IPC issues Draft Pharmacovigilance Guidance Document for Pharmaceuticals

It delineates the roles and responsibilities of various stakeholders, ensuring a systematic approach to pharmacovigilance.

The Health Master

February 23, 2024

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Table of Contents

Last Updated on March 6, 2024 by The Health Master

Pharmacovigilance

The Indian Pharmacopoeia Commission (IPC) has taken a significant stride in bolstering pharmacovigilance standards in India.

The release of the Draft Pharmacovigilance Guidance Document for Pharmaceutical Products, Version 2.0, signifies a pivotal moment.

The Commission now invites insights from Marketing Authorization Holders (MAHs), aligning with the objectives of the Drugs and Cosmetics (D&C) Act, 1940 & Rules, 1945, and the New Drugs and Clinical Trials (NDCT) Rules 2019.

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Enhancing Pharmacovigilance

The comments and feedback received are crucial steps towards augmenting pharmacovigilance standards, a vital component in safeguarding public health within India’s pharmaceutical landscape.

The National Coordination Centre (NCC)-Pharmacovigilance Programme of India (PvPI), IPC, in collaboration with the Central Drugs Standard Control Organization (CDSCO), spearheads this initiative.

Streamlining Safety Profiles

The guidance document focuses on streamlining the submission of safety profiles of drugs by MAHs involved in the manufacture, sale, import, and distribution of pharmaceutical products in India.

It delineates the roles and responsibilities of various stakeholders, ensuring a systematic approach to pharmacovigilance.

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In-depth Insights into Pharmacovigilance System

Delving into the document, one encounters comprehensive details regarding:

Pharmacovigilance System Master File,
Post-Marketing Surveillance,
Periodic Safety Update Report (PSUR) submission,
Quality Management System (QMS) implementation,
Audits,
Inspections, and
Risk management planning.

Scope and Stakeholders

Scope-wise, the document covers a wide array of products, including:

Drugs,
New drugs,
Subsequently approved drugs,
Biologics,
Radiopharmaceuticals, and
Phytopharmaceuticals.

Clear delineation of roles and responsibilities is provided for CDSCO, State(s)/UT(s) Drugs Controller, NCC-PvPI, IPC, and MAHs.

A Coordinated Approach

The document meticulously outlines the role and responsibilities of different authorities, such as:

CDSCO,
State Drugs Controllers,
Licensing Authority, and
NCC-PvPI.

CDSCO receives safety recommendations from PvPI, while the Licensing Authority oversees the licensing process, mandating MAHs to monitor and promptly report adverse drug reactions.

PvPI’s Pivotal Role

NCC-PvPI, situated within IPC, plays a pivotal role in coordinating pharmacovigilance activities.

This includes establishing adverse drug reaction (ADR) monitoring centers, capacity-building, and training initiatives.

Notably, PvPI collaborates with national and international stakeholders, contributing ADR data to the Uppsala Monitoring Centre (UMC) and serving as a WHO Collaborating Centre for Pharmacovigilance.

Public Health Initiatives

Engaging with Public Health Programmes (PHPs) like the National Tuberculosis Elimination Programme (NTEP), National Aids Control Programme (NACP), and National Centre for Vector-Borne Diseases Control (NCVBDC), PvPI extends its reach.

This collaboration aims to bolster pharmacovigilance efforts in public health initiatives.

Feedback Matters

Stakeholders are urged to actively participate by providing feedback on the draft guidance document.

The effectiveness of this document lies in collaborative efforts, promoting patient safety, and ensuring the rational use of medicines nationwide.

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.