CDSCO's Sampling Guidelines for Drugs, Cosmetics, & Devices

India Pharma Outlook Team | Friday, 16 February 2024

 India Pharma Outlook Team

The Central Drugs Standard Control Organization (CDSCO) has released the final version of its regulatory guidelines for sampling medicines, cosmetics and medical devices by central drug inspectors to simplify and streamline sampling procedures and maintain a transparent database—state control of drugs.

This guide uses available information and identifies risks for sampling and site selection to address the various drugs, cosmetics and medical devices that move to market from different locations: manufacturing, consumption, retail and distribution channels. Government distribution. In cities, towns and rural areas. Also, maintain monthly inventory of NSQ/dispense and post on the CDSCO website to prevent misuse.

"These guidelines will be useful for effectively monitoring the quality and efficacy of drugs and cosmetics sold in the market by adopting a uniform procedure for drug sampling for drug inspectors under state and central drug enforcement authorities. Drug law drug administrators said.

Guidelines that guide drug inspectors to prepare monthly and annual sampling plans, select samples based on identified risks, select sampling sites based on specific criteria and complete the process within the deadlines specified by the central drug control center. It must be completed.

In consultation with the authority, the drug inspector must prepare a monthly and annual sample plan covering the entire jurisdiction or area under the department. The sample plan should include drugs used in rural areas, tribal areas, isolated areas for specific diseases, seasonal diseases, etc. The regulator found that the quality of medicines for remote operators was not guaranteed as inland or rural areas were not included.Or the end user didn't decide.

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