foreign
component
o{ the
. looalAgenU
price have to be givenon C & F basissupportingthe Invoiceissuedby the foreignprinciple
manufacturer.
The Tenderoflersfrom foreign manufacturers./
suppliersshouldbe on C & F
basis.
02.5 This Tenderis coveredby Guidelineson GovernmentTenderprocedureissuedby the
i,linistryof Financeol the Government
of Sri Lanka,subjecttomodilication
and/ oramendments
madeintoit or will be madeintoit, by the respectiveauthoritiesfromtimeto nme_
026 The Tenderscouldquotefor one or moreitemsindicated
in the Annex - 1A and they
couldsubmitonlyoneofferforeachitem/ilems
TENDER
NO
DATEOF ISSUE
CLOSINGDATE& TIIVE
LANKATIME
SR NO DESCRIPTION
OF ITEMWITHSPECIFICATIONS
AT
l OOO HOURS SRI
PACKSIZE
QTY
see annexure 1A lor the specitications
Amountof Bid Bondslo be submitted:
Delivery
Schedule:
Note
1 Representative
samplesshouldbe receivedby SPC on or beforeclosingof the Tenderas
specifiedin paq 21 Even past suppliers,Otherthan lhe presentsupplierare liableto
submitrepresentativesamplesas specifiedtherein.
2.Tendersshould be submittedin the forms obtatnedfrom SPC or Foreiqn/SriLankan
missions
L
3. The ilemsofleredshouldstrictlybe in compliancewiththe specifications.
alongwiththeTenderas perpara08 (a)
4.TheBidBondshouldbe submitted
g'ven
to the TefmsandConditions
s.TheTendersthat do notconformor nonresponsive
herewithwill be rejected.
OFTENDER
O3SUBMISSION
03.1 Tendersshall be submittedin One Originaland One Duplicatesealedseparatelyand
Both Envelopesshalltogetherbe enclosedin
markedas 'Original'and 'Duplicate'respectively.
/ Ministry ProcurementCommittee,
to
The
Chairman
sealed
and
addressed
one EnveloDe
State PharmaceulicalsCotporation ol Sri Lanka, No- 75, Sir Baton JayatillakeMawatha,
Colombo1, Sri Lanka.
eitherby regisleredpostto the addressgivenaboveor
03.2 SealedTendersmaybe dispatched
purpose
at roomNo. GF 10 in the GroundFloorof the
depositedin the TenderBox keptlor the
aboveaddressto receiveon or beforeclosingtime and the date.
03 3 The eft handtop cornerof the envelopeshouldindicatethe tendernumberand the
closing
dateoi TenCer
in Annex1A
dateandtimespecified
on or beforelhe closlng
shoud be received
034 Tenders
un
opened
andwlllbe returhed
willnotbe accepted
LateTendefs
or
for the Tendermisplacement
03.5 The Corporationshall!!Of acceptresponsibility
given
(Para03.3)and'
or
above.
prematureopeningof otfersil thecoverhasnotbeenmarkedas
notdepositedin the correcttenderbox.
03.6 Sealedsamplesshouldbe sentto ChalrmanSPC lo be recevedon or beforethe
wlth
andshouldnotbe enclosed
shouldbe sentseparately
timeof the ienderSamples
closing
the
tender
with
submitted
tenderotfer Tendershouldcertifygenunenessof allthedocuments
to thetenderin the
attached
every
documents
each
and
to
ltst
oul
bv an affidavitlt is necessary
attached
to thetenderin thesaidaffidavil
saidaffidavilDocuments
04 FORMATOF OFFER
04 1
to the lcrmalglvenin Annex 1B
Tendersshouldbe madeoul accordlng
442
wrth
formator are not in strictconformlty
Tenderswhichare not in the prescnbed
relected
be
in
thls
lender
shall
laid-down
and speciflcatlon
the terms. conditions
or evenwrrtlngexceptas necessary
The Tendershallcontalnno interhneatrons,
04.3
to correcterrorsInadeby the Tendererin whlchcase such correctons shall be Inrlialed
by the personor personssigningthe ofter
04 4
All Tenders,literature
etc.,shouldbe in the EnglishLanguage.
04-5
The MinistryProcurement
Commineereservesthe ight to rejectanv tenderwhach
donotcontorm
rothespecifications
givenandornotreSpOniive
inanymannOr
atanytime.
lf suchnon-conformlty
or non responsiveness
disclosed.
05. TENDERFEE
A non-refundablelee of Rs. 3,000/= should be paid in cash to SpC for each set of
Tenderdocuments.
06
VALIDITY
OF OFFER
06 1
Tenderers
shouldkeeptheiroffersvalidfor acceptance
for a periodof at least
't80 days (onehundred
andeightydays)fromthe dateof ctoSingof tendei. No increasein
pricewillbe permitted
afteropening
of tendet.
06 2
However,
the MTBmay solicitthe tenderer's
consentto extendvalidityof offer
andif thetenderer
agreesto suchrequest,
thevalidityof the Bid Bond(if avatlabte)
should
alsobe extended
accordingly.
The{endererwi not be permjtted
to modifyor amendhis
tenderif validity
is extended
07.TENDER
OPENING
07.1Tenderswilt be openedimmediateJy
afterclosingat the He€dOfficeof the State
Pharmaceuticals
Corporation
at 75,Sir BaronJayatillake
Mawatha,
Colombo1 Sri Lankaat
thedaleandtimespecified
in AnnexI A.
07.2The tendereror their authorizedrepresentattves
will be permitted
to be present
openingof lenders.
07 3 Onlythe copyof thetendermarked,Original'
willbe openedat thetimeoi openin!,
of
Ienoers.
07.4 The committeewho opensthe tenderswill read out (or causeto be
presenl,lhe nameol eachtendereras wellas the arnountquotedtogether reao out) to those
withdiscounts,il anv.
07.5 Whetheror not a Bid Bondhas beensubmitted,
and the amount o, Bid Bondif
submrtted
shallalsobe announced.Details
of the make-up of any Tenderwt not be read
out
08
BONOS/GUARANTEES
(a) Bid Bond
Bid Bondas per Annex lll encashable
Tenderersshouldturnishan unconditional
08.1
itemintheAnnex1A ofthe
stated
against
each
demand
tothevaluo
onfirstwrilten
tender Bid Bond should be submitted togetherwith the Tender ol to reach -on or before
the closing date of tender. Tenders submittedwithout Bid Bonds, will not be
consideiedand will be rejected.
08.2 The Bid Bond shouldbe valid for at least30 days beyondthe validityof the offer'
at Annex lll and shallbe (para06.'1)issued
08.3 The Bid Bondshallbe as per specamen
by the one of the followinginstitutions
i. A Commercial
Bankoperatingin SriLanka,approvedby theCentralBankot SriLanka.
'Confirmed'by a
ii. A Bank based in anothercountrybut the securityor guarantee
CommercialBankoperatingin Sri Lanka.
iii. A Letterof Creditissuedby a ForeignBank,but
'Confirmed'by a Commercial.Bank
operatingin Sri Lanka.
AnyotherAgencyapprovedby theTreasuryfromtimeto time
Or
v
A cashdeposit
08.4 lvlasterBidBondsare notacceptable.
will be rejected.As per para 06.2
08.5 Tenderswhich do not complywith this requirements
il MTB makea requestto extend the validity of the Bid Bondthe tendere.will haveto honour
that request.
(b)
PerformanceBond
08.6 The successfultenderershall within 14 days from the notificaiionof award submit an
unconditionalPerformanceBond upto 10% of the total value of award if required.Failure to
complywith this requestshall constitutesuflicientgroundsfor the corporationto cancel
such awardand forfeitthe Bid Bond/Security.
08.7 However,the MinistryProcurementCommittee reseryesthe right to increasethe
Bondat theirdiscretion.
requiredPerformance
Annexlv- and shallbe issuedby
Bondshallbe as per spdcimen
08.8 The Performance
para
given
at
8.3
oneof the institution
Bondwill be made by the Cooperationon the very lirst
08.9Claimson the Pedormance
instancethe supplierlails to complywiththe termsand conditionsol Indentand UC.
