**Policy Summary:**
This document, issued by the Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services, Ministry of Health & Family Welfare, addresses the acceptance criteria for test and examination analyzer-based glucose reagents, specifically Blood Glucose Test Strips. Dated February 16, 2016, with File No. 29Misc42013DC22, the policy clarifies the applicable standards for these test strips.
The communication states that Blood Glucose Test Strips must conform to ISO 15197. While ISO 15197:2003 has been published by the Bureau of Indian Standards (BIS), the revised ISO 15197:2013, also adopted by BIS, will only become applicable 36 months after its publication date by BIS.
The communication instructs Dr. Reba Chhabra, Head, Immunodiagnostic Kit Laboratory, National Institute of Biologicals (NIB), Plot No. A-32, Sector-62, Institutional Area, Noida-201307, U.P., to take appropriate action and release test reports of Blood Glucose Test Strips accordingly. Dr. G.N. Singh, Drugs Controller General of India, is the issuing authority.
Key Entities Referenced
Central Drugs Standard Control Organisation: A regulatory body in India responsible for the approval of drugs, medical devices and cosmetics.
Directorate General of Health Services: An attached office of the Ministry of Health and Family Welfare in India.
Ministry of Health Family Welfare: The Indian government ministry responsible for public health.
Food Drugs Administration Bhawan, Kotla Road, New Delhi: Location of Central Drugs Standard Control Organisation
Blood Glucose Test Strips: Medical devices used for measuring blood glucose levels.
ISO 15197: 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.
National Institute of Biologicals NIB, Plot No. A32, Sector 62, Institutional Area, Noida, Uttar Pradesh: An autonomous institution under the Ministry of Health & Family Welfare, Government of India, responsible for quality control of biological and in-vitro diagnostic products.
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.).