ODISHA STATE MEDICAL CORPORATION LTD. (A Govt. of Odisha Undertaking) (Assuring Quality, Saving lives)

Transcription

1 Letter No /OSMC/I-12/2019/D&S (Division) DT CORRIGENDUM Re-Tender Document For Supply of Drugs & Medical Consumables, Anti-Cancer Drugs And Glucose For The Financial Year Bid Ref. No.: OSMCL/ /DRUGS-DHS-RE-TENDER/07 Sl. No Item Name/ Particulars Details as mentioned in the tender document Queries raised by the prospective bidders Clarifications/ Amendments in response to the queries. Bid Ref. No.: OSMCL/ /DRUGS-DHS-RE-TENDER/07 Queries relating to General Terms and Conditions 1 Section-V Clause No. 3.2 Notice Inviting Tender (NIT) Page no.- 3 and 10 Notice Inviting Tender (NIT) And Important Dates Modification of Important Dates 1. End Date & Time for online bid submission: ,6.00P.M 2. Start Date & Time for submission of original EMD and Hard Copy of Technical Bid: End Date & Time for submission of original EMD and Hard Copy of Technical Bid: , up-to A.M. 4. Date and Time for online Technical Bid Opening: , At A.M. 5. Last Date & time for submission of Sample as Per Section-: , up-to P.M. 2 Clause No (EMD) 34 & 24. D Glucose for Screening of GDM, 75 gm per Pouch / Packet. Modification of EMD Amount The EMD Amount is now amended to Rs. 12,68,000/- instead of Rs. 4,000/-. The item is coming under Bulk Drugs as per Clause No

2 3 Section 37, D Factor VII 16 4 Section Queries relating to Technical Specification Request for inclusion of Feiba-Anti-Inhibitor coagulation complex(human plasma protein with a Factor VIII Inhibitor bypassing activity of 500 U per vial) for inhibitor management in person with Hemophilia) as this completes the portfolio for inhibitor management D Factor VII 1mg Powder/Vial Each unit packet shall contain the following: i) 1Vial / 1 mg ii) 1 Vial Sterilized required diluents iii) 1 Transfer / Filter Set iv) 1 Disposable Syringe : 5 ml v) 1 Disposable Needle vi) 1 Winged Infusion Set / Twin Set vii) Alcohol Swab (Each test should contain all the materials required for performing the test including individually packed sterile lancets for pricking, alcohol swabs, heparinized capillary tubes (diameter-1mm) with relevant markings and reaction tubes with stand/ wells as required) Each test should contain all the materials required for performing the test including individually packed sterile lancets for pricking, alcohol swabs, heparinized capillary tubes (diameter-1mm) with relevant markings/ Blood collection Loop and reaction tube with stand/ wells as required (Optional) 5 Section 6 Section The required packing standards and labeling should meet the Good Manufacturing Practice (GMP) standard. The manufacturer should have International Organization for Standardization [ISO] certification. One should be able to perform the test with the blood taken by finger prick of the patient. In addition, to claim the The required packing standards and labeling should meet the Good Manufacturing Practice (GMP) standard/ QMS Certificate. The manufacturer should have International Organization for Standardization [ISO] certification. One should be able to perform the test with the blood taken by finger prick of the patient In addition, to claim the RDT Performance Criteria, the bidder must submit The required packing standards and label should meet the Good Manufacturing Practice (GMP) standard / Quality Management System (QMS) Certificate. The manufacturer should have International Organization for Standardization [ISO] certification. One should be able to perform the test with the blood taken by finger prick of the patient. In addition, to claim the RDT 2