(c) ExemPlpns
TenderDeposrtsor Bid Bondsprovaded
08.'10The followingare exemptedfrom refundable
previous
on
occasions
lheyhavenot defaulled
AoprovedSocieties.
StateCorporations,StatLltoryBoardsand other Slate Institutions
t,
StateTradingOrganizationsof ForeignGovemments(Acceptabledocumentaryevidence
should be submitted by representativesof ForeignGovernmentsin Sri Lanka)
TenderFee (para5) and
will not applyto non-.efundable
thisexemption
08.'11However,
Bond (para08 (b)above.
of Performance
the submission
FORCEMAJEURE
09
h the eventof the Supplie/sinabilityto successfullycompletecontraclualobligationsin
termsol the Letterof Creditandsuchdelayis dueto ForceMaieureincludingbut notlimited
to War,CivilCommotion,Fire,Floods,Epidemics,FreightEmbargoetc, suchdelaysmay
be excusedand the dateslor completionof supplybe extendedor awardcancelledat the
Committee.
of the ministryprocurement
discretion
10.
OF CONTRACT
ASSIGNMENT
or subletwithoutdue authorityThe StatePharmaceuticals
may be assigned
No Contract
reservesitselfthe rightto refuseto rccognizea Powerof Attorneyissuedby a
Corporation
such partyto carry on the contracton the
to any other partyauthorizang
Contractor
behalf
contractor's
11.
STOCKS
FRESH
recentlyconlormingto the
i11 Suppliesshouldbe from fresh stocksmanufactured
tesidual
1,A.
At
least
2/3.d
of
the
shelflife (subjectto a
in
Annex
specifications
stipulated
receipt
in
Sri
Lanka.
years)
shouldremainat the timeof
of 2
minimum
of goodssuppliedwith
reserves
the rightto callfor free replacement
11.2 Corporation
and refrainfrom its clearancefrom
residualshelflife,or rejectsuchconsignment
inadequate
thePort.
12
FREEREPLACEMENT
1 2 . 1- C o r p o r a t i o nr e s e r v e st h e r i g h t t o c a l l f o r f r e e r e p l a c e m e not r
loss/damage
or deterioration
of goods
in theeventof shortpacking,
reimbursement
dueto labels
withinthe shelf-life,
alsofor packswhichcannotbe identified
supplied
fallingoff.
by the NationalDrugQuality
shouldbe confirmed
/ complaints
12.2 All qualityproblems
(NDOAL)
Laboralory
or SPCOualityAssurance
Assurance
Laboratory
a ) F o r S P C p u r c h a s e s i h e C o r p o r a t r o nw r l l r e t a i n s a m p l e s f f o m i h e a v a i l a b l e
batch/batches
and the balancewili be destroyedby the authorizedofficersLrnderlhe
Cosmetics Devicesand DrLrgsAct and would issuea cedificateto back effeci
b) In case of Departmentsampleswill be testedby NDQALand followthe recaliprocedufe
approvedby Ministryof Healthand shouldbe destroyedaccording1o section72 of Drug
regulations
c) Incaseof withdrawalsdue to quality failure Supplrersshould ensure ihat the entire
quantityof eitherthe withdrawnbatchesor productswouldbe totallyreplacedor reimbursed.
DELIVERYDATES
13.1 See Annex I Successfultenderersshouldconformskictlyto de|verydates Failureto
Bond and/orcancellation
of the awardof
do so will resultin forfeitureof the Performance
tender In the event SPC purchasesthe item from anothersource at a higher price the
defaullingtenderershouldpay the lotal difierenceof priceto the Corporalron
132 Where awards are made to local suppliers,SPC may request supply in mofe
inslallmenls
thanindicated
rnAnnex1A
PACKINGAND STORAGE/ CONDITIONS
14.1 Pack Size otferedshouldconformto reouirementsof DGHS.Tendersfor
alternatepack sizes may be rejected.DGHS,D/MSDatter consulting.Exportworthypackingwhichwill preventdamagein transilshouldbe used.Detailsof
givenby D/MSD.
natureof packingshouldbe accordingto the specifications
ior storageand use undertropical
14.2. Packingof all itemsshouldbe suitable
p
a
c
k
i
n
g
F
i
n
a
l
E
x
p
o
r
t
s
h
o
u
l
d
i n d i c a t et h e r e q u i r e ds t o r a g e
conditions.
for goodswhichrequireRefrigeration/Cool
storage/Coldslorage
temperature
FreezerStorageenablingthe cargohandlingstaffat the Portof Destination
to
proper
goods
(Humidity
storage
for
such
immediately
on
arrival
in
Sri
arrange
Lankais usuallybehveen75% and 100%and temperatureis in the rangeof 50'
F to 91"F(15"Cto 33'C)).
14.3 All outer carton and inner box (if any) should contain
the following
information.
(a) Descriptionof the ttem
(b) Dateof Manufacture l
(c) Dateof Expiry
in 5 cm sizetetter/Figurein visibtemanner
r|
(d) BachNo.
(e) NameandAddressof Manulacturer
(f) MSDOrderNo.
(g)SPCIndentNo.
(h) StockReferenceNo
(i) StateMarkof Sri LankaGovernment
14.4. Containers
andclosures
usedshouldbe of suchquality
so -as norlo react
' -withthecontents
whilein "1orun"undertropical
conditions.
14.5 Containers
and closuresshouldpreventleakagein transitsalsosuitable
for safeandeasilyhandling
.
t,
packingshoutdbe in seaworthystrongcasesor cartons,
9^-,
-,,,|'lul.:rport
srenc
ted wrthbtuebandsin the form of a crosson eachfaceandin addilion
carryrng
the shippingmarks,detailsof whichwifl be providedwith order.
such
exportpacklnqshouldbe suitableto withsland
the longseajourneyand rough
handlingat portsof loadingand untoadingAug""rgo inouij
b; plttetizedand
shnnkwrapped.
Al burkpacks
containing
tabrets
oi capsures
shourd
incrude
a pouch
of
Silicacel, whichhasa colourguide.Thisis tmportant
to malntaln
ttte
siett
tife
ot
tne
product
under
highhumidity
conditions
whichprevail
in SriLanka
14.7
tablets(over25omgin weight)in bulkpacks(over5OOtablelsper pack)
,. ..Larger
should
notbe packedjn gtassbottesas glassbotfles
areljkeiyto be dama;edin kansit.
Suchitemsshouldbe packedin sealedpolyethylene
filmtags in""rt"i ,nto"trong
arrtight
metalor plastic
containers
14.8
is the responsibirity
of the manuracturer
/ supprierto ensurethat the conrarners
. .lt
wouldbe in tacks,andwithoutbeingdamageuntilthedrugs
are Oeing,deii;e,ed
to tutSO.
14.9
lf any damages(s)
causeddue to non_comptiance
of packtng
" to rhe above_
menlioneo
cond[ronssupplter
shoirld
oearthelullcostof damagea
'14.10
MSD order list Number,SR Numberand SpC IndentNumber
should be
indicatedin a supptyInvoicesand packingList.Also detailof batch
and respective
quantitycartonnumbercontainingsame.
I5. LABELLING
15.1
Alllabelsshouldbe printed
in English
Language
andthelabeling
requrremenrs
shouldbe according
to the specifications
required
lor regiskation
at CDDAas fo ows.
a) Theapprovednamefoundin officialpharmacopoeias
or formularaes.(The
source
shouldbe statedin abbreviations;
e.g.B.P.,USP.etc)
b) The BrandName
c) Listof the activeingredients
showing;
a) Theamountof eachpresentin eachdosageunil(e.g.per5mletc)
b) A Slatements
of the nettcontents(e.9.numberof dosageunits,weightor volume);
d) Any specialstorageconditions
thatmaybe necessary
:
e) Warningandprecautions
thatmaybe necessary
;
0 The Dateof Manufacture
g)TheDateof expirywhereapplicable;
h)Thebatchor lot numberassignedby the manufacturer
and
i)ThenameandAddressofthe manufacturer.
15. 2 Sizeot the letlersof the above (t), (g), (h) and the SR Numberon the ourercanon
shouldnot be lessthan5 cm.
