India: Sampling Regulatory Framework for Drugs, Cosmetics, & Medical Devices for Drug Inspectors (9 February 2024)

The Central Drugs Standard Control Organization (CDSCO) released a circular of the regulatory guidelines for the sampling procedure of the drugs, cosmetics, and medical devices and consolidated monthly records of the Not of Standard Quality (NSQ) or Spurious drugs to be published on the CDSCO website.

A few key factors were lined up in the guidelines to guide drug inspectors during the sampling: Sampling Plan, Selection of Samples, Selection of the Sampling Location, Number of Samples, Quantity of Samples, Timelines, Database/Monitoring, Testing Laboratories

Sampling Plan

Drug Inspectors are advised to prepare sampling plans on monthly basis with the consultation of the controlling authority and prepare finalized sampling locations annually. All rural, tribal areas and drugs to be used in the endemic areas for certain diseases and seasonal diseases must be included in the sampling plan.

Selection of Samples

Drug Inspectors should identify various factors that may indicate the possible higher risk that may affect the drug quality. Suggested guidance is to draw samples from different therapeutic categories, different formulations, and different manufacturers. Samples collected are limited to max 3 samples and records and approval shall be acquired upon excess samples.

Drug Inspectors must ensure at least all the identified risks listed in the guidance are utilized in the sampling for 6 months.

Number of Samples

Samples to be collected are at least 10 samples in a month, which include 9 samples of drugs and 1 sample of cosmetics or medical devices.

Timelines

Collected samples must be delivered to the laboratory on the same day or not more than the next day.

Name, address, and copy of the invoice shall be extracted from the drug or cosmetic owners for any possibility of Spurious drug. For patent drugs or new drugs, Drug Inspectors shall extract the method of analysis and reference/working standards from the manufacturers of the sample.

Before, sampling was limited to the individual knowledge of the drug inspector and challenges were identified concerning the limitation of product selection and the location of the sampling. Hence, evaluations were overlooked impacting patients’ access to good quality products. Sampling is important to ensure the quality of the products available in the market is safe for patients to use. The generated data from the sampling activity can assist manufacturers and authorities in planning strategies to achieve continuous availability of guaranteed good quality products in the market.

Source: Central Drugs Standard Control Organization (CDSCO)

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