In response to increased global scrutiny of Indian pharmaceutical products and to enhance quality assurance, the Indian government announced on Tuesday that Schedule M of the Drugs and Cosmetics Act, 1940, will be made mandatory for small and medium-scale manufacturers in a phased manner.

Union Health Minister Mr. Mansukh Mandaviya has urged micro, small, and medium enterprises (MSMEs) engaged in pharmaceutical manufacturing to adopt good manufacturing practices (GMP) through self-regulation.

Schedule M explicitly addresses the guidelines for maintaining GMP in pharmaceutical manufacturing units across India. This directive was given during a meeting with MSME pharma companies in Delhi.

According to a government statement, Mr. Mandaviya has instructed the Drugs Controller General of India (DCGI) to take stringent action against any pharmaceutical manufacturing unit producing spurious drugs.

Mr. Mandaviya revealed that special inspection teams have been established to monitor drug manufacturing companies, and stringent actions have been taken against offenders.

He further highlighted that regulatory authorities have initiated risk-based inspections and audits of plants to ensure the highest quality of pharmaceutical products. So far, 137 firms have been inspected, and action has been taken against 105 them.

(Source:https://www.business-standard.com/health/schedule-m-to-be-made-mandatory-for-all-pharma-units-in-phased-manner-123071100741_1.html )