Oviya MedSafe – Third Anniversary, US FDA Safety Updates & Indian Pharmacovigilance Developments
By admin Dear Colleagues,
It is with absolute jubilation that I share with you this March 2015 edition of Oviya MedSafe’s newsletter, in the background of our third anniversary celebrations!
Looking back at Oviya MedSafe’s humble beginnings in March 2012, I realize that we have indeed come a long way with our continual innovation and persistent efforts. Seizing this appropriate opportunity, I would like to thank you for your support and encouragement all through. I am overjoyed to see that my passion for Pharmacovigilance which instigated me to found Oviya MedSafe has percolated throughout the organization over the past three years and has, in fact, been recognized by our clients too. I am confident that, with all the goodwill, Oviya MedSafe will fly higher to attain greater altitudes in its chosen trajectory, in the years to come.
Moving on to the current pharmacovigilance scenario in the United States, the past few weeks have been intriguing. The US FDA approved the first biosimilar product earlier this month. A biosimilar is not ‘bio identical’ to the approved biologic it references and therefore, could be associated with different adverse effects in consumers. Due to this fact, there have been differing views on how a biosimilar should be named. Adopting the non-proprietary name associated with the reference product and suffixing a short code to it to identify the manufacturer seems to be the most acceptable option, especially because it allows for easier pharmacovigilance reporting. It is expected that the US FDA would release its long-sought ‘biosimilars labeling guidance document’ sometime in 2015 and clarify on not only the acceptable nomenclature for biosimilars but also on their specific safety monitoring processes, if any.
On the generics front, a debate on who should take the responsibility for label updates of generic medications is on. While there are pros and cons in entrusting this mandate either to the US FDA or to the industry in exclusivity, the trade groups for the generic and the brand-name drug makers have teamed to offer their own proposal for label changes. Interestingly, a recent report in The New York Times has claimed that most of the adverse event reports submitted to the US FDA database are incomplete, especially the demographic data. While this might have a bearing on the conclusions derived from the analysis of the submitted suspected adverse drug reaction reports, the news also provides justified reasons for all adverse event reports not having the complete data all the time.
Coming back to India, a good deal of announcements made in the recent past hold a lot of promise for Indian Pharmacovigilance. The Drugs Technical Advisory Board (DTAB), which advises the Indian central and state governments on technical matters pertaining to drug regulations, has recommended mandating pharmaceutical companies to report adverse effects of marketed drugs. Further, DTAB re-insisted on its 2011 recommendation for pharmacovigilance cells managed by a trained medical officer or pharmacist to be set up in all pharmaceutical companies. It also emphasized on sensitizing medical practitioners across the country by involving the Medical Council of India (MCI) and on training medical representatives for collecting adverse event reports from doctors. DTAB has called for setting up a panel to draft pharmacovigilance guidelines for India to streamline the participation of all stakeholders. Incidentally, Pharmabiz published Oviya MedSafe’s comments on the lacunae in the Indian Periodic Safety Update Report (PSUR) submission and review process just before these announcements were made. Earlier, Pharmabiz had also published another of my interview on the US FDA’s keenness to involve Indian regulators for their inspections to create awareness about its inspection activities in India.
The Indian Health Ministry has approved a few days ago the ‘Materio Vigilance Programme of India’ (MvPI) which would monitor Medical Device associated Adverse Events (MDAE) and be coordinated by the Indian Pharmacopoeia Commission (IPC) in collaboration with the Central Drug Standard Control Organisation (CDSCO). MvPI cells are to be established initially in 10 medical colleges in order to monitor the benefit-risk profile of medical devices. With these baby steps taken today towards achieving excellence in pharmacovigilance as well as materiovigilance in India, we can be confident that the country is marching in the right direction.
Before signing off, I would like to specially thank pharmaceutical industry media Pharma Asia and Life Science World for featuring my accolades on the respective portals recently.
Looking forward to connecting with you through our April 2015 newsletter edition,
With thanks & regards,
Dr J Vijay Venkatraman
MBBS, F. Diab., MBA, FPIPA (UK)
Managing Director & CEO,
Oviya MedSafe
Pharmacovigilance Consulting & Drug Safety Services
Coimbatore, India & London, UK
India Office: +91-422-2444442
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