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Regulatory Guidelines for Sampling of Drugs, Cosmetics & Medical Devices
Local Title:
Regulatory Guidelines for Sampling of Drugs, Cosmetics & Medical Devices by Drugs Inspectors of Central & State Drug Authorities
Country/Region:
India
Competent Authority:
Central Drug Standards Control Organization
Type:
Guideline
Status:
In force
Release Date:
2024-02-09
Implementation Date:
2024-02-09
Document
Language Source Title Access
EN
 Official Regulatory Guidelines for Sampling of Drugs, Cosmetics & Medical Devices
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Summary

On February 9, 2024, India Central Drugs Standard Control Organization (CDSCO) unveiled the finalized version of the Regulatory Guidelines for Sampling of Drugs, Cosmetics & Medical Devices (the Guidelines), aiming to refine and standardize the sampling procedure concerning these products across the country.

The Guidelines consists of 10 parts and 5 annexes, as shown below:

  1. Introduction

  2. Sampling Plan

  3. Selection of Sample

  4. Selection of Sampling Location

  5. Number of Samples

  6. Quantity of Samples

  7. Timelines

  8. Database/ Monitoring

  9. NSQ / Spurious Alerts

  10. Testing Laboratories

  11. Annexures 1-5

Noteworthy Information