3 7 Section, & Section RDT Performance Criteria, the bidder must submit relevant Documents regarding RDT performance criteria from WHO list of Pre-qualified Quality Control Laboratories. Each lot of RDT should be tested at a designated lot testing laboratory by using WHO protocol at the time of delivery. Only those lots with PASS report will be accepted for delivery relevant Documents regarding RDT performance criteria from WHO list of Pre-qualified Quality Control Laboratories or NIMR Laboratory Bidders with GMP certificate may be allowed to participate for the said item in the tender. Each lot of RDT should be tested at a designated lot testing laboratory by using WHO protocol / NABL laboratory at the time of delivery. Only those lots with PASS report will be accepted for delivery. Performance Criteria, the bidder must submit relevant Documents regarding RDT performance criteria from WHO list of Pre-qualified Quality Control Laboratories or National Institute of Malaria Research, New Delhi, India (NIMR) Laboratory. Clarification. As per pre-qualification criteria Cl. No of Section : In case of manufacturer, it shall have valid GMP certificate as per Revised Schedule M of Drugs & Cosmetics Rule 1945 / COPP (Certificate Pharmaceutical Products) / valid WHO GMP certificate issued by the concerned licensing authority. In case of bidders having license under Medical Devices Rules, 2017, no GMP certificate is required. However, the bidder have to submit Quality Management System (QMS) Certificate. 9 Section For the detection of Plasmodium vivax (Pv) in For the detection of Plasmodium species analytical sensitivity or minimum detection limit should be at least 3

4 10 Section 13, D009- Inj. Anti Rabies Vaccine for Human Use with diluents Section 92, D all transmission settings the panel detection score (PDS) against Pv samples should be at least 75% at 200 parasites/μl D009- Inj. Anti Rabies Vaccine for Human Use with diluents. Inj. Anti Rabies Vaccine IP for Human use (TCV) for ID Use. > 2.5 IU/vial (TCV of PVRV / PCEC) with 1ml diluents for ID Use. Packing: To be supplied with five (5) Nos. of 1ml Insulin Syringe (40units) with prefixed 26G Intradermal needles per one vial along with one (1) number of 2ml reconstitution syringe with 24G needle (recent IS specification) D Tab. Rifampicin 150 mg/ Dispersible Tab. 50parasites/µl. Additional Points to be added:- Dual colour technology based on black colour band control band and Black colour test band. Request to keep separate the 1ml insulin needles syringe (40 units) with prefixed 26G intra-dermal needle from price bid evaluation as it is not a part of product license. Along with dispersible tablet the items may also be accepted with capsule form. Again, the packing size mentioned in the tender for the said items may be changed as per available retail market. D Tab. Rifampicin 150 mg / Dispersible Tab. / Capsule. Clarification. Pack size mention at Colum No.5 of Section is Preferable Pack Size. Hence, the item can be supplied with appropriate packing size manufactured by a bidder. 4

5 12 Section 26, D D Cefadroxil Drop 100mg/ml 10ml/Bottle 20 Bottle /Box The Specification of the item may be changed to: Each 5 ml contains: Cefadroxil USP equivalent to anhydrous cefadroxil 125 mg (Dry Syp.) Or Each 5 ml contains: Cefadroxil monohydrate equivalent to 250 mg of cefadroxil. Again, the packing size mentioned in the tender for the said items may be changed 30 ml instead of 10 ml. 13 Section 29, D09166 D09166-Cefpodoxime Drop 25mg/ml 10 ml/bottle 20 Bottle /Box The Specification of the item may be changed to: Each 5 ml suspension contains: Cefpodoxime proxetil 15 equivalent to Cefpodoxime 50 mg. Again, the packing size mentioned in the tender for the said items may be changed 30 ml instead of 10 ml. 14 Section 66, D D Respules Salbutamol + Ipratropium The Specification of the item may be changed to: Each 2. 5 ml contains: Levosalbutamol sulphate IP equivalent Levosalbutamol 0.63mg in Isotonic saline solution Q.S. + Each 2. 5 ml contains: 5

6 General Clarification: The bidders have to quote the prices as per the format mentioned in Price BOQ in the e tender portal. The prices (Rates) are to be quoted per tab/ caps/ bottle/ amp./ vial/ PFS/ tube/ / cylinder/ jar/film/piece/lit./ kg./gm/test etc.( as the case may be) and not in unit pack, the quoted price includes packing, forwarding / transportation & Door Delivery and excludes GST. The amendments mentioned above are to be treated as amendments in the technical specification(s) and term(s) and condition(s) of the above tender references. All other technical specifications and terms conditions remain unchanged. SD/- Managing Director OSMC Ltd., Odisha 6