Monthly Archives: March 2024

Starting March 11, 2024, the process for submitting Periodic Safety Update Reports (PSURs) regarding Marketing Authorization of New Drugs, Subsequent New Drugs (SND), Fixed Dose Combinations (FDC), Biologicals, and Veterinary products must be made online via the Sugam portal at www.cdscoonline.gov.in.    Offline submissions in hard copy or any other mode

To enhance efficiency and consistency in the sampling procedures of drugs, cosmetics, and medical devices, while also ensuring the maintenance of a centralized monthly database of NSQ (Not of Standard Quality)/Spurious drugs, the CDSCO has drafted regulatory guidelines.    These guidelines have been formulated to be adopted by drug inspectors of

Department of Chemicals and Petrochemicals has revised the implementation dates for the mandatory requirement for ISI Marks for Methyl Acrylate and Ethyl Acrylate in a Quality Control Amendment.    Initially, the order was set to be implemented on 29th February 2024. However, after careful consideration, the Department has revised the implementation

In a groundbreaking move, the Department of Chemicals and Petrochemicals issued a Quality Control Order (QCO) on 26 Feb 2024 making ISI Mark mandatory for three distinct categories of petrochemical products which are as follows:    Indian Standard Title of Indian Standard Poly Vinyl Chloride (PVC) Homopolymers  IS 17658:2021  Polypropylene (PP)