WBHF/CMS/HST/1QC-36-2018 /NABL/2018-20/061/ GROUP-IV

Carboprost Tromethamine Inj.U.S.P. 125 mcg./ml.

Cardioplegia concentrate (Magnesium chloride hexahydrate 163 mg + Potassium chloride 60 mg + Procaine hydrochloride 14 mg / ml) - in 20 ml vial

Cefepime 1g + Tazobactum 125 mg Inj/vial

Cyclosporine inj 50 mg /Vial

Cytosine Arabinoside Inj. (Powder) 1g./ Vial

Cytosine Arabinoside Inj.I.P. (powder) 100mg/ Vial

Dacarbazine Inj.B.P. (powder) 100mg./ Vial

Dacarbazine Inj.B.P. (powder) 500mg./ Vial

Desferrioxamine Inj. 500mg/Vial

Diltiazem HCl Inj 5mg/ml in 5 ml vial

Dorzolamide Hydrochloride 2.0% Eye Drop in 5ml

Erythropoietin Inj. IP 2000 IU

Flupenthixol Inj. 20 mg/ml in 1 ml amp

Fluticasone Nasal Spray IP 50 mcg

Fondaparinux Sodium Inj. 2.5 mg

Fulvestrant Inj 250mg/Vial

Hepatitis B Vaccine Inj. IP 20 mcg

Hydrocortisone Acetate 10% w/w ENEMA

Hylan Polymer GF-20 Inj. 8mg/ml in 6 ml vial /PFS

Insulin Lispro Mix 25/75 Pen

Insulin Lispro Pen 100 IU./ml (Preloaded Syringe)

Isoflurane Inhalation 100 ml Bottle with complementary installation of vaporizer.

K binder 15 gm/sachet

Levosalbutamol 0.63 mg Solution for Nebulization in 2.5ml Amp.

Lidocaine and prilocaine Surface Anaesthetic Cream. Eutectic Mixture of Lidocane 2.5% w/w and Prilocaine 2.5% w/w

Lignocaine spray 10% w/v

Lignocaine Viscous 2% 100ml

Lorazepam Inj. B.P. 2 mg/ ml -2 ml Amp.

Mesalamine ENEMA 4 gm/60ml/Enema

Methotrexate Inj 15 mg /ml (Preservative Free) / Vial

Methyl cobalamin Inj 500 mcg / ml in 2 ml Amp

Mitomycin C Inj. 10mg /Vial

Mometasone IP 0.1% ointment

Nepafenac Eye Drop 0.1%w/v

Octreotide Inj. 50 mcg in Vial /Amp.

Palonosetron Inj 0.25mg/ Vial

Plasma Electrolyte Solution Type I USP

Polymixin B sulfate Inj. 5,00,000 units/vial

Porcine Surfactant Inj. 80mg/ml

Povidone Iodine Solution I.P 2 % w/v

Retinoic Acid 0.025% Cream

Rocuronium Bromide Inj. 10 mg/ ml Vial of 5ml

Sodium Chloride Inj. IP 0.9% w/v 100 ML FFS

Sodium Fusidate Cream 2%

Sodium Hyaluronate 1.4mg/ml Inj. for Ocular use in 1ml PFS

Tacrolimus 0.1% Ointment

Teicoplanin Inj. 200 mg /Vial

Terbinafine 1% Cream

Terlipressin Inj. 1 mg/10 ml Vial/Amp

Thiamine 100 mg. Inj. Per 2ml Ampule

Tocilizumab Inj. 200 mg/Vial

Tocilizumab Inj. 80 mg/Vial

Vasopressin Inj 2 mg/Amp

Vecuronium Bromide Inj. 10 mg / Vial

Vinblastine Inj. I.P. (Powder) 1 mg/ml - 10 ml Vial

Vincristine Inj.I.P. 1 mg./1 ml Vial.

