Joint inspections of firms by national & state drug regulators


New Delhi, Dec 27 (IANS): Under the directions of Union Health Minister Dr. Mansukh Mandaviya, the Central Drugs Standard Control Organisation (CDSCO) has started conducting joint inspections of identified Drug Manufacturing Units along with State Drugs Control Administration as per risk-based approach.

The Joint Inspections are being conducted all over the country as per the Standard Operating Procedures. A committee of two Joint Drugs Controllers has been constituted at CDSCO (HQ) to monitor the process of inspection, reporting and subsequent action so as to ensure compliance to the Drugs & Cosmetics Act, 1940 and Rules thereunder.

The joint inspection is being carried out to ensure high standards of quality compliance with respect to drugs manufactured in the country.

An action plan for nationwide inspection of manufacturing units, which are identified to be at the risk of manufacturing 'Not of Standard Quality' (NSQ)/adulterated/spurious drugs, was made prior to carrying out the inspections.

The objective of drug regulation is to ensure safety, efficacy and quality of the drugs available in the country. The drug control administration is required to ensure that manufacturing units comply with Drugs & Cosmetics Act, 1940 and Rules thereunder especially to the requirements of Good Manufacturing Practices (GMP).

 

  

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Title: Joint inspections of firms by national & state drug regulators



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