CDSCO Issues Draft Guidance on Risk-Based Approach for Monitoring Quality at Ports of Import: An Overview
The Central Drugs Standard Control Organization (CDSCO) has released a draft “Guidance Document on Risk-Based Approach for Monitoring Quality at the Ports of Import” for feedback. The document outlines a comprehensive strategy to regulate the import and export of drugs, cosmetics, and medical devices in India, using a risk-based approach to ensure public health safety. This draft is open for public comments and suggestions, which can be submitted to the office of the Drugs Controller General of India within 30 days.
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Key Points from the Draft Guidance:
CDSCO Port Officers will oversee the quality monitoring of imports based on the Drugs & Cosmetics Act and advise Customs Authorities in cases of non-compliance with Section 10 of the Act.
The risk-based approach streamlines quality assurance by focusing on high-risk products, ensuring that limited resources are used effectively.
The approach involves a three-tiered sampling strategy:
- Tier 1: Desktop and visual inspections to identify potential quality issues.
- Tier 2: Field-based testing for suspicious samples.
- Tier 3: Comprehensive compendial testing for high-risk or failed samples.
This initiative aims to strengthen public health protection by ensuring that imported drugs, cosmetics, and medical devices meet the required quality standards.
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Linkt to download the “Guidance Document on Risk-Based Approach for Monitoring Quality at the Ports of Import”