'15.3ldentrficatron
Marks
The StateMark"and"SRNo."whichwill be madeavailable
to the successful
tenoerer
shouldbe embossedor imprinted
in each(item)ampoule/vial/pack
/bot e or on the
affixedlable.
Thesemarksshouldbe indelible.
"DHS marksto be embossed
on eachcapsuleor tablet.
All tenderersshouldindicatein theirtenders,as to whethertheserequirements
couldbe
rnet;whichwillbe takenintoconsideration
at thetimeof evaluation
of the tender
Products
154 Anaesthetic
largeandclear'
beprinted
NameofDrugShotlld
( 1 ) Generic
(2) All ampouleshouldbe effectivelypre-cut.
(3) Labelsshouldbe eflectivelypastedto avoidlooseningwhen in contactwith
water STICKERLABELSto be providedfor OperatingTheatreuse
withthe'Standard
(4) Colou.codingof stickerlabelsshouldbe in accordance
for UserAppliedDrugLabelsin Anaesthesis"set oul by the
Specilication
ASTMD4774-88
lor Testingand Materials.
Society
American
Red
e g Relaxants
Violet
Vasopressors
Blue
Opiates
GreY
LocalAnaesthetacs
redband
shouldhavea distinct
ampoules
andadrenaline
withadrenaline
Lignocaine
andredlettering
drugs:forthefollowing
shouldbe provaded
labelsforsyringes
Slicker
Thiopentone
Diazepam
Midazolam
Ketamine
Suxamethonium
Tubarine
Pancufontum
Atracunum
Vacuronium
Neostigmine
Atropine
16.CURRENCY
Tenderersfrom a countryoLltsidethe Asian ClearingUnion shouldquote in a
161
cu(ency in Srl Lankasuchas U$ Dollarsor SterlingPoundsor Euro
freelyconvertible
However.member countriesof the Asian ClearingUnion should quote only in U$
Dollars.
in Sri Lankacould be quotedIn
Tendersfor the supplyof goodsmanufactured
16.2
lerms of the para 02.4 Quantumof the domesticpreperancewiil be governedby the
at the time of tenderclosure
circularsand guidelinesof lhe GeneralTreasuryapplicable
articlesoffered
pfesentlygrantedwill be a 20% for locallymanufactured
The preference
addedvalue
30%
is
a
minimum
of
critena
Eligibility
with importedarticles.
in competition
goods
manufacturedin Sri Lanka
in Sri Lanka at eK-factoryprice All tenderersoffering
'Domestic value added Calculation' lorm
should complete and submit the enclosed
along with their Tender. (Annex V). Tenderers should support their claim to
dom;stic Preferencewith documentaryproof Tender Board or the TechnicalEvaluation
Comminee appointedwill determineacceptabilityof the evidence submittedto support
the claim.
ll)
lO.f focattymanufactured
goodsshoutdcontainlocallabour,localrawmatenatanc,tocal
componenls
accounting
for at least30%of the EXWprice.Forlhis purposeany other
components
suchas financing
cost,factoryoverheads,
depreciation
of machinesprofit
marginare notconsidered
as a partof EXWprice.
164 ltislheresponsihility
ofthe tenderer
toprovide
acceolable
evidence
as103above
alongwith hjs tenderfor the satisfactionof the PC on his eligibility.
A tendererwho fails to complywith this conditionwill not be consideredfor domestic
preference.
17. COUI'ITRY
OF ORtGlN.pORT OF SHtpMETTAND NAMEOF MANUFACTURER
17.1 The Countryof Origin,Port of Shipmentand Nameof Manufacturer
shouldbe givenin
quotation
the
for each item otfered
17 2 Shipmentshouldbe made exclusivelyon vesselsbelonginEto the CeylonShipping
Corporationor those charleredby them However,shipmenton other vessels will be
permitted,
in instanceswherevesselsof the CeylonShippingCorpofatron
do not call at the
Portof Shipmentor if they are not avarlable
for linrelyshipmentof cargo
18.QUALITYCERTIFICATE
18 1 (a) Corporationreservesthe righl to nominateIndependeni
CompetentAulhorities
for the issue ol PreshipmentCertilication(Certrlicateol Quality,Ouantityand Loading).
In such event,the cost of such certilication must be borne by the suppiterand should
be includedin the offerin Annex 18.
(b)"SecretaryHealth;eservesthe righl to nominatesuitablepersonsto Inspecrlne
procluctionand quality controlfacilitiesof tenderersand manufaciurersand their
records Tenderers,who refusepermissionto our nomineesto carry out such an audit
will be automaticallydisqualifiedfrom the tender.
18.2Tenderers
shouldconformand shouldsubmitthe resultsof the Dissolutionand
8io-Equivalence
of the followingproducts:
Carbamazepinetablets
Sodiumvalproatetablets
Thiophvllin
tabletsand
Allthe slow release(SR)drugs
18.3
For oftersfor Antr-epileptic
Drugs,dissolutionand bio-equivalence
test results
shouldbe provided.
ll
19.
MOVING
IN INTERNATIONAL
COMMERCE
(CPP)issued
(a) ACertilicale
of Pharmaceutical
Product
by theCompetenl
Authority
in the
item
tendered
has
placed
Tenderer'sCountryconlirmingthat the
been authorizedto be
in
the marketfor sale and use in lhe countryot manufacture,
shouldbe submittedalongwith
the Tender.
(b) The Certificate
Products
of Pharmaceutica'
shouldalsocertifythatthe Manufactunng
PlantIn whichthe productis produced
is subjecllo inspection
at suitable
intervalsandthat
requirement
for
in
l\ranufacture
manufacturer
conforms
to
the
Good
Paactices
and
the
as recommended
by the WorldHeaithOrganisation,
in respeclof prodLrcts
OualityControl.
of originor to be exported.
to be soldor diskbutedwithinthecountry
(c) All batchesofieredshouldconlormto the requirements
ol the CompetentAuthorityfor sale
of where appropriateto published
or distributionwithin the countryol manufaclure
providedby the manufacturer.
specilications,
eg: BP/USPor to establishedspecitications
indicate
the
namb
and
dosage
form
of the product,the batch
These certificatesshould
number,the date ol manufacture,date ol expiry,storageconditions,date of packaging,
labelling,natureol the container,
resultsof analysisandotherdata(BATCHCERTIFICATES).
20.8EC.tg[8AL!.9!
,20
(CDDA)
1 WITHTHE COSMETICSDEVICES
AND DRUGSAUTHORITY
(a) All Pharmaceutical
and Surgicalproductsimportedto Sri Lankashouldbe registered
with the Cosmetics,Devices& DrugsAuthorityof Sri Lanka. (Pleasesee para 01.3)
Therefore,all ProspecliveBiddersshouldadvisetheirLocalRepresentatives
to attendto
such Regastration.
(b) A certrfied
copyof the regrstfation
cerlrfrcale
of each producttenderedshouldbe
submittedalongwith the tenders.Tenderersshouldsubmitcertiliedcopiesof their
certilicatesalongwiththe Tenderdocuments.
registration
of PublicContracts
20 2 TheRegistrar
Awardsover Sri LankanRupees(LKR)Ten Millionshouldbe registeredwith the
Begistrarof publiccontractsby the successlultenderer or his localagent.
tl
21 SAMPLES
21.1
samplesin respectof itemsofferedshouldbe submittedto reach
Representative
2 12
are advisedto submittheir samplesthroughtheir
Tenderers
All Prospective
withthis request.Evenpastst-lppliers
LocalAgentsif any to ensurecompliance
other,than presentsuppliersare liablelo submitsamplsas speciliedherein.
2 13
packed.
TheTenderNumber.
SR Numberwlth
shouldbe individually
All samples
jn
Nameshouldbe clearlyindicated the package.
