The Central Drugs Standard Control Organization (CDSCO) on August 07, 2024, issued a notification regarding the Implementation of Schedule M and the WHO Technical Report Series.
This is about the revision of Schedule M vide GSR No. 922(E) dated December 28, 2023, and various WHO TRS guidelines including WHO TRS 1044 Annexure- 2 "WHO good manufacturing practices for sterile pharmaceutical products" which are published by WHO from time to time.
In this regard, it is requested that all manufacturers take the necessary steps to comply with various requirements as per the above guidelines after due gap analysis.
This is for information and necessary compliance.
[Notification No. QMS/38/Misc/2024]
