Supply Of Chemicals, Antibiotics, Miscellaneous Items Under Nvbdcp Programme For The Year 2019-20(Nvbdcp)Kdl/Ad/Retnd/Nvbdcp/134/2019-20 1. Act (Artesunate Combination Therapy) Blister Sheets – Adult Dose (>15 Yrs)| White Colour| Total Dose Of Artenunate – 600Mg Divided Over Three Days, Sulphadoxine Pyremethamine (1500Mg + 75Mg) Single Dose Each Combi Blister Pack: Containing 3 Tablets Of Artesunate Each 200Mg Strength And 2 Tablets Of Sulphadoxine Pyremethamine Of Strength 750Mg + 37.5Mg Each Or 3 Tablets Of Strength 500Mg + 25Mg Each. Each Row – No. Of Tablets: First Row (Day 1): One Tablet Of Artesunate (200Mg) And Two Tablets Of Sulphadoxine Pyremethamine 750Mg + 37.5Mg Each Or 3 Tablets Of 500Mg +50Mg Each. Second Row (Day 2): One Tablet Of Artesunate (200Mg) Third Row (Day 3): One Tablet Of Artesunate (200Mg) Tablets Artesunate Of Above Strengths To The Specifications Should Be As Per International Pharmacopeia, Latest Version. Tablets Sulfadoxine/Pyremethamine Combination: Containing Above Strengths (I.E. Sulfadoxine I.P. 500Mg And Pyremethamine I.P. 25Mg Per Tablet And Sulfadoxine I.P. 750Mg And Pyremethamine I.P. 37.5Mg Per Tablet) Should Be As Per Ip Latest Version. Tablet Artesunate : 2 Years Tablet Sulfadoxine & Pyremethamine: 2 Years Each Pack Will Bear Shelf Life Of 2 Years On The Pack With Manufacturing Date And Expiry Date Of Each Of The Above Tablets – Separately. All The Packs In Different Groups Will Have Definite Colours As Indicated Above. The Tablets Will Be Placed In Three Rows With Transparent Top. Each Row Should Be Clearliy Marked As Day 1, Day 2 And Day 3 Giving Number Of Tablets In Each Row. Each Pack Should Indicate Dowe Schedule Per Kg Body Wt. For Both Tablet Artesunate And Tablet Sulphadoxine-Pyremethamine I.E. As-4Mg/Kg B.W. And 25Mg/Kg B.W Of Sulphadoxine + 1.25Mg/Kg B.W. Of Pyrimethamine , Respectively. All Sheets Should Carry The Legend “Nvbdcp Supply-Not For Sale”, On One Side. Marking: Printing / Marking On Blister/Catch Cover/Corrugated Box And Pack Will Be As Per Drug & Cosmetics Rules. Manufacturing And Expiry Dates Of Artesunate And Sulfadoxine-Pyremethamine Tablets Should Be Written Separately On The Blister Pack/Catch Cover. Each Blister Strip Will Be Stuffed In A Paper Catch Cover. 25 Blister Strips Will Be Placed In A Pack And 100 Such Packs Will Be Packed In A Corrugated Box. Each Blister Strip/Catch Cover/Pack And Box Should Be Marked “Nvbdcp Supply – Not For Sale”. Stores Shall Be Securely Packed In Normal Trade Packing Of Corrugated Boxes To Avoid Loss Or Damage During Transit By Rail/Road., 2. Act (Artesunate Combination Therapy) Blister Sheets – 9-14 Yrs Does| Red Colour| Total Dose Of Artenunate – 450Mg Divided Over Three Days, Sulphadoxine Pyremethamine (1000Mg + 50Mg) Single Dose Each Combi Blister Pack: Containing 3 Tablets Of Artesunate 150Mg Each And 2 Tablets Of Sulphadoxine Pyremethamine (500Mg + 25Mg Each) Each Row – No. Of Tablets: First Row (Day 1): One Tablet Of Artesunate (150Mg) And Two Tablets Of Sulphadoxine Pyremethamine (500Mg + 25Mg Each) Second Row (Day 2): One Tablet Of Artesunate (150Mg) Third Row (Day 3): One Tablet Of Artesunate (150Mg) Tablets Artesunate Of Above Strengths To The Specifications Should Be As Per International Pharmacopeia, Latest Version. Tablets Sulfadoxine/Pyremethamine