Schedule M
Schedule M is a part of the ‘Drugs and Cosmetics Act, 1940’.
It deals with ‘Good Manufacturing Practices’ for pharmaceuticals that should be followed by pharmaceutical manufacturing units in India.
Schedule M covers various aspects, including shop floors, quality control systems, labs, production, equipment cleaning, and housekeeping.
Recently in News
India’s small drugmakers in the micro, small, and medium enterprises (MSME) sector will soon be required to adhere to the good manufacturing practices outlined in Schedule M of the Drugs and Cosmetics Act.
Schedule M will be made compulsory for the MSME pharma sector in a phased manner.
Need of it
It is important for MSME pharma companies to be alert to quality of drugs and expeditiously move towards Good Manufacturing Practices (GMP) through self-regulation.
The need for self-regulation in the MSME pharma sector is important for India to maintain the status of Pharmacy of the World.
Recent incidents of deaths allegedly caused by drugs made in India highlight the importance of maintaining high standards.
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