Government of West Bengal Office of the Deputy Director of Health Services (E&S), WB Central Medical Stores 141, A J C Bose Road,Kolkata – 700 014 Phone No (033) 2265 4418/4417/4419 E mail : [email protected] NOTICE INVITING RE E-TENDER FOR PROCUREMENT OF FEW DRUGS, LABORATORY KITS, CHEMICALS & REAGENTS FOR THE YEAR 2014-2015 BY THE DEPUTY DIRECTOR OF HEALTH SERVICES (E&S), CENTRAL MEDICAL STORES, KOLKATA-700 014 (Through Pre-qualification) (Submission of Bid through NIC e tender portal) NIT No.:-HST/4T-02-2014/DCR-RT/2014-15/020 Dated- 26/12/2014, Kolkata The Deputy Director of Health Services (E&S) having its office at Central Medical Stores, 141, Acharya Jagadish Chandra Bose Road, Kolkata – 700 014 is going for Re e-tender on behalf of the Health & Family Welfare Department, Government of West Bengal for Preparing of Rate Schedule of few drugs, Kits, Chemicals & Reagents for the year 2014-15, and its extension, if required for a further period of 6 (Six) months from the Manufacturers/Direct Importers , for supply to Central Medical Stores, decentralized District Reserve Stores, Medical Colleges & Hospitals, decentralized Hospitals and other Direct Purchasing Health Units under the Health and Family Welfare Department all over the State of West Bengal. This is in continuation with this office NIT No HST/1P-02-13/GD/2014-15/003 Dated 20.01.2014 & HST /4T-02-2014/ CR /2014-15/009 Dated, 02.04.2014. Necessary earnest money to be submitted for participation in the Re Tender through Demand Draft is Rs. 50,000 per tenderer payable in favour of Dy. Director (Accounts) CMS, WB. 1. GENERAL INSTRUCTIONS: In the event of e-filing, intending bidder may download the tender documents free of cost from the website : http://wbtenders.gov.in directly with the help of Digital Signature Certificate or from the Health & Family Welfare Department’s website www.wbhealth.gov.in & necessary earnest money may be remitted to the office of the DDHS(E&S) through Demand Draft / Pay Order issued from any nationalized bank/scheduled bank in India payable at Kolkata drawn in favour of Deputy Director (Accounts), Central Medical Stores, Kolkata and also to be documented through e-filing. 2. SUBMISSION Of BIDS: Both Technical bid and Financial Bid are to be submitted concurrently duly digitally signed by the Company personnel only (having Authorization from the company management) in the website http:// wbtenders.gov.in. All papers must be submitted in English language with Page Marking. 3. Time Schedules for the Re-tender THE TIME SCHEDULE FOR OBTAINING THE BID DOCUMENTS, PRE BID MEETINGS, REGISTRATION WITH THE TENDERING AUTHORITIES, THE SUBMISSION OF BIDS AND OTHER DOCUMENTS ETC. WILL BE AS PER THE LIST PROVIDED IN CLAUSE NO 30, AS GIVEN BELOW. 4. ELIGIBILITY FOR QUOTING: Only Manufacturers & Direct Importers of the item/items who are able to supply the assured quantities as per requirement & have requisite Annual Average Turnover, as per clause no. 5, are only eligible for quoting. Manufacturers not having the capability to supply the minimum full assured supply quantity need not apply. Failure of submission of declaration of full assured supply to the Government of West Bengal will lead to cancellation of tender. The vendors who were declared L1 but did not execute agreement or did not supply even after execution of agreement up to 75% of the ordered value as on 30.11.2014 in the previous tender 1 floated by DDHS (E&S), Central Medical Stores or declared black listed by any State Govt. or Govt. Institutions are not eligible to participate in the current tender. The Vendors who have been black listed by any Govt. Concern for particular any item(s) need not quote for that item(s). 5. ANNUAL TURNOVER REQUIREMENTS: Principal Manufacturer(s)/Importer(s) (inside or outside of West Bengal), State Based PSUs and State Based Other manufacturing units/CPSU whose average annual Turn Over for last three financial years is more than Rs. 3 (Three) crore totaling 9 (Nine) crore for the last three years and S.S.Is, registered in West Bengal whose average annual Turn Over for last three financial years is more than Rs. 50 (Fifty) lack totalling 1.5 (One & half) crore for the last three years, are only eligible to participate in the Tender. 6. SUBMISSION OF THE TENDERS: The tender is to be submitted in a Two Bid System. The approved Bidders of the E-Tender (Drugs/Kits, Chemicals & Reagents Tender) 2013-14 should have to submit all the technical/financial documents afresh. Technical Proposal: 1. “BID A”: Technical Documents:Part I - STATUTORY COVER containing the following documents: (SINGLE FILE MULTIPLE PAGE SCANNED) One folder for earnest money deposit with copy of the Demand draft/Pay order should be uploaded. Local SSI(s) should upload certificate of registration/EM II for claiming EMD exemption. B C D Copy of Demand Draft of Rs 50,000/- (Fifty Thousand) in favour of Deputy Director (Accounts), Central Medical Stores submitted to DDHS (E&S) as Earnest Money for the whole tender. Certificate of registration/EM II in respect of local SSI CHECK LIST in the prescribed format List of items Quoted (to be filled in excel sheet) E Application in the prescribed format given in Annexure I F Authorization letter of signatory from Company in Annexure II G Certification from Chartered Firm about monthly production capacity and 10% sale in the open market in Annexure III. H Copy of agreement between the manufacturer and the Distributor in Annexure IV I Declaration from existing CMS approved drug vendors about supply of 75% over ordered value in Annexure V. J ANNEXURE VI as per Draft Affidavit Pro-forma. A 2 Part I I :-NON-STATUTORY/ MY DOCUMENTS (My Space), Containing the following documents:(a) Company Specific Technical Documents:(SINGLE FILE MULTIPLE PAGE SCANNED) Sl. Category No. A Certificates Sub Category A1. Certificates Sub Category Description PAN Card of the Bidder/Authorized Signatory who uploads the bid Professional Tax Registration certificate ESI Registration certificate EPF Registration certificate. Service Tax Registration certificate VAT/ CST Registration certificate B. COMPANY DETAILS B1. COMPANY DETAILS 1 Trade Licence/Enlistment Current Registration/EM II as local SSI, W.B. Registration with Registrar of Companies C. CREDENTIAL C1: CREDENTIAL 1 D. PAYMENT CERTIFICATE 1 FINANCIAL INFO PAYMENT CERTIFICATE 2 D1. P/L & BALANCE SHEET Up-to-date Drug Manufacturing Licence with revised schedule M & MIII compliance. Import Licence with validity of IEC Code (for importers) List of Purchaser with Credential Certificate from purchaser( for Importers) GLP Certificate from the concern Drug Control Authority with validity Market Standing Certificate for drug items for the last 3 years from State Drug Control authority. No conviction certificate from the concerned state Drug Control authority for the last three years. Affidavit About No Conviction From Judicial Magistrate/Executive Magistrate ( in Annexure VI) Income Tax Returns submitted for the Assessment year 2011-12 Income Tax Returns submitted for the Assessment year 2012-13 Income Tax Returns submitted for the Assessment year 2013-14 VAT/CST Returns (of the last quarter) for the year 2010-11 VAT/CST Returns (of the last quarter) for the year 2011-12 VAT/CST Returns (of the last quarter) for the year 2012-13 1. P/L & Balance sheet 2010-2011 3. P/L & Balance sheet 2011-2012 3. P/L & Balance sheet 2012-2013 3 (b) Product Specific Technical Documents (SINGLE FILE MULTIPLE PAGE SCANNED) Essential Requirements of the Tendering Firm for participation” shall contain all papers related to the essential requirements of the Tenderer for participation in the tender viz. A B C D CLAA with validity & Product approval Documents Drug Endorsement Certificate/Import Licence in F-10/ Product Approval Certificate for each item quoted (The items should be marked/highlighted with marker pen mentioning there in the CMS CAT No. for each particular item). List of Items imported during the Year 2013-14 ( for Importer) Market Standing Certificate for last three years from the State Drug Control authority of the particular products to be quoted in respect of items under drug ( for manufacturer). (The items should be marked/highlighted with marker pen mentioning there in the CMS CAT No. for each particular item) 2. “BID B ”: FINANCIAL COVER BOQ The folder as “Financial Bid” shall contain: Base Rate per Accounting Unit inclusive of Entry Tax, Customs Duty (if applicable), Transportation Charges, Insurance, Delivery Charges, Incidental Charges, Freight Charges, Testing Charges e.t.c. and exclusive of VAT/CST, Excise duty and Cess (wherever applicable) e.t.c. to be quoted. L1 will be determined on base price only. LOAN LICENCE- No drug manufactured under a Loan License shall be offered by a tenderer. But in case of essential medicines where manufacturer is not marketing the product, loan license will be allowed subject to the approval of the chairperson of the “TSC”. 7. The tenderers are required to submit the hard copy of Earnest Money Deposit (EMD) in original. Submission of hard copy of technical bid is not required to be submitted. Submission of hard copy of Financial Bid is totally prohibited and only be submitted through on line through NIC portal. 