Oviya MedSafe introduces support services for pharma companies to report ADRs in XML-E2B format to PvPI

The involvement of the pharma industry in PvPI would enable the national programme to gain access to the ADR data available with individual pharma companies

Oviya MedSafe, a global pharmacovigilance consulting and drug safety services providing organisation based out of Coimbatore, India and London, UK has introduced support services for Indian as well as international pharmaceutical companies which market their products in India, to comply with the Office Order dated 18-May-2015 (effective from 01-Jun-2015) issued by the Indian Pharmacopoeia Commission (IPC), the National Coordination Centre for the Pharmacovigilance Programme of India (PvPI) under the Ministry of Health & Family Welfare, Government of India.

The Office Order published on the Central Drugs Standard Control Organization (CDSCO) website, states that the pharma industry needs to submit Adverse Drug Reactions (ADRs) due to their respective pharmaceutical products in XML-E2B format to PvPI to hasten the process of uploading Individual Case Safety Reports (ICSRs) to VigiFlow, a web-based database of the WHO–UMC (World Health Organization – Uppsala Monitoring Centre). This measure is expected to enhance the process of assessment and signal detection.

Dr J Vijay Venkatraman, Managing Director and Chief Executive Officer, Oviya MedSafe said, “This initiative of PvPI is a milestone in Indian pharmacovigilance and is a promising step towards building a more integrated pharmacovigilance system in India, as it now involves all stakeholders. The involvement of the pharma industry in PvPI would enable the national programme to gain access to the ADR data available with individual pharma companies, perform causality analysis in a cumulative manner and share its recommendations with CDSCO for regulatory action. Although pharma companies in India collect suspected ADR reports from healthcare professionals through their marketing teams, only a few of them have pharmacovigilance departments and drug safety software databases to generate ADR reports in XML-E2B format needed to comply with the Office Order.”