India CDSCO Revises Regulatory Guidelines for Sampling of Drugs, Cosmetics and Medical Devices

On May 26, 2026, the Central Drugs Standard Control Organisation (CDSCO) of India released the revised Regulatory Guidelines for Sampling of Drugs, Cosmetics and Medical Devices by Drugs Inspectors of Central and State Drug Authorities, superseding the original version issued in February 2024. The revised guidelines retain the existing framework while introducing a new NSQ (Not of Standard Quality) Alert format (Annexure-6) and a Spurious Alert format (Annexure-7), requiring drugs inspectors to submit monthly reports on non-compliant and spurious products in a standardized format to strengthen post-market surveillance and regulatory transparency. CIRS Group has summarized the key provisions relevant to cosmetics below.

Background

The quality and safety of drugs, cosmetics, and medical devices directly impact public health. Sections 22 and 23 of the Drugs and Cosmetics Act, 1940 prescribe the procedures for sampling by Drugs Inspectors of Central and State authorities. However, historically, India's sampling practices have suffered from inconsistent methodologies, a high degree of randomness, inadequate coverage of remote areas, and in some regions, a complete absence of cosmetics sampling. There has also been a lack of a centralized database for non-compliant and spurious products.

To address these issues, CDSCO first published unified sampling guidelines in February 2024 to standardize sampling methods and enhance post-market quality surveillance. The revised version released on May 26, 2026, builds upon the original by adding structured reporting formats for non-compliant and spurious products.

Guideline Framework Overview

The revised guidelines comprise 10 chapters and 7 annexures:

• Chapter 1: Introduction
• Chapter 2: Sampling Plan
• Chapter 3: Selection of Sample
• Chapter 4: Selection of Sampling Location
• Chapter 5: Number of Samples
• Chapter 6: Quantity of Samples
• Chapter 7: Timelines
• Chapter 8: Database/Monitoring
• Chapter 9: NSQ/Spurious Alerts
• Chapter 10: Testing Laboratories
• Annexure 1: Quantity of Drugs Sample Required for Complete Analysis
• Annexure 2: Quantity of Cosmetics Sample Required for Complete Analysis
• Annexure 3: Quantity of Vaccine Sample Required for Complete Analysis
• Annexure 4: Quantity of Biological/Medical Device Samples
• Annexure 5: Quantity of Medical Device Samples
• Annexure 6: NSQ Alert Format (New)
• Annexure 7: Spurious Alert Format (New) 

Cosmetic Sampling Requirements 

Cosmetic Sample Quantities (Annexure 2) 

Annexure 2 specifies the required quantities for 18 categories of cosmetics:

NSQ Reporting Format Update (Key Revision)

The core change in this revision is the introduction of Annexure-6 (NSQ Alert format) and Annexure-7 (Spurious Alert format).

The CDSCO Enforcement Division requires that NSQ reports from central and state laboratories be submitted in the Excel format specified in Annexure-6, accompanied by a copy of the test report, preferably before the 10th of each month, for uploading to the CDSCO website as "Drug/Device/Cosmetic NSQ Alert" for public awareness.

The revised monthly NSQ report requires the following fields:

• Product Type
• Name of Product
• Brand Name
• Dosage Form
• Route
• NSQ Keyword
• Manufacturer Name
• Manufactured By
• Manufacturing State
• Manufacturing Date
• Expiry Date
• Reporting Source
• Reported by Lab/State
• Reporting Month & Year
• Batch No.
• NSQ Result
• Modified Dosage Form (if applicable)

Compared to the previous format, which only required basic information such as product and drug name, batch number, manufacturing and expiry dates, manufacturer details, NSQ result, and the reporting laboratory, the revised format significantly expands the level of detail, enabling more precise traceability and identification of non-compliant products.

Spurious Product Reporting Format (New)

Annexure-7 introduces a new reporting format for spurious products. The definition of "spurious" is based on Section 17-B of the Drugs and Cosmetics Act, 1940, and includes products manufactured under another drug's name, imitations or substitutes of other products, products bearing the name of a fictitious or non-existent manufacturer, products substituted wholly or in part by another substance, or products purporting to be from a manufacturer that did not actually produce them.

The revised spurious alert format requires: product name, batch number, manufacturing date, expiry date, manufacturer (marked as "under investigation"), reason for failure, sampling authority, firm's reply, and remarks. When spurious products are identified, Drugs Inspectors must attach a distribution chain break report and the original manufacturer's guidance on how to distinguish genuine products.

CIRS Reminder

The revised CDSCO sampling guidelines significantly strengthen post-market surveillance of drugs, cosmetics, and medical devices in India through structured NSQ and spurious product reporting mechanisms. Cosmetics enterprises exporting to India should pay attention to the following:

1. Monitor the NSQ public alert system. The revised guidelines require monthly publication of NSQ alerts on the CDSCO website. Companies should regularly check the CDSCO portal to stay informed about whether their own products or similar products have been listed, enabling prompt response.

2. Ensure product quality compliance. Indian Drugs Inspectors select samples based on a risk-based approach, focusing on consumer feedback, products and brands with frequent NSQ reports, and products from new manufacturers. Companies should maintain consistent product quality, ensure label compliance, and avoid becoming high-risk sampling targets. Companies should also familiarize themselves with the sampling quantities for each product category and maintain adequate retained samples in the Indian market to facilitate potential testing requirements.

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.

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Further Information:
Regulatory Guidelines for Sampling of Drugs, Cosmetics and Medical Devices