8. Evaluation of the tenders:During the tender evaluation process, the “BID A” will be opened first . Those Bidders who have qualified in respect of the essential & other requirements in “BID A” will be identified and only their financial bid i. e., “ BID B ” will be opened. The financial bid of those Tenderer failing to meet the technical & other requirements of participating in the tender will not be opened and be rejected. The Tenderer offering the item found suitable as per the tender specifications will only be selected. Final selection of the lowest bidders in respect of Financial Bid is subject to further verification. The manufacturing capability of the Tenderer and assured supply capability to the Health & Family Welfare department, Govt of West Bengal will also be assessed by the DDHS (E&S)/Tender Selection Committee and the manufacturer capable to supply the assured quantity as per the requirements of the state to the items for which he has quoted will also be identified and assessed before opening of financial bid. The Tenderer who have been so identified to have been technically suitable in the context of above and are having the manufacturing capability and confirmation about the assured supply requirements of the state during the tender period and/or have supplied 75% (as on the date of submission of tender) of the ordered value made to them up to 30th November, 2014 (in respect of existing vendors) will be deemed to have passed the test of essential and other requirement of the quoted item or items. The (Financial Bids) of only these tenderers passing the essential and other requirement test will be opened then subject to verification of hard copies of the audited balance sheet and Profit & Loss Accounts of the tenderer for the last three years i.e. for the year 2010-11 , 2011-12 & 2012-13. 4 If found suitable in the context of above pre qualification etc, the Tenderer quoting the lowest rate will be considered as successful. However, in the event of a particular vendor being L1 for more than one item, an opportunity of being heard may be given to him about confirmation of assured supply in respect of items before declaring him L1. Factory inspection may follow for determining manufacturing capacity and confirmation of assured supply to take final decision in this matter for determination of L1. For high volume, vital and life savings item or items, if the H&FW department considers selection or induction of more vendors for prompt supply for the interest better patient care services or in the exigency of the situation, counter offers shall be invited from the next higher quoter i.e. L2, L3 and L4 etc to supply at the lowest rate, i.e. at L1 rate. This division of orders shall continue till quoters assuring of supplying up to 120% of the estimated requirements of the State in respect of the particular item or items are identified. THE DECISION OF THE DDHS (E&S)/ TENDER SELECTION COMMITTEE WILL BE FINAL AND BINDING IN THIS MATTER. 9. APPOINTMENT OF AUTHORISED DISTRIBUTOR:(THE TERMS DISTRIBUTOR IMPLIES AUTHORISED DISTRIBUTOR, C&F AGENT, CSA AGENT, IN WHATEVER FASHION ADRESSED WHO SHALL FACILITATE THE PROCESS OF TAKING ORDERS, ENSURING TIMELY SUPPLIES AND COLLECTING PAYMENT ON BEHALF OF THE MANUFACTURERS) Local SSIs/local PSU/CPSU/local manufacturers are not allowed to engage Distributors for raising bill and receiving payment in the latter’s favour. All out of the state manufacturers/ tenderers must have a distributor in this state. If out-of-state manufacturer proposes that order and payment are to be made in the name of the Distributor, such Distributor must be an authorized distributor of the Tenderer with average annual turnover of 50 (Fifty) Lakh i.e. Rs 1.5 (One & Half) Crore for the last three years. The Tenderer shall submit relevant document to this effect (copy of agreement signed between the tenderer and the Distributor).If out of state manufacturer proposes that the order & payment are to be made in favour of the manufacturer & the manufacturer will supply and effect distribution through authorised C&F, the same is allowed. No annual turnover and agreement is necessary for such engagement. In the event of being selected, the hard copies for under mentioned documents along with ‘DISTRIBUTOR SUMMARY’ as per Proforma given herein relating to the Distributor must be submitted by the tenderer to the DDHS (E&S), before execution of the agreement: i. ii. iii. iv. v. vi. vii. Letter of Authority from the Tenderer (manufacturer) in the letter head of the manufacturer duly signed by the Authorized Signatory of the manufacturer in favour of Distributor stating clearly the status of the Distributor. Copy of agreement signed between the tenderer and the Distributor as proof of the Distributor as the authorized distributor of the manufacturer. PAN No. & Last year’s Income Tax Return submitted, VAT/ST Registration Certificate & Validity Documents of the Distributor. Drugs Licence & its current Renewal Certificate /Validity Certificate, Current Trade Licence. Current No-conviction certificate from the State Drug Control authority. Affidavit of non conviction sworn before a Notary/ First Class Judicial Magistrate/Executive Magistrate. Average Annual Turnover amounting to Rs. 50 (Fifty) Lakh for the year 2010-11, 2011-12 & 2012-13 totalling Rs. 1.5 (One & Half) Crore for last three years in case the order and payment are to be made in the name of the Distributor. Copies of annual audited accounts statements for the last three financial years are required to be submitted as proof. It is, however, made clear that agreement in pursuance of the accepted tenders will be executed only with the Tenderer who will be responsible for the supply. In case, the order and payment are to be made in the name of the Distributor, separate agreement will be executed with such distributor also. No agreement will, however be executed with the C&F and CSA agent. 5 10. Cost of Earnest Money:a. Each tender has to be submit, unless exempted under the existing orders of the West Bengal Govt. must deposit Earnest Money in the form of Demand Draft from any Nationalized Bank/Scheduled bank in India for Rs. 50,000 (Rs Fifty Thousand) only irrespective of the items quoted. b. The earnest money is to be deposited in the prescribed time during opening of Bid A. The onus of providing that a Tenderer is exempted from Earnest Money will lie on the Tenderer and must be proved by the submission of valid documents. c. The earnest money of the Tenderer will liable to be forfeited if the Tenderer withdraws his tender as a whole or for any particular item at any stage after the opening of the tender, or fails / refuses to enter into written agreement for any of all of the items of his accepted tender within the time specified when requested to do so/fails to furnish Performance Bank Guarantee within the stipulated time. d. The Earnest Money will be refunded after finalization of the tender or within 3 (three) months from the date of opening of tender whichever is later against the specific prayer of Tenderer. e. The Earnest Money will be refunded to the non-qualified bidders in respect of technical bid against the prayer of the bidder. 11. PREFERENCE & REGULATIONS FOR S.S.I., W.B. & OTHERS AS UNDER NOTED: Preference will be given to the S.S.I., W.B., P.S.U., W.B. and State Based Other Manufacturers as per West Bengal Financial Rule incorporated under notification No. 10500-F dated 19.11.04. Registration as a Small Scale Industries unit after the submission of the tender will not entitle the Tenderer to get exemption from payment of Earnest Money. 12. DRUGS LICENCE & IMPORT LICENCE: Certified copy of Drug Licence with current validity certificate along with full list of endorsement with items highlighted by colouring / underlining of items quoted in the tender must be submitted. The items should be Marked / Highlighted with marker pen mentioning there in the CMS CAT No. for each particular items. If the products are not under Drug License, the manufacturer / importer should submit the product Approval Certificate from the authority concerned. 13. Schedule M III Compliance Certificate/GMP Certificate, GLP certificate & 3 (Three) years Market Standing Certificate from the Drug Control Authority in respect of drug items. Only manufacturers having COMPLIANCE OF Revised M & MIII (GMP) & GLP Certificate with three years Market Standing Certificate of the items to be quoted from the concerned State Drug Control authority (if the products are under Drug License) are eligible 14. B.I.S. CERTIFICATE: The item(s) which are under I.S.I. specification must have certificate from Bureau of Indian Standard and valid endorsement copies. 15. SALES IN THE OPEN MARKET: The Tenderer must have sales in the open market. At least 10% of the total production of the material during the last three financial periods should have been sold to any other organisation/party/persons other than the Health & FW Dept., Govt of West Bengal. The Tenderer has to submit a declaration certified by a Chartered Accountant regarding total sales in the open market (i.e. sales other than sales in H&FW Department) during last three financial years (see – Annexure-III). The sales must have relevance to the product he is quoting. 6 This criterion will be used to exclude those Tenderer who do not have at least 10% of the production sold in the open market during the preceding three financial years. 