national institute of biologicals - sample quantity required … fees.pdf · 2020-03-17 ·...

National Institute of Biologicals

SAMPLE QUANTITY REQUIRED FOR TESTING AND TESTING FEE PAN - AAATN5228R

TESTING FEE EFFECTIVE FROM 01.07.2017 GSTIN - 09AAATN5228R1ZX

ST No. - AAATN5228RST001

TIN - 09466201769

TESTING RETAINED

A.1 Glucose Reagent 2*500 ml 1000 Tests 1000 Tests 58,218 10,479 68,697

A.2 Glucose Test Strips - 1200 Strips 1200 Strips 46,085 8,295 54,380

A.3 Glucometer Device NA 10 Nos. 02 Nos. 46,086 8,295 54,381

B. BLOOD REAGENTS LABORATORY (Blood Grouping Reagent Laboratory)

B.1 ABD Pad 48 cards 3 Boxes 2 Boxes 25,991 4,678 30,669

B.2 ABO confirmation card 48cards 3Boxes 2 Boxes 25,991 4,678 30,669

B.3 ABO Rh Typing Card 48cards 3Boxes 2 Boxes 25,991 4,678 30,669

B.4 Anti D (Verification of Weak D by IAT) 10ml 2 vials 2 vials 37,638 6,775 44,413

B.5 **Anti Kpb

Reagent 2ml 3vials 3vials 28,256 5,086 33,342

B.6 Anti-A (Bulk) 30ml 1vial 2 vials x 10ml 38,671 6,961 45,632

B.7 Anti-A (Concentrate Bulk) 30ml 1 vial 2 vials x 10ml 38,671 6,961 45,632

B.8 **Anti-A /B / D /K / control ABO card 48cards 3Boxes 2 Boxes 25,991 4,678 30,669

B.9 Anti-A Monoclonal 10ml/5ml 2 vials x 10ml 2 vials x 10ml 27,920 5,026 32,946

B.10 Anti-A1 (Lectin) 10ml/5ml 2 vials x 10ml 2 vials x 10ml 36,933 6,648 43,581

B.11 Anti-AB (Monoclonal) 10ml,/5ml 2 vials x 10ml 2 vials x 10ml 35,049 6,309 41,358

B.12 Anti-B ( Concentrate Bulk) 30ml 1 vial 2 vials x 10ml 38,307 6,895 45,202

B.13 Anti-B (Bulk) 30ml 1vial 2 vials x 10ml 38,307 6,895 45,202

B.14 Anti-B (Monoclonal) (10ml/5ml) 2 vials x 10ml 2 vials x 10ml 27,556 4,960 32,516

B.15 **Anti-Cw

Reagent 2ml/1ml 3vials/6vials 2vials/4vials 28,732 5,172 33,904

B.16 Anti-D ( RH1) (Totem) (10ml/5ml) 2 vials x 10ml 2 vials x 10ml 34,054 6,130 40,184

B.17 Anti-D (IgG) Monoclonal (10ml/5ml) 2 vials x 10ml 2 vials x 10ml 25,027 4,505 29,532

B.18 Anti-D (IgM) Monoclonal (10ml/5ml) 2 vials x 10ml 2 vials x 10ml 37,653 6,778 44,431

B.19 Anti-D (IgM)( Bulk) 30ml 1vial 1vial 37,638 6,775 44,413

PRODUCT NAME PACK SIZE GST @ 18

%

TOTAL TESTING

FEE

(INR)

QUANTITY REQUIRED PER BATCHTESTING FEE

PER BATCH

(INR)

NEW

CODE

A. BIOCHEMICAL KITS

Doc Id: NIB/SRRD/SQTF/2016 (R-38) dated 16.03.2020

1





TIN - 09466201769

TESTING RETAINED


%

TOTAL TESTING

FEE

(INR)


PER BATCH

(INR)

NEW

CODE


B.20 Anti-D (IgM)( Concentrate Bulk) 30ml 1vial 1 vial 37,638 6,775 44,413

B.21 Anti-D (IgM+IgG) (Bulk) 30ml 1vial 2 vials x 10ml 34,084 6,135 40,219

B.22 Anti-D (IgM+IgG) (Concentrate Bulk) 30ml 1vial 2 vials x 10ml 37,638 6,775 44,413

B.23 Anti-D (IgM+IgG) Monoclonal (10ml/5ml) 2 vials x 10ml 2 vials x 10ml 37,638 6,775 44,413

