IPC's New Draft: Advancing Pharmacovigilance in Pharmaceuticals

The Indian Pharmacopoeia Commission (IPC) has released the Draft Pharmacovigilance Guidance Document for Pharmaceutical Products in its latest version, Version 2.0. 

This initiative aims to enhance pharmacovigilance standards across India's pharmaceutical landscape, aligning with the objectives of the Drugs and Cosmetics (DandC) Act, 1940 and Rules, 1945, including the New Drugs and Clinical Trials (NDCT) Rules 2019. 

Marketing Authorization Holders (MAHs) are now invited to provide comments and suggestions on the draft document, marking a crucial step towards enhancing pharmacovigilance standards and safeguarding public health.

The guidance document is prepared by the National Coordination Centre (NCC)-Pharmacovigilance Programme of India (PvPI), IPC, in collaboration with the Central Drugs Standard Control Organization (CDSCO). Its objective is to streamline the submission of safety profiles of drugs by MAHs involved in the manufacture, sale, import, and distribution of pharmaceutical products in India. 

The document outlines the roles and responsibilities of various stakeholders, including CDSCO, State(s)/UT(s) Drugs Controller, NCC-PvPI, IPC, and MAHs. 

It covers preparing Pharmacovigilance System Master File, Post-Marketing Surveillance, Periodic Safety Update Report (PSUR) submission, Quality Management System (QMS) implementation, audits, inspections, and risk management planning. 

The scope of the document covers drugs, new drugs, subsequently approved drugs, biologics (including biosimilars, vaccines, cell lines/culture-based products), radiopharmaceuticals, and phytopharmaceutical products.  It clearly outlines the roles and responsibilities of different authorities, such as CDSCO, State Drugs Controllers, Licensing Authority, and NCC-PvPI. CDSCO receives drug safety recommendations from PvPI for regulatory actions. 

At the same time, the Licensing Authority oversees the licensing of manufacturing and sale/distribution of drugs, mandating MAHs to monitor adverse drug reactions and report them promptly. 

NCC-PvPI, housed within IPC, is pivotal in coordinating pharmacovigilance activities, including establishing adverse drug reaction (ADR) monitoring centers, capacity-building, and training initiatives. 

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