Amino Acid Injection I.P (not less than 10 %)

BCG Vaccine 40 mg/ml (Lyophilized)

Human Albumin Inj. 20% in 100ml Bottle

Pneumococal Polysaccharide Vaccine IP 23 Valent

Dasatinib 50mg Tab

Eltrombopag Tab 50mg

Erlotinib Tab 150 mg

Alteplase (Tissue Plasminogen Activator) 20mg Injection/Vial

Amphotericin B (liposomal) Inj 50 mg/vial

Azacitidine Inj 100 mg /Vial

Bortezomib 2mg Inj. (Powder for reconstitution)

Buprenorphine 20mcg Transdermal Patch

Carboplatin Inj. 450 mg.

Caspofungin Acetate Inj. 50 mg/Vial

Decitabine Inj 30 mg/vial

Docetaxel Inj IP 120 mg

Doripenem Inj 500 mg

Epirubicin Inj. 50 mg Vial

Gemcitabine Inj. 200 mg./Vial

Gemcitabine Inj. 1gm / Vial

L-Asparginase Inj. 10000 IU

Leuprolide depot Inj. 22.5 mg/vial

Oxaliplatin Inj. 100 mg./ Vial

Oxaliplatin Inj. 50 mg./ Vial

Rasburicase Inj 1.5mg/Vial

Rituximab 500 mg. Inj./Vial

Trastuzumab 440 mg Inj.

Zoledronic Acid Inj. IP 4 mg

Anti - Thymocyte Globulin 250 mg Inj.

Anti D Gamma Globulin (Polyclonal)Inj. 100 mcg in Vial / Pre-filled Syringe I.P.

Anti-Gas Gangrene Serum Inj IP 30000 IU

Filgrastim (GCSF) Inj. 300 mcg

Human Normal Immunoglobulin inj. 500 mg/ml in 10 ml amp

Pegylated Filgrastim (Pegylated recombinant human G-CSF)Inj 6 mg (pre-filled syringe)

PEGYLATED INTERFERON ALFA-2BCHRONIC HEPATITIS C 50 MCG

Recombinant Anti Hemophilic Factor IX 250 IU./ Vial

Recombinant Anti Hemophilic Factor VIII 1000 IU./Vial

Recombinant Anti Hemophilic Factor VIII 250 IU./ Vial

Absolute Alcohol I.P.

Acetone

Acetone free Methyl Alcohol

Activated Gluteraldehyde Solution 2.45%

AHG (Coombs) Test Card - Gel System

Albumin - Test Kit

Alkaline Phosphatase - Test Kit

Amikacin Antibiotic Disc

Ammonia - Test Kit

Ammonium Oxalate

AMMONIUM SULPHATE POWDER

Amoxicillin - Clavulanic Acid Antibiotic Disc

Amoxicillin Antibiotic Disc

Ampicillin Antibiotic Disc

Ampicillin/Salbactam Antibiotic Disc

Amylase - Test kit

Anti "AB" Serum (IgM monocolonal) (Minimum title at user end to conform to the WHO International Standard for Minimum Potency of blood grouping reagents.

Anti A Serum (IgM)

Anti A1 Lectin

Anti B Serum (IgM)

ANTI CCP ELISA KIT

Anti D Serum (IgG)

Anti D Serum (IgM)

Anti D Serum (IgM+IgG)

Anti DSDNA-(Elisa kit)

Anti H Lectin

Anti Nuclear Factor Rapid Test Kit

ANTI TPO ELISA KIT

Antiseptic Lotion 15% Cetrimide w/v + Chlorhexidine Gluconate Soln. I.P. 7.5% v/v (Container of 5 litres)

APTT Kit (Action FSL)

ASO LATEX AGGLUTINATION KIT

Azithromycin Antibiotic Disc

Aztreonam Antibiotic Disc

Bacillocid Solution 2%

Bacitracin Antibiotic Disc

Barium Chloride Powder

Barium Sulphate Powder(175gm)

