As all of us look forward to the beginning of 2014 with loads of enthusiasm and lots of expectations from the New Year, I take pleasure in wishing you and your families a very Happy and Propsperous New Year, on behalf of Oviya MedSafe, through this January 2014 edition of Oviya MedSafe’s newsletter!
We at Oviya MedSafe are exhilarated to start 2014 by announcing the enhanced continuation of our Bronze Partnership with Virtue Insight for their 6th Pharmacovigilance 2014 event at London on 4th and 5th March 2014, following our most recent association with them for the 5th Pharmacovigilance Congregation held at Mumbai on 20-Nov-2013. Being the first exhibition for Oviya MedSafe in Europe, this event is quite special to us. Along with the event organisers, we are happy to invite you to register for the event and visit us at our stall on these days.
A bunch of senior executives from Oviya MedSafe, including me, will be at London for the event and also intend to visit our existing as well as prospective clients present throughout the United Kingdom, over the next couple of weeks following the event. Please do let us know if you would like us to visit you at your office, with your preferred dates mentioned, so that we shall accordingly plan our travel and meet you for discussions on how we can help each other.
Looking back at 2013, it seems to have been a significant year for Indian Pharmacovigilance, with quite a lot of milestones having been reported in the media. We at Oviya MedSafe have attempted to provide a timeline of these developments, for the awareness and benefit of all stakeholders of pharmacovigilance in India, as follows:
- July 2013: According to the Indian Pharmacopoeia Commission (IPC), 150 new Adverse Drug Reaction (ADR) monitoring centres have been planned across the country by the end of 2014 to strengthen the Pharmacovigilance Programme of India (PvPI), which co-ordinated by IPC aims to attain its goal of setting up 350 ADR monitoring centres across the country by 2015, making PvPI the largest pharmacovigilance programme in the world.
- August 2013: According to the Drug Controller General of India (DCGI), drug packs will soon bear ‘rectangular box warnings’, i.e., labels with details of adverse drug reactions.
- August 2013: The Government of India allocated INR 100 crores (One Billion Indian Rupees) for surveillance monitoring of not just drugs but also expanded the ambit of surveillance to cover blood, blood products, biologicals and medical devices. Efforts are also on to set up an anti microbial resistance monitoring cell.
- October 2013: The IPC created a Toll Free number (1800-180-3024) under the PvPI to collect suspected adverse drug reactions, which was launched by Mr Sten Olsson, Chief WHO Programme Officer, World Health Organization – Uppsala Monitoring Centre (UMC), Sweden, who lauded the unique facility developed by the IPC.
- December 2013: Experts in the industry have recommended to the parliamentary standing committee on health and family welfare that examines the Central Drugs Administration (CDA) Bill to make pharmacovigilance mandatory in the proposed CDA Bill for continuous monitoring of ADRs.
- December 2013: The Government of Odisha, an Indian state, has requested the union health ministry to increase the funding for pharmacovigilance activities in Odisha, highlighting the beginning of the active participation of state governments of India in the PvPI.
- December 2013: WHO’s UMC recognized India’s concerted efforts in pharmacovigilance and stated that it was looking to make India a hub for pharmacovigilance training. It also observed that India needed to play a bigger role in the global landscape of ADR monitoring. The UMC also called for targeted and spontaneous monitoring for ADRs arising out of vaccination, especially with India being a global hub for manufacturing vaccines.
All of the above updates point towards the development and mainstreaming of pharmacovigilance as a concept in India, which is expected to eventually mandate pharmaceutical companies in India to strengthen their own pharmacovigilance departments and also sensitize practising doctors along with other healthcare professionals on their respective roles in making India as pharmacovigilant as possible.
The proposed empowerment of the state governments of India aimed at closer monitoring of the PvPI across all states and the increasing emphasis on the Indian drug regulators from WHO-UMC and industry bodies alike to include adverse event information from pharmaceutical industry sources along with the voluntary reports received through the PvPI, while submitting the pharmacovigilance data of India to WHO-UMC periodically, are expected to be turning points for Indian Pharmacovigilance from various perspectives and 2014 is all set to witness these welcome changes.
While treading on the topic of WHO-UMC, I am proud to recollect my first in-person meeting and long interaction with Mr Sten Olsson, WHO Programme Expert and head of the Global Outreach Department at the Uppsala Monitoring Centre, which happened at Bangalore during IPSCON 2013, the extremely well-organized 46th Annual Conference of the Indian Pharmacological Society, in which I had been invited to talk on Medication Safety. It was my honour that my talk just preceded Mr Sten Olsson’s lecture on the same topic, which he obviously dealt with much more detail and exhaustive data. The conference also gave me an opportunity to listen to the Who’s Who of Indian Pharmacovigilance as part of a panel discussion titled ‘A Brainstorming on Aspiration and Vision for Pharmacovigilance in India’.
Last but not the least, as an Executive Committee Member of the Indian Society for Clinical Research (ISCR) and on behalf of the Local Organizing Committee of the 7th Annual ISCR Conference, I take great pleasure in inviting you to participate in the conference which is to be held on 10th and 11th January 2014 at Bangalore. This prestigious annual conference is expected to see high number of participants from the Clinical Research industry (CROs and Pharmaceutical companies), Academia, Regulators and other associated stakeholders.
The 2 day-conference is planned so that latest updates on clinical research as well as the evolving regulations are discussed and deliberated by experienced and expert faculty from across India and aborad. Please click here for the details of the conference, including the scientific programme and the online registration system.
I thank you for your patient reading and look forward to meeting you at Bangalore on 10th and 11th January 2014.
With thanks & regards,
Dr J Vijay Venkatraman
MBBS, F. Diab., MBA
Managing Director & CEO,
Oviya MedSafe Pvt. Ltd.
Pharmacovigilance Consulting & Drug Safety Services
2nd Floor, KTVR Gardens,
220a-3, Marudha Konar Road,
Coimbatore – 641 025.
Tamil Nadu, India.
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