6)
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]001
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SRI LANKA '
STATE
PHARMACRT]TICA
(ESTABUSHED (JNDER T}IE STATE ACL NO 49 OF 1957)
IMPORTING ON BEHALF OF THE DIRECTOR GENERAL OF I{EALTH SERVICES
GLOBAL TENDER
(CAPC/MPC)
TENDER DOCUMENTS FOR
PROCUREMENT OF PHARMACEUTICALS
FOR THE DEPARTMENT OF HEALTH SERVICES
OF
THE GOVERNMENT OF SRI LANKA
All Shipping Documents and Correspondence
STATE PHARMACEUTICALS CORPORATION OF SRI LANKA
P O. Box l?57.
75, Sir Baron Jayatillake Mawatha. COLOMBO O I.
SRI LANKA.
Fax: 94-ll-24462M
STATE
PHARMACEUTICALS
CORPORATION
OF SRI LANKA
T E R M S
A N D
C O N D I T I O N S
O F T E N D E R
01. INTRODUCTION
01.1 The Slate Pharmaceutica s Corporalron (SPC) of Sn Lanka is a fully Sn Lanka Governmenl owned organization engaged in lhe procurement of Pharmaceuttcals, Surgical Consumable ltems, Laboratory Chemicals etc, for tts ow4 slocks and distflbution in the Privale Sector. and for use in all Government Hosprtals of the Departmenl of Health Servtces , and hospitals under lhe prov ncrals Councrls through N4edrcal Supplies Divis on (MSD)
01 2 Procuremenl is marnly done by World Wde Tenders strctly accordrng to terms conditions and specifications as stated In the documents herewrth
01 3 All Pharmaceutical products in]ported rnto Srt Lanka sholrld be those registered wrlh the Cosmetrcs Devices & Drlrgs Authorily of Sri Lanka Therefore. all crospeclive Brdders shoud advrse their Local Representatrves to attend lo such Regtstralon However we may
mporl drugs whicir are unregrstered under special crrcumslances
01 4 Payment for all rmports will be C&F bas s by rffevocable Letter of Credrt with 75% of the value of the.documentary credit being availabie to the supplrer at the time of shipment and lhe balance 25% after 60 days ffom the date of payment of the frrst Blll, provided all terms and conditions in the Documentary Credit have been skrctly complied wrth
01 5 All prospective tenderers are advrsed lo read and understand the lollowing terms & condrlions covefing this Tender as no plea of lack of informatron or insufficient infofmat on will be entertained after closing of Tender.
02. INVITATION TO TENDER
02.1 The Chaiman, Minislry Procurement Committee, Ministry ot Health will receive sealed Ten-ders forthe procurement ol the pharmaceuticals given in the Annex - 1A and receiving will be closed at 10.00 a.m. on the date given therein.
02.2 Foreign and Local Manufacturerysuppliers or theirAccredited Agents / Represenlatives for Sri Lankan Market are eligible to bid in this Tender lf tenderer is participating in the capacity ol agent, tenderer should provide valid documentary proof (s) to establish his authority to act on behalf ol lhe
02.4 The Tender offers lrom local manutacture; / suppliers should be inctusive ot Supply & Delivery wilhin Colombo Municipal Limits and the loreign component of the price will be paid direct to the principle manulacturer in loreign currency by opening of a letter ol credit against him, Local component of the price ancluding Local Agenl's Commission will be paid to the
. looal
AgenU
Representetive
in Sri Lankan
Cunency.
Accordingly
Foreign
component
o{ the
price have to be given on C & F basis supporting the Invoice issued by the foreign principle manufacturer. The Tender oflers from foreign manufacturers./ suppliers should be on C & F basis.
02.5 This Tender is covered by Guidelines on Government Tender procedure issued by the i,linistry of Finance ol the Government of Sri Lanka, subjectto modilication and/ oramendments made into it or will be made into it, by the respective authorities from time to nme_
026 The Tenders could quote for one or more items indicated in the Annex - 1A and they could submit only one offer for each item/ilems
T E N D E R N O DATE OF ISSUE
CLOSING DATE & TIIVE LANKA TIME
A T l O O O H O U R S S R I
SR NO DESCRIPTION OF ITEM WITH SPECIFICATIONS PACK SIZE QTY see annexure 1A lor the specitications
Amount of Bid Bonds lo be submitted :
Delivery Schedule:
Note
1 Representative samples should be received by SPC on or before closing of the Tender as specified in paq 21 Even past suppliers, Other than lhe present supplier are liable to submit representative samples as specified therein .
2.Tenders should be submitted in the forms obtatned from SPC or Foreiqn/Sri Lankan missions
3. The ilems oflered should strictly be in compliance with the specifications. 4.The Bid Bond should be submitted along with the Tender as per para 08 (a)
s.The Tenders that do not conform or non responsive to the Tefms and Conditions g'ven here with will be rejected.
O3 SUBMISSION OF TENDER
03.1 Tenders shall be submitted in One Original and One Duplicate sealed separately and marked as 'Original' and 'Duplicate' respectively. Both Envelopes shall together be enclosed in one EnveloDe sealed and addressed to The Chairman / Ministry Procurement Committee, State Pharmaceulicals Cotporation ol Sri Lanka, No- 75, Sir Baton Jayatillake Mawatha, Colombo 1, Sri Lanka.
