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Industry specific-Medical Central Ministry of Health & Family Welfare Drugs and Cosmetics Act, 1940

Issuance of Drugs Amendment Rules, 2023

28-Dec-2023 | G.S.R. 922(E)

Department of Health and Family Welfare has issued Drugs Amendment Rules, 2023, effective from 28th December 2023.

The key highlights are:

1. In the Drugs Rules, 1945, In Rules 74, 76, and 78 for the words Good Manufacturing Practices, the words Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products have been substituted.

2. The revised Schedule M has been notified as rules to ensure good manufacturing practices and requirements of premises, plant, and equipment for pharmaceutical products.

(a) The manufacturer must assume responsibility for the quality of the pharmaceutical products to ensure that they are fit for their intended use, comply with the requirements of the license, and do not place patients at risk due to inadequate safety, quality, or efficacy.

(b) The product quality system appropriate to the manufacture of pharmaceutical products shall ensure that product realization is achieved by designing, qualifying, planning, implementing, maintaining, and continuously improving a system that allows the consistent delivery of products with appropriate quality
attributes and product and process knowledge are managed throughout all lifecycle stages.

For detailed information, please refer to the attached document.

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