A. Sample submission requirements:

I. Essential Documents:

a. Forwarding Letter from Drug Regulatory Authority or any other statutory authority of the country which has been marked to NIB for testing/evaluation purpose.
b. Copy of Import License/Test License issued by Govt. of India

    i. Form -11 (Copy of Import License for Testing purpose)
   ii. Form -10 (Copy of Import License for Commercial purpose)
   iii. Form MD-15 (Copy of License to Import Medical Device)
   iv. Form MD-17 (License to Import Medical Devices for the purpose of Evaluation)
   v. Form MD-13 (License to Manufacture Medical Devices for the purpose of Testing)

c. Copy of Manufacturing License Issued by Govt. of India (In case of Indigenous Product) Form 25/28/29
d. Certificate of Analysis from Manufacturer in respect of the lot submitted for evaluation.
e. Batch Release Certificate (BRC) from Manufacturer/NCA/NCL of the Country of origin for the lot submitted for evaluation.
f. Pack insert and label Claim of the Product

II.  Product Specific requirements: 

    a)  Blood Products Lab- Plasma Based products: 

      1. Batch Release from the country of origin for imported samples
      2. Certification of analysis with name of pharmacopoeia complied

    b)  Biochemical kit lab (Glucose strips) 

        b1) Blood Glucose Test Strips:
                Quantity of Sample: A total of 1200 test strips for testing by laboratory & 350 test strips as retained sample by the SRRD unit.
                 Sample Accessories required:
                (i) Compatible 10 Nos. of Glucometers as a closed system
                (ii) Normal Control Solution (3 mL x 3 Vials)
                (iii) Pathological Control Solution (3 mL x 3 Vials)

        b2.1) Fully automated analyzer based Glucose Reagent- Open Ended Chemistry:
                 Quantity of Sample: 500 mL of Glucose reagent (sufficient to perform 1000 tests) for testing by laboratory & Nil for retained sample by the SRRD unit.
                 Sample Accessories required:
                (i) Calibrator
                (ii) Normal Control
                (iii) Pathological Control
                (iv) Machine protocol
Materials at (i), (ii) and (iii) to be submitted in quantity enough to last over 25 days of QC protocol execution – keeping in view the shelf life of the respective preparations.

        b2.2) Fully automated analyzer based Glucose Reagent- Closed Chemistry System:
                 Quantity of Sample: Glucose Reagents/ Test Cartridges/ Modules/ Slides/ Cassettes/ Packs/ Bottles/ Dry-chemistry Cards should be in sufficient quantity to be used for 25 working days for QC protocol execution/ 1000 tests (whichever applicable), irrespective of number of tests possible from each unit/pack/cartridge, keeping in view the on-board shelf life of the respective preparations & Nil for retained by SRRD unit.
                 Sample Accessories required:
                (i) Temporary installation of the Automated Analyzer
                (ii) ‘Calibrator’ preparation
                (iii) ‘Normal’ control preparation
                (iv) ‘Pathological’ control preparation
                 (v) Equipment related consumables- sample cups/ printer paper/ maintenance reagents/ solutions.
                (vi) Service/ technological/ training support with respect to the use of the equipment.
Materials at (ii), (iii), (iv) and (v) to be submitted in quantity enough to last over 25 days of QC protocol execution – keeping in view the on-board shelf life of the respective preparations.

        b3) Glucometer Device:
                 Quantity of Sample: Glucometer Devices 10 Nos. required for testing by laboratory and 2 Nos. shall be kept for taking care of exigencies as malfunction etc. to be retained in SRRD Unit.
                 Sample Accessories required:
                (i) Specific Blood Glucose Test Strips as accessory 1200 Strips
                (ii) Level 1 (Normal) Control solution 3ml x 3 vials per model
                 (iii) Level 2 (Pathological) Control Solution 3ml x 3 vials per model.

 

    B. Testing fee requirements: 

    Testing Fee Details 

   Payment modes: 

     1. 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  :  26290100001774 

        IFSC CODE  :   BARB0NOIDAX 

        SWIFT CODE  :   2BARBINBBNOI

       MICR CODE NO.  :   110012066

       PAN -AAATN5228R 

       GSTIN -09AAATN5228R1ZX 

       ST No.-AAATN5228RST001 

       TIN -09466201769

 

 2.  Net banking :  Payment of Testing Fees/Charges through Net Banking

     Note:

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

       b) 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. 

      c) 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. 

      d) Testing Fees submitted Online should also be intimated to the Institute through email (1) srrd@nib.gov.in (2) sksharma@nib.gov.in 

 

C. Sample forwarded under the Drugs & Cosmetics Act: Govt. Analysts under schedule C1 as per the Gazette notification are notified for the below mention class of drugs. Government Analyst

D. Documentation and Archiving: All documents and records are kept in compliance to ISO: 17025.

E. Surveillance: Complete Unit is under CCTV Surveillance for necessary security and maintenance of samples and records.

F.Customer feedback: is always acknowledged. Submission of feedback should be marked at srrd@nib.gov.in. Further a Suggestions / Complaints / Feedback Register has also being placed in the Unit for necessary redressal.