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Oviya MedSafe - UK bioConclave 2015, Pharmacovigilance in India and the Indian PSUR

Dear Colleagues,

As the product of our ardour, prowess and endeavour over the past three years results in fruition, I pen in rejuvenation the April 2015 edition of Oviya MedSafe’s newsletter!

Firstly, I am delighted to announce that Oviya MedSafe will participate in bioConclave 2015 , a conference to be held at London on 20-Apr-2015, organized with an intention to create closer collaborations between Indian and European Life Sciences companies. This gathering will bring together business leaders, policymakers, innovators, academics, entrepreneurs, investors and distributors on the same platform to exchange ideas, build relationships and forge future partnerships. If you plan to attend this event, please let us know so that we can ensure to meet up in person and discuss business synergies.

Nextly, I was honored by leading Indian pharmaceutical industry magazine Chronicle Pharmabiz, which invited me to author a featured article titled Current Status of Pharmacovigilance in India under its editorial on the same topic, both published in April 2015. This article traces the history of Indian Pharmacovigilance and presents its contemporary scenario in the background of the phenomenal growth of the global Pharmacovigilance outsourcing industry in India over the past eight years. The article also touches upon the significance of Pharmacovigilance as an applied specialty in Medical Practice and among the Academia as well. Moreover, it enlists the achievements of the Pharmacovigilance Programme of India (PvPI) and analyses the gaps in the Indian Pharmacovigilance System with suggestions on how it could be improved.

While on the topic, it is worthy to mention that the Drug Controller General of India (DCGI) has planned to integrate the Periodic Safety Update Reports (PSURs) with PvPI, a decision that has been made during a meeting between both the organizations, held on 30th March 2015. Interestingly, my interview titled Oviya MedSafe calls for streamlining Indian PSUR submission & review process published by Pharmabiz on 5th March 2015 highlighted various issues with the Indian PSUR and suggested some changes, with one of them being the integration of the processes of submission of PSURs to the Central Drugs Standard Control Organization (CDSCO) and reporting of Individual Case Safety Reports (ICSRs) to PvPI.

On the medical device vigilance side of things, with the Indian government planning to monitor adverse incidents reported with usage of medical devices, I am proud to mention that Oviya MedSafe is already prepared to offer the relevant Materiovigilance support not only for compliance with the MaterioVigilance Programme of India but also to fulfil any safety obligation of a medical device-maker for any market in question.

With the expectation that the Indian Health Ministry would release 16 Billion Indian Rupees under the 12th 5-year-plan to the CDSCO for strengthening regulatory apparatus, the stakeholders hope for welcome changes to manifest in the Pharmacovigilance system in India.

Looking forward to meeting you with more news in May 2015,

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
UK Office: +44-8452-733839

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