I am delighted to connect with you through this September 2017 edition of Oviya MedSafe‘s newsletter, which intends to focus on a landmark achievement in the history of pharmacovigilance in India, namely the release of the Pharmacovigilance Guidance Document for Marketing Authorization Holders (MAHs) of Pharmaceutical Products, by the Secretary, Ministry of Health and Family Welfare, Government of India, on 29-Sep-2017. In this context, I wish to recall Oviya MedSafe’s pioneering work not only in advocating regulatory pharmacovigilance obligations for the Indian pharmaceutical industry but standing by the industry in support too, by providing India-specific pharmacovigilance support services ever since 2013.
The pharmacovigilance guidance document was developed by the National Coordination Centre of the Pharmacovigilance Programme of India (PvPI), Indian Pharmacopoeia Commission, in collaboration with the Central Drugs Standard Control Organization (CDSCO), in order to ensure smooth functioning of pharmacovigilance activities by the pharmaceutical industry, with an aim to establish and ensure an effective pharmacovigilance system at their site according to the recent amendment in the Drugs & Cosmetics Rules, 1945, Schedule Y vide Gazette Notification G.S.R. 287(E) published on 08-Mar-2016. A number of prominent professionals from the industry, including me, shared with PvPI their insights and feedback on this document prior to its finalization, on their invitation.
For the purpose of this guidance document, the term MAH refers to the manufacturer or the importer of the drug who has a valid manufacturing or import license. The scope of the guidance document includes all drugs, biologics, radiopharmaceuticals and phytopharmaceutical products but excludes veterinary products and medical devices.
The Pharmacovigilance Guidance Document comprises of the following modules:
# MODULE 1 – Pharmacovigilance System Master File (PvMF)
# MODULE 2 – Collection, Processing & Reporting of Individual Case Safety Reports
# MODULE 3 – Preparation & Submission of Periodic Safety Update Reports
# MODULE 4 – Quality Management System at the MAH Organization
# MODULE 5 – Audits & Inspections of the Pharmacovigilance System at the MAH Organizaliion
# MODULE 6 – Submission of Risk Management Plans
With the guidance document all set to be effective from January 2018, it is imperative for all Indian MAHs to ensure that they are in compliance with the requirements laid out in all of the above six modules.
Oviya MedSafe has always been vocal about having well-defined pharmacovigilance regulations for India and has documented the dire need in articles, opinion pieces, editorials, conference presentations, media interviews and the past editions of our newsletter (particularly June 2015, Feb 2016 and Oct 2016 editions). Further, we promptly responded to industry needs by introducing India-specific pharmacovigilance services even when such a detailed guidance document was not available. Hence, it is our honour to re-dedicate ourselves to the domain of pharmacovigilance, on this positive occasion.
On a related note, I am happy to share with you that key experts are all set to discuss the pharmacovigilance guidance document, among other topics, in the forthcoming 4th National Pharmacovigilance Symposium of the Indian Society for Clinical Research, which is to be held at Hyderabad on Saturday 28-Oct-2017. The detailed agenda is to be uploaded shortly. I take this opportunity to invite you to register for this symposium and get benefited. For more information, please contact ISCR Secretariat.
Before I end, I wanted to share with you a few snaps from the 2nd International Pre-Conference Workshop on Pharmacovigilance conducted by Anurag Group of Institutions, Hyderabad in which event I participated as the Chief Guest on 15-Sep-2017 and delivered the inaugural address. Oviya MedSafe and Indian Pharmacopoeia Commission were collaborators with Anurag Group for this event.
Wishing you a very Happy Deepavali and waiting to write our October 2017 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,
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