16. RATE: a. Rates are to be quoted for items as per the list of the Catalogue as provided in Table above. b. Rate should be quoted in decimal coinage stating the particular item as per Catalogue of the Tender proposed to be supplied inclusive of all incidental charges including FREE DOOR DELIVERY to the Central Medical Stores, 141, Acharya J.C. Bose Road, Kolkata – 14 or 243, Rabindra Sarani, Kolkata – 700003 and other purchasing health institutions under the Dept. of Health & Family Welfare, Govt. of West Bengal, situated anywhere in the state. Sterile items are to be transported in such packaging so that there is no damage to the primary packaging during the transportation process. c. Rates quoted in respect of items shall not exceed the controlled price and/ or M.R.P. (maximum retail price) fixed by GOI wherever it is applicable. d. Rates shall be valid throughout the period to be covered by the contract to be executed with successful tenderers along with any extensions as may be made by the competent authority from time to time. e. THE BASIC RATE PER ACCOUNTING UNIT should be furnished inclusive of Entry Tax, Customs Duty (if applicable), Transportation Cost, Insurance, Freight, testing charges, Incidental Charges etc. but excluding of VAT/CST, Excise Duty & Cess etc. which shall be quoted separately in the template for Bill of Quantities (BOQ). f. Percentage of Excise Duty, CESS etc, Percentage of VAT/CST to be mentioned in the appropriate Column of the template for Bill of Quantities. Manufacturing capacity per month is to be mentioned in the appropriate column of the BOQ. 17. ORDER & SUPPLY: I. Orders for the supply of the approved products will be placed with the successful tenderers after the execution of the agreements, and such supply shall have to be made in such instalments as may be fixed or spread over the period to be specified in the supply orders to be made in pursuance of the agreements. The successful tenderer will have to supply within the specified time schedule that had been assured at the time of selection as supplier II. All supplies will have to be completed by door delivery within maximum 45 days from the date of order in the SMIS System from the procuring units. NO RELAXATION ON ANY ACCOUNT WILL BE ALLOWED FOR CONDONING DELAYED SUPPLIES. In addition to physical order, the selected vendors would have access to the Vendor Portal from which, the procurement order, Goods Received notes and Bill status can be seen on line. III. The permissible time period between the date of manufacture and the date of supply of the items should not be more than 1/6 the of the whole life period. No delivery will be taken of any drug if the date of manufacture and the date of expiry are not written on each and every unit supplied. IV. To ensure sustained supply without any interruption for facilitating prompt patient care services, the DDHS (E&S), Central Medical Stores, Kolkata with the approval of the Tender selection Committee reserves the right to split orders for supplying the requirements among more than one tenderers provided that, the rates and other conditions of supply are equal and with sufficient grounds. In case of non-supply/less supply of any item by any approved lowest quoted firm, the DDHS (E&S), Kolkata can ask for willingness to L2 / L3 / L4 etc firm to supply at L1 rate (lowest approved rate) and prepare the rate schedule with the same item in L1 rate sequentially till 120% of the estimated requirement are met. 7 18. LABELLING: All supplies of articles in drugs section should invariably contain the following information on its label and the carton. One information should not be overlapped by any other information needed to be furnished. a. Pharmacopoeia name. b. Manufacturing date. c. Expiry Date. d. Name & address of Registered Office of Manufacturers and place of manufacture. e. Manufacturing Licence Number. f. Batch Number g. All Chemicals quoted/supplied by tenderer MUST CONFORM TO B.P, U.S.P, I.P and N.F.I –III specification as noted against the item(s) in catalogue as applicable. For off and on change of specification like BP., I.P. etc, favourable documents need to be produced to the purchasing authority for acceptance. h. Month and Year of supply. i. The bottle label & carton should invariably marked with For C.M.S Supply ….. “C.M.S. supply. Not for sale” For supplies to decentralized units ….. “W B.Govt supply. Not for sale”. Note A: “The MRP Rate Should not be printed in the Strips, Bottles, Vials, Pack etc.” Note B: “Any information like Manufacturer’s Name & Address is strictly prohibited to be inscribed/ printed in any part of the wall of the bottle and cork.” 19. MANUFACTURING AND PACKAGING: a) Packing of medicine (tablets, capsules, solid & liquid preparation), and Lab Chemicals with standard packing materials 1. The rigid PVC used in blister packing should be of not less than 250 micron 2. All glass bottles should be new neutral glass. 3. Ointments should be packed in liquidized Aluminium Tubes. 4. Small Tablets packed in blisters should be packed to facilitate easy removal of the tablet without breaking / crushing. 5. All plastic containers should be made of virgin grade plastics. 6. All plastic jars above 450Gms / ml should carry an inner plastic lid. 7. Liquids and Drops should be packed with plastic dispensers b) Corrugated package box size limited to (12’’ H x 24”L x 24”W). 1. No corrugated box with contents should weigh more than 15 kgs (7 kgs in case of ointments and fragile materials) 2. The inner lining shall be not less than 120 gsm and outer carton not less than 150 gsm. 3. The non glass bottle containing cartons shall be of at least 5 ply with bursting strength not less than 9 kg/sq cm 4. Glass bottle containing cartons shall be of at least 7 ply with bursting strength not less than 12 kg/sq cm 5. No box should contain mixed products or mixed batches of the same product. 6. The product label on the cartoon should be large at least 15 cms x 10 cms dimension. It should carry the correct technical name, strength or the product, date of manufacturing, date of expiry, quantity packed and net weight of the box. 20. DRUG TESTING: (a) Dy. Director of Health Services (E&S), West Bengal and the heads of the direct demanding units and decentralized stores will be at liberty to get the supplied products tested at Govt. selected/ empanelled laboratory. Such testing will be in addition to tests that should be done by any authority exercising statutory powers of drug testing. The tenderer shall be bound to destroy the 8 defective & non-standard batch(s) as per assay and other quality test report under pharmacopeia norms. The tenderer shall be bound to replace the defective batch or batches if found defective as per wrong packaging or labeling. The cost of procurement of such non-standard Item(s) or defective batch(s) will not be paid or will be deducted from the security deposit and/or from the current or pending bills of that supplier or from the performance bank guarantee. Moreover, action under relevant Rules of the Drugs and Cosmetic Act will also be taken. In no circumstances request by the suppliers for replacement of non-standard Item(s) found defective or sub standard in the quality test will be entertained. (b) A sum @ 2% of bills exclusive of Govt. tax & duties will be deducted from the bills of the supplies of medicine by C.M.S./ all D.R.S. / other direct demanding units and deposited in the respective budget head to meet cost of handling and testing charges. (c) Each installment of supply of products must be accompanied with a test certificate from a GLP certified laboratory but these provisions may be relaxed for this tender only. The full name and qualification and the attested signature of the certifying chemist is to be submitted in a separate sheet. (d) Central Medical Stores will depend on testing reports obtained from empanelled laboratory as per norm for nondrug item also. 21. WITHDRAWAL /CANCELLATION & PURCHASE POLICY OF TENDERING AUTHORITY: The tendering authority reserves the right to withdraw any item from the tender at any stage. The selection of such item, if already made in favour of any Tenderer, shall be treated as cancelled. i) ii) iii) iv) v) The tendering authority reserves the right to reject or accept any tender or part thereof at any stage or to split any tender without assigning any reason. Withdrawal of tender or any revision after submission of tender by the Tenderer will not be allowed. The tendering authority reserves the right to accept or reject any tender, in part or in full, without assigning any reason. Purchase will, however be made following the existing purchase policy of the Govt of West Bengal and its amendment(s) made from time to time. The purchase policy of the State Government as provided in the West Bengal Financial Rules, the policy of price preference in particular incorporated under Notification No. 10500-F dated 19.11.04 should be observed in considering the tenders. The tendering authority reserves the right to purchase any item of the Catalogue at the approved rate from any outsider (Non- Tenderer) during the tender period in case of emergency, if the tenderer fails to supply such items on short notice, The tendering authority reserves the right to procure any item, of the tender directly from a state/ Central Govt. undertaking even if a tender for the same has been offered/ accepted. 22. NO- CONVICTION CERTIFICATE: No conviction certificate is to be submitted from the Drug Controlling Authority of the State where the manufacturer is registered for last three years. He will also submit an affidavit in the prescribed Pro-forma attached herewith from Notary/ first class Judicial Magistrate/Executive Magistrate. 23. PENALTY CLAUSESIT SHOULD BE REALISED BY ALL THE TENDERERS THAT THE ITEMS INCLUDED IN THE TENDER CONSTITUTE AN IMPORTANT PART OF THE ESSENTIAL MEDICINES REQUIRED FOR THE TREATMENT OF PATIENTS. THIS IS MORE SO IN CASE OF SERIOUS AND EMERGENCY PATIENTS. THERE CAN BE NO RELAXATION IN THE QUALITY AND TIMELY SUPPLY OF THESE ITEMS UNDER ANY CIRCUMSTANCES, AS THIS WOULD SERIOUSLY ADVERSELY AFFECT PATIENT CARE SERVICES. TENDERERS ARE 9 THEREFORE ADVISED TO CAREFULLY ASSESS THEIR MANUFACTURING ABILITY AND CAPABILITY FOR ENSURING TIMELY SUPPLY OF THE ASSURED QUANTITIES AS PROVIDED IN TABLE 1 ABOVE, PRIOR TO PARTICIPATING IN THIS TENDER. A) In case of supply of the sub-standard items found in the quality test as per quality assurance norms, the detective batch /batches determined by the appropriate authority will not be returned to the tenderers for replacement but will be destroyed and the payment of the defective batches will not be made to the supplier or if paid in the meantime, is to be deducted from the pending bills of the tenderer or from performance bank guarantee. B) In case of supply of defective item found in respect of packaging or lebelling, tenderer will be asked to replace the same. C) In addition to rejection of the supply, the Dy Director of Health Services (E&S) W.B and the heads of direct demanding units will have the right to cancel the supply order wholly or in part, to forfeit security deposit and to recover the loss, if any, of the Govt. by making deductions from any pending claim of the supplier/ Security Deposit or Performance Bank Guarantee, as may be deemed fit. Such Penalty for supply of a drug falling within the meaning of adulterated/ spurious/ misbranded under Section 17 (A), 17 (B) and 17 (C) of