DCGI's New Code for Drug Inspectors Focuses on Market Vigil and Regulatory Improvements

Sunday, 15 September 2024, 05:16

The DCGI has issued a new code for drug inspectors, aimed at ensuring better market vigil and regulatory system efficiency. This code standardizes the sampling methods to enhance the identification of risks in drug, cosmetic, and medical device inspections. Aimed at improving accountability and compliance, the updated guidelines replace over a decade-old framework and focus on robust monitoring processes.
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DCGI's New Code for Drug Inspectors Focuses on Market Vigil and Regulatory Improvements

DCGI Issues Fresh Code for Drug Inspectors

The Drugs Controller General of India (DCGI) has introduced a new code for drug inspectors, designed to make inspections and sample collections more uniform and predictable. As of September 12, these updated guidelines are set to enhance the regulatory system concerning drug, cosmetic, and medical device safety.

Key Updates in the Drug Inspector Code

  • Uniform Sampling Method: Drug inspectors must now adhere to a standardized sampling method, ensuring better identification of risks.
  • Monthly Sampling Plans: Each inspector, in consultation with their authority, will create a monthly sampling plan that includes rural areas and regions with endemic diseases.
  • Centralized Monitoring: A monthly list of sub-standard drugs will be maintained publicly to ensure accountability.

This initiative aims to effectively monitor the quality of drugs and cosmetics while ensuring compliance with Good Manufacturing Practices (GMP) standards. The move to replace the outdated guidelines reflects a commitment to advancing the regulatory framework while addressing the critical shortage of drug inspectors and enhancing public health safety.


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