As we begin our journey into 2019, I take great pleasure in wishing all of you and your families a very Happy & Prosperous New Year, through this December 2018 edition of Oviya MedSafe‘s newsletter!
When I look back at 2018, I am glad that I had foreseen 2018 as a Year of Hope for Pharmacovigilance in India, as it indeed lived up to its expectations. Not only did the PV Guidance Document for MAHs (Marketing Authorization Holders) began to get adopted by the pharmaceutical industry in India, but it also led to the formulation of the Draft Pharmacovigilance System Inspection Guideline by the CDSCO on which feedback from several industry associations was also sought. Although the Indian Drug Manufacturers’ Association (IDMA) has represented its concerns on this inspection guideline, the fact that IDMA has only requested for phase-wise (staggered) implementation of pharmacovigilance inspections instead of a blanket waiver indicates that the industry also understands the need for a robust and integrated pharmacovigilance system in India. It is heartening to note that IDMA has raised a pertinent point of creating pharmacovigilance awareness amongst medical practitioners and encouraging them to report suspected Adverse Drug Reactions (ADRs). However, the apprehension that a vast majority of the industry is underprepared in terms of infrastructure, resources and knowledge required to comply with the new pharmacovigilance obligations, appears to be a little far-fetched, as it can be easily addressed by choosing an appropriate pharmacovigilance partner and leveraging their expertise.
Time and again, Oviya MedSafe has proven to be a proficient, cost-effective and trustworthy pharmacovigilance partner to our diverse clientele located in several parts of the world in order to facilitate their pharmacovigilance compliance in a wide range of countries (regulated & semi-regulated markets) in a comprehensive manner. In spite of being a versatile provider of centralized global pharmacovigilance services, Oviya MedSafe has always shown special interest in Indian pharmacovigilance compliance, which is vindicated by our close involvement in almost all of the pharmacovigilance developments in India since 2012. In fact, Oviya MedSafe has a history of swiftly deploying a complete pharmacovigilance system in terms of proprietary written procedures as well as a regulatory-compliant software database managed by an experienced team, exclusively for Indian compliance on par with global standards, from as early as 2015. Further, Oviya MedSafe has the pride of being the first organization in the country to conduct a customized workshop and certify Pharmacovigilance Officers In-charge (PvOI) as soon as the PV Guidance Document for MAHs became effective in January 2018. It was followed by a variety of educational initiatives throughout 2018. Hence, I trust I am justified in claiming that Oviya MedSafe is best positioned to provide gold-standard India-specific pharmacovigilance services, with a global outlook, to the MAHs in India.
“What exactly happens after a suspected ADR is reported to a pharmaceutical company?” is a question many students who aspire to be pharmacovigilance professionals had asked me in the past. I recently tried to answer the question by making a relevant presentation at a students’ conference. Thanks to an invitation from Ms Viveka Roychowdhury (Editor of Express Pharma); I could paraphrase the presentation as an article titled ‘Monitoring Product Safety Beyond Clinical Trials – Industry Practices‘ for the magazine. This article aims to provide an overview of the various pharmacovigilance processes in vogue in the industry without specific reference to the regulations of any particular/region. Please click here to read the article which I now realize would also answer a medical practitioner having the same question. As usual, I will be happy to receive your comments and/or suggestions, if any, in response to the article.
While on this topic, I am delighted to share with you that I have been chosen once again by the Drug Information Association (DIA) as the ‘India Regional Editor‘ of their official publication ‘Global Forum‘, now for the period 2019-20. With thanks to the DIA for their reinforced trust in me, I take the privilege of presenting to you the most recent India regional report titled ‘Patient Engagement in India: Challenging Yet Worthwhile Road Ahead‘ by Dr Veena Jaguste who kindly accepted my invitation to write this opinion piece.
Last but not the least, let me thank you for your patronage of the pre-conference workshop ‘How the New Pharmacovigilance Obligations for MAHs in India may be fulfilled‘ which is to be held on 14th February 2019, just ahead of the 12th Annual Conference of the Indian Society for Clinical Research (ISCR) on 15th & 16th February 2019 at The Eros Hotel, New Delhi. Being the Workshop Director for this pharmacovigilance workshop, I welcome you to New Delhi to listen to industry experts as well as regulatory officials on this critical subject. Although I would like you to attend both the pre-conference workshop and the main conference, please note that registering for the main conference is not a pre-requisite to register for the pre-conference workshop.
Eager to meet you through our January 2019 newsletter,
With thanks & regards,
Dr J Vijay Venkatraman
MBBS, F. Diab., MBA, FPIPA (UK)
Managing Director & CEO,
Oviya MedSafe Pvt Ltd,
Oviya MedSafe UK Ltd,