03.2 Sealed Tenders may be dispatched either by regislered post to the address given above or deposited in the Tender Box kept lor the purpose at room No. GF 10 in the Ground Floor of the above address to receive on or before closing time and the date.
03 3 The eft hand top corner of the envelope should indicate the tender number and the closing date oi TenCer
03 4 Tenders shou d be received on or before lhe closlng date and time specified in Annex 1A Late Tendefs will not be accepted and wlll be returhed un opened
03.5 The Corporation shall !!Of accept responsibility for the Tender misplacement or premature opening of otfers il thecover has not been marked as given above. (Para03.3)and' or not deposited in the correct tender box.
03.6 Sealed samples should be sent to Chalrman SPC lo be receved on or before the closing time of the iender Samples should be sent separately and should not be enclosed wlth tender otfer Tender should certify genu neness of all the documents submitted with the tender bv an affidavit lt is necessary to ltst oul each and every documents attached to the tender in the said affidavil Documents attached to the tender in the said affidavil
04 FORMAT OF OFFER 04 1
4 4 2
Tenders should be made oul accordlng to the lcrmal glven in Annex 1B
Tenders which are not in the prescnbed format or are not in strict conformlty wrth the terms. conditions and speciflcatlon laid-down in thls lender shall be relected
04 4 All Tenders, literature etc., should be in the English Language.
04-5 The Ministry Procurement Comminee reserves the ight to reject anv tender whach
do not contorm
ro the specifications
given
and
or not reSpOniive
in any mannOr
at anytime.
lf such non-conformlty or non responsiveness disclosed.
05. TENDER FEE
A non-refundable lee of Rs. 3,000/= should be paid in cash to SpC for each set of Tender documents.
06 VALIDITY OF OFFER
06 1 Tenderers should keep their offers valid for acceptance for a period of at least 't80 days (one hundred and eighty days) from the date of ctoSing of tendei. No increase in price will be permitted after opening of tendet.
06 2 However, the MTB may solicit the tenderer's consent to extend validity of offer and if the tenderer agrees to such request, the validity of the Bid Bond (if avatlabte) should also be extended accordingly. The{enderer wi not be permjtted to modify or amend his tender if validity is extended
07. TENDER OPENING
07.1 Tenders wilt be opened immediateJy after closing at the He€d Office of the State Pharmaceuticals Corporation at 75, Sir Baron Jayatillake Mawatha, Colombo 1 Sri Lanka at the dale and time specified in Annex I A.
07.2 The tenderer or their authorized representattves will be permitted to be present opening of lenders.
07 3 Only the copy of the tender marked ,Original' will be opened at the time oi openin!, of Ienoers .
07.4 The committee who opens the tenders will read out (or cause to be reao out) to those presenl, lhe name ol each tenderer as well as the arnount quoted together
with discounts, il anv.
08 BONOS/GUARANTEES
(a) Bid Bond
08.1 Tenderers should turnish an unconditional Bid Bond as per Annex lll encashable
on first
wrilten
demand
to the
valuo
stated
against
each
item
in the
Annex
1A of the
tender Bid Bond should be submitted together with the Tender ol to reach -on or before the closing date of tender. Tenders submitted without Bid Bonds, will not be consideied and will be rejected.
08.2 The Bid Bond should be valid for at least 30 days beyond the validity of the offer'
08.3 The Bid Bond shall be as per specamen at Annex lll and shall be (para 06.'1) issued by the one of the following institutions
i. A Commercial Bank operating in Sri Lanka, approved by the Central Bank ot Sri Lanka.
ii. A Bank based in another country but the security or guarantee 'Confirmed' by a Commercial Bank operating in Sri Lanka.
A Letter of Credit issued by operating in Sri Lanka. Any other Agency approved
Or
v A cash deposit
08.4 lvlaster Bid Bonds are not acceptable.
08.5 Tenders which do not comply with this il MTB make a request to extend the validity that request.
a Foreign Bank, but 'Confirmed' by a Commercial.Bank
by the Treasury from time to time
requirements will be rejected. As per para 06.2 of the Bid Bond the tendere. will have to honour
iii.
(b) Performance Bond
08.6 The successful tenderer shall within 14 days from the notificaiion of award submit an unconditional Performance Bond upto 10% of the total value of award if required. Failure to comply with this request shall constitute suflicient grounds for the corporation to cancel such award and forfeit the Bid Bond/Security.
08.7 However, the Ministry Procurement Committee reseryes the right to increase the required Performance Bond at their discretion.
08.9 Claims on the Pedormance Bond instance the supplier lails to comply with
will be made by the Cooperation on the very lirst the terms and conditions ol Indent and UC.
(c) ExemPlpns
08.'10 The following are exempted from refundable Tender Deposrts or Bid Bonds provaded lhey have not defaulled on previous occasions
Aoproved Societies.
State Corporations, StatLltory Boards and other Slate Institutions
StateTrading Organizations of Foreign Govemments (Acceptable documentary evidence should be submitted by representatives of Foreign Governments in Sri Lanka)
t ,
08.'11 However, this exemption will not apply to non-.efundable Tender Fee (para 5) and the submission of Performance Bond (para 08 (b) above.
09 FORCE MAJEURE
h the event of the Supplie/s inability to successfully complete contraclual obligations in terms ol the Letter of Credit and such delay is due to Force Maieure including but not limited to War, Civil Commotion, Fire, Floods, Epidemics, Freight Embargo etc, such delays may be excused and the dates lor completion of supply be extended or award cancelled at the discretion of the ministry procurement Committee.
