Regulatory Focus™ > News Articles > India’s CDCSO Establishes New Testing Requirements for Blood Glucose Strips

India’s CDCSO Establishes New Testing Requirements for Blood Glucose Strips

Posted 11 August 2014 | By Louise Zornoza

India’s CDCSO Establishes New Testing Requirements for Blood Glucose Strips

India’s Central Drugs Standard Control Organization (CDSCO) is looking to tighten the regulation of blood glucose testing supplies, it announced last week.

In a 7 August 2014 notice issued to all local State Drugs Controllers and port authorities, CDSCO ordered that importers and manufacturers of blood glucose test strips and analyzer based glucose reagents must provide three batches for testing at the National Institute of Biologicals in Noida. 

Following the testing, a Performance Evaluation Report must be submitted by the importer or manufacturer with the import application or marketing authorization to the appropriate local authority. 

The new requirements were recommended by CSDCO’s expert advisory committee.

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