Last Updated on May 28, 2026 by The Health Master

Guidelines for Sampling

The Central Drugs Standard Control Organisation (CDSCO) has issued uniform guidelines for sampling of Drugs, Cosmetics and Medical Devices to ensure the continuous availability of safe, effective, and high-quality medicines.

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Download the CDSCO Guidelines for Sampling of Drugs, Cosmetics and Medical Devices

Substandard / Not of Standard Quality (NSQ), and spurious drugs pose severe risks. They lead to treatment failure, adverse drug reactions, increased morbidity, and the accelerated development of antimicrobial resistance.

CDSCO establishes the protocols for sampling from a random exercise to a structured, risk-based methodology.

1. The Core Objectives of Market Surveillance

The central purpose of pharmaceutical sampling is to verify that drugs, medical devices, and cosmetics available to the public align strictly with their approved specifications. This comprehensive surveillance strategy focuses on:

• Shelf-Life Monitoring: Continuous assessment of Active Pharmaceutical Ingredients (APIs), excipients, and finished formulations across every tier of the supply chain throughout their authorized shelf-life.
• Method Evaluation: Confirming that existing quality control and analytical methods remain robust and accurate.
• Investigating Faulty Batches: Rapidly evaluating products flagged as Not of Standard Quality (NSQ) to prevent further distribution.
• Rooting Out Illicit Trade: Systematically identifying unapproved products, unlicensed retail outlets, and counterfeit/spurious operations in the distribution chain.
• Vigilance Mapping: Creating a database of sales outlets that repeatedly stock non-compliant or spurious items to maintain targeted regulatory oversight.

2. Implementing a Strategic Sampling Plan

Historically, sample collection relied heavily on the individual knowledge of separate Drugs Inspectors / Drugs Control Officer, frequently leading to a data bias.

Surveillance was predominantly concentrated on well-known brands in accessible urban or suburban hubs, leaving rural, interior, and tribal regions largely unassessed.

To build a balanced, comprehensive database, each Drugs Inspector / Drugs Control Officer in coordination with their controlling authority, must now design structured monthly and annual sampling plans.

Drug Inspector / Drugs Control Officer & Controlling Authority ➔ Develops Monthly/Annual Sampling Plan ➔ Shared with HQ to Prevent Brand Duplication ➔ Wide Territory Coverage (Urban, Rural, Tribal)

This planning ensures optimal resource allocation, eliminates duplicate testing of identical commercial brands, and mandates the inclusion of seasonal or regional disease-specific therapies.

Must read: Drug Alert: NSQ Drugs Lists – Updated

3. Risk-Based Sample Selection Criteria

Rather than picking products at random, regulatory officials utilize a set of distinct risk factors to guide their selections.

A single sales outlet can be sampled for multiple therapeutic categories, formulations, and manufacturers based on these indicators:

Field and Consumer Intelligence

• Direct feedback or efficacy complaints received from healthcare professionals, medical representatives, consumers, or public media channels.
• Mandated surveillance schedules or surprise check schedules issued directly by the CDSCO.
• A history of frequent alerts or quality deviations noted in the centralized CDSCO and State Drug Authorities databases.

Market and Pricing Anomalies

• Identical product brands sold at drastically fluctuating price points targeting distinct market segments.
• Pharmaceuticals heavily discounted or sold outside standard ethical commercial practices.
• High-consumption volume products or medications that have a naturally narrow therapeutic index and low potency threshold.
• Products entering the market via secondary, unauthorized supply routes that bypass the traditional Super Stockist ➔ Stockist ➔ Wholesaler ➔ Retailer pipeline.

Visual and Physical Discrepancies

• Tampered product labels, spelling mistakes, missing critical batch parameters, or illegible product descriptions.
• Substandard primary packaging that compromises the formulation’s stability during seasonal environmental shifts.
• Imitations or physical packaging designs that closely resemble well-known, established pharmaceutical brands.