B.24 **Anti-Fya Reagent 2ml/1ml 3vials/6vials 3 vials x 2ml 28,442 5,120 33,562

B.25 **Anti-Fyb

Reagent 2ml/1ml 3vials/6vials 3 vials x 2ml 28,445 5,120 33,565

B.26 Anti-H (Lectin) 10ml/5ml 2vials/10ml 2vials/10ml 35,214 6,339 41,553

B.27 Anti-Human Globulin 10ml 2 vials x 10ml 2 vials x 10ml 41,827 7,529 49,356

B.28 **Anti-Jka Reagent 2ml/1ml 3vials/6vials 3 vials x 2ml 29,040 5,227 34,267

B.29 **Anti-Jkb Reagent 2ml/1ml 3vials/6vials 3 vials x 2ml 29,040 5,227 34,267

B.30 **Anti-k Reagent 2ml/1ml 3vials/6vials 3 vials x 2ml 29,172 5,251 34,423

B.31 **Anti-K Reagent 2ml/1ml 3vials/6vials 3 vials x 2ml 27,092 4,877 31,969

B.32 **Anti-Kpa Reagent 2ml/1ml 3vials/6vials 3 vials x 2ml 28,256 5,086 33,342

B.33 **Anti-Lea Reagent 2ml/1ml 3vials/6vials 3 vials x 2ml 28,732 5,172 33,904

B.34 **Anti-Leb Reagent 2ml/1ml 3vials/6vials 3 vials x 2ml 28,714 5,169 33,883

B.35 **Anti-M Reagent 2ml/1ml 3vials/6vials 3 vials x 2ml 28,732 5,172 33,904

B.36 **Anti-N Reagent 2ml/1ml 3vials/6vials 3 vials x 2ml 28,732 5,172 33,904

B.37 **Anti-Pi Reagent 2ml/1ml 3vials/6vials 3 vials x 2ml 28,732 5,172 33,904

B.38 **Anti-s Reagent 2ml/1ml 3vials/6vials 3 vials x 2ml 29,091 5,236 34,327

B.39 **Anti-S Reagent 2ml/1ml 3vials/6vials 3 vials x 2ml 29,040 5,227 34,267

B.40 Blood Grouping Cards 48cards 3 Boxes 2 Boxes 25,991 4,678 30,669

B.41 Blood Grouping Rapid Card Test 50tests 3Boxes 2Boxes 25,991 4,678 30,669

B.42 Bovine Serum Albumin - 2 vials x 10ml 2 vials x 10ml 32,795 5,903 38,698

B.43 CombiPack ABD Monoclonal Antibody 10ml each 3 combi packs 2 combi packs 93,129 16,763 1,09,892

B.44 **Gel Card Anti-M 48 cards 3 Boxes 2 Boxes 25,991 4,678 30,669

2





TIN - 09466201769

TESTING RETAINED


%

TOTAL TESTING

FEE

(INR)


PER BATCH

(INR)

NEW

CODE


B.45 **Gel Card Anti-N 48 cards 3 Boxes 2 Boxes 25,991 4,678 30,669

B.46 Gel Card Anti-A1 (Lectin) 48cards 3 Boxes 2 Boxes 26,719 4,809 31,528

B.47 **Gel Card Antigen Profile I 48 cards 3 Boxes 2 Boxes 25,991 4,678 30,669

B.48 **Gel Card Antigen Profile II 48 cards 3 Boxes 2 Boxes 25,991 4,678 30,669

B.49 **Gel Card Antigen Profile III 48 cards 3 Boxes 2 Boxes 25,991 4,678 30,669

B.50 Gel Card Anti-H (Lectin) 48cards 3 Boxes 2 Boxes 24,898 4,482 29,380

B.51 Gel card for Direct Anti Globulin test 48cards 3 Boxes 2 Boxes 24,864 4,476 29,340

B.52 *Gel card for new born 48cards 3Boxes 3 Boxes 27,782 5,001 32,783

B.53 Gel Card forward & reverse grouping 48cards 3 Boxes 2 Boxes 25,991 4,678 30,669

B.54 Gel Card forward grouping 48cards 3Boxes 2 Boxes 25,991 4,678 30,669

B.55 Gel Card Rh Subgroups 48 cards 3 Boxes 2 Boxes 25,991 4,678 30,669

B.56 *Gel Cards ABO/Rh for Newborns DVI Neg/Pos 48 cards 3 Boxes 2 Boxes 25,991 4,678 30,669

B.57 Gel Cards Anti-A/B/AB/DVI Pos/ DVI Neg/Ctl 48 cards 3 Boxes 2 Boxes 25,991 4,678 30,669

B.58 Gel Cards Anti-A/B/D/Rh subgroups 48 cards 3 Boxes 2 Boxes 25,991 4,678 30,669

B.59 **Gel Cards Anti-Cw 48 cards 3 Boxes 2 Boxes 25,991 4,678 30,669

B.60 Gel Cards Anti-D (Human) 48 cards 3 Boxes 2 Boxes 25,991 4,678 30,669

B.61 Gel Cards Anti-DVI 48 cards 3 Boxes 2 Boxes 25,991 4,678 30,669

B.62 **Gel Cards Anti Fya 48 cards 3 Boxes 2 Boxes 25,991 4,678 30,669

B.63 **Gel Cards Anti Fyb 48 cards 3 Boxes 2 Boxes 25,991 4,678 30,669

B.64 **Gel Cards Anti Jka 48 cards 3 Boxes 2 Boxes 25,991 4,678 30,669

B.65 **Gel Cards Anti Jkb 48 cards 3 Boxes 2 Boxes 25,991 4,678 30,669

B.66 **Gel Cards Anti K 48 cards 3 Boxes 2 Boxes 25,991 4,678 30,669

B.67 **Gel Cards Anti-k 48 cards 3 Boxes 2 Boxes 25,991 4,678 30,669

B.68 **Gel Cards Anti-Kpa 48 cards 3 Boxes 2 Boxes 25,991 4,678 30,669

B.69 **Gel Cards Anti-Kpb 48 cards 3 Boxes 2 Boxes 25,991 4,678 30,669

3





TIN - 09466201769

TESTING RETAINED


%

TOTAL TESTING

FEE

(INR)


PER BATCH

(INR)

