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“Indirect Tax I Indirect Tax Litigation I Customs & FTP I Central Licensing I Arbitration I Advisory”

Dated: 28.05.2026

Revised Regulatory Guidelines for Sampling of Drugs, Cosmetics & Medical Devices in India

Ensuring the quality and safety of drugs, cosmetics, and medical devices is critical for public health. The Central Drugs Standard Control Organization (CDSCO) has issued revised regulatory guidelines to streamline and rationalize the sampling procedures carried out by Drug Inspectors under Central and State Drug Authorities. These guidelines aim to maintain a centralized monthly database of Not of Standard Quality (NSQ) and spurious drugs, which is published on the CDSCO website for public awareness.

Importance of Quality Surveillance

Substandard and spurious drugs can lead to treatment failures, adverse reactions, increased morbidity and mortality, and drug resistance. Vulnerable populations are especially at risk. Effective regulation involves both pre-market approval and post-marketing surveillance, including routine sampling, quality control testing, and pharmacovigilance.

Key Objectives of Sampling

• Monitor the quality of Active Pharmaceutical Ingredients (API), excipients, and finished products throughout the distribution chain.
• Ensure control methods are satisfactory.
• Investigate NSQ products and identify unapproved or spurious products.
• Maintain vigilance on sales outlets with repeated NSQ/spurious reports.

Sampling Plan

Drug Inspectors must prepare monthly and annual sampling plans in consultation with their controlling authority. Plans should cover the entire jurisdiction, including rural and tribal areas, and focus on drugs used for endemic and seasonal diseases. Sharing annual plans with headquarters helps avoid repetitive sampling and ensures broad coverage.

Sample Selection Criteria

Samples are chosen based on risk factors, including:

1. Feedback from citizens and healthcare professionals.
2. CDSCO-provided sampling schedules for specific therapeutic categories.
3. Alerts on frequent NSQ/spurious drugs.
4. Seasonal influences (e.g., antimalarials during malaria season).
5. Brands with price variations or high consumption volumes.
6. Drugs with low potency, narrow therapeutic index, or tampered labels.
7. Products from new manufacturers or with suspicious packaging.
8. Outlets lacking proper purchase/sale records or operating outside authorized supply chains.

Drug Inspectors should apply these risk factors over a six-month period and limit sampling to three samples per outlet unless otherwise approved.

Sampling Location Selection

Locations are chosen based on:

• Frequent NSQ reports and market complaints.
• Outlets not sampled recently.
• Government and private medical stores, hospitals, wholesalers, and retailers.
• Outlets near schools, colleges, or border areas.
• Disease prevalence and seasonal needs.
• Manufacturing and distribution chain complexity.

Number and Quantity of Samples

Each Drug Inspector must collect at least 10 samples monthly:

• 9 drug samples (API, excipients, formulations)
• 1 cosmetic/medical device sample

Sample quantities vary by product type. For example, 100 tablets for Form-18 samples, 20 tablets for survey samples, and specific quantities for cosmetics, vaccines, and medical devices (see annexures for detailed tables).

Timelines for Sampling and Reporting

• Samples should be sent to laboratories on the same day or, if delayed, by the next day.
• Disclosure of purchase details is required to rule out spurious drugs.
• Drug Inspectors must obtain analysis methods and reference standards from manufacturers for timely testing.
• CDSCO Drug Inspectors use the SUGAM Lab Portal for online and offline sample submission.

Database and Monitoring

Drug Inspectors maintain monthly data on:

• Number of samples drawn and tested
• NSQ reports and actions taken (alerts, recalls, legal proceedings)
• Spurious product cases and actions (seizures, arrests, court cases)

A centralized list of outlets involved in spurious product distribution is prepared and publicized for consumer awareness.

NSQ and Spurious Alerts

• NSQ and spurious drug reports are submitted monthly in specified formats for publication on the CDSCO website.
• Spurious drugs are defined under Section 17-B of the Drugs and Cosmetics Act, 1940, including imitation, substitution, or false labeling.

Testing Laboratories

India has a network of central and state laboratories for testing drugs, cosmetics, and medical devices. States without their own labs use central facilities. Six Central Medical Device Testing Laboratories (CMDTL) are notified for device testing.

Annexures: Sample Quantities

Detailed tables specify required sample quantities for drugs, cosmetics, vaccines, biologicals, and medical devices. For example:

• Drugs: 100 tablets (Form-18), 20 tablets (survey)
• Cosmetics: 3 x 50 gm skin cream (Form-18), 1 x 50 gm (survey)
• Medical Devices: 50 hypodermic syringes (Form-18), 10 syringes (survey)

Revision History

Recent revisions include formats for NSQ and spurious alerts to enhance transparency and public awareness.

These guidelines ensure uniformity, transparency, and effectiveness in the surveillance of drugs, cosmetics, and medical devices, safeguarding public health across India.

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Source: CDSCO

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