Tenderer's
(Page
(Please
3)-1
seeNote
dals0ftender
theclosing
)
us0norbefore
requirement
andall Tendersthatdo
It shouldbe notedthatthisis a compulsory
willbe rejected.
not complywiththisrequirement
21 5
lf the tendererdoes not havea LocalAgentthen samplesshouldbe sentto
"STATEPHARIiIACEUTIoALS
OF SRI LANKA, 25, SIR
CORPORATION
'1,
E A W A T H AC, O L O M B O S R I L A N K A " A N o B A R O NJ A Y A T I L L A KM
nominalvaloefor cuslom'spurposeonly)
ValueInvoice(indicating
Commercial
copy
to the consignee's
Certificates
shouldbe attached
withAnalytical
together
Pharmaceuticals
be
sent
direct
to
the
State
of Air Waybillanda copyshouldalso
Mawatha,
Colombo1, Sri Lanka.All these
75,Sir BaronJayatillake
Corporation,
which
andall sampleoacksshouldbearthe TenderNumber(without
documents
permit
clearance).
wrllnot
thecusloms
21.6
mustbe in theiroriginaltrade
All samples(exceptbulkdrugsor raw materials)
to
propey labeled
and shouldbe accordrng
in the EnglishLanguage
containers
section15 1 ofthisdocumenl.
21.7
in the TenderOffer SamplesshoLldbe sent
Samplesshouldnot be included
fromtenderotfers.
separately
(Annex'lA)published
wilh
of samplesare doneas per specifications
21.8 Evaluations
thetenderdocuments.
For
(Should
ExcePt
T.adeConlainers
Required
BeIn TheirOriginal
Of Samples
21.9 Ouantities
or Chemicals)
Rawlllaterials
3 Containers
and
Minimum
300tablets/capsules.
Minimum
- 125ampoules(Containers)
b)ParenteralPreparations Injections
- 100vials(Containers)
Powderlor Inj.
Intravenouslnlusions, I
for I
ConcenkatedSolutrons
lniections
J- 30 (Containers)
or Capsules
a) Tablets
- Sufllcientquantityfor
Analysis
c) VaccineandSerum
l3
- 50 Containers
DroPs
EyeDrops/Ear
DroPs
Nasal
/ Cream/ Oral/ Liquids/
e) Ointment
DustingPowder
Inhalatlons
Solution/ Syrups/ Pressurised
s)
Extracts/ Tinctures
h)
/ SuPPositories
Pessaries
- 12Containers
- 04 Containers
- 04 Containers
- 50 Pessariesor SuPPosrtoaes
- 2009
i) Waxes
ana'vs's
further
,, ,0
iin"$eli:i:'ror
r,",,,1,?"5'.1;1"","j1r.,:i.;;:.,ipi:ili$
Oosage
Tablets/CaPsulles
lnfusions
Injections
Powderfor Ini
Strength/Vollume
ovc.
ther Concl tions in the event ofaward
, bc supplicd from freshly manufacturcd stock.
irc productshouldhrn'ca ninimum of 24 months shclf lifc at thc time dclilcry.
rrch rmpoulc,r.i:rlor bottlc to bcat l)cscriptionof ltcm, l)ate of Manufacturc,l)atc of l.i,xpirr',
Slt
No. .urd"S.l';\'lll Nlr\llli" of Srij-xnkr(;o!ernmcnt.
-1. l)escr':ptionof llenr, l)rtc of N.lanuflchrtc,Namc and addrcssof munrrficrurer,l)rtc r
crpil llrtch No., NlSl) ()rdcr list No., Slt No., Slr(l Indcnt No. and S l rVl l,l 1\1,\ltl(()f S
l,en (lovetnmcnt should bc cleerlymrrkcd on the outcr covcting contninir.rg
rhc irrn xrl
r thc ()Lltcrc(^'cr ol thc cartrxr/,r,*.
5 \ll ()utcrclrtons shoultl bear rl,e llatch No., l)ate of manuficturc,l)^rc of l,ixpiryin sizr
'lhis
:m lcltcrs/figurcsrn promincntly visiblc manncr.
may be printcd, srcncilcdor lal>
nffixcd.
6. ()ffcrs iirr lnr othct cconomicallvviablcpack sizc atc acceptable,
rvith thc prior apprrtr.llr
1
2
3
l)/Nr l).
7. I\lSl- .)rder J-istNo. "Slt No." of ltcm and SP(l Indent No. shouldbc indicateclin all supp
'
. oiccsirntll)ackinglist.
lJ. L)lIS" mark to l:lc
a- crnbosscdor printctlin cescof tablcts
b. printrtl irr cascofclpsulcs
REO. NO. MSD/P,/006/08
ITEM } 'O
DESCRIPTION OF ITEM WITH SPECIFICATION PACKSIZE
/SB-NIL
15 /060076 AdsorbedTetanus Vaccine BP Singledose (0.5m1)
OR
TetanusToxoid AdsorbedUSPsingledose(0,5m1)
1. Each0.5nrlsingledoseampoule
shouldcontahan
OTY.
100ampoules
in a box 2,800,000
arnpoules
estimatedpotency of oot lessthan 40 units of
Tetanus Toxoid. The vaccine to contain Tetanus
Toxoid produccd by the grorvth ofclostridium
teranaiin the form ofTetanus Iremoral'lbxoid.
2. I,refetencc will be given fot the suppliets,
recommcnded for bulk purchaseby the VHO for
bulk purchasefor rhe U.N. Agcncres.
3. The following documcnts should be submitted preshipment for each lot ofvaccine dispatched.
.
Invoice
o Certificate of Origin
.
.
Ceitificateofanalysis.
4. The product should be only from ftesh stocks and
shodd have a minimum of 24 months at the tirne
ofdelivery at Medical Supplied Division.
5. The vaccine dhould also comply with the general
requirements fot vaccine in the BP (2002).
6. Vaccine Monitors should be provided ot at least
cold chain rnonitots shoutd be included for each
100 dosesand the cold chain should be maintained
according to the manufacturer's instructions dudng
storage&ansport and delivery ofvacche.
7. The vaccine should be protected from light and
should be stored at a temperaturerange of2"C to
8"C. Vaccine should not be frozen.
8. Each ampoule should be labelledaccordingty.
9. The vaccine should me€t the mosr recerr
requfemcnts of w'HO when testedby the rnelhods
oudined by WHO.
DeliverySchedule:300,000ampoulesinJanuary2fl)8
300,000ampoulesin Match 2008
300,000ampoulesin June 2008
300,000
ampoulesin September
2008
400,000ampoulesin Januery2009
400,000ampoulesin March2009
400,000
ampoulesin June2009
400,000
ampoulesin September
m09
Amount of Bid Bond Rs.,1l75,600/=.
- noflrg/6-9-?oo?
]001
? l AuG
coR
STATEPHARMACRT]TICA
(ESTABUSHED(JNDERT}IE STATE
)SRI7LANKA
4 '
ACL NO 49OF 1957)
IMPORTING ON BEHALF OFTHE DIRECTORGENERALOF I{EALTH SERVICES
GLOBAL TENDER
(CAPC/MPC)
TENDER DOCUMENTS FOR
PROCUREMENTOF PHARMACEUTICALS
FOR THE DEPARTMENTOF HEALTH SERVICESOF
THE GOVERNMENTOF SRI LANKA
All ShippingDocuments
andCorrespondence
STATEPHARMACEUTICALSCORPORATIONOF SRI LANKA
P O. Box l?57.
75, Sir Baron JayatillakeMawatha.
COLOMBOOI.
SRI LANKA.
Fax:
94-ll-24462M
Tphone: (00) 94- l l -2391538ot 2326227o( 2120356.9
E- mail : [email protected]
CORPORATION
STATEPHARMACEUTICALS
OF SRILANKA
TERMS
A N DC O N D I T I O N
OSFT E N D E R
01. INTRODUCTION
s Corporalron(SPC) of Sn Lanka is a fully Sn Lanka
01.1 The Slate Pharmaceutica
Surgical
Governmenlowned organizationengaged in lhe procurementof Pharmaceuttcals,
in the Privale
ltems,Laboratory
Chemicalsetc, for tts ow4 slocksand distflbution
Consumable
Hosprtals
of
the
Departmenl
of
Health
Servtces
for
use
in
all
Government
Sector.and
, and
throughN4edrcal
SuppliesDivison (MSD)
hospitals
underlhe provncralsCouncrls
01 2 Procuremenlis marnlydone by World Wde Tendersstrctly accordrngto terms
herewrth
and specifications
as statedIn the documents
conditions
productsin]portedrntoSrt Lankasholrldbe those registered
01 3
All Pharmaceutical
wrlhthe CosmetrcsDevices& DrlrgsAuthorilyof Sri Lanka Therefore.all crospecliveBrdders
to attend lo such Regtstralon However we may
shoud advrsetheir Local Representatrves
underspecialcrrcumslances
mporldrugswhicirare unregrstered
Letterof Credrtwith 75%
01 4 Paymentfor all rmportswill be C&F bass by rffevocable
of the valueof the.documentary
creditbeingavailabieto the supplrerat the time of shipment
and lhe balance25% after60 daysffom the date of paymentof the frrstBlll,providedall terms
in the Documentary
Credithavebeenskrctlycompliedwrth
andconditions
the lollowingterms&
tenderersare advrsedlo readand understand
01 5 All prospective
plea
insufficient
infofmaton will
no
of
lack
of
informatron
or
covefingthis Tenderas
condrlions
be entertained
afterclosingof Tender.
