Health Ministry To Strengthen Role Of AMCs For AEFI Surveillance System

Mumbai, 11 Jan 2021:

Even as the country is bracing up for the vaccination for coronavirus, the Union health ministry is in the process of outlining a plan to strengthen the role of 311 adverse drug reaction (ADR) monitoring centers (AMCs) under the Pharmacovigilance Programme of India (PvPI) for the adverse events following immunization (AEFI) surveillance system.

This will be instrumental in achieving vaccine pharmacovigilance right from collecting to coding and finally sending individual case safety reports (ICSRs) to PvPI.

There is an evolving AEFI surveillance system in India for the vaccines delivered through the Universal Immunization Programme (UIP) of the government sector but the reporting remained suboptimal for long in the country.  

The Central Drugs Standard Control Organisation (CDSCO) is also in talks with global regulators, PvPI and the immunization programme of India to scale up pharmacovigilance systems to meet the requirements for reporting vaccine ADRs. The Union health ministry has also been discussing with World Health Organisation (WHO) India about the roles and responsibilities of all stakeholders for pharmacovigilance in India with a specific focus on adverse event AEFI surveillance system in India.

AEFI is a critical component of the immunization program. The risk of AEFI with vaccination is always weighed against the risk of not immunizing a child.

The vaccines are foreign for human bodies, given to healthy infants and children. In the natural process of developing immunity, a vaccine may cause fever, erythema, local pain etc. Besides, there is a risk of foreign body reaction to the components in the vaccines.

These factors are likely to cause some concerns in the caregivers/parents. Whatever the cause, an AEFI may upset people to the extent that they may refuse further vaccination for their children. This may lead to the children much more likely to get a vaccine-preventable disease, become seriously ill, disabled, and risk death. AEFI surveillance, therefore, helps to preserve public confidence in the immunization programme.

The serious AEFIs (death, disability, cluster, and hospitalization) need to be reported immediately and investigated in detail as per the laid down procedures. Once a serious AEFI happens, the primary or urban health centre should be immediately informed by the pediatricians practicing in rural or urban areas, respectively.

The Indian Academy of Pediatrics (IAP) believes that pediatricians, especially in the private sector have a crucial role to play with reporting of AEFI with newer/underutilized vaccines. Programmatic error, vaccine reaction, injection reactions, coincidental and unknown are the five broad categories of AEFI for programmatic purposes.

Representations have earlier been made from WHO, CDSCO, Indian Pharmacopoeia Commission (IPC) and MHRA-UK to plan the effective implementation of pharmacovigilance systems focused on the generation of signals from VigiFlow ICSR database for rotavirus vaccine.

CDSCO representatives have also deliberated on the regulatory requirement of pharmacovigilance for market authorisation holders (MAHs) in India with a focus on the current situation of post-authorisation safety studies (PASS).Pharmabiz