10. ASSIGNMENT OF CONTRACT
No Contract may be assigned or sublet without due authority The State Pharmaceuticals Corporation reserves itself the right to refuse to rccognize a Power of Attorney issued by a Contractor to any other party authorizang such party to carry on the contract on the contractor's behalf
11. FRESH STOCKS
i11 Supplies should be from fresh stocks manufactured recently conlorming to the stipulated specifications in Annex 1,A. At least 2/3.d of the tesidual shelf life (subject to a minimum of 2 years) should remain at the time of receipt in Sri Lanka.
1 2 FREE REPLACEMENT
1 2 . 1 - C o r p o r a t i o n re s e r v e s t 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 n t o r reimbursement in the event of short packing, loss/damage or deterioration of goods supplied within the shelf-life, also for packs which cannot be identified due to labels falling off.
12.2 All quality problems / complaints should be confirmed by the National Drug Quality Assurance Laboratory (NDOAL) or SPC Ouality Assurance Laboralory
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 n w r l l r e t a i n s a m p l e s ff o m i h e a v a i l a b l e batch/batches and the balance wili be destroyed by the authorized officers Lrnder lhe Cosmetics Devices and DrLrgs Act and would issue a cedificate to back effeci
b) In case of Department samples will be tested by NDQAL and follow the recali procedufe approved by Ministry of Health and should be destroyed according 1o section 72 of Drug regulations
c) Incaseof withdrawals due to quality failure Supplrers should ensure ihat the entire quantity of either the withdrawn batches or products would be totally replaced or reimbursed.
DELIVERY DATES
13.1 See Annex I Successful tenderers should conform skictly to de|very dates Failure to do so will result in forfeiture of the Performance Bond and/or cancellation of the award of tender In the event SPC purchases the item from another source at a higher price the defaulling tenderer should pay the lotal difierence of price to the Corporalron
132 Where awards are made to local suppliers, SPC may request supply in mofe inslallmenls than indicated rn Annex 1A
PACKING AND STORAGE / CONDITIONS
14.1 Pack Size otfered should conform to reouirements of DGHS. Tenders for alternate pack sizes may be rejected. DGHS, D/MSD atter consulting. Export-worthy packing which will prevent damage in transil should be used. Details of nature of packing should be according to the specifications given by D/MSD.
14.2. Packing of all items should be suitable ior storage and use under tropical c o n d i t i o n s . F i n a l E x p o r t p a c k i n g s h o u l d in d i c a t e t h e r e q u i r e d s t o r a g e temperature for goods which require Refrigeration/Cool storage /Cold slorage Freezer Storage enabling the cargo handling staff at the Port of Destination to arrange proper storage for such goods immediately on arrival (Humidity in Sri Lanka is usually behveen 75% and 100% and temperature is in the range of 50'
14.3 All outer carton and inner box (if any) should contain the followinginformation. (a) Description of the ttem
(b) Date of Manufacture l
(c) Date of Expiry | in 5 cm size tetter/ Figure in visibte manner (d) Bach No. r
(e) Name and Address of Manulacturer (f) MSD Order No.
(g) SPC Indent No. (h) Stock Reference No
(i) State Mark of Sri Lanka Government
14.4. Containers and closures used should be of such quality so as nor lo react with the contents while in "1orun" under tropical conditions. '
--14.5 Containers and closures should prevent leakage in transits
also suitable for safe and easily handling .
t,
9^-, -,,,|'lul.:rport packing shoutd be in seaworthy strong cases or cartons, srenc ted wrth btue bands in the form of a cross on each face and in addilion carryrng the shipping marks, details of which wifl be provided with order. such export packlnq should be suitable to withsland the long sea journey
and rough handling at ports of loading and untoading Aug ""rgo inouij b; plttetized and shnnk wrapped. Al burk packs containing tabrets oi capsures shourd incrude a pouch
of Silica cel, which has a colour guide. This is tmportant to malntaln ttte siett tife ot tne
product under high humidity conditions which prevail in Sri Lanka
14.7
,. ..Larger tablets (over 25omg in weight) in bulk packs (over 5OO tablels per pack) should not be packed jn gtass bottes as glass botfles are ljkeiy to be dama;ed in kansit. Such items should be packed in sealed polyethylene film tags in""rt"i ,nto "trong arrtight metal or plastic containers
14.8
. .lt is the responsibirity of the manuracturer / supprier to ensure that the conrarners would be in tacks, and without being damage until the drugs are Oeing,deii;e,ed to tutSO. 14.9 lf any damages(s) caused due to non_comptiance of packtng to rhe above_
menlioneo cond[rons supplter shoirld oear the lull cost of damagea " '14.10
I5. LABELLING
15.1 Alllabels should be printed in English Language and the labeling requrremenrs should be according to the specifications required lor regiskation at CDDA as fo ows.
a) The approved name found in official pharmacopoeias or formularaes.(The source should be stated in abbreviations; e.g.B.P.,USP.etc)
b) The Brand Name
c) List of the active ingredients showing;
a) The amount of each present in each dosage unil (e.g. per 5ml etc)
b) A Slatements of the nett contents (e.9. number of dosage units, weight or volume);
d) Any special storage conditions that may be necessary :
e) Warning and precautions that may be necessary ;
0 The Date of Manufacture
g)The Date of expiry where applicable;
h) The batch or lot number assigned by the manufacturer and
i)The name and Address ofthe manufacturer.
