In order to meet the requirements for reporting vaccine adverse drug reactions (ADRs), the Central Drugs Standard Control Organisation (CDSCO) is planning to strengthen pharmacovigilance systems for vaccine ADR in collaboration with global regulators, Pharmacovigilance Programme of India (PvPI) and immunization programme of India.
This will be instrumental in achieving vaccine pharmacovigilance right from collecting to coding and finally sending individual case safety reports (ICSRs) to PvPI.
Representatives from World Health Organisation (WHO), CDSCO, Indian Pharmacopoeia Commission (IPC), MHRA-UK shared experiences on the same with marketing authorisation holders (MAHs) to collect, report, share ADR reports and access database for signal detection in a meet held at CDSCO headquarters recently.
The meet which was meant to plan effective implementation of pharmacovigilance system at MAH level also focused on generation of signals from VigiFlow ICSR database for rotavirus vaccine.
CDSCO representatives deliberated on regulatory requirement of pharmacovigilance for MAHs in India with focus on the current situation of post authorisation safety studies (PASS). MAH representatives from GSK, MSD, Bharat Biotech and Serum companies also participated in the meet.
Dr Jai Prakash, senior principal scientific officer, Dr V Kalaiselvan, principal scientific officer and Vipin Kumar, senior pharmacovigilance associate represented IPC, Ghaziabad. They deliberated on pharmacovigilance guidelines covered under guidance documents of pharmacovigilance for MAHs and reporting system of ICSRs by MAHs to PvPI.
During the meet, Dr Viola Macolic, technical officer, WHO (HQ) gave insights about WHO programme for international drug monitoring comprising VigiBase, VigiLyze, VigiAccess and its linkage with the national pharmacovigilance programme, PV system, E2B features in ADR reporting and importance of MedDRA coding in ICSRs for better signal detection activities.
Dr Madhur Gupta, technical officer, WHO India discussed the roles and responsibilities of all stakeholders for pharmacovigilance in India with specific focus on adverse event following immunisation (AEFI) surveillance system in India.