NEW

CODE


B.70 **Gel Cards Anti-Lea 48 cards 3 Boxes 2 Boxes 25,991 4,678 30,669

B.71 **Gel Cards Anti-Leb 48 cards 3 Boxes 2 Boxes 25,991 4,678 30,669

B.72 **Gel Cards Anti-Lua 48 cards 3 Boxes 2 Boxes 25,991 4,678 30,669

B.73 **Gel Cards Anti-Lub 48 cards 3 Boxes 2 Boxes 25,991 4,678 30,669

B.74 **Gel Cards Anti-Pi 48 cards 3 Boxes 2 Boxes 25,991 4,678 30,669

B.75 **Gel Cards Anti-S 48 cards 3 Boxes 2 Boxes 25,991 4,678 30,669

B.76 **Gel Cards Anti s 48 cards 3 Boxes 2 Boxes 25,991 4,678 30,669

B.77 Gel Cards Crossmatch Testing (CT) 48 cards 3 Boxes 2 Boxes 25,991 4,678 30,669

B.78 Gel Cards Neutral 48 cards 3 Boxes 2 Boxes 25,991 4,678 30,669

B.79 **Gel Cards Rh subgroups + Cw

+ K 48 cards 3 Boxes 2 Boxes 25,991 4,678 30,669

B.80 **Gel Cards Rh subgroups + K 48 cards 3 Boxes 2 Boxes 25,991 4,678 30,669

B.81 Gel Cards Type + Screen 48 cards 3 Boxes 2 Boxes 25,991 4,678 30,669

B.82 Microplate for forward & Reverse grouping 48cards 3 Boxes 3 Boxes 25,991 4,678 30,669

B.83 *Newborn casette for AntiA/AntiB/ Anti AB/ Anti D/

Control / Anti IgG48 cards 3Boxes 2Boxes 25,991 4,678 30,669

B.84 Sera/Gel Card for AHG & C3d 48cards 3 Boxes 2 Boxes 24,864 4,476 29,340

B.85 Gel cards for Anti-A, B, DVI-/Enzyme/AHG 48cards 3 Boxes 2 Boxes 24,864 4,476 29,340

B.86 Gel cards for DAT Anti-IgG-Dilution 48cards 3 Boxes 2 Boxes 24,864 4,476 29,340

B.87 Gel cards for LISS/Coombs+ Enzyme Test 48cards 3 Boxes 2 Boxes 24,864 4,476 29,340

C. IMMUNODIAGNOSTIC KIT & MOLECULAR DIAGNOSTIC LABORATORY

C.1 Anti HBc IgM CLIA NA 96 Tests x 03 Kits 96 Tests x 03 Kits 42,083 7,575 49,658

C.2 Anti HBc IgM ELFA NA 96 Tests x 03 Kits 96 Tests x 03 Kits 42,083 7,575 49,658

* These products to be received along with red blood cells of new borns

** The testing facility of yellow highlighted products are also available subject to supply of panel cells by manufacturer

NOTE:

4





TIN - 09466201769

TESTING RETAINED


%

TOTAL TESTING

FEE

(INR)


PER BATCH

(INR)

NEW

CODE


C.3 Anti HBc IgM ELISA NA 96 Tests x 03 Kits 96 Tests x 03 Kits 42,083 7,575 49,658

C.4 Anti HBe Ag-Ab CLIA NA 96 Tests x 03 Kits 96 Tests x 03 Kits 42,083 7,575 49,658

C.5 Anti HBe Ag-Ab ELFA NA 96 Tests x 03 Kits 96 Tests x 03 Kits 42,083 7,575 49,658

C.6 Anti HBe Ag-Ab ELISA NA 96 Tests x 03 Kits 96 Tests x 03 Kits 42,083 7,575 49,658

C.7 Anti HBs CLIA NA 96 Tests x 03 Kits 96 Tests x 03 Kits 42,083 7,575 49,658

C.8 Anti HBs ELFA NA 96 Tests x 03 Kits 96 Tests x 03 Kits 42,083 7,575 49,658

C.9 Anti HBs ELISA NA 96 Tests x 03 Kits 96 Tests x 03 Kits 42,083 7,575 49,658

C.10 Anti-HBeAg CLIA NA 96 Tests x 03 Kits 96 Tests x 03 Kits 42,083 7,575 49,658

C.11 Anti-HBeAg ELFA NA 96 Tests x 03 Kits 96 Tests x 03 Kits 42,083 7,575 49,658

C.12 Anti-HBeAg ELISA NA 96 Tests x 03 Kits 96 Tests x 03 Kits 42,083 7,575 49,658

C.13 Chikungunya IgM ELISA NA 96 x 2 kits 96 x 2 kits 42,083 7,575 49,658

C.14 Dengue IgM ELISA NA 96 x 2 kits 96 x 2 kits 42,083 7,575 49,658

C.15 HBc IgM CLIA NA 96 Tests x 03 Kits 96 Tests x 03 Kits 42,083 7,575 49,658

C.16 HBc IgM ELFA NA 96 Tests x 03 Kits 96 Tests x 03 Kits 42,083 7,575 49,658

C.17 HBc IgM ELISA NA 96 Tests x 03 Kits 96 Tests x 03 Kits 42,083 7,575 49,658

C.18 HBc Total CLIA NA 96 Tests x 03 Kits 96 Tests x 03 Kits 42,083 7,575 49,658

C.19 HBc Total ELFA NA 96 Tests x 03 Kits 96 Tests x 03 Kits 42,083 7,575 49,658

C.20 HBc Total ELISA NA 96 Tests x 03 Kits 96 Tests x 03 Kits 42,083 7,575 49,658