Basic Fuchsin

Benedict Solution

Bile Esculin Disc

Bile salt

BIVALENT ANTIGEN-DETECTING RAPID DIAGNOSTIC TESTS (RDTs) FOR P. FALCIPARUM AND P. VIVAX MALARIA UNDR NVBDCP TECHNICAL SPECIFICATIONS: - A. Description of the Test Kit: The Bivalent Rapid Diagnostic Test (RDT) for Malaria should comprise of test card (cassette) and reagents including buffer solution in a dropping bottle. The test kit should be able to rapidly diagnose both P. Falciparum and P. Vivax. The test should be based on the principle of capture of parasite antigen from blood using monoclonal antibodies specific for antigen targets. Each test kit should contain all the materials required for performing the test including individually packed sterile lancets for pricking, heparinised capillary tubes (diameter-1mm) with relevant markings and reaction tubes with stand /wells as required. The manufacturer should have specified International Organisation for Standardization (ISO) certification. One should be able to perform the test with the blood taken by finger prick of the patient. Temperature stability data: information on thermal stability data for the lab product should be available. TYPE OF RDT- The RDT should be able to detect P. Falcciparaum Histidine –Rich Protein – 2 (HRP2) and P. Vivax Lactate Dehyydrogenase (pLDH) and not aldolase. RDT Performance Criteria :- The products should conform to the following set of criteria (A-D), based on the results of the evaluation of the WHO Malaria RDT Product Testing. A. For the detection of Plasmodium falciparum (Pf) in all transmission settings the panel detection score (PDS) against Pf samples should be at least 75% at 200 parasites/uL. B. For the detection of Plasmodium Vivax (Pv) in all transmission settings the panel detection score (PDS) against Pv samples should be at least 75% at 200 parasites /uL. C. The false positive rate should be less than 10% . D. The invalid rate should be less than 5%. Each lot of RDT should be tested at a designed lot testing laboratory by using WHO protocol at the time of delivery. Only those lots with PASS report will be accepted for delivery. Content of Kit and Packaging: Each kit should be hermetically sealed in non-permeable pouch and should have moisture absorbent material. 10 such test cards (cassette), or lesser quantity as required by the programme should be packed in a box containing the reagents and the test plates. Adequate literature detailing the test kit components, principle , methodologies and validity criteria as specified under ‘RDT performance criteria’ should be provided in the kit inserts with the test kits. Storage conditions, expiry dates and limitations of test should be provided. The small box should be packed in bigger cardboard carton containing 5 such small boxes. The carton should be sealed with a sealing tape. C. Shelf Life : Shelf life from manufacturing date to expiry date should be at least 2 years and the RDTs should not have lost more than 1/6th of their effective life from the date at the time the material is offered for inspection .Losses due to premature deterioration as a result of biological and other activities during the life of potency of the Rapid Diagnostic Tests will be made good by the firm at its own cost. D. Stability requirements at temperatures of intended storage, transport and use : RDTs should have high thermal stability for use in areas with very high ambient temperatures as per the evaluation by WHO Malaria RDT Product Testing against a single cultured P. falciparum isolate at 200 parasites /uL at based line and after 60 days of incubation at room temperature, 350 C and 450 C. E. Quality Assurance :- The product should comply with ISO 13485. F. Marking /Labelling: i. Each card (cassette) should have space for recording particulars of patients, time and date of the test. ii. The large carton (containing 10 small boxes) and small box (containing 10 tests) should have the following markings: a. Name of the Test b. Lot number c. Manufacturing and expiry date d. Name of the manufacturer with address e. Details of the contents f. Storage conditions. g. Handling procedures h. Disposal instruction for the box and its contents i. GOI,NVBDCP Supply –NOT FOR SALE G. Details regarding approval of license: i. Manufacturing and Marketing License for manufacturing of Rapid Malaria Diagnostic Tests should have been obtained from the concerned Regulatory authority in the country by the manufacturer. ii. The Bidders must submit scientific study report in support of their claim of performance criteria of the offered product, i.e. WHO FIND report mentioning the Panel detection score, false positivity rate, invalid rate, ease of use ,thermal stability data etc. Claim should be supported by reports of actual shelf life studies. iii. Reports of proven performance of the offered product in conditions similar to Indian field conditions (room temperature up to 400 C) with certification of no adverse report for the offered product from the end users during the last five years must be submitted with the bid. iv. The Bidders must submit a sample of their product (for example as two kits to procurement Agent for assessment of user friendliness by the Procurement Agent. v. Recommended conditions for storage (e.g. room temperature) and shelf life should clearly be mentioned on the label of RDT. H. Shipping from manufacturer : Before shipping : The manufacturer should provide to the consignees the details of airway bill numbers, airline carrier, flight number, numbers of containers, expected arrival tiem . These details should be sent by email and flowed up by fax. The shipper (air carrier) should be notified of temperature storage requirements by the manufacturer in writing and by clear markings on cartons and related documents.(Stowage of the shipment close to the skin of some aircraft may result in freezing.) The manufacturer should initiate shipment only when the consignee has confirmed the receipt of shipping notification. Manufacturer should ensure/arrange to have customs agents or other personnel on site to receive materials. Shipments should be moved immediately to moderate temperature storage places (less than 300 C ) .Leaving materials on airport tarmacs, in customs sheds , or in vehicles should be avoided. I. Ground Transportation : Ground transportation should be carried out during any stage of delivery without delay, maintaining temperature requirements while the vehicle is moving and is parked. Avoid leaving RDTs in vehicles parked in the sun.

