**Summary:**
This policy directive, issued by the Central Drugs Standard Control Organization (CDSCO), Ministry of Health and Family Welfare, addresses the specifications and criteria for acceptance of blood glucose test strips and analyzer-based glucose reagents in India. Effective November 1, 2014, manufacturers and importers of these products are required to have three batches of their products evaluated at the National Institute of Biologicals (NIB), Noida, prior to being granted a license for import, manufacture, or sale within the country. A Performance Evaluation Report from NIB must be submitted to the concerned Licensing Authority along with the license application. The specifications and acceptance criteria mandate that the accuracy of blood glucose test strips meet the ISO 15197:2003 standard, with maximum allowable deviation of less than 15% at glucose concentrations ≥75mg/dL and within 20% at glucose concentrations <75mg/dL, aligning with World Health Organization (WHO) guidelines for laboratory diagnosis and monitoring of Diabetes Mellitus, 2002. Inquiries can be directed to the Drugs Controller General at the CDSCO headquarters in New Delhi.
Key Entities Referenced
Central Drugs Standard Control Organization: A national regulatory body for pharmaceuticals and medical devices in India.
Ministry of Health Family Welfare: The Indian government ministry responsible for health policy.
Blood Glucose Test Strip: A medical device used to measure blood glucose levels.
Analyzer Based Glucose Reagents: Reagents used in laboratory analyzers to measure glucose levels in blood samples.
NIB, Noida: National Institute of Biologicals, located in Noida, Uttar Pradesh, India, is a testing laboratory for biological products.
Uttar Pradesh: A state in India where Noida is located.
IS0 15197:2003: An international standard related to in vitro diagnostic test systems requirements.
World Health Organization: The directing and coordinating authority on international health within the United Nations system.
Central Drugs Standard Control Organization
Directorate General of Health Services
Ministry of Health & Family Welfare
(Medical Devices Division)
Food & Drugs Administration Bhawan,
Kotla Road, New Delhi-110002
File No. 29/Misc./3/2014-DC (36) Date: E7 AUG 2014
To
4. All State/UTs Drugs Controllers
2. All zonal/sub-zonal/port offices of CDSCO
Subject: “Specification” and “Criteria for Acceptance” for test performed on blood
glucose test strip and analyzer based glucose reagents- Reg.
Sir,
In order to finalize the specification and criteria for acceptance of "Blood Glucose
Test Strip” and “Analyzer Based Glucose Reagents”, a meeting of the expert committee
was held and It was decided that before grant of license to import/ manufacture for sale of
such products in the country, evaluation of three batches of such products are required to
be done at NIB, Noida in addition to the random samples from the market.
In view of above, you are requested to direct all the importers/manufacturers that
w.ef, 01.11.2014, in case of “Blood Glucose Test Strip” and "Analyzer Based Glucose
Reagents”, three batches of the products should be got evaluated at NIB, Noida and
Performance Evaluation Report should be submitted to the concerned Licensing Authority
alongwith the application before considering such applications for grant of license to
import/manufacture for sale of the products in the country.
Yours faithfully,
(Dr. GIN. Singh)
Drugs Controller/General (I)
Copy to:
1, Medical Device & Diagnostics Associations: FICCI/CIl/ ADMI etc.
C.C.:
PS to JS(R)National
Institute of
Biologicals
(Ministry of Health & Family Welfare)
A-32, Sector-62,
NOIDA-201 309 (UP)
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_