NEW DELHI: The government has come out with a “structured” guidance document for the pharmaceutical industry including importers and manufacturers of human vaccines for spontaneous reporting of adverse events, amid controversies surrounding Covid-19 vaccines’ side-effects.The new report released last week aims to provide guidance to the manufacturers and importers of vaccines in the country so as to strengthen their AE/AEFI (adverse events following immunisation) monitoring and reporting and pharmacovigilance department to ensure patient safety.
The new document calls for manufacturers and importers to have in place systems and procedures for the receipt, handling, evaluation and reporting of adverse events/AEFI that are adequate to sustain AEs/AEFI reporting.
All cases involving serious unexpected adverse reactions must be reported to the licensing authority within “fifteen days” of initial receipt of information by the applicant.
It is mandatory for the licensee of the product to have a pharmacovigilance system in place for collecting, processing and forwarding of reports to the licensing authorities for information on the adverse drug reactions emerging from the use of drugs manufactured or marketed by the licensee.
It says that the importers should also have a procedure on how complaints and AE/AEFI are tracked/logged, procedure on how complaints are assessed in order to determine if it is an AE/AEFI. It is also their responsibility to identify key personnel who are responsible for forwarding of AE/AEFI reports to the marketing authorisation holder (MAH), to report AE/AEFI to the MAH within an appropriate time-frame to allow for expedited reporting and all serious adverse events to be reported within 15 days of receipt of information to CDSCO.
There is also a requirement to follow up with the MAH to ensure that AE/AEFI have been assessed and sent to drugs controller general (India), and a requirement to maintain records of all AE/AEFI received and AE/AEFI sent to the MAHs.
It also makes it mandatory to conduct a critical analysis of AE reports received.