Combination: Containing Above Strengths (I.E. Sulfadoxine I.P. 500Mg And Pyremethamine I.P. 25Mg Per Tablet And Sulfadoxine I.P. 750Mg And Pyremethamine I.P. 37.5Mg Per Tablet) Should Be As Per Ip Latest Version. Tablet Artesunate : 2 Years Tablet Sulfadoxine & Pyremethamine: 2 Years Each Pack Will Bear Shelf Life Of 2 Years On The Pack With Manufacturing Date And Expiry Date Of Each Of The Above Tablets – Separately. All The Packs In Different Groups Will Have Definite Colours As Indicated Above. The Tablets Will Be Placed In Three Rows With Transparent Top. Each Row Should Be Clearliy Marked As Day 1, Day 2 And Day 3 Giving Number Of Tablets In Each Row. Each Pack Should Indicate Dowe Schedule Per Kg Body Wt. For Both Tablet Artesunate And Tablet Sulphadoxine-Pyremethamine I.E. As-4Mg/Kg B.W. And 25Mg/Kg B.W Of Sulphadoxine + 1.25Mg/Kg B.W. Of Pyrimethamine , Respectively. All Sheets Should Carry The Legend “Nvbdcp Supply-Not For Sale”, On One Side. Marking: Printing / Marking On Blister/Catch Cover/Corrugated Box And Pack Will Be As Per Drug & Cosmetics Rules. Manufacturing And Expiry Dates Of Artesunate And Sulfadoxine-Pyremethamine Tablets Should Be Written Separately On The Blister Pack/Catch Cover. Each Blister Strip Will Be Stuffed In A Paper Catch Cover. 25 Blister Strips Will Be Placed In A Pack And 100 Such Packs Will Be Packed In A Corrugated Box. Each Blister Strip/Catch Cover/Pack And Box Should Be Marked “Nvbdcp Supply – Not For Sale”. Stores Shall Be Securely Packed In Normal Trade Packing Of Corrugated Boxes To Avoid Loss Or Damage During Transit By Rail/Road., 3. . 1. The Elisa Kit Should Be Designed For Qualitative Detection Of Dengue Ns1 Antigen Of All 4 Dengue Serotypes In Human Serum. 2. 2. The Kit Should Be Provided With The Following Materials And Reagents: A. Anti-Ns1 Antibody Coated Breakway Microwells (12 X 8 = 96 Wells Or 6 X 8 = 48 Wells - For Convenience). Desicant Should Be Provided For Storing The Unused Microwells Which Are To Be Resealed Immediately. B. Horseradish Peroxidase Conjugated Anti-Ns1 Monoclonal Antibody With Preservatives. C. Chromogenic Substrate In Buffer D. Positive Control In The Form Of Recombinant Antigen With Preservatives And Antibiotics E. Negative Control In The Form Of Confirmed Negative Human Serum With Preservativ Es And Antibiotics F. Calibrators In The Form Of Recombinant Antigen With Preservatives And Antibiotics G. Sample Diluents H. Wash Buffer 3. The Time Required For Performing The Test For Detection Of Dengue Ns1 Antigen By Elisa Should Range Between 2-4 Hours. 4. The Elisa Kit For Detection Of Dengue Ns1 Antigen Should Have A Sensitivity Of >90% And A Specificity Of >95% Taking Rt-Pcr As The Gold Standard. The Kit Should Have A Shelf-Life Of Atleast 8 Months When Stored At An Ambient Temperature Of 20C - 80 C. Transportation To The Consignee Address Should Be Strictly Under Cold Chain. The Quantity Of 200 Kits Is For 12 X 8 =- 96 Well - Plates Only. Incase, 6 X 8 = 48 Well Plates Are Provided, The Quantity Should Be Doubled I.E. 400 Kits. Reagents And Materials Should Also Be Sufficient For 400 Kits., 4. Rapid Diagnostics Test Kits (Bi-Valent) The Rapid Diagnostic Kit (Rdk) For Malaria Should Comprise Of Test Card/Cassettes And Reagents Including Buffer Solution In A Dropper