CDSCO releases regulatory guidelines for sampling of drugs, cosmetics and medical devices

Written by Ruchika Sharma Published On 2024-02-19T18:30:00+05:30 | Updated On 21 March 2024 4:26 PM IST

New Delhi: In order to streamline and rationalize the sampling procedure of drugs, cosmetics and medical devices and maintaining a centralized monthly database of Not of Standard Quality (NSQ) /Spurious drugs to publish on Central Drugs Standard Control Organisation (CDSCO) website, the apex drug regulator has released regulatory guidelines for sampling of drugs, cosmetics and medical devices by Drugs Inspectors of Central and State Drug Authorities.

Earlier, the draft regulatory guidelines for sampling of drugs, cosmetics and medical devices by Drugs Inspectors of Central and State Drug Authorities was circulated to all zonal/sub zonal offices of CDSCO and State Licensing Authorities for their inputs and suggestions. After evaluating all the essential feedback on the draft guidelines, the drug regulator has now issued final guidelines.

The main objective of the guidelines is to check the quality & efficacy of drugs & cosmetic available in the market with their approved specifications and to monitor the quality of the API, Excipients and finished products of drugs, cosmetic and medical devices in all parts of the distribution chain throughout the authorized shelf-life. It also aims to ensure that existing control methods are satisfactory and to investigate the Not of Standard Quality (NSQ) Product, identify Unapproved Products/ Without License sales outlets, and identify Spurious drugs in the distribution chain. Moreover, it focuses on identifying sales outlets where repetitive NSQ/ Spurious drugs are reported, among other purposes

The document outlines the regulatory guidelines for the sampling of drugs, cosmetics, and medical devices by drugs inspectors of the Central and State Drug Authorities in India. It emphasizes the importance of good quality medicines for effective disease management and highlights the risks of substandard or spurious drugs to patients.

Further the guidelines focus on the sampling plan, selection of samples and sampling locations, number and quantity of samples, timelines, database/monitoring, NSQ/Spurious alerts, and testing laboratories. It also addresses the lack of defined methodology for sample selection in the past and provides detailed criteria for sample selection, including various identified risks and factors to consider.

Through its annexures, the guidelines specifies the quantity of drugs, cosmetics, vaccine, medical devices sample required for complete analysis.

To read the official notice, click on the following link:

https://medicaldialogues.in/pdf_upload/dcgi-circularregulatory-guidelines-for-sampling-232561.pdf

CDSCOCentral Drugs Standard Control Organisationmedical devices

Ruchika Sharma