TO TENDER
02. INVITATION
02.1The Chaiman,MinislryProcurement
Committee,Ministryot Healthwill receivesealedTengivenin the Annex - 1A and receivingwillbe
procurement
pharmaceuticals
the
dersforthe
ol
closedat 10.00a.m. on the date given therein.
for
or theirAccredited
Agents/ Represenlatives
02.2 Foreignand LocalManufacturerysuppliers
in the capacityol
Sri LankanMarketare eligibleto bid in this Tender lf tendereris participating
agent,tenderershouldprovidevaliddocumentaryproof(s) to establishhis authorityto act on
behalfol lhe orincioalto be usedin Sri Lankaas per
02.3 The itenvilemsofferedshouldbe carrieda validregistration
oara01.3above.
02.4 The Tenderofferslrom local manutacture;/ suppliersshouldbe inctusiveot Supply&
DeliverywilhinColomboMunicipalLimitsand the loreigncomponentof the pricewill be paid
direct to the principlemanulacturer
in loreigncurrencyby openingof a letterol creditagainst
him, Local componentof the price ancludingLocalAgenl's Commissionwill be paid to the
Representetive
in SriLankanCunency.
Accordingly
Foreign
component
o{ the
. looalAgenU
price have to be givenon C & F basissupportingthe Invoiceissuedby the foreignprinciple
manufacturer.
The Tenderoflersfrom foreign manufacturers./
suppliersshouldbe on C & F
basis.
02.5 This Tenderis coveredby Guidelineson GovernmentTenderprocedureissuedby the
i,linistryof Financeol the Government
of Sri Lanka,subjecttomodilication
and/ oramendments
madeintoit or will be madeintoit, by the respectiveauthoritiesfromtimeto nme_
026 The Tenderscouldquotefor one or moreitemsindicated
in the Annex - 1A and they
couldsubmitonlyoneofferforeachitem/ilems
TENDER
NO
DATEOF ISSUE
CLOSINGDATE& TIIVE
LANKATIME
SR NO DESCRIPTION
OF ITEMWITHSPECIFICATIONS
AT
l OOO HOURS SRI
PACKSIZE
QTY
see annexure 1A lor the specitications
Amountof Bid Bondslo be submitted:
Delivery
Schedule:
Note
1 Representative
samplesshouldbe receivedby SPC on or beforeclosingof the Tenderas
specifiedin paq 21 Even past suppliers,Otherthan lhe presentsupplierare liableto
submitrepresentativesamplesas specifiedtherein.
2.Tendersshould be submittedin the forms obtatnedfrom SPC or Foreiqn/SriLankan
missions
L
3. The ilemsofleredshouldstrictlybe in compliancewiththe specifications.
alongwiththeTenderas perpara08 (a)
4.TheBidBondshouldbe submitted
g'ven
to the TefmsandConditions
s.TheTendersthat do notconformor nonresponsive
herewithwill be rejected.
OFTENDER
O3SUBMISSION
03.1 Tendersshall be submittedin One Originaland One Duplicatesealedseparatelyand
Both Envelopesshalltogetherbe enclosedin
markedas 'Original'and 'Duplicate'respectively.
/ Ministry ProcurementCommittee,
to
The
Chairman
sealed
and
addressed
one EnveloDe
State PharmaceulicalsCotporation ol Sri Lanka, No- 75, Sir Baton JayatillakeMawatha,
Colombo1, Sri Lanka.
eitherby regisleredpostto the addressgivenaboveor
03.2 SealedTendersmaybe dispatched
purpose
at roomNo. GF 10 in the GroundFloorof the
depositedin the TenderBox keptlor the
aboveaddressto receiveon or beforeclosingtime and the date.
03 3 The eft handtop cornerof the envelopeshouldindicatethe tendernumberand the
closing
dateoi TenCer
in Annex1A
dateandtimespecified
on or beforelhe closlng
shoud be received
034 Tenders
un
opened
andwlllbe returhed
willnotbe accepted
LateTendefs
or
for the Tendermisplacement
03.5 The Corporationshall!!Of acceptresponsibility
given
(Para03.3)and'
or
above.
prematureopeningof otfersil thecoverhasnotbeenmarkedas
notdepositedin the correcttenderbox.
03.6 Sealedsamplesshouldbe sentto ChalrmanSPC lo be recevedon or beforethe
wlth
andshouldnotbe enclosed
shouldbe sentseparately
timeof the ienderSamples
closing
the
tender
with
submitted
tenderotfer Tendershouldcertifygenunenessof allthedocuments
to thetenderin the
attached
every
documents
each
and
to
ltst
oul
bv an affidavitlt is necessary
attached
to thetenderin thesaidaffidavil
saidaffidavilDocuments
04 FORMATOF OFFER
04 1
to the lcrmalglvenin Annex 1B
Tendersshouldbe madeoul accordlng
442
wrth
formator are not in strictconformlty
Tenderswhichare not in the prescnbed
relected
be
in
thls
lender
shall
laid-down
and speciflcatlon
the terms. conditions
or evenwrrtlngexceptas necessary
The Tendershallcontalnno interhneatrons,
04.3
to correcterrorsInadeby the Tendererin whlchcase such correctons shall be Inrlialed
by the personor personssigningthe ofter
04 4
All Tenders,literature
etc.,shouldbe in the EnglishLanguage.
04-5
The MinistryProcurement
Commineereservesthe ight to rejectanv tenderwhach
donotcontorm
rothespecifications
givenandornotreSpOniive
inanymannOr
atanytime.
lf suchnon-conformlty
or non responsiveness
disclosed.
05. TENDERFEE
A non-refundablelee of Rs. 3,000/= should be paid in cash to SpC for each set of
Tenderdocuments.
06
VALIDITY
OF OFFER
06 1
Tenderers
shouldkeeptheiroffersvalidfor acceptance
for a periodof at least
't80 days (onehundred
andeightydays)fromthe dateof ctoSingof tendei. No increasein
pricewillbe permitted
afteropening
of tendet.
06 2
However,
the MTBmay solicitthe tenderer's
consentto extendvalidityof offer
andif thetenderer
agreesto suchrequest,
thevalidityof the Bid Bond(if avatlabte)
should
alsobe extended
accordingly.
The{endererwi not be permjtted
to modifyor amendhis
tenderif validity
is extended
07.TENDER
OPENING
07.1Tenderswilt be openedimmediateJy
afterclosingat the He€dOfficeof the State
Pharmaceuticals
Corporation
at 75,Sir BaronJayatillake
Mawatha,
Colombo1 Sri Lankaat
thedaleandtimespecified
in AnnexI A.
07.2The tendereror their authorizedrepresentattves
will be permitted
to be present
openingof lenders.
07 3 Onlythe copyof thetendermarked,Original'
willbe openedat thetimeoi openin!,
of
Ienoers.
07.4 The committeewho opensthe tenderswill read out (or causeto be
presenl,lhe nameol eachtendereras wellas the arnountquotedtogether reao out) to those
withdiscounts,il anv.
07.5 Whetheror not a Bid Bondhas beensubmitted,
and the amount o, Bid Bondif
submrtted
shallalsobe announced.Details
of the make-up of any Tenderwt not be read
out
08
BONOS/GUARANTEES
(a) Bid Bond
Bid Bondas per Annex lll encashable
Tenderersshouldturnishan unconditional
08.1
itemintheAnnex1A ofthe
stated
against
each
demand
tothevaluo
onfirstwrilten
tender Bid Bond should be submitted togetherwith the Tender ol to reach -on or before
the closing date of tender. Tenders submittedwithout Bid Bonds, will not be
consideiedand will be rejected.