Bottle. The Test Kit Should Be Able To Conduct The Rapid Diagnosis For Both P. Vivax And P. Falciparum Simultaneously, In The Same Card/Cassette. The Test Should Be Based On The Principle Of Capture Of Parasite Antigen From Blood Using Monoclonal Antibodies Specific For Antigen Target. Tracer Antibodies Should Be Present As Immobile Phase. Each Test Kit Should Contain All The Material Required For Conducting The Test Including Individually Packed Sterile Lancets For Pricking, Heparinised Capillary Tubes (Diameter – 1Mm) With Relevant Markings And Reaction Tubes With Stand/Wells If Required. The Required Packing Standards And Labeling Should Meet The Good Manufacturing Practices (Gmp) Standards. One Should Be Able To Perform The Test With The Blood Taken By Finger Prick Of The Patient. Each Batch Of Rdks Should Be Tested During Time Of Delivery To Ensure Sensitivity And Specificity At Minimum Of 90% To 95% ; At Parasite Density Level Of 200 Asexual Parasites Per Microlitre Of Blood. Each Kit Should Be Packed In A Hermetically Sealed And Non Permeable Pouch And Should Have Moisture Absorbent Material. 25 Such Test Cards/Strips Should Be Packed In A Box Containing The Reagents And The Test Plates. Adequate Literature Detailing The Components Methodologies, Validity Criteria, Storage Conditions, Expiry Date 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. Shelf Life From Manufacturing Day To Expiry Date Should Be At Least 2 Years And It Should Not Pass More Than 1/6Th Of Their Effective Life From The Date Of Manufacture, At The Time When 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 Test Kits Will Be Made Good By The Firm At Their Cost. I. Each Card/Strip Cassettes Should Have Space For Patient’S Particulars And Date Of The Test. Ii. The Small Box Containing 25 Tests Should Have The Following Markings: • Name Of Test • Lot Number • Manufacturing And Expiry Date • Name Of Manufacturer With Address • Details Of Contents • Storage Conditions • Handling Procedures • Disposal Instructions For The Box And Its Contents • Nvbdcp Supply – Not For Sale Iii. The Large Carton Containing 5 Small Boxes Should Have The Following Markings: • Name Of Test • Lot Number • Manufacturing And Expiry Date • Name Of Manufacturer With Address • Details Of Contents • Storage Conditions • Handling Procedures • Disposal Instructions For The Box And Its Contents Nvbdcp Supply – Not For Sale. 1. Manufacturing And Marketing License For The Manufacturing Of Rapid Malaria Diagnostic Kits Should Have Been Obtained From The Concerned Regulatory Authority In The Country Of Manufacturer At The Time Of Tender Opening. 2. The Bidders Must Submit Scientific Study Report In Support Of Their Claim Of Sensitivity And Specificity Of The Offered Product From An Institution Recognized For The Purpose. Rdk Should Be Stable Up To 400C. Claim Should Be Supported By Actual Shelf Life Studies. Reports Of Proven Performance Of The Offered Product In Conditions Similar To Indian Field Conditions (Room Temperature Up To 400C) With Certification Of No Adverse Report For The Offered Product From The End Users During The Lasts Five Years Must Also Be Submitted With The Bid. 3. The Bidders Must Submit A Sample Of Their Product I.E. Two Kits To Nvbdcp Technical Staff To Assess The User-Friendliness. Recommended