Collection, Processing & Reporting of Individual Case Safety Reports

 The guidance of pharmacovigilance for Marketing authorization holders in India has described the following points regarding collection, processing and reporting of ICSR (individual case safety reports)

Under-reporting of AEs/ADRSs is a well-known problem associated with spontaneous reporting, therefore, MAHSs shall have different sources/methods to report AEs/ADRs to the organization. The following sources/methods required to be established by MAHs to strengthen spontaneous reporting.

1. Medical inquiries

2. Contact us, e-mail and website inquiry forms

3. MAH employees

4. Contractual partners

5. Information on AEs/ADRs from the interned or digital media

6. Solicited reports

7. Miscellaneous sources for reporting

8. Literature reporting