08.2 The Bid Bond shouldbe valid for at least30 days beyondthe validityof the offer'
at Annex lll and shallbe (para06.'1)issued
08.3 The Bid Bondshallbe as per specamen
by the one of the followinginstitutions
i. A Commercial
Bankoperatingin SriLanka,approvedby theCentralBankot SriLanka.
'Confirmed'by a
ii. A Bank based in anothercountrybut the securityor guarantee
CommercialBankoperatingin Sri Lanka.
iii. A Letterof Creditissuedby a ForeignBank,but
'Confirmed'by a Commercial.Bank
operatingin Sri Lanka.
AnyotherAgencyapprovedby theTreasuryfromtimeto time
Or
v
A cashdeposit
08.4 lvlasterBidBondsare notacceptable.
will be rejected.As per para 06.2
08.5 Tenderswhich do not complywith this requirements
il MTB makea requestto extend the validity of the Bid Bondthe tendere.will haveto honour
that request.
(b)
PerformanceBond
08.6 The successfultenderershall within 14 days from the notificaiionof award submit an
unconditionalPerformanceBond upto 10% of the total value of award if required.Failure to
complywith this requestshall constitutesuflicientgroundsfor the corporationto cancel
such awardand forfeitthe Bid Bond/Security.
08.7 However,the MinistryProcurementCommittee reseryesthe right to increasethe
Bondat theirdiscretion.
requiredPerformance
Annexlv- and shallbe issuedby
Bondshallbe as per spdcimen
08.8 The Performance
para
given
at
8.3
oneof the institution
Bondwill be made by the Cooperationon the very lirst
08.9Claimson the Pedormance
instancethe supplierlails to complywiththe termsand conditionsol Indentand UC.
(c) ExemPlpns
TenderDeposrtsor Bid Bondsprovaded
08.'10The followingare exemptedfrom refundable
previous
on
occasions
lheyhavenot defaulled
AoprovedSocieties.
StateCorporations,StatLltoryBoardsand other Slate Institutions
t,
StateTradingOrganizationsof ForeignGovemments(Acceptabledocumentaryevidence
should be submitted by representativesof ForeignGovernmentsin Sri Lanka)
TenderFee (para5) and
will not applyto non-.efundable
thisexemption
08.'11However,
Bond (para08 (b)above.
of Performance
the submission
FORCEMAJEURE
09
h the eventof the Supplie/sinabilityto successfullycompletecontraclualobligationsin
termsol the Letterof Creditandsuchdelayis dueto ForceMaieureincludingbut notlimited
to War,CivilCommotion,Fire,Floods,Epidemics,FreightEmbargoetc, suchdelaysmay
be excusedand the dateslor completionof supplybe extendedor awardcancelledat the
Committee.
of the ministryprocurement
discretion
10.
OF CONTRACT
ASSIGNMENT
or subletwithoutdue authorityThe StatePharmaceuticals
may be assigned
No Contract
reservesitselfthe rightto refuseto rccognizea Powerof Attorneyissuedby a
Corporation
such partyto carry on the contracton the
to any other partyauthorizang
Contractor
behalf
contractor's
11.
STOCKS
FRESH
recentlyconlormingto the
i11 Suppliesshouldbe from fresh stocksmanufactured
tesidual
1,A.
At
least
2/3.d
of
the
shelflife (subjectto a
in
Annex
specifications
stipulated
receipt
in
Sri
Lanka.
years)
shouldremainat the timeof
of 2
minimum
of goodssuppliedwith
reserves
the rightto callfor free replacement
11.2 Corporation
and refrainfrom its clearancefrom
residualshelflife,or rejectsuchconsignment
inadequate
thePort.
12
FREEREPLACEMENT
1 2 . 1- C o r p o r a t i o nr e s e r v e st h e r i g h t t o c a l l f o r f r e e r e p l a c e m e not r
loss/damage
or deterioration
of goods
in theeventof shortpacking,
reimbursement
dueto labels
withinthe shelf-life,
alsofor packswhichcannotbe identified
supplied
fallingoff.
by the NationalDrugQuality
shouldbe confirmed
/ complaints
12.2 All qualityproblems
(NDOAL)
Laboralory
or SPCOualityAssurance
Assurance
Laboratory
a ) F o r S P C p u r c h a s e s i h e C o r p o r a t r o nw r l l r e t a i n s a m p l e s f f o m i h e a v a i l a b l e
batch/batches
and the balancewili be destroyedby the authorizedofficersLrnderlhe
Cosmetics Devicesand DrLrgsAct and would issuea cedificateto back effeci
b) In case of Departmentsampleswill be testedby NDQALand followthe recaliprocedufe
approvedby Ministryof Healthand shouldbe destroyedaccording1o section72 of Drug
regulations
c) Incaseof withdrawalsdue to quality failure Supplrersshould ensure ihat the entire
quantityof eitherthe withdrawnbatchesor productswouldbe totallyreplacedor reimbursed.
DELIVERYDATES
13.1 See Annex I Successfultenderersshouldconformskictlyto de|verydates Failureto
Bond and/orcancellation
of the awardof
do so will resultin forfeitureof the Performance
tender In the event SPC purchasesthe item from anothersource at a higher price the
defaullingtenderershouldpay the lotal difierenceof priceto the Corporalron
132 Where awards are made to local suppliers,SPC may request supply in mofe
inslallmenls
thanindicated
rnAnnex1A
PACKINGAND STORAGE/ CONDITIONS
14.1 Pack Size otferedshouldconformto reouirementsof DGHS.Tendersfor
alternatepack sizes may be rejected.DGHS,D/MSDatter consulting.Exportworthypackingwhichwill preventdamagein transilshouldbe used.Detailsof
givenby D/MSD.
natureof packingshouldbe accordingto the specifications
ior storageand use undertropical
14.2. Packingof all itemsshouldbe suitable
p
a
c
k
i
n
g
F
i
n
a
l
E
x
p
o
r
t
s
h
o
u
l
d
i n d i c a t et h e r e q u i r e ds t o r a g e
conditions.
for goodswhichrequireRefrigeration/Cool
storage/Coldslorage
temperature
FreezerStorageenablingthe cargohandlingstaffat the Portof Destination
to
proper
goods
(Humidity
storage
for
such
immediately
on
arrival
in
Sri
arrange
Lankais usuallybehveen75% and 100%and temperatureis in the rangeof 50'
F to 91"F(15"Cto 33'C)).
14.3 All outer carton and inner box (if any) should contain
the following
information.
(a) Descriptionof the ttem
(b) Dateof Manufacture l
(c) Dateof Expiry
in 5 cm sizetetter/Figurein visibtemanner
r|
(d) BachNo.
(e) NameandAddressof Manulacturer
(f) MSDOrderNo.
(g)SPCIndentNo.
(h) StockReferenceNo
(i) StateMarkof Sri LankaGovernment
14.4. Containers
andclosures
usedshouldbe of suchquality
so -as norlo react
' -withthecontents
whilein "1orun"undertropical
conditions.
14.5 Containers
and closuresshouldpreventleakagein transitsalsosuitable
for safeandeasilyhandling
.
t,
packingshoutdbe in seaworthystrongcasesor cartons,
9^-,
-,,,|'lul.:rport
srenc
ted wrthbtuebandsin the form of a crosson eachfaceandin addilion
carryrng
the shippingmarks,detailsof whichwifl be providedwith order.
such
exportpacklnqshouldbe suitableto withsland
the longseajourneyand rough
handlingat portsof loadingand untoadingAug""rgo inouij
b; plttetizedand
shnnkwrapped.
Al burkpacks
containing
tabrets
oi capsures
shourd
incrude
a pouch
of
Silicacel, whichhasa colourguide.Thisis tmportant
to malntaln
ttte
siett
tife
ot
tne
product
under
highhumidity
conditions
whichprevail
in SriLanka
14.7
tablets(over25omgin weight)in bulkpacks(over5OOtablelsper pack)
,. ..Larger
should
notbe packedjn gtassbottesas glassbotfles
areljkeiyto be dama;edin kansit.