C.21 HBe Ag-Ab CLIA NA 96 Tests x 03 Kits 96 Tests x 03 Kits 42,083 7,575 49,658

C.22 HBe Ag-Ab ELFA NA 96 Tests x 03 Kits 96 Tests x 03 Kits 42,083 7,575 49,658

C.23 HBe Ag-Ab ELISA NA 96 Tests x 03 Kits 96 Tests x 03 Kits 42,083 7,575 49,658

C.24 HBsAg CLIA NA 96 Tests x 07 Kits 96 Tests x 07 Kits 44,457 8,002 52,459

C.25 HBsAg ELFA NA 96 Tests x 07 Kits 96 Tests x 07 Kits 44,457 8,002 52,459

C.26 HBsAg ELISA NA 96 Tests x 07 Kits 96 Tests x 07 Kits 44,457 8,002 52,459

C.27 HBsAg Neutralization* NA 100 Tests 100 Tests 42,590 7,666 50,256

C.28 HBsAg Rapid NA 600 Tests 600 Tests 44,625 8,033 52,658

5





TIN - 09466201769

TESTING RETAINED


%

TOTAL TESTING

FEE

(INR)


PER BATCH

(INR)

NEW

CODE


C.29 HCV Ab CLIA NA 96 Tests x 07 Kits 96 Tests x 07 Kits 46,148 8,307 54,455

C.30 HCV Ab ELFA NA 96 Tests x 07 Kits 96 Tests x 07 Kits 46,148 8,307 54,455

C.31 HCV Ab ELISA NA 96 Tests x 07 Kits 96 Tests x 07 Kits 46,148 8,307 54,455

C.32 HCV Ab LIA NA 100 Tests 100 Tests 44,269 7,968 52,237

C.33 HCV Ab Rapid NA 600 Tests 600 Tests 46,371 8,347 54,718

C.34 HCV Ab RIBA NA 100 Tests 100 Tests 44,269 7,968 52,237

C.35 HCV Ab Western Blot NA 100 Tests 100 Tests 44,269 7,968 52,237

C.36 HCV Ag-Ab ELFA NA 96 Tests x 07 Kits 96 Tests x 07 Kits 46,148 8,307 54,455

C.37 HCV Ag-Ab ELISA NA 96 Tests x 07 Kits 96 Tests x 07 Kits 46,148 8,307 54,455

C.38 HIV 1&2 Ab CLIA NA 96 Tests x 07 Kits 96 Tests x 07 Kits 44,912 8,084 52,996

C.39 HIV 1&2 Ab ELFA NA 96 Tests x 07 Kits 96 Tests x 07 Kits 44,912 8,084 52,996

C.40 HIV 1&2 Ab ELISA NA 96 Tests x 07 Kits 96 Tests x 07 Kits 44,912 8,084 52,996

C.41 HIV 1&2 Ab LIA NA 100 Tests 100 Tests 43,044 7,748 50,792

C.42 HIV 1&2 Ab Rapid NA 600 Tests 600 Tests 44,855 8,074 52,929

C.43 HIV 1&2 Ab Western Blot NA 100 Tests 100 Tests 43,044 7,748 50,792

C.44 HIV Ag CLIA NA 100 Tests 44,912 8,084 52,996

C.45 HIV Ag ELFA NA 100 Tests 100 Tests 44,912 8,084 52,996

C.46 HIV Ag-Ab CLIA NA 96 Tests x 07 Kits 96 Tests x 07 Kits 44,912 8,084 52,996

C.47 HIV Ag-Ab ELFA NA 96 Tests x 07 Kits 96 Tests x 07 Kits 44,912 8,084 52,996

C.48 HIV Ag-Ab ELISA NA 96 Tests x 07 Kits 96 Tests x 07 Kits 44,912 8,084 52,996

C.49 HIV Ag-Ab Rapid NA 600 Tests 600 Tests 44,855 8,074 52,929

C.50 HIV TP Combo Rapid NA 600 Tests 600 Tests 43,537 7,837 51,374

C.51 HIV,HCV Combo Rapid NA 600 Tests 600 Tests 43,537 7,837 51,374

C.52 HIV,HCV,HBV Combo Rapid NA 800 Tests 800 Tests 43,886 7,899 51,785

C.53 HIV-2Ab Western Blot NA 100 Tests 100 Tests 43,044 7,748 50,792

C.54 Paclitaxel for HIV, HBsAg, HCV NA 01 Vial 01 Vial 1,970 355 2,325

6





TIN - 09466201769

TESTING RETAINED


%

TOTAL TESTING

FEE

(INR)


PER BATCH

(INR)

NEW

CODE


C.55 Pool Plasma for HIV, HBsAg, HCV NA 03 Vials x 05 ml 03 Vials 05 ml 1,970 355 2,325

C.56 Syphilis CLIA NA 96Tests x 03 Kits 96Tests x 03 Kits 43,392 7,811 51,203

C.57 Syphilis ELISA NA 96Tests x 03 Kits 96Tests x 03 Kits 43,392 7,811 51,203

C.58 Syphilis Rapid NA 250 Tests 250 Tests 53,087 9,556 62,643

C.59 Syphilis RPR NA 250 Tests 250 Tests 53,087 9,556 62,643

C.60 Syphilis TPHA NA 250Tests 250 Tests 52,983 9,537 62,520

C.61 Infection diagnostic test for HBV (Qualitative) NA 72 Tests 72 Tests 36,835 6,630 43,465

