Last Updated on January 21, 2025 by The Health Master
New guidelines
New guidelines: Now a days the global health crisis is Antimicrobial Resistance (AMR) which is a big threat to treating infections effectively.
In India, this challenge is compounded by The misuse and overuse of antibiotics is a big challenge in India, which often leads to an inaccurate and delayed diagnosis and treatment.
To overcome this issue, we need soem diagnostic instruments, kits, etc. that are affordable and have the capacity to give accurate results.
CDSCO: New Guidelines
In this regard, the Central Drugs Standard Control Organisation (CDSCO) has issued new guidelines for the development and validation process of rapid diagnostics for the identification of pathogens and testing of antimicrobial susceptibility (AST).
These new guidelines are a joint effort between CDSCO, the Indian Council of Medical Research (ICMR), and leading experts that aim to:
- Streamlining the regulatory process: By establishing a clear and standard framework for reviewing the tests on diagnostics, the new guidelines simplify the way to market approval for innovators.
- Encouraging innovation: The new guidelines give encouragement to the developers with the knowledge and provide new tools to develop diagnostics that are of good quality and affordable to the healthcare system.
- Improving the accuracy of diagnostics: The main aim is accuracy in validation, which ensures that only accurate and effective tests will enter the market, which leads to more accurate diagnosis and later the best treatment.
Key Features of the New Guidelines:
Comprehensive Framework:
The new guidelines give a systematic process for evaluating the performance of the diagnostics, which covers as under:
- Precision: The consistency of test results when repeated on the same sample.
- Accuracy: The ability of the test to identify the target pathogen correctly and detect AMR genes.
- Reproducibility: The consistency of results when the test is performed in different laboratories or by different operators.
- Clinical utility: The ability of the test to give appropriate clinical decision-making.
Clear Acceptance Criteria:
The new guidelines provide specific performance thresholds and acceptance criteria that ensure that only effective and safe diagnostics are approved.
Focus on Emerging Technologies:
The new guidelines are designed to be adaptable and accommodate advancements in diagnostic technologies, e.g., molecular diagnostics and artificial intelligence.
1. What is the significance of these new guidelines for AMR control in India?
These new guidelines are a very important step towards combating AMR in India. By establishing a clear and standard framework for reviewing the tests on diagnostics, the new guidelines simplify the way to market approval for innovators.
2. How will these new guidelines benefit diagnostic developers?
Precision: The consistency of test results when repeated on the same sample.
Accuracy: The ability of the test to identify the target pathogen correctly and detect AMR genes.
Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.
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