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CDSCO renames post licensure monitoring division as PMDSMD
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Gireesh Babu, New Delhi
February 26 , 2025
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The Central Drugs Standard Control Organisation (CDSCO) has renamed its post licensure monitoring division as Post Marketing Drugs Safety Monitoring Division (PMDSMD), with immediate effect.
The Organisation has issued an office order, renaming the existing PSUR/PV/AEFI Division, which monitors the Periodic Safety Update Report (PSUR), Pharmacovigilance and Adverse Events Following Immunization (AEFI) data and reports across the country. The renaming is expected to better reflect all the functions the division handles under a comprehensive name.
The PSUR/PV/AEFI Division at CDSCO Headquarter monitors all post licensure activities of vaccine related to AEFI surveillance, PSUR review, PV Inspection, Audit and any other data on vaccine safety as and whenever required as per Drugs and Cosmetics Act 1940 and Rules.
The division is responsible for the coordination with National Coordination Centre- Pharmacovigilance Programme of India (IPC, Ghaziabad) and AEFI Secretariat, Immunization Division, Ministry of Health and Family Welfare for the various AEFI reported in the field, and attending various meeting with the stakeholders for coordination purpose or whenever situation arises.
It is also assigned to collect all the adverse events and serious adverse events reported by the Marketing Authorisation Holders (MAH), various stakeholders, Immunization Division and IPC, which is reviewed by the PSUR Expert Committee constituted for this purpose for taking further regulatory action.
Post Marketing Studies and PSUR, being conditions for Market Authorization and Licensing and therefore to ensure the regulatory conformance and proper design of postmarketing studies, this division also works with coordination of the licensing division.
It is also responsible for collecting, compiling and collating the data received from the MAH as per the requirements of Fifth Schedule of New Drugs and Clinical Trials Rules 2019. The compiled PMS/PSUR data are then reviewed by the advisory committee constituted by the Drugs Controller General (India). According to the drug regulator, based on the analysis of the PSUR Expert Committee, regulatory decisions will be taken by CDSCO.
As per the regulations, all cases involving serious unexpected adverse reactions must be reported to the Licensing Authority within 15 days of initial receipt of the information by the industry. The regulatory decision shall be taken in accordance with Drug & Cosmetics Act 1940 and Rules. If marketing of the new drug is delayed by the applicant after obtaining approval to market, such data will have to be provided on a deferred basis beginning from the time the new drug is marketed, it says.
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