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Oviya MedSafe - XML-E2B Reporting of ICSRs by Industry to Pharmacovigilance Programme of India

Dear Well-wishers,

On this unique Leap Day, I am delighted to write for you this February 2016 edition of Oviya MedSafe’s newsletter, to elucidate on some developments in the Indian pharmacovigilance scenario, in the context of electronic reporting of Individual Case Safety Reports (ICSRs) in XML-E2B format by the pharmaceutical industry to the Pharmacovigilance Programme of India (PvPI).

This topic gained prominence with the issue of an Office Order dated 18-May-2015 (effective from 01-Jun-2015) by the Indian Pharmacopoeia Commission (IPC), the National Coordination Centre for PvPI. The Office Order which was formally published on the website of India’s drug regulatory agency – the Central Drugs Standard Control Organization (CDSCO) and also sent to many pharmaceutical companies in the country, stated that the pharmaceutical industry needed to submit ADRs associated with their respective pharmaceutical products in XML-E2B format to PvPI to hasten the process of uploading ICSRs to VigiFlow, a web-based database of the Uppsala Monitoring Centre. This measure was expected to enhance the process of assessment and signal detection.

Ever since this Office Order was issued, it became a subject of intense deliberation among drug manufacturers and importers/distributors. Many pharmacovigilance professionals welcomed the move and heralded this announcement as an assertive and crucial step towards an integrated pharmacovigilance system for India. The Office Order did result in all types of pharmaceutical companies in India focusing more on pharmacovigilance and coordinating with their marketing teams to collect suspected ADR reports from medical practitioners. But, this improvement was not without its practical challenges, as the pharmaceutical industry in India had been reporting ADRs only in CIOMS format to the CDSCO in person until then and was not entirely ready for this digital upgrade.

The Office Order did not imply much difficulty for large Indian pharmaceutical companies that were already selling their products in regulated markets, as they had invested long ago in pharmacovigilance professionals and drug safety software databases for their global compliance. However, it was indeed a challenge for smaller drug manufacturers and importers/distributors that did not have a pharmacovigilance system in place to comply with the new requirement. It was at that point which we at Oviya MedSafe committed to make a difference and rolled out all-inclusive support services for pharmaceutical companies impacted by the Office Order.

With Oviya MedSafe’s expertise in global pharmacovigilance consulting and our experience of delivering drug safety services to comply with the regulations of different countries, we identified novel ways to render functional pharmacovigilance support coupled with the deployment of our 21 CFR Part 11 & E2B compliant drug safety software database. This combination resulted in a reliable and comprehensive yet simple and cost-effective solution for any pharmaceutical company in India to adhere to the Office Order. Since Oviya MedSafe, by then, had already been recognized as a pioneer in providing India-specific pharmacovigilance services including but not limited to authoring PSURs for submission to CDSCO, adding XML-E2B format ADR reporting activities completed and complemented our portfolio of offerings for Indian pharmacovigilance compliance.

Although Oviya MedSafe has been working with many Indian pharmaceutical companies over the past 4 years, the necessity of an efficient ICSR management team and a regulatory-compliant drug safety database to comply with the Office Order has resulted in Oviya MedSafe seeing a significant rise in the number of clients approaching us for our services for Indian compliance after the issue of this Office Order. We at Oviya MedSafe are quite proud of being able to carry out end-to-end Indian pharmacovigilance compliance activities for our clients irrespective of whether they are Indian or foreign companies. We firmly believe that the future for the safety of Indian patients is brighter than ever before, thanks to this appreciable initiative of the PvPI, and find ourselves honoured to be part of it.

Having spoken so much about Indian Pharmacovigilance, it is quite appropriate at this time for me to announce a dedicated colloquium for brainstorming on the pharmacovigilance issues faced by Indian-headquartered pharmaceutical companies for compliance with the drug safety regulations of Indian as well as the well-regulated markets: Indian Pharmacovigilance Day 2016, a one-day conference to be organized by Italy-based EasyB srl, at Mumbai, India on Friday, 22-July-2016. EasyB is renowned throughout Europe for the Pharmacovigilance Day series of events which they had been conducting in several European countries over the past two years. I take this opportunity to thank EasyB for designating me as the Chair of the first Indian Pharmacovigilance Day and assure you that more information about this event will be revealed in due course.

Before I sign off, I wish to announce, with all gratefulness to EasyB, that I have been invited by them to Chair their UK Pharmacovigilance Day 2016 conference to be held at London on Tuesday 18-Oct-2016 following the success of the first UK Pharmacovigilance Day in 2015 which too I had chaired.

Looking forward to meeting you through our March 2016 edition with some more snippets,

With thanks & regards,
Dr J Vijay Venkatraman
MBBS, F. Diab., MBA, FPIPA (UK)

Managing Director & CEO,
Oviya MedSafe Pvt Ltd,
Coimbatore, India
Phone: +91-422-2444442

Director,
Oviya MedSafe UK Ltd,
London, UK
Phone: +44-8452-733839

Web: www.oviyamedsafe.com
Mail: info@oviyamedsafe.com
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