Suchitemsshouldbe packedin sealedpolyethylene
filmtags in""rt"i ,nto"trong
arrtight
metalor plastic
containers
14.8
is the responsibirity
of the manuracturer
/ supprierto ensurethat the conrarners
. .lt
wouldbe in tacks,andwithoutbeingdamageuntilthedrugs
are Oeing,deii;e,ed
to tutSO.
14.9
lf any damages(s)
causeddue to non_comptiance
of packtng
" to rhe above_
menlioneo
cond[ronssupplter
shoirld
oearthelullcostof damagea
'14.10
MSD order list Number,SR Numberand SpC IndentNumber
should be
indicatedin a supptyInvoicesand packingList.Also detailof batch
and respective
quantitycartonnumbercontainingsame.
I5. LABELLING
15.1
Alllabelsshouldbe printed
in English
Language
andthelabeling
requrremenrs
shouldbe according
to the specifications
required
lor regiskation
at CDDAas fo ows.
a) Theapprovednamefoundin officialpharmacopoeias
or formularaes.(The
source
shouldbe statedin abbreviations;
e.g.B.P.,USP.etc)
b) The BrandName
c) Listof the activeingredients
showing;
a) Theamountof eachpresentin eachdosageunil(e.g.per5mletc)
b) A Slatements
of the nettcontents(e.9.numberof dosageunits,weightor volume);
d) Any specialstorageconditions
thatmaybe necessary
:
e) Warningandprecautions
thatmaybe necessary
;
0 The Dateof Manufacture
g)TheDateof expirywhereapplicable;
h)Thebatchor lot numberassignedby the manufacturer
and
i)ThenameandAddressofthe manufacturer.
15. 2 Sizeot the letlersof the above (t), (g), (h) and the SR Numberon the ourercanon
shouldnot be lessthan5 cm.
'15.3ldentrficatron
Marks
The StateMark"and"SRNo."whichwill be madeavailable
to the successful
tenoerer
shouldbe embossedor imprinted
in each(item)ampoule/vial/pack
/bot e or on the
affixedlable.
Thesemarksshouldbe indelible.
"DHS marksto be embossed
on eachcapsuleor tablet.
All tenderersshouldindicatein theirtenders,as to whethertheserequirements
couldbe
rnet;whichwillbe takenintoconsideration
at thetimeof evaluation
of the tender
Products
154 Anaesthetic
largeandclear'
beprinted
NameofDrugShotlld
( 1 ) Generic
(2) All ampouleshouldbe effectivelypre-cut.
(3) Labelsshouldbe eflectivelypastedto avoidlooseningwhen in contactwith
water STICKERLABELSto be providedfor OperatingTheatreuse
withthe'Standard
(4) Colou.codingof stickerlabelsshouldbe in accordance
for UserAppliedDrugLabelsin Anaesthesis"set oul by the
Specilication
ASTMD4774-88
lor Testingand Materials.
Society
American
Red
e g Relaxants
Violet
Vasopressors
Blue
Opiates
GreY
LocalAnaesthetacs
redband
shouldhavea distinct
ampoules
andadrenaline
withadrenaline
Lignocaine
andredlettering
drugs:forthefollowing
shouldbe provaded
labelsforsyringes
Slicker
Thiopentone
Diazepam
Midazolam
Ketamine
Suxamethonium
Tubarine
Pancufontum
Atracunum
Vacuronium
Neostigmine
Atropine
16.CURRENCY
Tenderersfrom a countryoLltsidethe Asian ClearingUnion shouldquote in a
161
cu(ency in Srl Lankasuchas U$ Dollarsor SterlingPoundsor Euro
freelyconvertible
However.member countriesof the Asian ClearingUnion should quote only in U$
Dollars.
in Sri Lankacould be quotedIn
Tendersfor the supplyof goodsmanufactured
16.2
lerms of the para 02.4 Quantumof the domesticpreperancewiil be governedby the
at the time of tenderclosure
circularsand guidelinesof lhe GeneralTreasuryapplicable
articlesoffered
pfesentlygrantedwill be a 20% for locallymanufactured
The preference
addedvalue
30%
is
a
minimum
of
critena
Eligibility
with importedarticles.
in competition
goods
manufacturedin Sri Lanka
in Sri Lanka at eK-factoryprice All tenderersoffering
'Domestic value added Calculation' lorm
should complete and submit the enclosed
along with their Tender. (Annex V). Tenderers should support their claim to
dom;stic Preferencewith documentaryproof Tender Board or the TechnicalEvaluation
Comminee appointedwill determineacceptabilityof the evidence submittedto support
the claim.
ll)
lO.f focattymanufactured
goodsshoutdcontainlocallabour,localrawmatenatanc,tocal
componenls
accounting
for at least30%of the EXWprice.Forlhis purposeany other
components
suchas financing
cost,factoryoverheads,
depreciation
of machinesprofit
marginare notconsidered
as a partof EXWprice.
164 ltislheresponsihility
ofthe tenderer
toprovide
acceolable
evidence
as103above
alongwith hjs tenderfor the satisfactionof the PC on his eligibility.
A tendererwho fails to complywith this conditionwill not be consideredfor domestic
preference.
17. COUI'ITRY
OF ORtGlN.pORT OF SHtpMETTAND NAMEOF MANUFACTURER
17.1 The Countryof Origin,Port of Shipmentand Nameof Manufacturer
shouldbe givenin
quotation
the
for each item otfered
17 2 Shipmentshouldbe made exclusivelyon vesselsbelonginEto the CeylonShipping
Corporationor those charleredby them However,shipmenton other vessels will be
permitted,
in instanceswherevesselsof the CeylonShippingCorpofatron
do not call at the
Portof Shipmentor if they are not avarlable
for linrelyshipmentof cargo
18.QUALITYCERTIFICATE
18 1 (a) Corporationreservesthe righl to nominateIndependeni
CompetentAulhorities
for the issue ol PreshipmentCertilication(Certrlicateol Quality,Ouantityand Loading).
In such event,the cost of such certilication must be borne by the suppiterand should
be includedin the offerin Annex 18.
(b)"SecretaryHealth;eservesthe righl to nominatesuitablepersonsto Inspecrlne
procluctionand quality controlfacilitiesof tenderersand manufaciurersand their
records Tenderers,who refusepermissionto our nomineesto carry out such an audit
will be automaticallydisqualifiedfrom the tender.
18.2Tenderers
shouldconformand shouldsubmitthe resultsof the Dissolutionand
8io-Equivalence
of the followingproducts:
Carbamazepinetablets
Sodiumvalproatetablets
Thiophvllin
tabletsand
Allthe slow release(SR)drugs
18.3
For oftersfor Antr-epileptic
Drugs,dissolutionand bio-equivalence
test results
shouldbe provided.
ll
19.
MOVING
IN INTERNATIONAL
COMMERCE
(CPP)issued
(a) ACertilicale
of Pharmaceutical
Product
by theCompetenl
Authority
in the
item
tendered
has
placed
Tenderer'sCountryconlirmingthat the
been authorizedto be
in
the marketfor sale and use in lhe countryot manufacture,
shouldbe submittedalongwith
the Tender.
(b) The Certificate
Products
of Pharmaceutica'
shouldalsocertifythatthe Manufactunng
PlantIn whichthe productis produced
is subjecllo inspection
at suitable
intervalsandthat
requirement
for
in
l\ranufacture
manufacturer
conforms
to
the
Good
Paactices
and
the
as recommended
by the WorldHeaithOrganisation,
in respeclof prodLrcts
OualityControl.
of originor to be exported.
to be soldor diskbutedwithinthecountry
(c) All batchesofieredshouldconlormto the requirements
ol the CompetentAuthorityfor sale
of where appropriateto published
or distributionwithin the countryol manufaclure
providedby the manufacturer.
specilications,
eg: BP/USPor to establishedspecitications
indicate
the
namb
and
dosage
form
of the product,the batch
These certificatesshould
number,the date ol manufacture,date ol expiry,storageconditions,date of packaging,
labelling,natureol the container,
resultsof analysisandotherdata(BATCHCERTIFICATES).
