Aimed at ensuring robust quality control for pharma and biopharmaceutical products, the Union Health Ministry on January 6 notified revised rules under Schedule M of the Drugs and Cosmetics Rules, 1945.
Schedule M prescribes the Good Manufacturing Practices (GMP) for pharmaceutical products and the revised Schedule M has been notified as rules to ensure GMP is adhered to, and requirements of premises, plant, and equipment for pharmaceutical products.
GMP is mandatory standards which builds and brings quality into a product by way of control on materials, methods, machines, processes, personnel, and facility/environment, etc. GMP was first incorporated in Schedule M of the Drugs and Cosmetics Rules, 1945 in the year 1988 and the last amendment was done in June, 2005.
