1. New Draft Proposals for a Revised Schedule M published by Central Drugs Standard Control Organization, Directorate General of Health Services, Ministry of Health & FW, Government of India.
1) Revised Schedule M:
Govt sets deadline for pharma industry
August 3, 2023
Now, WHO-GMP standards have been seamlessly integrated into the revised Schedule M.
In a significant move to elevate the quality management standards of Indian pharmaceutical manufacturers, the Health Ministry has unveiled a crucial initiative for the revised schedule M.
As per Notification: G.S.R. 922(E) dated 28.12.2023, the new set of rules as per revised Schedule M guidelines must be implemented by pharma companies with turnover <=250 crores within 12 months from the date of publication (5.1.2024).
2. Draft Guidelines for GMP in Cosmetics introduced by US Food and Drug Administration.
What’s New
May 3, 2023
FDA intends to withdraw or revise and reissue this draft guidance as appropriate, based on the GMP rulemaking required by the Modernization of Cosmetics Regulation Act (MOCRA) of 2022.