the Drugs and Cosmetic Act will be in addition to action which may be taken by police, the Drug Control Authority or by tendering authority of the State Govt or the Govt of India or by any individual under the law of the land. D) Debarment from participation in next tender processes of the Health & Family Welfare Department: The tender selection committee reserves the right to declare a firm/ Company blacklisted for three (03) years due to the following reasons: If the supplier i) Withdraws from agreement after achieving the “Lowest Quoted Tenderer” ii) Failure in supply throughout the state within the stipulated period for five occasions during the tenure of the tender period or its extensions. iii) In case of supply of spurious drugs (as applicable)/, along with proceedings under the provisions Drugs and Cosmetic Act, 1940 and Rules framed there iv) For supply of Non – standard items as per quality test within tender period as determined by the testing of the item as per discretion of Tender Selection Committee in respect of particulars items only. v) In consequence of submission of false or fabricated documents by any firm/ company for participating in the tender, if proved later on. vi) Quoting absurdly high or low rate in the opinion of Tender selection Committee, with the intention to vitiate the tender process. The assessment of too low or too high will be made by a team of Health officials in the context of NPPA norms or any other norms under Govt. vii) Supply of items with short expiry dates in violation of Clause 15 (iii) on more than three occasions. viii) Submission of tender for the product /products for which the concerned company / its Principals/ or sister concern (where its Principals or Promoters have more than 10% shares) has been blacklisted either by the state Government/ other State / Central Government Organization for any reason whatsoever ix) Submission of tender during the period of blacklisting of Concern / Company / its Principals/ or sister concern (where its Principals or Promoters have more than 10% shares) either by Tender Inviting Authority or by any State Government or by other State/Central Government The H&FW Department will have the right to inspect the manufacturing units of the tenderers before accepting the rates quoted by them or at any point of time during continuance of the tender and the Department will also have the right to reject tender or terminate/ cancel the purchase order(s) and/ or not to re- order based on the adverse reports brought during those inspections. 10 E) Financial Penalties for deficiencies in services/supplies during the period of the tender and its subsequent extensions: 1. For delay in the supply of items ordered beyond the stipulated date. The procuring authority has to justify with proof of receipt of supply order along with receipt of way bill (wherever applicable for invoking this clause). Part supply will not be considered as supply in full unless specified in the supply order. a. In respect of all consignment, stipulated period will be 45 (Forty Five) days from the date of order generated in SMIS. The Order(s), generated from the SMIS will carry the same status that of Signed Order(s). b. If the supplies are not made in full within the stipulated period of placing the order, 0.5% of the basic cost of the materials not supplied will be deducted from the existing / pending bills of the supplier per day’s delay up to 60 days. c. For delays beyond 60(Sixty) days, the work order for the non- supplied portion will be considered as cancelled straightaway. d. However, if the stipulated period ends on Sunday, Saturday or, Govt. Holidays, supply should be made on the next working day and in that case, no penalty would be chargeable. e. The provision of Penalty is system generated and cannot be waived in any case. f. The Firm will be blacklisted after issuance of a Show cause letter for such delay beyond 60 days in five occasions. In that case, the firm quoting L2, will be selected. 2. For firms who fail to supply the full order on five occasions for any particular item within the stipulated time within the tender period and its extensions- the Performance Bank Guarantee deposited for the item concerned will be forfeited and the Principal firm will be debarred from participation in the CMS, DoHFW or WBMSC tenders for the next three years. 3. Supply of items with short expiry dates in violation of Clause 17 (iii) on more than two occasions - 5% of the cost of the items or Rs 50,000, whichever is higher will be deducted from the bills. 4. The names of the defaulting suppliers will be put up in the Departmental website Enhancement of rates of raw materials etc or the fact that the tender period has been extended will not be acceptable as a plea for not supplying the materials within the stipulated period as provided in the work order F) 24. APPEAL: Appeal against the decision of the Dy. Director of Health Services (E&S), West Bengal and the head of the direct demanding units to impose such a penalty will lie with Tender Selection Committee. Review against the decision of the T.S.C. will lie with Health & F.W. Deptt of the Govt The Special Secretary/Secretary/Principal Secretary will be the appellate authority within the Department of Health & Family Welfare, Government of West Bengal. Before imposing any penalty as per clauses 21, 22and 23 the concerned supplier may appeal to the authority citing the proper reasons for non- imposing the penalty as stated. PENALTY FOR FORMATION OF CARTEL OR FURNISHING OF FRADULENT/ MISLEADING DOCUMENTS: If during the tender process or at any state during the validity of the tender period, it is found that a Tenderer(s) has formed a cartel in what so ever form or name to fix up the rates or suppliers to the detriment of the fairness of the tender process, penal measures shall be initiated. Similar penal measures shall also be initiated against those tenderers who have submitted false/ misleading/ fraudulent documents or made incorrect declarations. The penal measure will be i) Forfeiture of Earnest Money ii) Forfeiture of Performance Bank Guarantee if enlisted as a supplier iii) Cancellation from the approved list of suppliers and debarment from further supply orders iv) Black listing from all Departmental tenders (called by the CMS or others) of the Tenderer, the Principals of the firm(s) and the concerned distributor(s) for a period of three years 11 25. AGREEMENT: On a tender being accepted, intimation of acceptance will be forwarded through departmental website by the Dy. Director of Health Services (E&S) W.B. After communication of the same, the Tenderer and the selected distributor (in the event of distributor to receive order and payment in his name) will have to execute agreement in the prescribed form along with submission of requisite amount of performance Bank Guarantee with the Dy. Director of Health Services (E&S) W.B., within ten (10) days from the date of issue of invitation. In case any direct purchasing unit wishes to go for a separate agreement the head of the purchasing unit must get written permission to that effect from his controlling authority. This present document and the tender forms filled in by the Tenderer or copies thereof in so far as they are not inconsistent with these terms & Conditions will be incorporated as part of the agreement. Such agreement will be binding on the Tenderer and distributor. 26. VALIDITY PERIOD OF AGREEMENT: The contract period will be for a period up to 31st May, 2015 which may be extended up to six months with prior approval of the Department of Health & Family Welfare, Government of West Bengal, if necessary. 27. ‘PERFORMANCE BANK GUARANTEE’ i. The performance bank guarantee will be mandatory for all approved suppliers and will not be waived in any case. ii. The successful tenderers shall be required to furnish the “Performance Bank Guarantee” a. For Items under Table 1 A (List of Drug Items) @ 2% of assessed base rate of Annual requirement, subject to a minimum of Rs. 30,000 and maximum of Rs. 5,00,000 per item and for which the Tenderer has been selected as supplier. b. For Items under Table 1 B (List of Laboratory Kit, Chemicals and Reagent) @ 2% of assessed base rate of Annual requirement, subject to a minimum of Rs. 25,000 and maximum of Rs. 1,00,000 per item and for which the Tenderer has been selected as supplier. iii. If out of State manufacturer proposes that order & payment are to be made in the name of an authorized distributor, the distributor then should have to submit “Performance Bank Guarantee” a. For Items under Table 1 A (List of Drug Items) @ 1% of assessed base rate of requirement with minimum of Rs. 10,000 and maximum of Rs. 1,00,000 per item(s) for the distributors. b. For Items under Table 1 B (List of Laboratory Kit, Chemicals and Reagent) @ 1% of assessed base rate of requirement with minimum of Rs. 10,000 and maximum of Rs. 50,000 per item(s) for the distributors. iv. v. vi. The Performance Bank Guarantee from any nationalized/ scheduled bank in India acceptable to the Government of West Bengal should be submitted to the Dy. Director of Health Services (E&S), West Bengal, within 15 (fifteen) days from the date of acceptance of tender. If Agreement has not been executed along with submission of performance bank Guarantee within 15 days from the date of acceptance of tender, the candidature will be cancelled and the next Bidder will subsequently be accepted. The Performance Bank Guarantee will be liable to forfeiture as enumerated in Clauses 23 above. 12 28. INSPECTION: The competent authority may visit any factory at any day at any time in a regular basis for inspection. In case of tenderer bag L1 status for more than 3 items, physical inspection will follow to adjudge its production capability and assured supply and take decision accordingly for L1 status. 29. PAYMENT TERMS: Payment will be made through e payment system through ECS/RECS/RTGS after execution of due supply as ordered subject to : 1. Submission of Performance Bank Guarantee in terms of Clause 27 and subject to penalty clause in terms of Clauses 23 & 24. 