C.62 Infection diagnostic test for HCV (Qualitative) NA 72 Tests 72 Tests 36,835 6,630 43,465

C.63 Infection diagnostic test for HIV-1 (Qualitative) NA 72 Tests 72 Tests 36,835 6,630 43,465

C.64 Blood donor Screening multiplex (HBV, HCV & HIV)

Test (Qualitative)NA 120 Tests 120 Tests 45,224 8,140 53,364

C.65 Viral load monitoring Kit for HBV NA 24 Tests 24 Tests 36,835 6,630 43,465

C.66 Viral load monitoring Kit for HCV NA 24 Tests 24 Tests 36,835 6,630 43,465

C.67 Viral load monitoring Kit for HIV-1 NA 24 Tests 24 Tests 36,835 6,630 43,465

C.68 HIV Ag Confirmatory Test NA 100 Tests 44,912 8,084 52,996

D. BLOOD PRODUCTS LABORATORY

D.1 Anti-D Immunoglobulin for Intravenous use 1 ml 110vials 110vials 33,602 6,048 39,650

D.2.1 1ml 50 vials 50 vials 33,602 6,048 39,650

D.2.2 0.5ml 100 vials 100 vials 33,602 6,048 39,650

D.3 Anti-Inhibitor Coagulant Complex 500 IU 08 vials 08 vials 32,914 5,925 38,839

D.5.1 0.5ml 60 vials 60 vials 1,47,517 26,553 1,74,070

D.5.2 1ml 33 vials 33 vials 1,47,517 26,553 1,74,070

D.5.3 2ml 18 vials 18 vials 1,47,517 26,553 1,74,070

* At S.No. C.27- Along with accessories,calibrators, QC material, screening kit in case of Neutralization confirmatory assay at the time of submission.

Anti-D (Rho) Immunoglobulin (Intramuscular)

Hepatitis B Immunoglobulin (Intramuscular)

7





TIN - 09466201769

TESTING RETAINED


%

TOTAL TESTING

FEE

(INR)


PER BATCH

(INR)

NEW

CODE


D.5.4 Hepatitis B Immunoglobulin ( subcutaneous) 0.4ml 60 vials 60 vials 1,47,517 26,553 1,74,070

D.6.11ml 110 vials 110 vials 1,48,279 26,690 1,74,969

D.6.2 2ml 55 vials 55 vials 1,48,279 26,690 1,74,969

D.7 Human Albumin 250ml/100ml/50ml 04 Bottles 04 Bottles 1,08,737 19,573 1,28,310

D.8 Human Coagulation Factor - IX 500 IU/1000 IU 06 vials 06 vials 71,527 12,875 84,402

D.9 Human Coagulation Factor - IX (rDNA) 500 IU/1000 IU 06 vials 06 vials 71,527 12,875 84,402

D.10 Human Coagulation Factor - VIII (Dried Human

Antihaemophilic Fraction)

250 IU/ 500 IU/ 1000

IU07 vials 07 vials 1,05,165 18,930 1,24,095

D.11 Human Normal Immunoglobulin (IM) 2ml 25 vials 25 vials 1,19,677 21,542 1,41,219

D.12Human Normal Immunoglobulin (Intramuscular) (Bulk) - 04 Bottles 04 Bottles 84,434 15,198 99,632

D.13.1 50 ml 05 Bottles 05 Bottles 1,02,799 18,504 1,21,303



D.14 Human Plasma Protein Fraction 250ml/ 100ml 04 Bottles 04 Bottles 72,342 13,022 85,364

D.15 Human Prothrombin Complex 500 IU/1000 IU 10 Bottle 10 Bottle 40,515 7,293 47,808

D.16 Human Specific Immunoglobulin (IV) (Bulk) - 03 Bottle 03 Bottle 1,02,799 18,504 1,21,303

D.17 Rabies Immunoglobulin 2ml 20 vials 20 vials 1,62,103 29,179 1,91,282

D.18Recombinant Coagulation Factor- VIII (rDNA) 250 IU/500 IU/ 1000 IU 06 vials 06 vials 49,234 8,862 58,096

D.19 Tetanus Immunoglobulin (Intramuscular) 1 ml 50 vials 50 vials 38,537 6,937 45,474

D.20 Tetanus Immunoglobulin (Intramuscular) (Bulk) - 04 Bottles 04 Bottles 84,434 15,198 99,632

D.21 Human Fibrinogen 08 vials 08 vials 63,652 11,457 75,109

D.22

Human Normal Immunoglobulin (IgG) (subcutaneous

administration) 20 ml 04 bottles 04 bottles 1,19,677 21,542 1,41,219

Human Normal Immunoglobulin for Intravenous use

Hepatitis B Immunoglobulin (Intravenous)

8





TIN - 09466201769

TESTING RETAINED


%

TOTAL TESTING

FEE

(INR)


PER BATCH

(INR)