15. 2 Size ot the letlers of the above (t), (g), (h) and the SR Number on the ourer canon should not be less than 5 cm.
'15.3 ldentrficatron Marks
The State Mark" and "SR No." which will be made available to the successful tenoerer should be embossed or imprinted in each (item) ampoule/vial/pack /bot e or on the affixed lable.
These marks should be indelible.
"DHS marks to be embossed on each capsule or tablet.
15 4 Anaesthetic Products
Generic
Name
of Drug
Shotlld
be printed
large
and clear'
All ampoule should be effectively pre-cut.
Labels should be eflectively pasted to avoid loosening when in contact with water STICKER LABELS to be provided for Operating Theatre use
Colou. coding of sticker labels should be in accordance with the'Standard Specilication for User Applied Drug Labels in Anaesthesis" set oul by the American Society lor Testing and Materials. ASTM D4774-88
e g Relaxants Red Vasopressors Violet Opiates Blue LocalAnaesthetacs GreY
Lignocaine with adrenaline and adrenaline ampoules should have a distinct red band and red lettering
Slicker labels for syringes should be provaded for the following
drugs:-( 1 )
(2)
(3)
(4)
Thiopentone Diazepam Midazolam Ketamine
Suxamethonium Tubarine
Pancufontum Atracunum Vacuronium Neostigmine Atropine
16. CURRENCY
161 Tenderers from a country oLltside the Asian Clearing Union should quote in a freely convertible cu(ency in Srl Lanka such as U$ Dollars or Sterling Pounds or Euro However. member countries of the Asian Clearing Union should quote only in U$ Dollars.
16.2 Tenders for the supply of goods manufactured in Sri Lanka could be quoted In lerms of the para 02.4 Quantum of the domestic preperance wiil be governed by the circulars and guidelines of lhe General Treasury applicable at the time of tender closure The preference pfesently granted will be a 20% for locally manufactured articles offered in competition with imported articles. Eligibility critena is a minimum of 30% added value in Sri Lanka at eK-factory price All tenderers offering goods manufactured in Sri Lanka should complete and submit the enclosed 'Domestic value added Calculation' lorm along with their Tender. (Annex V). Tenderers should support their claim to dom;stic Preference with documentary proof Tender Board or the Technical Evaluation Comminee appointed will determine acceptability of the evidence submitted to support the claim.
lO.f focatty manufactured goods shoutd contain local labour, local raw matenat anc, tocal componenls accounting for at least 30% of the EXW price. For lhis purpose any other components such as financing cost, factory overheads, depreciation of machines profit margin are not considered as a part of EXW price.
16
4 lt is lhe
responsihility
of the tenderer
to provide
acceolable
evidence
as 10
3 above
along with hjs tender for the satisfaction of the PC on his eligibility.
A tenderer who fails to comply with this condition will not be considered for domestic preference.
17. COUI'ITRY OF ORtGlN. pORT OF SHtpMETT AND NAME OF MANUFACTURER
17. 1 The Country of Origin, Port of Shipment and Name of Manufacturer should be given in the quotation for each item otfered
17 2 Shipment should be made exclusively on vessels belonginE to the Ceylon Shipping Corporation or those charlered by them However, shipment on other vessels will be permitted, in instances where vessels of the Ceylon Shipping Corpofatron do not call at the Port of Shipment or if they are not avarlable for linrely shipment of cargo
18. QUALITY CERTIFICATE
18 1 (a) Corporation reserves the righl to nominate Independeni Competent Aulhorities for the issue ol Preshipment Certilication (Certrlicate ol Quality, Ouantity and Loading). In such event, the cost of such certilication must be borne by the suppiter and should be included in the offer in Annex 18.
(b)"Secretary Health ;eserves the righl to nominate suitable persons to Inspecr lne procluction and quality control facilities of tenderers and manufaciurers and their records Tenderers, who refuse permission to our nominees to carry out such an audit will be automatically disqualified from the tender.
18.2Tenderers should conform and should submit the results of the Dissolution and 8io-Equivalence of the following products:
Carbamazepine tablets Sodium valproate tablets Thiophvllin tablets and
Allthe slow release (SR) drugs
18.3 For ofters for Antr-epileptic Drugs, dissolution and bio-equivalence test results should be provided.
1 9 .
MOVING IN INTERNATIONAL COMMERCE
(a) ACertilicale of Pharmaceutical Product (CPP)issued by the Competenl Authority in the Tenderer's Country conlirming that the item tendered has been authorized to be placed in the market for sale and use in lhe country ot manufacture, should be submitted along with the Tender.
(b) The Certificate of Pharmaceutica' Products should also certify that the Manufactunng Plant In which the product is produced is subjecl lo inspection at suitable intervals and that the manufacturer conforms to the requirement for Good Paactices in l\ranufacture and Ouality Control. as recommended by the World Heaith Organisation, in respecl of prodLrcts to be sold or disk buted within the country of origin or to be exported.
(c) All batches ofiered should conlorm to the requirements ol the Competent Authority for sale or distribution within the country ol manufaclure of where appropriate to published specilications, eg: BP/USP or to established specitications provided by the manufacturer. These certificates should indicate the namb and dosage form of the product, the batch number, the date ol manufacture, date ol expiry, storage conditions, date of packaging, labelling, nature ol the container, results of analysis and other data (BATCH CERTIFICATES).