Bleaching Powder - IS 1065 /1989 [Containing not less than 30% w/w of available chlorine & Stability (max.) = 1 / 15 ]

Boric Acid IP.

Bovine Albumin I.P. (10 ml Vial)

Brain Heart Infusion Agar

Brain Heart Infusion Broth

Calcium Reagent Test Kit

Canada Balsam

CEA ELISA KIT

Cedarwood Oil 25 gms.

Cedarwood Oil 30 ml

Cefaclor Antibiotic Disc

Cefadroxyl Antibiotic Disc

Cefazolin Antibiotic Disc

Cefdinir Antibiotic Disc

Cefepime Antibiotic Disc

Cefixime Antibiotic Disc

Cefoperazone Antibiotic Disc

Cefoperazone/ Salbactam Antibiotic Disc

Cefotaxime Antibiotic Disc

Cefpirome Antibiotic Disc

Cefpodoxime Antibiotic Disc

Cefprozil Antibiotic Disc

Ceftazidime Antibiotic Disc

Ceftizoxime Antibiotic Disc

Ceftriaxone /Salbactum Antibiotic Disc

Ceftriaxone Antibiotic Disc

Cefuroxime Antibiotic Disc

Cefuroxime Sodium Antibiotic Disc

Cephalexin Antibiotic Disc

Cephaloridine Antibiotic Disc

Cephalothin Antibiotic Disc

Chloramphenicol Antibiotic Disc

Chlorhexidine Gluconate 4% w/v for Surgical Scrubbing

Chloroform A.G.

Chlorohexidine Gluconate 3%(w/v) and Strong Cetrimide 6% Solution

Cholesterol - Test Kit

Ciprofloxacin Antibiotic Disc

Citric Acid

Citrosteril Disinfectant Chemical Lotion

Clarithromycin Antibiotic Disc

Clindamycin Antibiotic Disc

Cloxacillin Antibiotic Disc

Collodian

Conc. Hydrochloric Acid

Conc. Sulphuric Acid

Coombs Diluents (Gel System)