NEW

CODE


D.23

D.23.1 Tisseel Lyo 2ml, 4 ml, 10 ml 07 vials 07 vials 26,693 4,805 31,498

D.23.2 Evicel 1 ml, 2 ml, 10 ml 06 vials 06 vials 26,693 4,805 31,498

D.23.3 Floseal 5ml, 10ml 06 vials 06 vials 26,693 4,805 31,498

E. ENZYMES & HORMONE LABORATORY

E.1 Heparin Sodium injection 5000 IU 08 vials 08 vials 62,676 11,282 73,958

E.2 Human Chorionic Gonadotropin (HCG) Bulk NA 10mg x 3 vials - 1,07,709 19,388 1,27,097

E.3 Human Chorionic Gonadotropin (HCG) injection 5000/10000/2000 IU 08 vials 08 vials 1,07,709 19,388 1,27,097

E.4 Menotropin (Human Menopausal Gonadotropin) Bulk NA 06ml x 01 vials - 89,309 16,076 1,05,385

E.5.1 75 IU 17 vials 17 vials 89,309 16,076 1,05,385

E.5.2 150 IU 14 vials 14 vials 89,309 16,076 1,05,385

E.7

Recombinant Human Somatropin injection

4 IU

5mg/ 1.5ml

10mg/1.5ml

15mg/1.5ml

11 vial 11 vial 46,330 8,339 54,669

E.8 Recombinant Streptokinase injection 15,00,000 IU/ vial 12 vials 12 vials 81,777 14,720 96,497

E.10 Streptokinase Bulk NA 25mg x 3 vials - 81,777 14,720 96,497

E.11.1 7,50,000 IU 10 vials 10 vials 81,777 14,720 96,497

E.11.2 15,00,000 IU 10 vials 10 vials 81,777 14,720 96,497

E.12.1 40mg/vial 4 vial 2 vial 1,40,123 25,222 1,65,345

E.12.2 30mg/vial 4 vial 2 vial 1,40,123 25,222 1,65,345

E.13 Urofollitropin Bulk NA 10mg x 3 vials - 1,20,643 21,716 1,42,359

Menotropin (Human Menopausal Gonadotropin) injection

Streptokinase injection

Fibrin Sealant Kit

Tenecteplase for injection (TNK-Tpa)

9





TIN - 09466201769

TESTING RETAINED


%

TOTAL TESTING

FEE

(INR)


PER BATCH

(INR)

NEW

CODE


E.14.1 75 IU 11 vials 11 vials 65,882 11,859 77,741

E.14.2 50 IU/150 IU 11 vials 11 vials 93,262 16,787 1,10,049

E.15Urokinase Bulk/Final NA

25mg x 1 vial/ 05mg x 8

vials - 84,239 15,163 99,402

E.16Urokinase injection 5,00,000 IU/ vial 08 vials 08 vials 84,239 15,163 99,402

E. 17 Elaprase 02 mg/ml 04 vials 04 vials 1,62,733 29,292 1,92,025

E.18 VPRIV 400 units/vial 06 vials 06 vials 1,66,152 29,907 1,96,059

E. 19 Replagal 01 mg/ml 04 vials 04 vials 1,55,988 28,079 1,84,067

F. RECOMBINANT PRODUCT LABORATORY

F.1.1 Biphasic Isophane Insulin (25/75) 3ml-PFS 28 28 79,892 14,381 94,273

F.1.2 Biphasic Isophane Insulin (25/75) 10ml-vial 14 14 79,892 14,381 94,273





F.2 Dulaglutide 0.75 mg / 1.5 mg 13 13 57,713 10,388 68,101

F.3 Exenatide 1.2ml – Pen 15 15 58,134 10,464 68,598

F.4Filgrastim Injection (rh. GCSF) 1ml / < 1ml – Vial/PFS 6 6 99,421 17,896 1,17,317

F.5 Insulin Aspart bulk aliquots 6g - 82,963 14,933 97,896

F.6.1 3ml-PFS/Pen 28 28 75,927 13,667 89,594

F.6.2 10ml – Vial 14 14 75,927 13,667 89,594

Urofollitropin injection

Insulin Aspart

10





TIN - 09466201769

TESTING RETAINED


%

TOTAL TESTING

FEE

(INR)


PER BATCH

(INR)