20.8EC.tg[8AL!.9!
,20 1 WITH THE COSMETICS DEVICES AND DRUGS AUTHORITY (CDDA)
(a) All Pharmaceutical and Surgical products imported to Sri Lanka should be registered with the Cosmetics, Devices & Drugs Authority of Sri Lanka. (Please see para 01.3) Therefore, all Prospeclive Bidders should advise their Local Representatives to attend to such Regastration.
(b) A certrfied copy of the regrstfation cerlrfrcale of each product tendered should be submitted along with the tenders. Tenderers should submit certilied copies of their registration certilicates along with the Tender documents.
20 2 The Registrar of Public Contracts
Awards over Sri Lankan Rupees (LKR) Ten Million should be registered with the Begistrar of public contracts by the successlul tenderer or his local agent.
21SAMPLES 2 1 . 1
2 1 2
2 1 3
Representative samples in respect of items offered should be submitted to reach
us
0n or before
the
closing
dals
0f tender
(Please
see Note
(Page
3)-1
)
All Prospective Tenderers are advised to submit their samples through their Local Agents if any to ensure compliance with this request .Even past st-lppliers other, than present suppliers are liable lo submit sampls as specilied herein.
All samples should be individually packed. The Tender Number. SR Number wlth Tenderer's Name should be clearly indicated jn the package.
It should be noted that this is a compulsory requirement and all Tenders that do not comply with this requirement will be rejected.
21 5 lf the tenderer does not have a Local Agent then samples should be sent to "STATE PHARIiIACEUTIoALS CORPORATION OF SRI LANKA, 25, SIR B A R O N J A Y A T I L L A K E M A W A T H A , C O L O M B O ' 1 , SRI LANKA" A No-Commercial Value Invoice (indicating nominal valoe for cuslom's purpose only) together with Analytical Certificates should be attached to the consignee's copy of Air Waybill and a copy should also be sent direct to the State Pharmaceuticals Corporation, 75, Sir Baron Jayatillake Mawatha, Colombo 1, Sri Lanka. All these documents and all sample oacks should bear the Tender Number (without which the cusloms wrll not permit clearance).
21.6 All samples (except bulk drugs or raw materials) must be in their original trade containers prope y labeled in the English Language and should be accordrng to section 15 1 ofthis documenl.
21.7 Samples should not be included in the Tender Offer Samples shoLld be sent separately from tender otfers.
21.8 Evaluations of samples are done as per specifications (Annex'lA) published wilh the tender documents.
21.9 Ouantities Of Samples Required (Should Be In Their Original T.ade Conlainers ExcePt For Raw lllaterials or Chemicals)
a) Tablets or Capsules Minimum 3 Containers and
Minimum 300 tablets/capsules. b)ParenteralPreparations Injections
Powder lor Inj.
- 125 ampoules (Containers) - 100 vials (Containers)
- Sufllcient quantity for Analysis
Intravenouslnlusions, I Concenkated Solutrons for I
lniections J- 30 (Containers)
c) Vaccine and Serum
e)
s)
Eye Drops/Ear DroPs
Nasal
DroPs
Ointment / Cream / Oral / Liquids / Dusting Powder
Solution / Syrups / Pressurised Inhalatlons
Extracts / Tinctures
Pessaries / SuPPositories
- 50 Containers
- 12 Containers
- 04 Containers
- 04 Containers
- 50 Pessaries or SuPPosrtoaes
- 2009 h) Oosage Tablets/CaPsulles lnfusions Injections
Powder for Ini
Eye/Ear DroPs Mixtures /Elixirs
Aoolications/Tinctures Or;l Rehydration Salts (ORS)
Strength /Vollume <or=2mg ,2mg <or= 200m1 >200m1 <or=3ml >3ml <or= 2mg r2mg
i) Waxes
,, ,0
r,",,,1,?"5'.1;1"","j1r.,:i.;;:.,ipi:ili$
iin"$eli:i:'ror
further
ana'vs's
SamPle Size
200 Units 100 Units 20 Unrts
1 5 U n r t s 85 Units 50 Units 85 Units 65 Units 45 Units 06 Unts (UnoPened) 02 Units 15 Units
ln case of requesling to lest for microblal contamlnalion or dlscoloration tn bulk packs at least two t02) unopened packs should be senl
22. TESTING OF BATCH SAMPLES
22j In the case of distribution to SPC outlets random batch samples and ranoom post-marketing ""tptu" ot "tr gioo! "-'ppri"o *irr be tested at the Qualitv Assurance & [."""?"i-i"i"'""w ot tne Siate Pharmaceuticals corporation and reports on rts suitability issued The findings "'f ttt" t"p"'f" *'l be final and blndrng,'Goods-
reported
as unsuitable
"no not "on'o'ting
i-o ii" r"io Jo"n "p":'fi::!:l-"^ ljl
be rejected
and
subsequently destroyed fn" "u"ppti"'" should agree to replace free of charge the reiected quantity or refuno n" '"nl-Ji"o"t *ithin 30 d;ys from the date of intimation ,77* rii t"titr"t aoard has the authority to decide whether pre-shiPment samples
lo
i! Lo"a ir "" ,n. ""pplier will have to bear the cost of testing
22.3 Product Liability
(a) In the event of an order being placed, the supplier should indemnify the State Pharmaceuticals Corporation of Sri Lanka against all product liability claims arising out
of the
items
supplied
on this
tender
0 g. duc
lo incorrect
labclling,
deviation
from
agreed
specifications etc.