Cord Blood Processing Kit (CBP Kit) for the Cord Blood Bank 1. The CBP Kit must consist of three bags integrally connected by tubing, two of which are PVC bags-one larger bag & one smaller bag and a third smallest bag which is the Cryo bag / freezing bag. 2. The larger bag should have a fill volume of 200ml with an attached spike for transferring content from a different collection bag. It must have one leak proof access port for injecting chemicals inside or taking out sample. One additional entry port to this bag is preferred for injecting chemicals only through the nozzle of the syringe without using needle with very narrow calibre connecting tubing for administration of Cryoprotectant(s). 3. Other smaller bag should have a fill volume of 150ml. It must have one leak proof access port for injecting chemicals inside or taking samples from the bag. 4. The third integrally attached bag (Cryo bag / Freezing bag) consists of EVA material or approved material for storing stem cells at ultra low temperature (minus 196˚C) of liquid nitrogen. It must be a 3D bag (3 dimensional) with two compartments of 20ml & 5ml capacity with intercommunication. 5. Length of this Cryo bag/Freezing bag is 85-87mm & width 63-65mm (However the total width is 71-73mm including the height of the two ports (for connecting spike for transplant) of the bag one connected with the 20ml part and other connected with the 5ml part. This Cryo bag/Freezing bag along with at least 90mm integral tube segment should fit inside the metal cassette with dimension 91-92mm (Length) X 84-85mm (Width) X 8-9mm (thickness) for preservation. 6. Temperature range of storage should be minus 196˚C plus 40˚C. 7. Easily manipulative clamp must be present on every connecting tubing from bag to bag and from bag to spike and bag to entry or exit ports. 8. The kit should have an expiry of at least 2 years from the date of manufacture. 9. The kit manufacturing process should follow the national and or international standards like ISO etc. so that the bags are pyrogen free, sterilised, animal pathogenicity test passed, can withstand the shearing force during centrifugation etc. 10. Should provide copy of the supply order to other national or international cord blood banks. 11. Should provide customer satisfaction certificate for the product. 12. Specimen of the kit must be provided to the tender committee for precise verification of the size, shape, measurement and other specifications. 13. Other requirement (if approved and order is placed for purchase):-Each supply lot/batch has to be provided with Certificate of Analysis (quality assurance certificate) otherwise the kit will not be accepted. 14. Should have ICMED 13485 Certification by QCI or IS / ISO 13485 Certification or CE Certificate or US FDA approval Certificate.

Co-trimoxazole Antibiotic Disc

CPK (MB) Test Kit

CPK Test Kit

C-Reactive Protein (Immunoterbedimetric) - Test Kit

Creatinine -Test Kit

Cresol with Soap Solution 50% I.P.

De Ionized Water

Dengue Detection Kit (IgG Antibody) -Elisa

Dengue IgM capture ELISA kit Technical Specification: 1) The ELISA kit should be designed for qualitative detection of dengue IgM antibodies of all 4 dengue serotypes in human serum. 2) The kit should be provided with the following materials and reagents: a. Anti-Human IgM coatedBreak-apart Microwells (12*8=96 wells). Desiccant should be provided for storing the unused Microwells which are to be resealed immediately. b. Horseradish peroxidase conjugated monoclonal antibody tracer with preservatives. c. Chromogenic substrate in buffer. d. Positive Control in the form of positive human serum with preservatives and antibiotics. e. Negative control in the form of confirmed negative human serum with preservatives and antibiotics. f. Calibrators. g. Sample diluents. h. Wash buffer. i. Stop solution. 3) The time required for performing the test for detection of dengue IgM,should range between 2-4 hours. 4) The ELISA kit for detection of dengue IgM should have a sensitivity of >95% and a specificity of >98%. 5) The kit should be such that, one well is to be consumed for evaluation of each sample (barring the wells used for control). 6) Test ELISA kit should distinguish between Dengue and other diseases with similar clinical presentation. 7) The kit should have a shelf-life of at least one year when stored at an ambient temperature of 2ºC - 8ºC. 8) Transportation should be under cold chain 9) Test kit should fit in all the commonly available Brand/Make of ELISA reader & washer machine. 10) The volume of each and every reagents or consumables supplied in a pack (for 96 wells) should be such that, tests can be run at least in twelve occasions by using the 96 wells. 11) User certificates from the reputed institution.

Dengue NS1 Antigen detection kit (Elisa)

Developer (X-Ray film)

Disinfectant Fluids (Black), Phenolic Type, Grade 3 (RW coeff 5-7) IS 1061:1997

Doxycyclin Antibiotic Disc

Drabkin’s Solution

Durham’s Tube

E.D.T.A. Powder

Ceg Test House and Research Centre Pvt Ltd

Sophisticated Industrial Materials Analytic Labs Pvt. Ltd

Delhi Test House

STANDARD ANALYTICAL LABORATORY ND PVT LTD

Interstellar Testing Centre Private Limited

DEVANSH TESTING & RESEARCH LABORATORY PVT LTD

Ceg Test House and Research Centre Pvt Ltd

ITL LABS PVT. LTD

Interstellar Testing Centre Private Limited

STANDARD ANALYTICAL LABORATORY ND PVT LTD