2. Supply of the materials as per specification as provided in the tender documents and the catalogue 3. Supply of the materials within the supplied period as specified in the work orders 4. The status of orders, Goods received note and payments will be available on-line for the vendors in the vendors portal in the Departmental website www.wbhealth.gov.in : Vendor Portal. 5. On being selected, the successful vendors will have to submit one application stating the name of the payee/ recipient, Bank account no with MICR code, IFSC of the payee/recipient for making e payment. No manual payment will be made. 30. SPECIAL TERMS & CONDITIONS in respect of Kits used in ICTCs Viz. HIV (Rapid) Test Kit I, Kit II, Kit III , Whole Blood Finger-prick Test etc. i. The shelf life of the kits has to be defined as 60% of residual life or a shelf life of 12 months at the time of dispatch to the consignee, whichever is more. ii. The supplier/local agent should have the facility to store kits at 2 degree to 8 degree C iii. The supplier should supply kits for at least 600 tests free of cost from each lot for random evaluation at the identified laboratories for pre-dispatch lot verification. Protocols for each batch to be attached. iv. The kits should not be using the comb device as the feasibility study reported by NARI, Pune has difficulty in performances using the comb tests in field conditions. Minimum Requirements:1. Product and package specifications 1.1 The required packing standards and labeling must meet the requirements given in this Technical Specification and Part. 1.2 Not only the goods but also the packaging components should also meet specifications suitable for use in a climate similar to that prevailing in the country of the Purchaser. All packaging must be properly sealed and tamperedproof. 1.3 All labeling and packaging inserts shall be in the language requested by the Purchaser or English if not otherwise stated. 1.4 Goods requiring refrigeration or freezing for stability must specifically indicate storage requirements on labels and containers and be shipped in special containers to ensure stability in transit from point of shipment to port of entry. 1.5 Upon award, the successful Supplier shall, on demand, provide a translated version in the language of the bid of the prescriber’s information for any specific goods the Purchaser may request. 2. Product Information 2.1 The following information will be required for each pharmaceutical product offered by the Bidder : i) International Non-Proprietary Name (INN), if applicable; ii) Brand name (if it appears on label); iii) Name and address of the manufacturer; iv) Country of origin; and Compendia standards 13 2.2 2.3 Upon award, the supplier shall, on demand, provide a translated version in English, of the prescriber’s information for any specific product, the Purchaser may request. Failure to include any of this information, at the discretion of the Purchaser, may render the bid non-responsive 3. Expiration Date All products must indicate the dates of manufacture and expiry. In addition, unless otherwise stated in Part A of these Specifications, all products must arrive at the final consignee point with a remaining shelf life of at least fivesixths (5/6ths) of the total stipulated shelf life at the time of manufacture. 4. Recalls If products must be recalled because of problems with product quality as a result of quality check carried out during the life span of the drug or adverse reactions to the pharmaceutical, the supplier will be obligated to notify the purchaser providing full details about the reason leading to the recall and shall take steps to replace the product in question at its own cost with a fresh batch of acceptable pharmaceuticals, or withdraw and give a full refund if the product has been take off the market due to safety problems. 5. Labeling instructions 5.1 The label for each Goods shall include: (a) the Purchaser’s logo and code number and any specific color coding if required. (b) content per pack (c) instructions for use (d) special storage requirements (e) batch number (f) date of manufacture and date of expiry (in clear language, not code) (g) name and address of manufacture with license number any additional cautionary statement 5.2 The outer case or carton should also display the above information 6. Details of Packing/Cases 6.1 All cases should prominently indicate the following: (a) The generic name of the product; (b) date of manufacture and expiry (in clear language not code); (c) batch number; and quantity per case 6.2 No case should contain same item from more than one batch. 7. Unique Identifier The Purchaser shall have the right to request the Supplier to imprint a logo on the containers used for packaging and in certain dosage forms such as tablets and this will be indicated in Part A of the Technical Specifications. The design of such logo shall be provided to the supplier at the time of Contract award. 8. Qualifications of Manufacturer The bidder shall furnish a certificate from the competent FDRA that the manufacturer of the pharmaceutical r vaccine product covered by this Invitation for Bids is licensed to manufacture these products. 14 9. Standards and Quality Assurance Requirements 9.1 All products must: a. Meet the requirements of manufacturing legislation and regulation of pharmaceuticals or vaccines in the country of origin b. Conform to all the specifications contained herein; and c. Must undergo strict raw material inspection, in process checks, appropriate material handling to eliminate cross contamination (of molecules) and final product testing to ensure quality and consistency of the products. 9.2The Bidder is required to furnish to the Purchaser: (a) With each consignment, a certificate of quality assurance test results concerning quantitative assay, chemical analysis and other tests, as applicable to the product being supplied and part A of these Specification. (b) Assay methodology of any or all tests if requested. (c) Evidence of basis for expiration dating and other stability data on the offered package (as per climatic conditions prevalent in India) concerning the commercial final package upon request. (d) Package integrity test results 9.3 The Bidder will also be required to provide the purchaser with access to its manufacturing facilities to inspect its facilities, quality control procedures for raw materials, test methods, in-process tests, and finished Goods 31. Dates & Information: Sn Items 01. 02. Date of uploading of N.I.T. Documents (online) Pre BID Meeting in the chamber of the DDHS(E&S), Central Medical Stores, 141, A J C Bose Road, Kolkata 700 014 Documents Download Start Date (Online) Bid Submission Start Date Date of hoisting of documents at departmental website(www.wbhealth.gov.in) Bid Submission Closing Date (Online) Last date of submission of original copy for the cost of earnest money deposit (off line) Bid Opening Date (Online) – Technical Bid i.e., Bid A Date of uploading list for technically qualified bidder (online) Date of opening of Financial Bid i.e., Bid B Date of uploading of list of bidders along with the approved rate 03. 04. 05. 06. 07. 08. 09. 10. 11. Publishing date(s) 02.01.2015 05.01.2015 at 12.00 noon 02.01.2015 02.01.2015 02.01.2015 22.01.2015 at 5:00 p.m. 22.01.2015 at 4:00 p. m 27.01.2015 at 12:00 noon 27.01.2015 onwards 27.01.2015 onwards 27.01.2015 onwards 32. DDHS (E&S) RESERVES THE RIGHT TO CHANGE THE ABOVE SCHEDULE IN CASE OF ANY EXIGENCIES AFTER PUTTING UP A NOTICE IN THE DEPARTMENTAL WEBSITE AND CMS NOTICE BOARD. 33. If any change in Opening the financial bid / uploading of list of bidders as per schedule be decided will BE NOTIFIED LATER ON. No objections in this respect will be entertained raised by any Bidder who will present during opening of bid, or from any Bidder who will absent at the time of opening of Financial Bid. No informal tenderer will be entertained in the Bid further. 15 34. During the scrutiny, if it comes to the notice to tender inviting authority that the credential or any other paper found incorrect/ manufactured/ fabricated, that bidder would not allowed to participate in the tender and that application will be out rightly rejected without any prejudice. 35. A HELP DESK is set up in the office of the Deputy Director of Health Services (E&S), Central Medical stores, 141, A J C Bose Road, Kolkata – 700 014 to help and guide the prospective bidders about their registration, holding of Digital Signature Card and allied matter. Prospective bidders may contact personally or over phone vide phone no (033) 2265 4419 or mail their querries in the following e mail addresses : a. [email protected] b. [email protected] 36. The Tender Selection Committee reserves to right to cancel the N.I.T. due to unavoidable circumstances and no claim in this respect will be entertained. Deputy Director of Health Services (E&S) Central Medical Stores 141, A J C Bose Road, Kolkata – 700 014 16 Table - 1 (List of Items with Tentative Annual Requirement ) Sn Catalogue No. Item Name Acc. Unit Tentative annual requirement based on accounting unit A. List of items under Drugs : 1 11.13(a)/T Amikacin Inj IP 100 mg/2 ml vial 2 11.13(a)/T 3 30,000 Amikacin Inj IP 250 mg/2 ml vial Box of 10 Vials Box of 10 Vials 11.13(a)/T Amikacin Inj IP 500 mg/2 ml vial Box of 10 Vials 80,000 4 24.05/T Omeprazole Cap 20 mg Strip of 10 Capsules 5. 2.08(a)/P-1 Tramadol HCL Inj 100 mcg/2ml Amps Box of 10 Amp 40,000 6. 35.01(a)/P-1 Box of 10 Amp 7500 7. 18.09(a)/S Ergometrine Maleate Inj BP 0.2mg/ml in Amp Digoxin Tab IP 0.25mg Strip of 10 Tabs 20,000 8. 2.12(a)/P-1 Diclofenac Sodium 50mg Tab Strip of 10 Tabs 30,000 9. 