Condition For Storage (Eg. Room Temperature) And Shelf Life Should Clearly Be Mentioned On The Label Of Rdk, 5. Temephos 50% (W/W) Emulsifiable Concentrate – With Isi (Bis) Mark And Certification - Larvicide For Vector Control As Per Is: 8498 Specification; Licensed And Labeled As Per Central Insecticide Board Norms. (Expiry: 2 Yrs From The Date Of Manufacture With A Margin Of 1/6Th From The Date Of Manufacture, As Shelf Life At The Time Of Supplies) Sampling And Testing As Per Regular Procedures., 6. Biocide-Bacillus Thuringiensis Israliensis (Bti) Strain 164, Serotype, H-14 W.P Or Bacillus Thuringiensis Var Israeliensis (Bti) 5% Wp, Strain Designation: Abil, Accession No: Naimcc-B-01318 As Per Specifications Given In Cib Registration Certificates Of Above Strains To Have The Following Composition And Potency:- Composition 1 :- B. Thuringiensis Var Israelensis Spores – 5% - 8% W/W Delta Endotoxin – 5% To 8% W/W Nutrient Medium Residues – 30% To 35% W/W Sodium Chloride – 15 – 20% W/W Powdery Lignosulphonate – 22-41% W/W Moisture – 4-7% W/W Or Composition 2:- B.Thuringiensis Var Israelensis – 5% (Min) W/W Spore Count – 4.8 X 108/Gm. (Min) Delta Endotoxin – 2% (Min) Nutrient Medium Residues – 40% W/W Beta Exotoxin Content: Absent Adjuvant (Kaolin/Ppt Silica): Q.S. Total: 100% Potency:- I) 5380 Iu/Mg. Min. On Aedes Aegypti Ii) 5370 Iu/Mg. Min. On An.Culicifacies Iii) 5450 Iu/Mg Min. On An.Stephensi Iv) 5440 Iu/Mg Min. On Cx.Quinquefasciatus Or 7000 Iu/Mg Min.(Against Culex, Anopheles And Aedes Larvae). The Material Should Be Stable For Storage : - Upto 450C For Strain 164 (Serotype H-14 Wp) Or - Upto 470C For Strain Designation Abil- Bti 5% Wp (Accession No. Naimcc-B-01318) (As Per Cib Registration/Certification) At The Time When The Stores Are Offered For Supplies, The Life Of Bio-Larvicide Should Not Have Passed More Than 1/6Th Of The Effective Life Of The Same, Counted From The Date Of Manufacture. Shelf Life As Per Cib Is Two Years For Strain 164 (H-14 Wp) And One Year For Strain Designation Abil-Bti 5% Wp (Naimcc-B-01318) The Stores Shall Have To Be Packed As Per Registration Certificate, In 5Kg, 10Kg And 50 Kg Ldpe Bags Of Thickness Not Less Than 0.062Mm And As Per Is: 2508-1984. Primary Packs Shall Be Individually Packed In Fiber Board Drum As Per Is:7601-1983. Marking And Labeling Should Be Legibly And Indelibly On Each Container As Per Information Required Under The Insecticide Act 1968. Any Other Information Should Be Provided Under The Standards Of Weights And Measures (Packaged Commodities) Rules, 1977. The Samples And Stores For Inspection Should Accompany With The Test Certificate Provided By A Standard Testing Laboratory Approved/Recognized By Cib/Nvbdcp/Nimr For The Respective Batches. 1. Strain 164, Serotype, H-14 W.P. : Potable & Polluted Water: 5 Kg In 200 Lts Of Water/H.A. – Fortnightly Application 2. Strain Designation: Abil, Accession No: Naimcc-B-01318 : Potable Water: 7.5 Kg In 200 Lts Of Water/H.A. Polluted Water: 10 Kg In 200 Lts Of Water/H.A. With Weekly Application., 7. Pyrethrum Extract 2% (W/W) - Liquid Concentrate – With Isi (Bis) Mark And Certification - Space Spray Adulticide For Vector Control As Per Is: 1051/1980 Specification; Licensed And Labeled As Per Central Insecticide Board Norms. (Expiry: 2 Yrs From The Date Of