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Schedule M of Drugs and Cosmetics Act, 1945



Published on 23 Mar 2025

• Pharmaceutical Companies sought more time to implement revised manufacturing practices rules under Schedule M of the Drugs and Cosmetics Act, 1945

• Schedule M under the Act, outlines the Good Manufacturing Practices (GMP) that must be followed for the manufacture of pharmaceutical products.

• It doesn’t list specific drugs but sets standards for facilities, equipment, and procedures to ensure drug quality and safety.

• These regulations apply to all pharmaceutical products, including tablets, capsules, injectables, and other dosage forms, ensuring that drugs are consistently produced to meet quality standards.

• GMP was first incorporated in Schedule M in 1988.

Keywords:

Schedule M of Drugs and Cosmetics Act scheduled drugs Schedule M Pharmaceutical industries Pharmaceuticals