Guidelines for Sampling Cosmetics and Drugs Introduced in India

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Introduction

The Guidelines introduce a uniform drug sampling methodology to ensure effective surveillance of the quality and efficacy of drugs and cosmetics in the market.

Sampling plan

Drug inspectors must collaborate with their controlling authority to prepare monthly and annual sampling plans, ensuring efficient use of resources and communication, and share them with headquarters for review and variety.

Selectionof Sampling

Drugs Inspectors select samples from different therapeutic categories, formulations, and manufacturers, ensuring all identified risks are utilized for six months, and excess sampling must be approved by the controlling authority.

Selection of sampling location

A list of approaches is provided in this section which is not exhaustive and is only indicative

Number of Samples

Each Drugs Inspector shall collect at least 10 samples per month comprising of following:

a. 9 samples of drugs (Active Pharmaceutical Ingredients (API), excipients and formulations)

b. 1 sample of cosmetics/ medical device.

Quantity of Samples

Samples are essential for laboratory testing and re-testing, with quantities varying. Insufficient samples may result in reduced testing, with portions divided into primary/secondary labels.

Timelines

To avoid delays in testing and laboratory reports, it is critical that drug alerts and product recalls are issued promptly to stop the use of identified NSQ products.

Database/Monitoring

Drugs Inspectors must submit monthly sampling data to their authority for execution and use this data to plan the next month's sampling plan.

NSQ / Spurious Alerts

NSQ reports from state and central laboratories must be submitted in the Excel format given in this section, with test reports preferably uploaded on the CDSCO website by the 10th of each month.

Testing Laboratories

List of testing laboratories at central and state level