20.8EC.tg[8AL!.9!
,20
(CDDA)
1 WITHTHE COSMETICSDEVICES
AND DRUGSAUTHORITY
(a) All Pharmaceutical
and Surgicalproductsimportedto Sri Lankashouldbe registered
with the Cosmetics,Devices& DrugsAuthorityof Sri Lanka. (Pleasesee para 01.3)
Therefore,all ProspecliveBiddersshouldadvisetheirLocalRepresentatives
to attendto
such Regastration.
(b) A certrfied
copyof the regrstfation
cerlrfrcale
of each producttenderedshouldbe
submittedalongwith the tenders.Tenderersshouldsubmitcertiliedcopiesof their
certilicatesalongwiththe Tenderdocuments.
registration
of PublicContracts
20 2 TheRegistrar
Awardsover Sri LankanRupees(LKR)Ten Millionshouldbe registeredwith the
Begistrarof publiccontractsby the successlultenderer or his localagent.
tl
21 SAMPLES
21.1
samplesin respectof itemsofferedshouldbe submittedto reach
Representative
2 12
are advisedto submittheir samplesthroughtheir
Tenderers
All Prospective
withthis request.Evenpastst-lppliers
LocalAgentsif any to ensurecompliance
other,than presentsuppliersare liablelo submitsamplsas speciliedherein.
2 13
packed.
TheTenderNumber.
SR Numberwlth
shouldbe individually
All samples
jn
Nameshouldbe clearlyindicated the package.
Tenderer's
(Page
(Please
3)-1
seeNote
dals0ftender
theclosing
)
us0norbefore
requirement
andall Tendersthatdo
It shouldbe notedthatthisis a compulsory
willbe rejected.
not complywiththisrequirement
21 5
lf the tendererdoes not havea LocalAgentthen samplesshouldbe sentto
"STATEPHARIiIACEUTIoALS
OF SRI LANKA, 25, SIR
CORPORATION
'1,
E A W A T H AC, O L O M B O S R I L A N K A " A N o B A R O NJ A Y A T I L L A KM
nominalvaloefor cuslom'spurposeonly)
ValueInvoice(indicating
Commercial
copy
to the consignee's
Certificates
shouldbe attached
withAnalytical
together
Pharmaceuticals
be
sent
direct
to
the
State
of Air Waybillanda copyshouldalso
Mawatha,
Colombo1, Sri Lanka.All these
75,Sir BaronJayatillake
Corporation,
which
andall sampleoacksshouldbearthe TenderNumber(without
documents
permit
clearance).
wrllnot
thecusloms
21.6
mustbe in theiroriginaltrade
All samples(exceptbulkdrugsor raw materials)
to
propey labeled
and shouldbe accordrng
in the EnglishLanguage
containers
section15 1 ofthisdocumenl.
21.7
in the TenderOffer SamplesshoLldbe sent
Samplesshouldnot be included
fromtenderotfers.
separately
(Annex'lA)published
wilh
of samplesare doneas per specifications
21.8 Evaluations
thetenderdocuments.
For
(Should
ExcePt
T.adeConlainers
Required
BeIn TheirOriginal
Of Samples
21.9 Ouantities
or Chemicals)
Rawlllaterials
3 Containers
and
Minimum
300tablets/capsules.
Minimum
- 125ampoules(Containers)
b)ParenteralPreparations Injections
- 100vials(Containers)
Powderlor Inj.
Intravenouslnlusions, I
for I
ConcenkatedSolutrons
lniections
J- 30 (Containers)
or Capsules
a) Tablets
- Sufllcientquantityfor
Analysis
c) VaccineandSerum
l3
- 50 Containers
DroPs
EyeDrops/Ear
DroPs
Nasal
/ Cream/ Oral/ Liquids/
e) Ointment
DustingPowder
Inhalatlons
Solution/ Syrups/ Pressurised
s)
Extracts/ Tinctures
h)
/ SuPPositories
Pessaries
- 12Containers
- 04 Containers
- 04 Containers
- 50 Pessariesor SuPPosrtoaes
- 2009
i) Waxes
ana'vs's
further
,, ,0
iin"$eli:i:'ror
r,",,,1,?"5'.1;1"","j1r.,:i.;;:.,ipi:ili$
Oosage
Tablets/CaPsulles
lnfusions
Injections
Powderfor Ini
Strength/Vollume
ovc.
ther Concl tions in the event ofaward
, bc supplicd from freshly manufacturcd stock.
irc productshouldhrn'ca ninimum of 24 months shclf lifc at thc time dclilcry.
rrch rmpoulc,r.i:rlor bottlc to bcat l)cscriptionof ltcm, l)ate of Manufacturc,l)atc of l.i,xpirr',
Slt
No. .urd"S.l';\'lll Nlr\llli" of Srij-xnkr(;o!ernmcnt.
-1. l)escr':ptionof llenr, l)rtc of N.lanuflchrtc,Namc and addrcssof munrrficrurer,l)rtc r
crpil llrtch No., NlSl) ()rdcr list No., Slt No., Slr(l Indcnt No. and S l rVl l,l 1\1,\ltl(()f S
l,en (lovetnmcnt should bc cleerlymrrkcd on the outcr covcting contninir.rg
rhc irrn xrl
r thc ()Lltcrc(^'cr ol thc cartrxr/,r,*.
5 \ll ()utcrclrtons shoultl bear rl,e llatch No., l)ate of manuficturc,l)^rc of l,ixpiryin sizr
'lhis
:m lcltcrs/figurcsrn promincntly visiblc manncr.
may be printcd, srcncilcdor lal>
nffixcd.
6. ()ffcrs iirr lnr othct cconomicallvviablcpack sizc atc acceptable,
rvith thc prior apprrtr.llr
1
2
3
l)/Nr l).
7. I\lSl- .)rder J-istNo. "Slt No." of ltcm and SP(l Indent No. shouldbc indicateclin all supp
'
. oiccsirntll)ackinglist.
lJ. L)lIS" mark to l:lc
a- crnbosscdor printctlin cescof tablcts
b. printrtl irr cascofclpsulcs
REO. NO. MSD/P,/006/08
ITEM } 'O
DESCRIPTION OF ITEM WITH SPECIFICATION PACKSIZE
/SB-NIL
15 /060076 AdsorbedTetanus Vaccine BP Singledose (0.5m1)
OR
TetanusToxoid AdsorbedUSPsingledose(0,5m1)
1. Each0.5nrlsingledoseampoule
shouldcontahan
OTY.
100ampoules
in a box 2,800,000
arnpoules
estimatedpotency of oot lessthan 40 units of
Tetanus Toxoid. The vaccine to contain Tetanus
Toxoid produccd by the grorvth ofclostridium
teranaiin the form ofTetanus Iremoral'lbxoid.
2. I,refetencc will be given fot the suppliets,
recommcnded for bulk purchaseby the VHO for
bulk purchasefor rhe U.N. Agcncres.
3. The following documcnts should be submitted preshipment for each lot ofvaccine dispatched.
.
Invoice
o Certificate of Origin
.
.
Ceitificateofanalysis.
4. The product should be only from ftesh stocks and
shodd have a minimum of 24 months at the tirne
ofdelivery at Medical Supplied Division.
5. The vaccine dhould also comply with the general
requirements fot vaccine in the BP (2002).
6. Vaccine Monitors should be provided ot at least
cold chain rnonitots shoutd be included for each
100 dosesand the cold chain should be maintained
according to the manufacturer's instructions dudng
storage&ansport and delivery ofvacche.
7. The vaccine should be protected from light and
should be stored at a temperaturerange of2"C to
8"C. Vaccine should not be frozen.
8. Each ampoule should be labelledaccordingty.
9. The vaccine should me€t the mosr recerr
requfemcnts of w'HO when testedby the rnelhods
oudined by WHO.
DeliverySchedule:300,000ampoulesinJanuary2fl)8
300,000ampoulesin Match 2008
300,000ampoulesin June 2008
300,000
ampoulesin September
2008
400,000ampoulesin Januery2009
400,000ampoulesin March2009
400,000
ampoulesin June2009
400,000
ampoulesin September
m09
Amount of Bid Bond Rs.,1l75,600/=.
- noflrg/6-9-?oo?