Summary of CDSCO requirements and background
Central Drugs Standard Control Organization (CDSCO) is an Indian regulatory authority which runs the PvPI program i.e. pharmacovigilance program of India.
PvPI is run across country with the help of ADR monitoring centers that are attached in hospitals and medical colleges. This centers collect the adverse events and report to PvPI and PvPI reports to WHO database. MAH are also required to report the adverse events.
There is lot of good work and progress done by PvPi steadily over years contributing and achiveing their objective of patient safety. We will cover the MAH requirements/expectation by PvPI . The objectives, background, organogram is available on the website.
Reference: https://www.ipc.gov.in/PvPI/pub/Guidance%20Document%20for%20Marketing%20Authorization%20Holders.pdf
ICSR requirements:
All serious cases within 15 days and all non serious cases witthin 30 days.
Aggregate requirements:
PSUR within 30 days. For first 2 years every 6 month and annually for next 2 years. After 4 years its upto CDSCO to decide if PSUR is required. PSUR template is provided in gudiance document.
Signal process:
Mandatory to have process for signal at MAH end. Signal details are to be shared as part of PSUR and otherwise. SRP (Signal review panel) at NCC-PvPI will take decision for signal and also reocmmend plan of action
Risk management plan:
Template is provided in guidance document.
PvMF (Phamracovigilance master file) akin to PSMF:
Should contain PV process with SOP, QMS, Trainings, details of local PV officer in charge (akin to QPPV) , computer system, SDEA etc.
The module is crisp, clear and concise and can help as standalone document for implementation of PV process for operations need. However it is recommended to refer to drug and cosmetics act wherever needed.
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