2.12/P-1 Diclofenac Sod Inj IP 75mg/3ml Amp Box of 10 Amps 30,000 10 39.04(a)/S-S Vincristine Inj 1mg/ml Vial of 1 Mg. 11 22.02/T Bisacodyl Tab Strip of 10 Tabs 50,000 12 6.02(e)/S-S Cefaperazone + Sulbactum 1.5gm Inj. Vial 20,000 13 N-18.34/ Clopidogrel 75mg Tab. Strip of 10 Tab 20,000 14 11.20(a)/P-1(a) Cefadoxim Proxetil 200 mg tab Strip of 10 Tab 20000 30,000 1,50,000 8000 B. List of Laboratory Kit, Chemicals and Reagents : 1 43.04/ Absolute Alcohol I.P. Bottle of 500 ml 1500 2 43.04(b)/ Acetone free Methyl Alcohol Bot. of 500 ml 2000 3 41.02(c) Activated Gluteraldehyde Solution 2.45% for Instrument Sterilisation Cont. of 5 Litres 500 4 K/01 5 K/04 AFP ELISA KIT 96 Wells 100 Ammonia - Test Kit 1 ml 6 K/11 ANTI CCP ELISA KIT 96 Wells 100 7 K/12 Anti D Serum (IgG) 10ml Vial 1000 8 K/15 Anti DSDNA-(Elisa kit) 96 Test 1000 9 K/16 Anti H Lectin 5ml Vial 1000 10 K/17 Anti Human Globulin (Coombs) Vial of 5 ml 1000 11 K/20 Anti Nuclear Factor Rapid Test Kit Per Test 100 12 K/23 ASO Elisa Kit 96 Test 100 13 ABD-07 Aztreonam Antibiotic Disc Per 50 Disc 350 14 ABD-08 Bcitracin Antibiotic Disc Per 50 Disc 350 15 43.34/ 16 K/26 Boric Acid IP. Bot. of 500 gm Ca-125 Kit 96 Test 17 50000 1000 100 17 K/28 CD4 Reagent Kit I - 100 kit in one box for partec CD4 machine Box of 100 Kit 80 18 K/29 CD4 Reagent Kit II - 50 kit in one box for BD fax count machine Box of 50 Kit 350 19 K/30 CD4 Reagent Kit III - 50 kit in one box for BD fax caliber CD4 machine Box of 50 Kit 300 20 K/31 CEA ELISA KIT 96 Wells 100 21 ABD-13 Cefdinir Antibiotic Disc Per 50 Disc 350 22 ABD-14 Cefepime Antibiotic Disc Per 50 Disc 350 23 ABD-17 Cefoperazone/ Salbactam Antibiotic Disc Per 50 Disc 350 24 ABD-19 Cefpirome Antibiotic Disc Per 50 Disc 350 25 ABD-20 Cefpodoxime Antibiotic Disc Per 50 Disc 350 26 ABD-21 Cefprozil Antibiotic Disc Per 50 Disc 350 27 ABD-23 Ceftizoxime Antibiotic Disc Per 50 Disc 350 28 ABD-24 Ceftriaxone /Salbactum Antibiotic Disc Per 50 Disc 350 29 ABD-28 Cephalexin Antibiotic Disc Per 50 Disc 350 30 41.16(b)/ Cetrosterile Disinfectant Chemical lotion Chloramphenicol Antibiotic Disc Bottle of 500 ml 100 Per 50 Disc 350 32 K/34 33 ABD-36 Control Plasma N 1 ml Co-trimoxazole Antibiotic Disc Per 50 Disc 350 34 44.17(a)/ 35 44.17(b)/ Detergent 1000gm, IS 4955 Jar of 1kg 500 Detergent 500gm, IS 4955 Jar of 500 gm 500 36 K/42 DHEAS ELISA KIT 96 Wells 100 37 K/44 EQAS Immunossary 1 ml 38 L/16 Esbachs Reagent Bottle of 500 ml 39 K/45 Estradiol Elisa Kit 96 Wells 40 43.03(a)/ Ethanol 95% v/v (Rectified Spirit) Bottle of 100 ml 20000 41 43.03/ Ethanol 95% v/v (Rectified Spirit) Bottle of 500 ml 40000 42 K/46 Extran Test Kit Bottle of 500 ml 500 43 41.09/ 44 K/48 Formaldehyde Solution I.P. Bottle of 500 ml 1000 fPSA - Elisa 96 wells per kit 75 45 K/50 FT3- Elisa 96 wells per kit 275 46 K/51 FT4- Elisa 96 wells per kit 275 47 ABD-39 Furazolidone Antibiotic Disc Per 50 Disc 350 48 21.03/P-1 Gamma Benzene Hexachloride I.P. Bottle of 500 ml 1000 49 K/52 Gamma Glutamyl Tranpepdase kit ( IFCC Method ) Per Kit 1000 50 41.06/ Gentian Violet N.F. Bottle of 25 gms 1000 51 L/20 Glycerin I.P. Bottle of 500 gm 500 52 L/21 Glycin Irrigation Fluid 3 Lit. 100 53 L/22 Haemodialysis Fluid with Bi-Carb 10 Lit 5000 31 ABD-31 18 1000 10000 1000 100 54 L/23 Hamatoxyllin Eosin Stain Powder Per 5 gm. 55 K/59 Per Kit HbsAg (Elisa) Kit Specification: a. The kit should be third generation Elisa kit with solid phase micro plate Elisa. b. The kit should be based on „Sandwich principle of Enzyme Linked Immuno sorbent Assay‟ (Elisa) for the detection of Hepatitis B Surface Antigen (HBs Ag) in human serum or plasma. 500 6250 c. The test kit should detect all known sub-types. d. The Elisa plate should be coated with Anti-HBs Antibody ( mouse monoclone) e. The kit should have sensitivity of equal to or more than 99.8%. f. The kit should have specificity of equal to or more than 98%. g. The assay should have reactive and non-reactive control with each kit. h. Adequate literature detailing the component, methodology, validity criteria, performance characteristics, storage condition and expiry date should be provided with each kit. i. The shelf-life of the kit should have minimum of 12 (Twelve) months at the port of dispatch or the consignee‟s end, whichever is applicable. 56 K/61 57 K/62 j. The manufacturer/authorized agent should ensure maintenance of coldchain during storage and transport at 2°C – 8°C. k. The kits should have approval of the statutory authority in its country of origin. In case of imported kits, it should have been registered and licensed in India by Drugs Controller General( India). l. The package size should be 96 wells per kit HCG Elisa Test Kit HCV (Elisa) Kit Specification: 19 Per Kit 1000 Per Kit 6250 a. Microplate ELISA with recombinant / synthetic peptide antigens for core, NS3, NS4 and NS5. 58 K/66 b. Should provide sero conversion data of the kits from WHO accredited centres. c. Adequate literature detailing the components, methodologies, validity criteria, performance characteristics, storage conditions, manufacturing and expiry dates should be provided with each kit. d. Should have a sensitivity of 99.8% and above and specificity of 98% and above. e. Shelf life should be minimum of 12 (twelve) months at the port of discharge or consignee‟s end whichever is applicable. f. The kit procured should have approval of the statutory authority in its country of origin. In case of imported kits it should have been registered and licensed in India by DCG (I). g. In case of indigenous manufacturers they shall have license issued by the competent authority defined under Drugs & Cosmetics Act, 1940, after appropriate evaluation by the centres approved by DCG (I). h. The supplier / local agent should have facility of storage of kits at 2° C – 8°C. i. The Kit size should be 96 wells per kits Hepatitis A test Kit 96 Wells 500 59 K/67 Hepatitis E test Kit 96 Wells 500 60 K/68 HIV (Elisa) Kit Specification: a. Should be solid phase microplate ELISA using HIV I & II recombinant and/or synthetic peptide antigens. Per Kit b. The assay should detect HIV-I & HIV-II antibodies. c. The assay should detect antibodies to all sub-types of HIV-I. d. The assay should be able to detect antibodies of HIV-I & HIV –II during early sero-conversion period. Evidence based sero-conversion data should be from WHO accredited centers. 20 6250 e. The assay should have reactive and non-reactive controls with each kit. f. The kit should have a shelf life of minimal 12 months at the port of discharge or consignees end, whichever is applicable. g. Adequate literature detailing the components, methodologies, validity criteria, performance characteristics, storage conditions, manufacturing and expiry dates should be provided with each kit. h. The kit procured should have approval of the statutory authority in its country of origin. In case of imported kits it should have been registered and licensed in India by DCG(I). i. In case of indigenous manufacturers they shall have license issued by the competent authority defined under Drugs and Cosmetics Act, 1940, after appropriate evaluation by the centers approved by DCG(I). j. The assay should have sensitivity level at 99.8% and above and specificity level at 98% and above. k. The manufacturer/authorized agent should ensure maintenance of cold chain during storage and transport at 2° C – 8°C. l. The kit size should be 96 tests per kit. 61 K/69 HIV (Rapid) Kit Specification: a. The indigenous HIV antibody rapid test kits should have a valid license issued by the competent authority defined under Drugs & Cosmetics Act, 1940 after appropriate evaluation by centers approved by DCG(I). The imported rapid test kits should have the approval of the statutory authority in the country of Origin / manufacture and should satisfy the requirements of Drugs & Cosmetics Act in India. b. The assay should be able to detect antibodies of HIV1, HIV2 and all the subtypes by detection of antibodies by the agglutination method. 21 Per Test 250000 c. The assay should have sensitivity of 99.5%or more and specificity of 98%or more as per data from an identified national reference laboratory. d. The assay should have solid phase / particles coated with synthetic and/or recombination or both types of antigens of HIV1 & HIV2. e. Total procedure time should not be more than 30 minutes. f. The manufacturers should ensure that: i. The test kit should be packed such that there is a provision to conduct single test at a time; ii. The assay components should include HIV positive and negative serum controls sufficient for conducting 20% of the tests (10% negative and 10% positive controls); and iii. The pack size of HIV rapid test kits should not be more than 50 tests per kit. g. The HIV rapid test kit should have a shelf life of 12 months at the time of dispatch to the consignee. The kits should be sent by the shortest route in cold chain. h. The supplier should supply kits for at least 22 kits free of cost from each lot for random evaluation at the identified laboratories for Pre-dispatch lot verification. Protocols for each batch to be attached. i. The supplier / local agent should have the facility to store kits at 2° C to 8° C. j. Literature, detailing the components, methodologies, validity criteria, performance characteristics, storage conditions, manufacturing and expiry dates should be provided with each kit. 62 K/73 HIV (Rapid) Test Kit II - [BY ANY OTHER PRINCIPLE EXCLUDING AGGLUTINATION AND ENZYME IMMUNO ASSAY] Specifications:- 22 Per test 60000 1. The indigenous HIV antibody rapid test kits should have a valid license issued by the competent authority defined under Drugs & Cosmetics Act. 1940 after appropriate evaluation by the centres approved by DCG(I). The imported rapid test kits should have the approval of the statutory authority in the country of Origin/manufacture and should satisfy the requirements of Drugs and Cosmetics Act in India. 2. The assay should be able to detect antibodies of HIV-I and HIV-2 and all the subtypes by detection of antibodies by any other method excluding agglutination and enzyme immune assay. 3. The assay should have sensitivity of 99.5% or more and specificity of 98% or more as per data from an identified national reference laboratory. 4. The assay should have solid phase/particles coated with synthetic and/or recombination or both types of antigens of HIV1 & HIV2. 