Regulatory Cap: To maintain a fair and effective monitoring system, Drugs inspectors / Drugs Control Officers are instructed to utilize these risk indicators over a rolling 6-month window, limiting standard collections to a maximum of three samples per retail outlet unless special approval is recorded.

4. Selecting Strategic Sampling Locations

To guarantee that the quality of medicines remains uncompromised at the final point of consumption, sample collection locations must span a varied geographic and operational spectrum. High-priority testing areas include:

• Locations with frequent historical NSQ reports or unresolved consumer complaints.
• Manufacturing sites and commercial outlets that have not been audited or sampled within the past calendar year.
• Government Medical Store Depots (GMSDs), public sector manufacturing units, and state or central government hospital pharmacies handling local procurement.
• Non-traditional sales premises, including outlets operating exclusively during non-standard morning/evening hours, facilities near schools or colleges, and border-zone retailers.
• Regions undergoing seasonal disease outbreaks or pandemics where specific target therapies face sudden high demand

5. Mandatory Protocols: Quantities and Timelines

To uphold administrative and legal validity under Sections 22 and 23 of the Drugs & Cosmetics Act, 1940, strict compliance regarding quantities, documentation, and transfer timelines is mandatory.

Minimum Sampling Quotas

Each Drug inspector / Drugs Control Officer must collect a minimum of 10 samples per month. This quota is divided into:

• 09 Samples: Distributed across Active Pharmaceutical Ingredients (APIs), excipients, and finished therapeutic formulations.
• 01 Sample: Dedicated exclusively to cosmetics or registered medical devices.

Managing Quantity Deficiencies

Surveillance requires adequate sample portions to accommodate full analytical testing and potential re-testing before an official NSQ declaration can be made.

However, smaller rural or retail counters may lack the stock required for standard four-part divisions.

In these scenarios, Drug Inspectors / Drugs Control Officer can implement a reduced testing protocol focused primarily on product identification and active assays to instantly rule out spurious formulations.

Streamlined Operational Timelines

To maximize public safety, administrative delays must be minimized so that product recalls and drug alerts can be executed immediately.

Step in Surveillance Process: Compulsory Timeline / Protocol

Laboratory Forwarding: Samples must be dispatched to the laboratory on the exact day of collection.

Transit Adjustments: Distant or remote rural collections must reach the testing laboratory no later than the following day.

Supply Chain Verification: Full tracing under Section 18A must be initiated during sampling to establish a clear paper trail from retailer to original manufacturer.

Analytical Standards: For proprietary or newly approved molecules, the Drug Inspector / Drugs Control Officer must secure the method of analysis and reference standards from the manufacturer immediately for the testing facility.

Note: CDSCO field officers utilize the unified SUGAM Lab Portal to generate electronic Forms 17, 17A, and 18, ensuring rapid synchronization between digital trails and offline sample delivery.

6. Official Specifications: Sample Requirements for Analysis

The following verified testing thresholds outline the precise quantities required by state and central laboratories to perform exhaustive analytical assessments:

Finished Pharmaceutical Formulations & APIs     

Quantity of Drugs Sample Required For Complete Analysis

S. No.	Name of Drug Sample	Legal Samples	Survey Samples
1.	Tablets	100 Tablets	20 Tablets
2.	Capsules	100 Capsules	20 Capsules
3.	Syrups / Oral Liquids / Suspensions	12 Bottles	2 Bottles
4.	Injection (Ampoule) (1-10 ml)	40 Ampoules	10 Ampoules
5.	Injection (Ampoule) (10-100 ml)	25 Ampoules	10 Ampoules
6.	Large Volume Parentrals (more than 100 ml )	10 Bottles	2 Bottles
7.	Powder for injection ( Sterile)	40 Vials	5 Vials
8.	Dry Powder for Oral/ Liquid Suspension	25 Bottles	5 Bottles
9.	Oral Rehydration Salt Sachets	30 Pcs	5 Pcs
10.	API Drug	2 x 10 gm	5 gm
11.	Ointment / Creams / Paste / Gel (Non Sterile)	12 Pcs	2Pcs
12	Ointment / Creams / Paste / Gel (Sterile)	20pcs	5pcs
13.	Eye / Ear Drops	40 Vials/ pcs	5 Vials/ pcs
14.	Nasal Preparation	20 Vials	5 Vials
15.	Inhalers/ Spray	40 Pcs	5 Pcs
16.	Pessaries / Lozenges	60 Pcs	20 Pcs
17.	Empty Gelatine Capsules	500 Capsules	100 Capsules

