Why Schedule M is mandatory for all pharma units

With an eye on improving quality assurance in the wake of increased global scrutiny on Indian pharma products, the Centre on Tuesday said that Schedule M of the Drugs and Cosmetics Act, 1940 will be made compulsory for small and medium scale manufacturers in a phased manner. Union Health Minister Mansukh Mandaviya has asked micro-small and medium enterprises in pharma manufacturing to move towards good manufacturing practices (GMP) through self regulation. “This will help in quality assurance and also reduce compliance burden,” Mandaviya.