NEW

CODE


F.7.1 Insulin Aspart & Insulin aspart protamine suspension

Mixed in 30/70 mix 3ml – PFS/Pen 28 28 76,790 13,822 90,612

F.7.2 Insulin Aspart & Insulin aspart protamine suspension

Mixed in 50/50 mix3ml – PFS/Pen 28 28 76,790 13,822 90,612

F.8 Insulin Degludec 3ml Pen 28 28 79,126 14,243 93,369

F.9 Insulin Degludec / Insulin Aspart 3ml Pen 28 28 79,126 14,243 93,369

F.10 Insulin Detemir 3ml - Pen 28 28 57,536 10,356 67,892

F.11.1 1.5ml – PFS/Pen 45 45 76,715 13,809 90,524

F.11.2 3 ml – PFS/Pen 28 28 76,715 13,809 90,524

F.11.3 10ml-vial 14 14 76,715 13,809 90,524

F.12.1 3ml – PFS/Pen 28 28 76,679 13,802 90,481

F.12.2 10ml-vial 14 14 76,679 13,802 90,481

F.13 Insulin Lispro bulk aliquots 6g - 84,510 15,212 99,722

F.14 Insulin Lispro 3ml - PFS/Pen 28 28 78,352 14,103 92,455

F.15.1 Insulin Lispro & Insulin Lispro Protamine Suspension

(Mixed in 25/75 Mix)3ml PFS/Pen 28 28 79,812 14,366 94,178

F.15.2 Insulin Lispro & Insulin Lispro Protamine Suspension

Mixed in 50/50 Mix3ml - PFS/Pen 28 28 79,812 14,366 94,178

F.16 Interferon alpha 2b injection 3MIU/ml PFS 10 5 1,20,815 21,747 1,42,562

F.17.1 3ml – PFS/Pen 28 28 79,872 14,377 94,249

F.17.2 10ml-vial 14 14 79,872 14,377 94,249

F.18 Liraglutide (Glucagon like Peptide-1) 3ml-Pen 28 28 57,713 10,388 68,101

F.19 Peg Filgrastim Injection (PegGCSF) 6mg/ 0.6 ml PFS/vial 6 6 1,20,815 21,747 1,42,562

Insulin Glulisine

Isophane insulin (NPH)

Insulin Glargine

11





TIN - 09466201769

TESTING RETAINED


%

TOTAL TESTING

FEE

(INR)


PER BATCH

(INR)

NEW

CODE


F.20

Peg Interferon alpha 2b inj

50 µg/ 0.5ml PFS/vial

80 mcg/ 0.5ml PFS/vial

100 mcg/0.5 ml

PFS/vial10 5 1,20,815 21,747 1,42,562

F.21 Peg Interferon Beta 1a inj 125µg/0.5ml PFS/vial 12 12 1,20,815 21,747 1,42,562

F.22 rh – Insulin bulk aliquots 6g - 82,571 14,863 97,434

F.23 rh- Erythropoietin bulk aliquots 10ml - 1,09,139 19,645 1,28,784

F.24rh. Erythropoietin injection 1ml / < 1ml – Vial/Pen 6 6 1,09,139 19,645 1,28,784

F.25 rh. Interferon beta 1a Injection 0.5ml - PFS 10 5 1,20,815 21,747 1,42,562

F.26.13ml – PFS/Pen 28 28 78,432 14,118 92,550

F.26.2 10ml-vial 14 14 78,432 14,118 92,550

F.27 Teriparatide (rh.ParaThyroid Hormone-PTH) 600 mcg/2.4ml 12 12 84,458 15,202 99,660

F.28 Xultophy (Liraglutide & Degludec) 3ml Pen 28 28 79,126 14,243 93,369

F.29 Peg Erythropoietin 35 PFS 20 15 1,09,139 19,645 1,28,784

F.30.1 63 µg/ 0.5 ml PFS/vial 12 12 1,20,815 21,747 1,42,562

F.30.2 94 µg/ 0.5 ml PFS/vial 12 12 1,20,815 21,747 1,42,562

F.31 Insulin Glargine Bulk aliquots 6g - 81,773 17,949 99,722

F.32 Recombinant interferon beta 1b injection 250 µg/ ml 1 ml 10 vials 5 vials 1,16,901 25,661 1,42,562

Soluble insulin (Regular)

Peg Interferon Beta 1a inj

12





TIN - 09466201769

TESTING RETAINED


%

TOTAL TESTING

FEE

(INR)


PER BATCH

(INR)

NEW

CODE


H.1 Cell Culture Rabies vaccine 1 ml 21 vials 21 vials 1,46,458 26,362 1,72,820

H.2.1 0.5ml 20 vials 20 vials 1,13,862 20,495 1,34,357

H.2.2 1.0ml 12 vials 12 vials 1,13,862 20,495 1,34,357

H.3.1 0.5ml 20 vials 20 vials 1,16,995 21,059 1,38,054

H.3.2 1.0ml 12 vials 12 vials 1,16,995 21,059 1,38,054

H.3.3 1.5ml 12 vials 12 vials 1,16,995 21,059 1,38,054

H.4 Japanese Encephalitis Vaccine (Human) 0.5ml 20 vials 20 vials 1,11,216 20,019 1,31,235

H.5.1 0.5ml 20 vials 20 vials 1,13,907 20,503 1,34,410

H.5.2 5.0 ml 14 vials 14 vials 1,13,907 20,503 1,34,410

H.6.1 0.5ml 20 vials 20 vials 85,619 15,411 1,01,030

H.6.2 5.0 ml 14 vials 14 vials 85,619 15,411 1,01,030

H.7.1 0.5ml 20 vials 20 vials 85,619 15,411 1,01,030

H.7.2 5.0ml 14 vials 14 vials 85,619 15,411 1,01,030

H.8

Bacillus Calmette Guerin (BCG) Vaccine

1 ml

(0.5ml-20 doses/

0.1 ml-10 doses)

57 vials 57 vials 98,155 17,668 1,15,823

H.9.1 Single dose 0.5ml 55 vials 55 vials 1,37,900 24,822 1,62,722

H.9.2 Multi dose 5.0ml 18 vials 18 vials 1,37,900 24,822 1,62,722

H.10Oral Cholera Vaccine

Single Human Dose

(SHD)20 vials 20vials 1,15,311 20,756 1,36,067

H.11 Oral Polio Vaccine 2 ml 10 vials 10 vials 77,345 13922 91267

Hepatitis A

Hepatitits B

Measles Mumps & Rubella Vaccine

Measles Vaccine

Rubella vaccine

Haemophilus Influenzae Type-b- (Hib)-TT Conjugate

Vaccine

NOTE: Under validation studies

H. VACCINES & ANTISERA LABORATORY

13





TIN - 09466201769

TESTING RETAINED


%

TOTAL TESTING

FEE

(INR)


