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Oviya MedSafe - Negotiating the Paradigm Shift in Pharmacovigilance Outsourcing

Dear Well-wishers,

It is with tremendous jouissance that I publish this July 2017 edition of Oviya MedSafe’s newsletter, following the grand success of the Indian Pharmacovigilance Day 2017 conference that I chaired at Hyderabad on 28-July-2017. Organized for the second time in India by Italy-based EasyB Srl renowned for their ‘Pharmacovigilance Day‘ series of conferences they conduct in several parts of the world, the event was locally coordinated in India by VHEO Ventures, an event management firm. Oviya MedSafe was a proud sponsor of the event.

The conference began with the video welcome address of EasyB’s Managing Director Mr Enrico Pedroni and went on to deliberate on several aspects of relevance to Pharmacovigilance and India, harnessing the knowledge and experience of the distinguished speakers and panellists, whom I wish to sincerely thank from the bottom of my heart, for making this conference impactful with their active involvement. A detailed post-event note was published by Express Pharma, a media partner of the conference. The event had a good number of delegates from industry, academia and the student community. The complete set of 100 photographs clicked at the conference is available for public viewing and/or downloading from this link.

I had an enjoyable opportunity of moderating a colloquium titled ‘Operational Excellence in Pharmacovigilance Outsourcing – Pros & Cons’ as part of this conference. While preparing for the session, I could not help wondering at the metamorphosis that the global pharmacovigilance outsourcing industry in India has undergone over the past decade. I also reflected upon the evolution of Oviya MedSafe as a provider of global Pharmacovigilance consulting & Drug Safety services, since Oviya MedSafe’s founding in 2012. I realized that a key reason for Oviya MedSafe’s achievements was that we were able to foresee and were ready to negotiate the paradigm shift that the industry was to see in due course.

Centralizing global pharmacovigilance operations in India, either in an in-house model or by having a service-provider as a partner, has been proven to be rewarding for most pharmaceutical companies especially in terms of the quick scalability required to manage their increasing workloads and the attractive cost-effectiveness needed to retain their intended profit margins, among other assessment parameters. While most of the leading global innovators set up pharmacovigilance operations in India by forming strategic relationships with service-providers, Indian multinational generic pharmaceutical companies saw this as an opportunity to reclaim their global pharmacovigilance operations from their service-providers whose operations were based in the regulated markets in which the generic companies were marketing their products.

The scenario further changed with other business models also coming into the picture. Some global innovators set up their captive pharmacovigilance units in India and kept these units as services subsidiaries totally disconnected from their product-selling legal entities in India. This approach, to a great extent, helped them counter the headcount limitations they had with the latter. Another development was that many of the Indian generic companies began to disbelieve in outsourcing, given the fact that outsourcing within India was not much less expensive for them in comparison with their global counterparts. Nevertheless, with more and more of the small & medium-sized Indian pharmaceutical firms expanding their businesses to regions which started mandating pharmacovigilance, the domestic businesses of Indian pharmacovigilance service-providers continued to grow too. Inquiries for more cost-effective pharmacovigilance software databases and related technology enhancements emerged.

Marking an end of a full circle, we see today that not all pharmaceutical companies (particularly in the generic segment) have succeeded with the in-house model. In fact, all the stakeholders seem to have started understanding that the traditional horizontal departmental approach followed in large manufacturing companies is probably not in cultural synchronization with the vertical-focused competitive operational environment found in the service-providing companies in the pharmacovigilance domain. I see this as an extrapolation of the concept that the reasons for pharmacovigilance outsourcing have begun to move from ‘more financial’ to ‘more strategic’.

Given this mindset change happening across the pharmacovigilance domain, especially in a large pharmaceutical market like India where domestic pharmacovigilance obligations for pharmaceutical companies are already in vogue and are shortly expected to be formalized in a more structured manner, we at Oviya MedSafe believe that pharmacovigilance outsourcing will continue to remain relevant for a client-focused boutique consultancy like ours and look forward to expanding our scope of services to include futuristic pharmacovigilance offerings, which I hope to explain on another occasion.

Looking forward to meeting you through our August 2017 newsletter,

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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