India Introduces Regulatory Guidelines for the Sampling of Cosmetics and Drugs

The comprehensive Guidelines covers various aspects of sampling, including sampling plans, sample selection, sampling location selection, sampling batch quantity and sample quantity, timelines, testing laboratories, etc.

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.

Comprising 10 parts and 5 annexes, this comprehensive Guidelines covers various aspects of sampling, including sampling plans, sample selection, location selection, sample numbers and quantities, timelines, testing laboratories, etc.

Key Highlights of the Guidelines

1. Addressing Methodological Gaps: The Guidelines rectifies the previous lack of a defined methodology for the selection of sampling products and locations. A uniform drug sampling methodology is adopted to ensure effective surveillance of the quality and efficacy of drugs and cosmetics available in the market.

2. Informed Sampling Decisions: Unlike the past, where sampling (e.g., the selection of sampling products and locations) was based on the knowledge of the drug inspector, the new Guidelines uses available information and identified risks to guide sampling decisions, enabling the comprehensive coverage of drugs, cosmetics, and medical devices nationwide.

3. Structured Sampling Plans: The Guidelines mandates the preparation of monthly and annual sampling plans by drug inspectors in consultation with the controlling authority. These plans cover the entire jurisdiction or area under their office, including rural and tribal areas and regions endemic to certain diseases. The annual sampling plan shall be shared with the headquarters of their offices for review, to avoid repetitive sampling of one brand and to ensure a comprehensive coverage of brands and/or categories in the proposed sampling schedule.

4. Sampling Numbers: Each month, a minimum of 10 samples must be collected, comprising 9 samples of drugs and 1 sample of cosmetics or medical devices.

5. Sampling Quantities: The Guidelines specifies the quantities of samples required for complete analysis of various cosmetics, as shown in the table below.

S.N.	Name of Cosmetic Sample	Form-18 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 gm	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 cosmetics	3 Packs	1 Pack

6. Sampling Timelines: Collected samples shall be delivered to the laboratory on the same day as sampling. In case of delays due to transit from rural or distant locations to the office, samples must be delivered no later than the following day to ensure timely and efficient processing.