July 21 , 2023
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- Union Ministry of Chemicals and Fertilizers has directed regulatory authorities to conduct risk-based inspections and audits of manufacturing plants.
- It also added that Schedule M shall be made compulsory for the MSME pharma sector in a phased manner.
- Schedule M part of Drugs and Cosmetics Act 1940 deals with ‘Good Manufacturing Practices’ for pharmaceuticals.
- It aims to strengthen quality assurance and protect India's reputation as a global pharmaceutical powerhouse.
- It covers various aspects, including shop floors, quality control systems, labs, production, equipment cleaning, and housekeeping.
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