Pharmacovigilance principally involves the identification and evaluation of safety signals. Here, safety signal refers to a concern about an excess of adverse events compared to what would be expected to be associated with a product’s use.
The main focus of this guideline is to identify the risks, formulate the risk profile of a vaccine and its administration programme, design of appropriate pharmacovigilance plan to mitigate such risks and to explore the missing critical information which did not emerge during premarket phase-I/II/III trials and therefore safety profile had not been established.
This document rationally places guidance that all Marketing Authorization Holder (MAH) of Human vaccines(importers and manufacturers)should establish an appropriate pharmacovigilance system with an adequate number of qualified, trained, experienced manpower to collect, collate all AEFI (minor, severe and serious). This pharmacovigilance system within the company should conduct decisive causality analysis of the collated AEFI cases, after due investigation and prepare case closure report.
In a comprehensive PSUR, all such information shall have to be placed as per the norms stipulated in Schedule-Y of Drugs & Cosmetics Act 1940 and Rules 1945 and submitted to the Licencing Authority i.e DCG(I) in CDSCO (HQ) in a timely manner. CDSCO shall convene the meeting of the PSUR committee within a reasonable time period and give opportunities to the concerned Marketing Authorization Holder (MAH) to present their case and PSUR in general. Based on the recommendation of the PSUR committee the vaccine Licensing Authority i.e. DCG(I) will take appropriate regulatory action in accordance with Drugs & Cosmetics Act 1940 and Rules 1945, so as to monitor the safety and effectiveness of the human vaccine in the market.
MAHs must have a system in place that enhances the overall quality of the receipt, processing and reporting of ADE while ensuring that accurate and complete pharmacovigilance information is provided to CDSCO.