On 28th December 2023, the Union Ministry of Health and Family Welfare implemented the Drugs (Amendment) Rules, 2023. Their objectives are to reinforce Good Manufacturing Practices (GMP) and establish requirements for premises, plant, and equipment in pharmaceutical products. The guidelines focus on principles such as Pharmaceutical Quality System (PQS), Quality Risk Management (QRM), Sanitation and Hygiene, Qualification and Validation, Complaints and Adverse Reactions, Product Recalls, and Change Control.
As per the notification dated 28th December 2023, the Union Ministry of Health and Family Welfare introduced the Drugs (Amendment) Rules, 2023.
The amendments include the replacement of the term "Good Manufacturing Practices" in Rules 74, 76, 78 of the Drug Rules, 1945 to "Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products"
A new set of guidelines for Schedule M has been implemented titled, "Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products" and is included in the principal rules. These guidelines outline principles such as Pharmaceutical Quality System (PQS), Quality Risk Management (QRM), Sanitation and Hygiene, Qualification and Validation, Complaints and Adverse Reactions, Product Recalls, and Change Control which are to be strictly adhered to by pharmaceutical manufacturers.