PER BATCH

(INR)

NEW

CODE


J. THERAPEUTIC MONOCLONAL ANTIBODY LABORATORY

J.1.1 40mg/0.8ml 10 PFS 10 PFS 1,31,507 23,671 1,55,178

J.1.2 20mg/0.4ml 11 PFS 11 PFS 1,31,507 23,671 1,55,178

J.2.1 100mg/4ml 5 vials 5 vials 1,31,507 23,671 1,55,178


J.3 Etarnercept 25mg/0.5ml 9 PFS 9 PFS 1,31,507 23,671 1,55,178

J.4 Pertuzumab 420mg/ 14ml 5 vials 5 vials 1,31,507 23,671 1,55,178



J.6 Ranibizumab 23mg/230ml 16 vials 16 vials 1,31,507 23,671 1,55,178

J.7.1 100mg/10ml 5 vials 5 vials 93,701 16,866 1,10,567

J.7.2 500mg/50ml 5 vials 5 vials 93,701 16,866 1,10,567

J.8.1 150mg/7.2ml 6 vials 6 vials 1,31,507 23,671 1,55,178


J.9.1 1 ml 33 vials 33 vials 33,602 6,048 39,650

J.9.2 0.5 ml 36 vials 36 vials 33,602 6,048 39,650

J.10.1 Single dose 0.5ml 50 vials 50 vials 1,47,517 26,553 1,74,070

J.10.2 Single dose 1 ml 33 vials 33 vials 1,47,517 26,553 1,74,070

J.10.3 Multi dose 2 ml 18 vials 18 vials 1,47,517 26,553 1,74,070

J.10.4 Multi dose 3 ml 13 vials 13 vials 1,47,517 26,553 1,74,070

J.10.5 Multiple dose 10 ml 6 vials 6 vials 1,47,517 26,553 1,74,070

J.10.6 Multiple dose 40 ml 3 vials 3 vials 1,47,517 26,553 1,74,070

J.11 Rabies Immunoglobulin (Human) (RIg) (Monoclonal) 2 ml 18 vials 18 vials 1,62,103 29,179 1,91,282

J.12.1 1ml/vial 33 vials 33 vials 38,537 6,937 45,474

J.12.2 2ml/vial 18 vials 18 vials 38,537 6,937 45,474

J.13 Obinutuzumab 1000mg/40ml 4 vials 4 vials 93,701 16,866 1,10,567

J.14 Omalizumab 150mg/1ml 9 vials 9 vials 1,31,507 23,671 1,55,178

Bevacizumab

Ramucirumab

Rituximab

Trastuzumab

Anti-D Immunoglobulin, I.M (Monoclonal)

Human Hepatitis B Immunoglobulin (Intramuscular)

(Monoclonal)

Tetanus Immunoglobulin (Monoclonal),

Tetclone

Adalimumab

14





TIN - 09466201769

TESTING RETAINED


%

TOTAL TESTING

FEE

(INR)


PER BATCH

(INR)

NEW

CODE


J.15 Natalizumab 300mg/ 15ml 4 vials 4 vials 1,31,507 23,671 1,55,178

J.16 Pembrolizumab 100mg/4ml 4 vials 4 vials 1,31,507 23,671 1,55,178

J.17 Infliximab 100mg 10vials 10Vials 1,31,507 23,671 1,55,178

K.1 Cockroach Allergen - - - 87,679 15,782 1,03,461

L. Other Services

L.1

L.2

FOR PAYMENT/DEPOSIT OF TESTING FEE THOUGH BANK TRANSFER

NAME OF BANK BANK OF BARODA SECTOR-29, NOIDA (U.P)

NAME OF ACCOUNT NATIONAL INSTITUTE OF BIOLOGICALS

S.B. ACCOUNT

IFSC CODE BARB0NOIDAX (5th digit is Zero)

SWIFT CODE BARBINBBN0I (10th digit is Zero)

MICR CODE NO. 110012066

Payment can be made through Online Payment Gateway: http://www.nib.gov.in/testing_fee.htmlTesting Fees submitted Online should also be intimated to the Institute through email (1) [email protected] (2) [email protected]

TESTING FEES IS REQUIRED TO BE SUBMITTED IN ADVANCE ALONG WITH THE RESPECTIVE BATCH SENT TO THE INSTITUTE FOR TESTING

Change Control: Doc. Id: - NIB/SRRD/SQTF/2016(R-37) is superseded by NIB/SRRD/SQTF/2016 (R-38) dated 16.03.2020

NOTE: Under validation studies

K. ALLERGEN

2. Testing Fees submitted at NIB for Samples which cannot be tested at NIB can be refunded or adjusted against other samples within a month of submission of testing fee.

Scrutiny of summary batch production and quality control protocol for the purpose of batch release fee will be Rs.2360/- (including 18% GST)

For scrutinizing of technical dossiers (CMC module whenever applicable) at the time of granting marketing approval of the biological product, imported/indigenously

produced fee will be Rs.11800/- (including 18% GST)

1. Testing Fees once submitted at NIB for Samples forwarded through Zonal / Sub-zonal/ Port Offices of CDSCO which can be tested at NIB cannot be refunded.

26290100001774

Note:

15

national institute of biologicals - sample quantity required … fees.pdf · 2020-03-17 ·...

Documents