Aimed at ensuring robust quality of pharma products, the Union Minister of Chemicals and Fertilizers Mansukh Mandaviya has directed regulatory authorities to conduct risk-based inspection and audit of manufacturing plants. He also added that Schedule M shall be made compulsory for the MSME pharma sector in a phased manner.
“This will help in quality assurance and also reduce compliance burden,’’ he said.
Schedule M part of Drugs and Cosmetics Act 1940 deals with ‘Good Manufacturing Practices’ for pharmaceuticals that should be followed by pharmaceutical manufacturing units in India.