(b) Where a supplier is tendering lor a producl which has not been supplied belore, or w h e r e a s u p p l i e r i s n o t w e l l k n o w n fo r a p a r t i c u l a r p r o d u c t , t b e P r o c u r e m e n l Committee reserves the right to purchase only parl quantity trom such supplier; and to purchase the balance quantity lrom another supplier.
(c) However, in such cases lhe price offered for the tolal amount should be maintained for the smaller quantity.
23, PAYMENT I LETTERS OF CREDIT
23 1 The Payment will be by settled accordrng to the folowrng basrs
(a) Foreign Component ofthe price wr be paid direct to the principal manulacturer In foreign currency by a letter of credit opened aga nst h m
(b) Local component of the price / custom levis, Porl Charges, Transport Charges, Local Agent's commission etc. will be paid lo LocalAgent in Sri Lankan currency.
23.2 Paymentterms willbe by irrevocable Letter ol Credit at sight, unless otherwise agreed. Suppliers should strictly conlorm to the terms and conditions ol Indents and Letters of Credit initiated Corporation and should not request amendments.
23 3 Orders may have to be cancelled and Performance Bond forferled if supolers request amendmenls/extensrons to Leller o'C'edit a'ld delay'ng sJpp res
23 4 Please note that the following clauses whrch will be lncorporated in ihe Letter of Credii and which clauses will not be deleted by us
(a) A certilicale lrom shipping Agents in Port of Shipment that cargo and / or interesls are carried by a mechanically self-propelled seaworthy vessel classed under Lloyd's Registerof Shipping as 100A | (or equivalent classilication in other recognized registers), provided such vesgels are not over 15 years ol age, or over 15 years but not over 25 years ol age, and have an eslablished schedule to load and a regular panern ot trading on an advertised schedule to load and unload at specific ports.
{b) Paymenl of irrevocable Letter of Credit may be reskicled to 75% of ihe value of the Bill of Exchange on presentation of such blll The balance 25% wrll be pald a{ler 60 days from the date of payment of bill for 750ld oi the value. and if the supplier has conformed to all terms of the contract and the Letter of Credit This 25% is retarned to cover claims. if any, on the supplrer.
(c) Local suppliers should forv/ard their Invoices together with lhe delivery orde' duly aiknowledged by the DirectorMedical Supplies Division or his Authorised Officer and lrank stamped also with Certificate ol Quality'
(d) Special consideration will be granted to the tenderers who offer favorable interest free credil terms and based on period of credit offered
(e) Where a purchase for a particular item is being made for the first time from a suoolier. or where there are previous quality failure on goods supplied by a partlcular supplier payments will only be made upon testing the quality and standards of the goods and comparison the bulk supply with the samples provided along wrth the offer
(l) The suppliers should give the name and address ol beneficiary in their original otfer and any change will not be accepted atter closing ol tender. In case of any change where UCs have to be cancelled and re-opened, or where UCs have to be amended, the suDDlier should bear the full cost of such amendments together with a Service Charge of USD 100.00.
24 BANK CHARGES
24 1 All Bank Charges incurred outside Sri Lanka shall be to the beneficiaiY (s) accounl Delivery should be made wlthin validity of L/C and extension wll be granted onlv In exceptronal crcumslances and costs of such extensions wll be to the account ol beneficiarY
24.2 For various reasons this Corporation may have to cancel order placed by Fax or Indent or Letter. Corporation reserves the right to cancel orders or lndents lor quantaties where a lirm UC has not been established
24,3 NOMINATION OF BANK
Letter of Credit wtll be advised through the correspondent Bank of our Bankers In lhe successful Tendereis country. However, if the tenderer wishes to negotiate documenls through any particular Bank of their choice such deiails should be Indicated in thelr offer 25 PATENT RIGHTS (AT8 OTHER THIRD PARTY RIGHTS) AND ROYALTIES
The supptiers shall at all times indemnify and keep this Corporalion indemnified againsl any and all claims ansing at any time on Account of Patent nghts or olher righls whether from
_ manufaclurers or others, from the Llse of the supplied goods in Sri Lanka'
26 CONTRACT AND ARBITRATION (A) CONTRACT
The successlul supplier should agree to enter inlo a Contract / Agreement (as per Annex vi-vii) with the corporation within 14 days of receipt of the letter of award All stamp fees (lf any) in connection with this Agreement will have to be borne by the successful supplier' A specimen of ihe Contract / Agreement is attached with the Conditions ot Tender'
(B) ARBITRATION
lf during the continuance ol this Contract or at any time atter the termination there of, any differences or disputes which may arise between the parties hereto in regard to the interpretation ol any of the provisions herein contained or any other matter or thing relating
to this
conlract
(other
than
arty
dillerence
or dispute
in respect
0f which
a decision
0l the
MPC is declared to be linal and binding on the parties hereto) such ditlerence or disPute shall be forthwith relerred to an Arbitral Tribunal in Sri Lanka. Composition of the Arbitral Tribunal, jurisdiction of the Arbitral Tribunal, Conduct of Arbitration Proceedings, awards and any other matlers relating to the Arbitration shall abide by Arbitration Act No. 11 ol 1995 ol the Democratic Socialist Republic of Sri Lanka. The place ol Arbitration shall be in Sri LanKa.
