The Indian government is to make 'Schedule M' compulsory for medium, small, and micro enterprises (MSMEs) involved in drug manufacturing, to help in quality assurance and also reduce compliance burden in the pharmaceutical sector.
Schedule M lays down Good Manufacturing Practices (GMP) that such units must adhere to.
In order to ensure better quality assurance, small drugmakers will have to follow good manufacturing practices prescribed in Schedule M of the Drugs and Cosmetics Act, said Minister Mansukh Mandaviya.
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