Cosmetic Formulations

Quantity of Cosmetics Sample Required For Complete Analysis

S. No	Name of Cosmetic Sample	Legal Samples	Survey Samples
1.	Skin Cream	3 x 50 gm	1 x 50 gm
2.	Hair Cream	3 x 50 gm	1 x 50 gm
3.	Shampoo	3 x 200 ml	1 x 200 ml
4.	Soap	3 x 150 gm	1 x 150 gm
5.	Transparent Toilet Soap	3 x 150 gm	1 x 150 gm
6.	Tooth Powder	3 x 50 gm	1 x 50 gm
7.	Shaving Cream	3 x 15 gm	1 x 15 gm
8.	Cosmetic Pencil	20 Pencils	5 Pencils
9.	Hair Dyes (Liquid, Gel & Cream)	3 x 100 ml	1 x 100 ml
10.	Powder Hair Dyes	4 x 20 gm	1 x 20 gm
11.	Liquid Toilet Soap	3 x 100 ml	1 x 100 ml
12.	Bathing Bar	3 x 75 gm	1 x 75 gm
13.	Hair Oil	3 x 50 ml	1 x 50 ml
14.	Lipstick	15 Packs	5 Packs
15.	Nail Polish	15 Packs	5 Packs
16.	Talcum Skin powder	3 Packs	1 Pack
17.	Kajal	10 Packs	1 Pack
18.	Any other cosmetic	3 Packs	1 Pack

 

Medical Devices

Quantity required for Complete Analysis of Medical Device Samples

S. No	Name of Medical Device	Legal Samples	Survey Samples
1.	Hypodermic Syringe	50 pcs	10 pcs
2.	Hypodermic Needle/Disposable Syringe Needles	50 pcs	10 pcs
3.	Infusion Set/Transfusion Set	50 pcs	10 pcs
4.	IV Cannulas	50 pcs	10 pcs
5.	Roll Bandage/Surgical Dressings	20 pcs	10 pcs
6.	Sterile Gauze Swab	50 pcs	10 pcs
7.	Surgical Suture (absorbable)	50 pcs	30 pcs
8.	Surgical Suture (Non-absorbable)	50 pcs	30 pcs
9.	Medicated Tape (Band-aid)	100 pcs	20 pcs
10.	Absorbent Cotton Wool I.P.	200 gm	100 gm
11.	Catheter or Ryles Tube	30 pcs	10 pcs
12.	Tubing for Micros-surgery or Endoscope	50 pcs	10 pcs
13.	Male Rubber Latex Condoms	100 pcs	100 pcs
14.	Copper T	120 pcs	20 pcs
15.	Tubal Rings	100 pcs	20 pcs
16.	Blood Bags	10 bags	5 bags
17.	Absorbent Sponge	50 pcs	5 pcs

 

 7. Centralized Monitoring

Data collected from ongoing field sampling feeds directly into centralized safety channels.

Every month, field offices compile comprehensive registries detailing total samples collected, finalized laboratory outcomes, and verified supply chains.

The Monthly Drug Alert System

When a batch fails to meet standard criteria, the results are formatted and sent ahead by the 10th of every month for publication on the official CDSCO portal.

If a batch is confirmed as Spurious (as defined under Section 17-B of the Act due to identity theft, imitation, or fictitious manufacturer labeling), a public alert is generated.

This alert links the manufacturer’s technical data with clear guidance on how stakeholders can distinguish authentic products from identified market counterfeits safeguarding public health at scale.

Note: Must read the CDSCO guidelines for full detail, link given above.

Compiled by:
Rakesh Dahiya, Asstt. State Drugs Controller, FDA Haryana