5. Total procedure time should not be more than 30 minutes. 6. The control dot/band should be able to detect the presence of Human Immunoglobulins and should not be just a procedural control or meant for merely checking the flow of reagents or integrity of the antigen except in lots using “Lateral flow through” technology. 7. The manufactures should ensure that a. The test kit should be packed such that there is a provision to conduct single test at a time without compromising the quality of the remaining part of the kit; b. The assay components should include HIV positive and negative serum controls sufficient for conducting 20% of the tests (10% negative & 10% positive controls); and c. The pack size of HIV rapid test kits should not be more than 50 tests per kit. 23 8. The HIV rapid test kit should have a shelf life of 12 months at the time of dispatch to the consignee. The kits should be sent by the shortest route in cold chain. 9. The supplier/local agent should have the facility to store kits at 2 degree to 8 degree C 10. The supplier should supply kits for at least 600 tests free of cost from each lot for random evaluation at the identified laboratories for pre-dispatch lot verification. Protocols for each batch to be attached. Literature detailing the components, methodologies,, validity criteria, performance characteristics, storage conditions, manufacturing and expiry dates should be provided with each kit 63 K/76 HIV (Rapid) Test Kit III - [BY ANY OTHER PRINCIPLE EXCLUDING AGGLUTINATION AND ENZYME IMMUNO ASSAY] Specifications:1. The indigenous HIV antibody rapid test kits should have a valid license issued by the competent authority defined under Drugs & Cosmetics Act. 1940 after appropriate evaluation by the centres approved by DCG(I). The imported rapid test kits should have the approval of the statutory authority in the country of Origin/manufacture and should satisfy the requirements of Drugs and Cosmetics Act in India. 2. The assay should be able to detect antibodies of HIV-I and HIV-2 and all the subtypes by detection of antibodies by any other method excluding agglutination and enzyme immune assay. 3. The assay should have sensitivity of 99.5% or more and specificity of 98% or more as per data from an identified national reference laboratory. 4. The assay should have solid phase/particles coated with synthetic and/or recombination or both types of antigens of HIV1 & HIV2. 24 Per Test 60000 5. Total procedure time should not be more than 30 minutes. 6. The control dot/band should be able to detect the presence of Human Immunoglobulins and should not be just a procedural control or meant for merely checking the flow of reagents or integrity of the antigen except in lots using “Lateral flow through” technology. 7. The manufactures should ensure that a. The test kit should be packed such that there is a provision to conduct single test at a time without compromising the quality of the remaining part of the kit; b. The assay components should include HIV positive and negative serum controls sufficient for conducting 20% of the tests (10% negative & 10% positive controls); and c. The pack size of HIV rapid test kits should not be more than 50 tests per kit. 8. The HIV rapid test kit should have a shelf life of 12 months at the time of dispatch to the consignee. The kits should be sent by the shortest route in cold chain. 9. The supplier/local agent should have the facility to store kits at 2 degree to 8 degree C 10. The supplier should supply kits for at least 600 tests free of cost from each lot for random evaluation at the identified laboratories for pre-dispatch lot verification. Protocols for each batch to be attached. Literature detailing the components, methodologies,, validity criteria, performance characteristics, storage conditions, manufacturing and expiry dates should be provided with each kit 64 44.03(a)/ Hydrogen Peroxide 11% w/v +diluted Silver Nitrate 0.01% w/v Jar of 1 litre 1000 65 44.03/ Hydrogen Peroxide Soln. (20Vol) I.P. Bottle of 500 ml 1000 66 L/33 67 ABD-43 KOH Solution 10% L 100 ml Bot 100 Levofloxacin Antibiotic Disc Per 50 Disc 350 68 ABD-44 Lincomycin Antibiotic Disc Per 50 Disc 350 69 ABD-45 Lineazolid Antibiotic Disc Per 50 Disc 350 25 71 43.21/ Magnesium Sulphate I.P. 72 K/86 Malaria Pf & Pv Combined Ag Immunochromatographic kit 73 K/88 MB/BACT Antibiotic Suppliment Kit 100 kit 100 74 41.15(a)/P-1 Merbromin (liquid) Bottle of 50 ml 500 75 ABD-47 Meropenem Antibiotic Disc Per 50 Disc 350 76 ABD-48 Minocyclin Antibiotic Disc Per 50 Disc 350 77 ABD-49 Moxifloxacin Antibiotic Disc Per 50 Disc 350 78 41.17(a)/P-1(a) O.T.sterilization solution for fumigation/mopping, in powder form, Composition :-Potassium Mono per Sulphate (Triple Salt )- 40% to 50 %, Sodium C 10-13 Alkyl benzene Sulphate 10% to 20% and Sodium Chloride - 1% to 5%. Bottle of 500 gm 79 ABD-54 Ofloxacin Antibiotic Disc Per 50 Disc 80 K/91 81 ABD-57 pH paper range 1 to 14 50 strip Pipercillin-Tazobactam Antibiotic Disc Per 50 Disc 350 82 L/32 83 41.15(e)/P-1 Poly Sodium Citrate Bot. of 500gm. 500 Potassium Permanganate I.P. Bot. of 100 gm 1000 84 K/93 85 43.01/ Progesterone Elisa Kit 96 Wells Puriffied Water I.P. Jar of 5 litre 86 L/35 87 L/36 PYR Reagent Bot. of 100 ml 100 PYR strip per 100 strip 100 88 K/95 Rapid diagnostic kit for Kala-azar pouch pack 50 89 ABD-59 Roxithromycin Antibiotic Disc Per 50 Disc 350 90 L/38 91 L/40 SDA with CC Bot. of 500 gm 100 Sodalime Per Kg 92 L/42 Sodium Para Amino Salicylate (NaPAS) 80% Bio-Availability Jar of 100 Gms. 500 93 41.17(b)/ Solution for instrumental sterilization in powder form, Composition : Sodium Perborate Monohydrate 50% w/w (0.26% per acetic acid) Teicoplanin Antibiotic Disc Bottle of 810 gm 1000 Per 50 Disc 350 95 K/103 96 L/44 Testesterone Elisa Kit 96 Wells 100 Toludine Blue Bot. of 25 gm 500 97 K/105 98 ABD-66 Total PSA Elisa Kit Trimethoprim Antibiotic Disc 96 Wells Per 50 Disc 100 350 99 K/111 VDRL Kit - latex kit 100 Test Per Kit 10 K/112 0 10 K/113 1 Vitamin D Elisa Kit 96 Wells 100 Whole Blood Finger-prick Test Technical Specifications Per Test 660000 94 ABD-62 26 Packet of 500 gm. Per Test 500 750000 5000 350 10000 500 28000 1000 1000 1. The indigenous HIV antibody rapid test kits should have a valid license issued by the competent authority defined under Drugs & Cosmetics Act. 1940 after appropriate evaluation by the centres approved by DCG(I). The imported rapid test kits should have the approval of the statutory authority in the country of Origin/manufacture and should satisfy the requirements of Drugs and cosmetics act in India. The imported kits should also get evaluated in our country. 2. The assay should be able to detect antibodies of HIV-I and HIV-2 and all the subtypes by detection of antibodies by the agglutination, Enzyme Immune Assay or any other principal. 3. The assay should have sensitivity of 99.5% or more and specificity of 98% or more as per data from an identified national reference laboratory. 4. The assay should have solid phase/particles coated with synthetic and/or recombination or both types of antigens of HIV1 & HIV2. 5. Total procedure time should not be more than 30 minutes. 6. The manufactures should ensure that a. The test kit should be packed such that there is a provision to conduct single test at a time. b. The assay components should include HIV positive and negative serum controls sufficient for conducting 20% of the tests (10% negative & 10% positive controls); and c. The pack size of HIV rapid test kits should not be more than 50 tests per kit. 10 2 L/09 Bovine Albumin I.P. (10 ml Vial) 27 10ml Vial 1000 FORMAT FOR CHECK LIST in respect of “E- TENDER FOR FEW DRUGS, LABORATORY KIT, CHEMICALS & REAGENTS FOR THE YEAR 2014-15” NIT No. ………………........ Date ………… Name of the Tenderer: - ___________________________________________ Full Address of the Tenderer: _______________________________________ __________________________________________________________________________________ ______________________________________________ E-Mail : - ________________________________________________________ Contact person relating to vendor & Mob. No. :- _________________________ Tendering as: Manufacturer / Importer (Strike out which is ot applicable) Status of Manufacture: State based S.S.I., State based P.S.U.,State based Others, Others Outside W.B.) (Strike out which is ot applicable) Average Annual Turn Over: Rs……………………………… Name of the proposed Distributor : with Address & Contact No. (For Outside Vendors only) Pl mark Sn Items 1 2 Application submitted in Annexure I Annexure II ( Authorization letter of signatory from the Company) Annexure III ( Certification from Chartered Firm about the monthly production capacity and % of sale in the open market) Annexure IV ( Copy of agreement between the manufacturer and the Distributor as prescribed) Annexure V (75% GRN Report). Annexure VI (Draft Affidavit Proforma for Non conviction) Copy of Demand Draft of Rs 50,000/- in favour of Deputy Director (Accounts), Central Medical Stores, Kolkata as Earnest Money Current registration as SSI as applicable Copy of PAN Card of the authorised signatory : Last 3 financial years’ returns of Income Tax i.e. for 2010-11, 2011-12& 2012-13 Last quarters of last 3 financial years’ returns of VAT for 2010-11, 2011-12& 2012-13 Last quarters of last 3 financial years’ returns of CST for 3 4 5 6 7 8 9 10 11 12 28 Yes Yes No No Yes No Yes No Yes Yes No No Yes No Yes Yes Yes No No No Yes No Yes No Page no.