The Indian Pharmacopoeia Commission (IPC), which is the National Coordination Centre-Pharmacovigilance Programme of India (PvPI), will organise a workshop on "Basics of Pharmacovigilance & Establishment of Pharmacovigilance System in Pharmaceutical Industries - A Way Forward" on August 31, 2017 at PGIMER, Chandigarh.
The main objective of this 2nd regional workshop is to sensitize manufacturers, importers, distributors and other stakeholders about the need for a properly-designed Pharmacovigilance system across the user domain, to monitor Adverse Drug Reactions (ADRs) aimed at establishing safer drug use in the country.
The workshop is aimed at bringing together regulatory authorities and pharma professionals/experts to discuss the practice of pharmacovigilance in the country. It will also widen the knowledge spectrum of pharma professionals in the field of pharmacovigilance.
Professionals in pharmacovigilance, quality assurance (QA) and regulatory affairs (RA) in pharmaceutical companies and healthcare systems are the targeted audience of this workshop. And creation of an agreeable roadmap for pharmaceutical companies and healthcare providers for the establishment of a harmonised and sustainable pharmacovigilance system for collection, collation and processing Aes/ADRs is the expected outcome of this workshop.
The pharmaceutical products are primarily approved by CDSCO and subsequently licensed for either manufacturing and/or import by Drug Regulatory Authorities at centre and states for marketing in the country. During pre-market test and trials many adverse reaction related to such medicines may remain unnoticed. When a larger section of population belonging to various age groups and socio-economic strata are exposed to such medicines, many undesirable AEs/ADRs may emerge. This has necessitated the strengthening of pharmacovigilance standards and realization of the importance of a properly-designed pharmacovigilance system in the pharmaceutical companies as well as healthcare system.
The Union Health Ministry launched a nationwide PvPI in 2010 to monitor the ADRs ensuring that the benefits of medicine outweigh the risks associated with its use and the IPC has been functioning as NCC for PvPI since April 15, 2011. To monitor the ADRs, Adverse Drugs Monitoring centres (AMCs) have been established across the country under the PvPI. The PvPI has taken a leap forward during the last five years. The programme has broadened its scope of activities and influence, providing a stage for interaction and partnership in the sphere of Pharmacovigilance. In compliance with the recent amendment to Schedule Y, Drugs & Cosmetics Rules, 1945, vide Gazette Notification No. G.S.R. 287 (E) dated March 8, 2016, Pharmacovigilance has been mandate for Marketing Authorization Holders (MAHs) in India. To ensure the effective implementation, there is an urgent need for the MAHs to set up a Pharmacovigilance system at their site.