Manufacture)., 8. Synthetic Pyrethroid 10% Wp Suitable For Use In Indoor Residual Spray Under National Vector Borne Disease Control. Programme With Isi/Bis Mark & Certification The Product Should Have Isi/Bis Mark And A Valid Certification Of Isi/Bis. The Material Shall Be In Provided As ‘Soluble Sachet’ Each Of Which Should Weigh 62.5 Gms, For Easy And Safe Handling During The Spray Operations. The Product Should Have Valid Registration Certificate From The Central Insecticide Board And Should Have Packing And Labelling Procedures As Per Cib Norms. The Material Shall Be In Provided As ‘Soluble Sachet’ Each Of Which Should Weigh 62.5 Gms, For Easy And Safe Handling During The Spray Operations. The Expiry Date I.E. The Date Upto Which The Insecticide Shall Retain Its Efficacy And Potency Shall Be For A Period Of Atleast Two Years From The Date Of Its Manufacture Which Means That The Material Shall Meet With The Requirements Given In The Cib Registration Certificate For A Period Of Two Years. At The Time When The Stores Are Offered For Inspection, The Life Of The Insecticide Should Not Have Passed More Than 1/6Th Of The Effective Life Of The Same Counted From The Date Of Manufacture. The Material Shall Be Packed In 8 Kg (128 Soluble Sachet Of 62.5Gms) Or 10 Kg (160 Soluble Sachet Of 62.5Gms) Containers. Regular Sampling Procedures Will Be Followed For Further Testing Of The Active Ingredient Content, After The Supplies Are Made To The Consignees., 9. Technical Malathion For Outdoor Fogging. Malathion – Technical Grade 95%. The Material Should Have Minimum 95% Malathion Content % By Mass And Shall Have No Foul Or Disagreeable Odour. The Material Shall Be In The Form Of Colourless To Amber Liquid, Free From Extraneous Impurities, Sediments Or Added Modifying Agents. The Product Should Have Isi/Bis Mark And A Valid Certification Of Isi/Bis As Per Is 1832:1978 (Reaffirmed – 2002) With Upto Date Amendments. 1. The Product Should Have Valid Registration Certificate From The Central Insecticide Board And Should Have Packing And Labelling Procedures As Per Cib Norms. 2. The Product Should Have Bis Mark And Certification As Per Sl. No. (2) Above. The Minimum Quantity To Be Packed Is In 20 Lts. Standard Mild Steel Drums, Which Should Be Leak Proof And Pilfer Proof. The Product Shall Be Packed In Accordance With Is:1890(Part Ii)-1980 - Liquid Pesticide. The Drums Should Be Suitably Lacquered To Avoid Decomposition Of Malathion During Storage The Expiry Date I.E. The Date Upto Which The Insecticide Shall Retain Its Efficacy And Potency Shall Be For A Period Of Atleast One Year From The Date Of Its Manufacture Which Means That The Material Shall Meet With The Requirements Given In The Cib Registration Certificate For A Period Of One Year. At The Time When The Stores Are Offered For Inspection, The Life Of The Insecticide Should Not Have Passed More Than One Month Of The Effective Life Of The Same Counted From The Date Of Manufacture. A Leaflet As Approved By The Cib Registration Committee, Should Be Affixed To The Packaging Containing And Shall Be Printed N English, Indicating The Product Detail, Direction For Use, Precautions, Symptoms Of Poisoning And First-Aid With Antidote, Disposal Of Used Containers, Storage Conditions And Manufacturer’S Name And Other Such Details.,