27 LOCAL AGENT
The suoplier shall in his lender indicate name, address, telephone/facsimile/E-mail number/s of his agent in Sri Lanka. Also the percentage ot Commission, payable to him with its value in Sri Lankan Rupees.
28 EXAMINATION. EVALUATION AND COMPARISON OF OFFERS
28.1 The purpose ol bid evaluation is to determine the lowest evaluated bid trom lhe substantially responsive bids received.
i) Preliminarvexamination
The otfers received will be examined by the Technical Evaluation Commiftee appoanted for each lender to determine whether they are complete, whether lhey are from elagible tenderers, whether required bid bond has been furnished in required format' whether the document has been properly signed, whether there is only one offer, whether any computational errors and whether the samples are provided if required and whether the specimen tender form at Annex l(a) and Annex I (b) has been followed and the price schedule as per Annex I (b) has been followed.
ii) Prior to detailed evaluation
The TEC will determine the substantial responsiveness of each offer to the tender documents as pursuant to clause 28.'1.(i). A substantially responsive bid is one, which conlorm to all the conditions described in clausd 28.1 (i) without any devaation. A tender determined as not substantially responsive will be rejected and may not subsequently be made responsive by the tenderer by correction of the non conformity
The offers, which are previously determined to be substantially responsive to clauses 28. 1(i), (ii) will be further evaluated.
iii) The TEC and the Corporation wall also examine the Bids in order lo ensure the coraectness of the Tenders. Arithmetical errors, if any, wall be correcled on the
follov',ing basis;
a) If Discrepancy is between Unit Price and Total Price, then the Unit Price shall Drevail and the Total Price will be corrected.
b) lf Discrepancy is between words and flgures, the amount in words will prevail.
c) lf a Discrepancy appears between the original bid and the duplicate, the original willprevail.
v) All the items offered in Annex 1 B should conform strictly to the technical
specifications set out in the Annex 1A of this document and will be taken in to account at the time of evaluation.
28 2 This Coporation reseNes the right lo nominate suitable persons to inspect the production and quality conlrol facilities of tenderers and manufacturers and their records. Such an audit will be done durang normalworking hours.
28.3 Tenders, who refuse permission lo Corporation nominee to carry out such an audat will be automatically disqualilled from the tender.
28 4 lf lhere is any disagreement on quality farlures found at the SPC Laboratory, the suppllers or their representatives could personally observe the tests done at Corporation Laboratory
29 TENOER AWARO
29.1 The Corporation will notify the successfull tenderers by Fax Conlirmed by a registered letter (letier ol award) that his Tender has been accepted.
29.2 Awards are made to suppliers taking into consideration among other lactors; prices 'quoted,
past performance, quallty of samples, delivery olfered, product registration etc., and the decision of the Procurement Committee is final. No correspondence will be entertained hom unsuccesslul lenderers.
29.3 The Procuremenl Committee reserves to itself lhe right without question lo
(a) Accept any tender, or portion of a tender;
(b) Accept portions of more than one tender,
(c) Reject allor any tenders;
{d} Okect thal fresh ienders be called lor'
(e) Cancelthe tender
30. TENOERS FROM THOSE OTHER THAN MANUFACTURERS
Tenders tor supply of goods which are not manufactured by the Tenderer should be sup-ported by a Certificate of Authority issued by the Manufacturer at the lime o{ rssuing tendef documents indicating that the Tenderer has been duly authorized to supply the goods tendered for Failure to comply will result in the ofter being reJected.
3'1. COPY OOCUMENTS
31.1 The suDcesslul tenderer (suppliet) should agree to despatch by fax./courier the following copy documents immediately the goods are put on board/air freighted.
i- Copy BL/AWB Copy of Bill of Lading (wathout Shipped on Board stamp acceptable) Notation Reefer Cargo" should appear in the BUAWB if goods require refrigeration
ii. Certificate of Quality, Quantjty and Loading or Analytical Certificate should indicate the Date of iranufacture & Expiry for each Batch/Lot.
iii. Packing List indicating individual gross weight and net weight in kg , and ouler dimensions of packages in metric units and also the contents of each package with date of Manufacture and Expiry.
iv. Invoice indicating break-up value of CPT/CFR (into FOB and Freight), Batch Numbers, Date of Manufacture & Expiry in addition to the other details.
31.2 Documents in respect of Air Freight cargo should necessaraly be senl by fax This is a compulsory requirement which the successfulTenderer has to comply with, to facilitate early clearance ol cargo on arrival, withoul payment of Demurrage charges. Demurrage charges, if any, which become payable due to the supplier's failure to ' comply with above requarements will be claimed from the supplier
31 .3 The suppllers should advice their steamer agents to send a blanket approval to their Local Agent to issue delivery orders to this Corporation on submission ol bank guaranlee.
32.
Ar"rEr'rDnENI
32.1 The MPC reserves the right, attime ol award to decrease the quantity required, by25% without any change in price or olher lerms and conditions.
32.2 In casa lowest evaluated responsive supplier is tendering lor a producl which has not been supplied belore, lhe Proourement Committee reserves the tight to purchase only parl quantity trom such supplier and to get a leedback from the end users to decide on the bal-ance quantity.
