Introduction

The Biochemical Kit Laboratory is notified by the Government of India as Central Drugs Laboratory (CDL) for quality control evaluation of Blood Glucose Test Strips and Fully Automated Analyzer based Glucose Reagents. The laboratory also tests Glucometer samples. The Laboratory has been delivering on its mandate since 2010 with a view to regulate the quality of blood Glucose measuring systems as Fasting/ PP blood Glucose values of an individual is an important investigation related to diagnosis and monitoring of Lifestyle associated disorders in the modern world. It has the infrastructure and expertise for testing Product batches of ‘Glucometers’, ‘Blood Glucose Test Strips’ & ‘Open-ended and Closed- Chemistries of Glucose Reagents’. Since a large majority of these Medical Devices are imported and arrive from diverse parts of the globe and obscure regulatory environments, assessment of their performance parameters is required to ensure quality and reliability of such products. As there are no statutory standards laid down in the Indian Pharmacopoeia or any other pharmacopoeia for testing Medical Devices in this category, the Laboratory uses guidelines developed by ISO and CLSI for evaluating various parameters related to their Performance characteristics. The laboratory uses the ‘Method Comparison’ principle for evaluating the ‘Accuracy’ of these devices using a Laboratory Reference Method whose performance is subjected to continuous validation using SRM from NIST, USA and Calibrator Material that are traceable to International Reference Measurement procedures.

Notification

Laboratory was notified as CDL vide Gazette No. G.S.R. 908(E), dated, 22nd December, 2014 Subsequently, it was notified as CMDTL vide Gazette No. S.O.223T(E), dated, 1st June 2018

Accreditation

The Laboratory has been accredited by NABL for conforming to ISO/IEC 17025:2017 standards for testing of Fully automated analyzer-based Glucose Reagents and Blood Glucose Test Strips/ Glucometers vide Certificate No. TC-7725

Batch Release Testing

The Laboratory uses QC protocols that are based on International guidelines as ISO15197: 2013, CLSI EP9-A2, CLSI EP6-A and CLSI EP5-A2 for evaluating the performance related parameters as; Precision, System Accuracy, Bias, Linearity and Analytical Measurement Range of the different Product Batch samples. The laboratory also has notified Government Analyst and notified Medical Device Testing Officer for receiving samples on FORM 18 and FORM MD-38.

Monographs

The Products tested by the Laboratory fall under the category of Medical Devices that are not listed in the Indian Pharmacopoeia or any other Pharmacopoeia.

Training

The Biochemical Kit Laboratory has been imparting Training under the National Skill Development & Hands-on Training programme organized by National Institute of Biologicals, NOIDA to Post-graduate students from various Universities. It has also been training and sensitizing people from Indigenous Glucometer Device Industry and other Apex Testing Laboratories on aspects of LQMS and QC Protocols related to performance evaluation of analytical tests.