**Summary:**
This document, dated February 16, 2016, from the Central Drugs Standard Control Organisation (CDSCO), addresses the acceptance criteria for test and examination analyzer-based glucose reagents. Specifically, it concerns the implementation of standards for blood glucose test strips.
The communication clarifies that blood glucose test strips shall conform to ISO 15197. While ISO 15197:2003 is published by the Bureau of Indian Standards (BIS), the revised ISO 15197:2013, also adopted by BIS, will become applicable 36 months after its publication date by BIS.
Dr. G.N. Singh, Drugs Controller General of India, directs Dr. Reba Chhabra, Head of the Immunodiagnostic Kit Laboratory at the National Institute of Biologicals (NIB) in Noida, U.P., to take appropriate action and release test reports of blood glucose test strips accordingly. The NIB's address is Plot No. A32, Sector-62, Institutional Area, Noida-201307, U.P. The document references an email dated January 27-28, 2016, regarding this matter. The file number for this communication is 29Misc42013DC22.
Key Entities Referenced
Central Drugs Standard Control Organisation: A regulatory body in India responsible for the approval of drugs, diagnostics, and medical devices.
Directorate General of Health Services: An attached office of the Ministry of Health and Family Welfare in India.
Ministry of Health Family Welfare: A government ministry in India responsible for public health.
Blood Glucose Test Strips: Medical devices used for measuring blood glucose levels.
ISO 15197: An international standard for in vitro diagnostic test systems - requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus.
Bureau of Indian Standards: The National Standards Body of India responsible for standardization, marking and quality certification of goods.
Dr. G.N. Singh: Drugs Controller General of India
National Institute of Biologicals NIB, Noida, Uttar Pradesh: An autonomous institution under the Ministry of Health & Family Welfare, Government of India, that serves as the apex body for quality control of biologicals in India.
Central Drugs Standard Control Organisation
Directorate General of Health Services
Ministry of Health & Family Welfare
(Medical Devices & Diagnostics Division)
Food & Drugs Administration Bhawan,
Kotla Road, New Delhi-110002
File No.: 29/Misc/4/2013-DC(22)
Date: 16 FEB 2016
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Subject: Acceptance criteria for test and examination
& Analyzer based glucose reagent-Reg. ,
Please refer to your email dated 27 & 28 Jan. 2016 with regard to implementation of
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decided that there is IS!SO-15197:2003 is published by BIS. Therefore the Blood Glucose
test Strips shall conform only ISASO-15197.
As regard.
of Blood Glucose Test Strips’
to revised ISO-15197:2013 published in 2013 which also adopted by
Bureau of Indian Standards (BIS) for evaluation of Blood glucose test strips. Therefore the
revised IS/ASO-15197:2013 will be applicable only after 36 months from the date of its
publication by BIS.
In view of above, you are requested to take appropriate action and release test
reports of Blood glucose test strips accordingly.
: (Dr. G.N.Singh)
Drugs Controller Geyeral (India)
To,
Dr. Reba Chhabra,
Head, immunodiagnostic Kit Laboratory,
National Institute of Biologicals (NIB),
Plot No. A-32, Sector-62, Institutional Area,
Noida-201307 (U.P.).