33. ALTERNATIVE BIDS
lf alternaiive otfers are submitted, the Tenderer should mark the tenders as "Original Offer'
and
'Alternative
ffef'. ff the item
lalls
within
the range
of items
rYhere
Bid Bonds
are
required, the Bid Bond should specitically indicate that it covers the original and the alternative olter. lf these requirements are noi met, only the lower priced Tender will be scheduled:
34 rEBUS_ANp_e.q!9lIl9rg
Prospective tenderers should acquaint themselves, fully with these terms and conditions and if any further clarification is required please contact the undersigned. No plea of lack of information or insufticient information will be entertained at any stage
CHAIRMAN . MINISTRY PROCUREMENT COMMITTEE STATE PHARMACEUTICALS CORPOMTION OF SRI LANKA 75, Sir Baron Jayathilaka Mawatha,
Colombo 01 Sri Lanka.
Fax: 0094-11-2446204
Tel: 0094- 1 1-2391 53A. 2326227
, \ N N I i \ I
TEI:.LRNO. : DHS/(M)P/158/2008-2009
| \ l,E
0f Issr'[
. ]01r
JIJI_Y,2007
LOSING Dt IE & TIME : 10rH SEPTEMBER. 200? AT 1000 HOURS SRt I-ANKA TIME rDecial C. rditions for rcndcrinq
f .icrs shotrltl lt lccornprniccl rvith thc valid rcgistrati()n ccrtificatc issrred by thc (irsrleric , )cr.iccs and l)rugs r\uthoriq in Sri l,anka.
2 lfthc ship:rcnt is being cffcctcd on lr(ll,basis, borh IiOII and l.tcighr chargcs shoultl be quotc(i scpirarclv ^glinsr cich ircm in addirion to thc cluotcd C& [l priLc.
l. l hc r , 'lumc of thc toml guantity ofeach itcm should l>c gitcn in cubic mcter (Ml)
4. Offcr. should be cithcr on C & F (CPT/CFR) Colombo basis ot Delivetcd Ptice to MSD war hor'' basis. FOB offcrs witl be tciectcd nt the tendet opening.
5 ' .rx/E-mail offcts dircctly sent to State Pharmaceuticals Corporation are not acceptablc , endcrcrs are requestcd to draw their attcntion to (he clause ,,Submission ofTenders" of the cndcr d()cument in this regard
Wc tcscr|c thc riglrt to rejcct offcrs rvhich do oot complv al>ovc.
ther Concl tions in the event ofaward
1 , bc supplicd from freshly manufacturcd stock.
2 irc product should hrn'c a ninimum of 24 months shclf lifc at thc time dclilcry.
3 rrch rmpoulc, r.i:rl or bottlc to bcat l)cscription of ltcm, l)ate of Manufacturc, l)atc of l.i,xpirr', Slt No. .urd "S.l';\'l ll Nlr\llli" of Sri j-xnkr (;o!ernmcnt.
-1. l)escr':ption of llenr, l)rtc of N.lanuflchrtc, Namc and addrcss of 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 cleerly mrrkcd on the outcr covcting contninir.rg rhc irrn xrl
r thc ()Lltcr c(^'cr ol thc cartrxr/,r,*.
5 \ll ()utcr clrtons shoultl bear rl,e llatch No., l)ate of manuficturc, l)^rc of l,ixpiry in sizr :m lcltcrs/figurcs rn promincntly visiblc manncr. 'lhis may be printcd, srcncilcd or lal> nffixcd.
6. ()ffcrs iirr lnr othct cconomicallv viablc pack sizc atc acceptable, rvith thc prior apprrtr.ll r
l)/Nr l).
7. I\lSl- .)rder J-ist No. "Slt No." of ltcm and SP(l Indent No. should bc indicatecl in all supp '
. oiccs irntl l)acking list. lJ. L)lIS" mark to l:lc
ITEM } 'O
/SB-NIL
15 /060076
REO. NO. MSD/P,/006/08
DESCRIPTION OF ITEM WITH SPECIFICATION
Adsorbed Tetanus Vaccine BP Single dose (0.5m1) OR
Tetanus Toxoid Adsorbed USP single dose (0,5m1) 1. Each 0.5nrl single dose ampoule should contah an
estimated potency of oot less than 40 units of Tetanus Toxoid. The vaccine to contain Tetanus Toxoid produccd by the grorvth ofclostridium teranai in the form ofTetanus Iremoral 'lbxoid. 2. I,refetencc will be given fot the suppliets,
recommcnded for bulk purchase by the VHO for bulk purchase for rhe U.N. Agcncres.
3. The following documcnts should be submitted pre-shipment 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 doses and 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 temperature range of2"C to 8"C. Vaccine should not be frozen.
8. Each ampoule should be labelled accordingty. 9. The vaccine should me€t the mosr recerr
requfemcnts of w'HO when tested by the rnelhods oudined by WHO.
Delivery Schedule: 300,000 ampoules inJanuary 2fl)8 300,000 ampoules in Match 2008 300,000 ampoules in June 2008 300,000 ampoules in September 2008
400,000 ampoules in Januery 2009 400,000 ampoules in March 2009 400,000 ampoules in June 2009 400,000 ampoules in September
m09
Amount of Bid Bond Rs.,1l75,600/=.
PACKSIZE OTY.
100 ampoules in a box 2,800,000 arnpoules
