Last Updated on June 17, 2024 by The Health Master
Pharmacovigilance
The Central Drugs Standard Control Organisation (CDSCO) is seeking industry feedback on a new draft Pharmacovigilance guidance document aimed at strengthening vaccine safety monitoring in India.
This comprehensive initiative highlights India’s commitment to public health by ensuring the continued safety and efficacy of vaccines used throughout the country.
Enhancing Patient Safety Through Pharmacovigilance
The draft “Guidance for Industry on Pharmacovigilance requirements for Human Vaccines, Version 2.0″ emphasizes the importance of pharmacovigilance – the science of monitoring the effects of medications after they are marketed.
This proactive approach allows for the identification and management of potential risks associated with vaccines, safeguarding public health.
Key Provisions of the Draft Guidance
Collaboration for Robust Monitoring:
Developed in collaboration with relevant stakeholders like the Adverse Events Following Immunization (AEFI) Secretariat and the Indian Pharmacopoeia Commission’s (IPC) Pharmacovigilance Programme of India (PvPI), the guidance aligns with the latest New Drugs and Clinical Trial Rules (NDCTR) 2019.
Stakeholder Responsibilities:
The document outlines clear roles and responsibilities for various stakeholders involved in the vaccine lifecycle, including Marketing Authorization Holders (MAHs), CDSCO, PvPI, immunization divisions, and healthcare practitioners.
This collaborative approach ensures efficient vaccine safety monitoring.
Risk Management and Reporting:
The guidance mandates MAHs to establish robust pharmacovigilance systems for collecting, analyzing, and reporting all Adverse Events Following Immunization (AEFIs) as per the NDCTR 2019.
This includes both minor and serious AEFIs, ensuring comprehensive safety data collection.
Periodic Safety Reporting:
The document details the process for submitting Periodic Safety Update Reports (PSURs) to CDSCO.
PSU Rs provide a comprehensive overview of a vaccine’s safety profile, including cumulative patient exposure data, post-marketing surveillance findings, and information on special populations.
Benefits of the New Guidance
Strengthened AEFI Monitoring:
The guidance is expected to enhance the quality and efficiency of AEFI reporting by MAHs.
This will provide CDSCO with more accurate and complete data for informed decision-making regarding vaccine safety.
Improved Risk Management:
By outlining a clear framework for risk identification, assessment, and mitigation, the guidance empowers stakeholders to proactively manage potential vaccine safety concerns.
Enhanced Public Health Protection:
By prioritizing vaccine safety through robust pharmacovigilance practices, the new guidance ultimately contributes to safeguarding public health in India.
Public Participation and Next Steps
The CDSCO is inviting comments and suggestions from stakeholders on the draft guidance document.
This open consultation process allows for valuable industry feedback to be incorporated into the final version.
The finalized guidance is expected to significantly strengthen vaccine safety monitoring in India, ensuring the continued trust and confidence in vaccines as essential public health tools.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
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