Schedule M refers to the mandatory guidelines established by the Indian government that specify Good Manufacturing Practices (GMP) for medium, small, and micro enterprises (MSMEs) involved in drug manufacturing.
The Indian government aims to ensure quality assurance, reduce the compliance burden in the pharmaceutical sector, and bolster the confidence of consumers in the products manufactured by MSMEs. Furthermore, it seeks to reinforce India's reputation as the pharmacy of the world.
Schedule M outlines practices related to shop floors, quality control systems, quality control labs, production, and equipment cleaning.
The government has established a special squad to inspect drug manufacturing companies. Stringent actions are in place against manufacturers who make spurious medicines or fail to adhere to quality compliance standards.
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