& folder name Remarks ( for office use only) 13 14 15 16 17 18 19 20 22 23 2010-11, 2011-12& 2012-13 ESIC & EPF Registration Certificates Service Tax, Professional Tax Regn. Certificate Trade Licence/ Enlistment Certificate Up-to-date Drug manufacturing Licence/Import Licence & validity documents. Up-to-date Drug endorsement copy/ Product Enorsement Copy for each item quoted (marked with CMS Cat. No.) Certificate of market standing of the products to be quoted from the State Drug Control authority for the last three years i.e., 2010-11 , 2011 -12 & 2012-13 for drug items. Current GMP certification with Revised Schedule M compliance certificate Current GLP certificate Current No-conviction certificate from the Director, Drug control of the concerned state Affidavit of non conviction affirmed before a First Class Judicial Magistrate/Executive Magistrate or Notary public (affidavit sworn after 01.12.2013), in Annexure-VI Yes Yes Yes Yes No No No No Yes No Yes No Yes No Yes Yes No No Yes No Date: Signature of the Participating Bidder with Designation & Office seal 29 Annexure I APPLICATION FORMAT ( To be furnished in the Company’s official letter pad with full address and contact no etc) To The Deputy Director of Health Services (E&S), Central Medical Stores, 141, Acharya Jagadish Chandra Bose Road, Kolkata – 700 014 Sub: Ref: - NIT for E-Tender for Chemicals & Reagents for the Government health facilities of West Bengal for the year 2014-15 DDHS(E&S) N.I.T. No ………… ………………………………………………..dated …………………….. Sir, Having examined the pre-qualification & other documents published in the N.I.T, I /we hereby submit all the necessary information and relevant documents for evaluation : 1. That the application is made by me / us on behalf of………………………………………………………… In the capacity……………………………………………..…duly authorized to submit the offer. The authorization letter from the Company is attached in Annexure II. 2. We accept the terms and conditions as laid down in the NIT mentioned above and declare that we shall abide by it for throughout the tender period. 3. We are offering rate for the following item /items with manufacturing capacity* and assured supply to the Health & Family Welfare Department, Government of West Bengal: Sn Catalogue No Drug name Endorsed in Manufacturing Yearly assured Mfg. License capacity per month supply to the H&FW No. / Imp. Dept, GoWB in the License No. event of being selected * To be certified by a Chartered Firm in Annexure III 4. We declare that we have achieved / have not achieved (strike out whichever is not applicable) minimum 10% of sale of the production in the open market other than Health & Family Welfare Dept, Government of West Bengal. The certification from Chartered Firm is attached as per Annexure III. 5. We declare that we have not been convicted under any provision of Drug and Cosmetics Act, 1940 and any other law in force from any competent authority or by any Court of law. 6. a. We propose that the order and bill should be raised in our name. We have appointed M/S ……………………………………………………………………………….. having its office at ………………………………………………………………………………. (address, contact no and e mail address) as C&F /CS Agent (strike out whichever is not applicable), Contact Person & No. being ………., as per clause 9 of the NIT( This clause is applicable for out of state manufacturers) OR b. We propose that order and bill should be raised in favour of our authorized distributor. For that purpose, we have appointed M/S …………………………………………… having its office at ……………………………………………………….. (address with contact no and e mail address) as authorized Distributor who will receive order and payment in his name on our behalf. 30 c. The agreement between ourselves and the distributor/C&F& CS Agent other documents as prescribed is attached in annexure IV( This clause is applicable for out of state manufacturers). 7. In the event of being selected, the Distributor Summary as asked for will be provided by us before execution of agreement with the DDHS (E&S) ** (** This clause is valid for outside state manufacturer only. Local SSI/Firms/PSU/CPSU are not allowed to engage Distributor. ) 8. We are the existing vendors in the CMS / We are not the existing vendor in the CMS (strike out whichever is not applicable). 9. Being an existing CMS approved drug vendor for the year 2013-14, necessary declaration of items wise Good Received Note (GRN) over ordered value through Store Management Information system (SMIS) is given in Annexure V (applicable for existing vendors only, others should strike out the clause) In the event of being selected, I will make the supply within the stipulated period excepting the condition which is beyond our control. 10. 11. We understand that: (a) Tender Selection Committee/ H&FW Dept can amend the scope & value of the contract bid under this project. (b) Tender Selection Committee/ H&FW Dept reserves the right to reject any application without assigning any reason. Date :Signature of applicant including title and capacity in which application is made. Contact no : Tele : Mobile : E Mail id. 31 Annexure II Authorization letter in favour of the applicant (other than Managing Director/ Proprietor) – from the competent authority. FORMAT ( To be furnished in the Company’s official letter pad with full address and contact no, E mail address etc) (TO WHOM IT MAY CONCERN) This is to certify that Mr. ........................................................................................(Name), employee of this Organisation as ............................................................ (Official Designation) is hereby authorised to submit tender online , Vide NIT No.............................................................., Dated......................... on behalf of the Organisation. Signature of the competent authority with Seal ..................................................... (Signature of the Authorised Person) Signature of Mr................................................... ..............................................is hereby attested. Signature of the competent authority with Seal 32 Annexure III (Certificate from Chartered Firm) This is to certify that having been examined the audited balance sheet/P/L accounts and other records that M/S …………………………………………………………………………………….……………. having its office at …………………………………………………………. do have a monthly production capacity of the materials as given hereunder : Sn Name of the drug for which applied for Monthly production capacity It is certified that M/S …………………………………………………………………. have achieved average minimum 10% sale of the production in the open market other than Health & Family Welfare Dept, Government of West Bengal for the drug or drugs for the year 2010-11, 2011-12 & 2012-13. It is also certified that Annual Turnover of the firm for the Financial years 2010-11, 2011-12 & 201213 are Rs...............Cr., Rs..............Cr. & Rs...............Cr. respectively (as per P & L Balance sheet of the firm, submitted) Please note that Hard copies of the Annual Balance sheet and P/L account the year 2012-13, 201112 & 2010-11 will have to be submitted for verification after being L1. Signature of the Chartered Firm with Registration No Countersigned Authorised signatory (tenderer) 33 Annexure IV All out of the state manufacturers/ tenderers must have a distributor in this state. Copy of agreement signed between the tenderer and the Distributor/C&F/Liaisoner as proof be submitted here. (Before execution of agreement between tenderer and tendering authority). 34 Annexure V Declaration from existing CMS approved drug vendors about supply of 75% of the ordered value in Quantity as on 30.11.2014 made through STORE MANAGEMENT INFORMATION SYSTEM as on the date of submission of tender Sn Catalogue No Name of the Ordered value as drug per vendor portal (including close order) as stood on 30th November, 2014 GRN made as per portal as stood on …………(date of submission of bid) % of GRN over order value as on submission of tender 1 2 3 etc Signature of the authorized signatory 35 ANNEXURE VI Draft Affidavit Proforma I, Sri/Smt. ……………………………………………………………………… The Managing Director/Proprietor (etc.) of the Firm. ,……………………………………………………………… (Name of the firm) At (address)…………………………………………………………………….… P.O… ………………………………………………… P.S………………………………Dist…………………………………………… do hereby solemnly affirm and declare as follows: That I have not ever been convicted of any offence making myself or my Company liable to be disqualified to supply of Drugs, Laboratory Kits, Chemicals, & Reagents etc. to any Govt. or Govt. undertaking Organization /Institution in the State of West Bengal or other State or States. That no case is pending against me or against my firm in any criminal court of law to supply of drugs, Chemicals, Lab. Chemicals & Reagents to the Govt. or Govt. undertaking Organization / Institution in the State of West Bengal other State or States. ( If any case is pending, state the details ). That, I also declare that if any information subsequently found incorrect or false will it automatically render the tender submitted by me cancelled and make me/my company liable for penal/legal action as per law of the country. That I do further affirm that the statements made by me in this tender are true to the best of my knowledge and belief and all the documents attached are genuine. Deponent(s). 36 IMPORTANT INFORMATION ABOUT ONLINE TENDERING 1. SEARCHING THE TENDER After Login on wbtenders.gov.in with DSC Click on Search Active Tenders In keyword write WBHF or Tender memo. no. as reference no. on NIC website. 2. DOWNLOADING THE TENDER DOCUMENTS After searching the particular tender you will find NIT & BOQ click on those to download and save the documents. Then fill the login Id and password which is written on top or your own login id and password; the same page will appear again click on NIT & BOQ to download. While downloading the BOQ please do not change the name of the BOQ. 3. REGARDING MY DOCUMENTS First upload all the My Documents before starting the Bid Submission process. While starting the Bid submission process after the EMD payment you will find an option Do you want to submit other Important documents. Here click on YES to submit the MY DOCUMENTS and then tick mark the check boxes to tag those documents in that particular tender. 4. This process will be carried out in each and every GROUP that you are participating. BOQ While first opening the BOQ there is an option at top of the rows. “Security warning Macros have been disabled” Click on options Select “Enable the content” then OK. This will provide you the Total in Words 37
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